COSENTYX
secukinumab
Quick Facts
Used For
Plaque Psoriasis COSENTYX is used to treat moderate to severe plaque psoriasis in adults and...
Common Side Effects
Adverse Reactions Discussed Elsewhere in This Label – Infections – Allergic reactions...
What You Should Know
Reading Your Medicine Information Read the patient information that comes with your medicine. Risk of...
Prescription
Not Required
Generic Available
No
Indications and Usage
Plaque Psoriasis
COSENTYX is used to treat moderate to severe plaque psoriasis in adults and children 6 years and older who need systemic therapy or phototherapy.
Psoriatic Arthritis
COSENTYX is used to treat active psoriatic arthritis in adults and children 2 years and older.
Ankylosing Spondylitis
COSENTYX is used to treat active ankylosing spondylitis in adults.
Non-Radiographic Axial Spondyloarthritis
COSENTYX is used to treat active non-radiographic axial spondyloarthritis in adults with signs of inflammation.
Enthesitis-Related Arthritis
COSENTYX is used to treat active enthesitis-related arthritis in children 4 years and older.
Hidradenitis Suppurativa
COSENTYX is used to treat moderate to severe hidradenitis suppurativa in adults and children 12 years and older.
1.1 Plaque Psoriasis
COSENTYX ® is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy.
1.2 Psoriatic Arthritis
COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older.
1.3 Ankylosing Spondylitis
COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).
1.4 Non-Radiographic Axial Spondyloarthritis
COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
1.5 Enthesitis-Related Arthritis
COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older.
1.6 Hidradenitis Suppurativa
COSENTYX is indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older.
Dosage and Administration
Before Starting Treatment
Get tested for tuberculosis (TB) before your first Cosentyx dose. Do not start treatment if you have active TB. Treat latent TB first if needed.
Get all recommended vaccines before starting treatment.
How Cosentyx Is Given
Cosentyx is given as a shot under the skin (subcutaneous) or as an intravenous (IV) infusion into a vein.
Subcutaneous Injection (Under the Skin)
Adults can give themselves the injection after training. Children should have an adult caregiver give the injection.
Give each injection in a different spot. You can use:
– Upper arms
– Thighs
– Stomach (any area)
Do not inject into areas where skin is tender, bruised, red, hardened, or has psoriasis.
Plaque Psoriasis Dosage
Adults: 300 mg at weeks 0, 1, 2, 3, and 4, then every 4 weeks. This can be one 300 mg shot or two 150 mg shots. Some adults may use 150 mg instead.
Children (6 years and older):
– Less than 50 kg: 75 mg
– 50 kg or more: 150 mg
Psoriatic Arthritis Dosage
Adults: 150 mg at weeks 0, 1, 2, 3, and 4, then every 4 weeks. If needed, increase to 300 mg every 4 weeks.
Can be given with or without methotrexate.
Ankylosing Spondylitis Dosage
Adults: 150 mg at weeks 0, 1, 2, 3, and 4, then every 4 weeks. If needed, increase to 300 mg every 4 weeks.
Non-Radiographic Axial Spondyloarthritis Dosage
Adults: 150 mg at weeks 0, 1, 2, 3, and 4, then every 4 weeks.
Hidradenitis Suppurativa (Acne Inversa) Dosage
Adults: 300 mg at weeks 0, 1, 2, 3, and 4, then every 4 weeks. If needed, can increase to every 2 weeks.
Children (12 years and older):
– 30 kg to less than 90 kg: 150 mg
– 90 kg or more: 300 mg
Juvenile Psoriatic Arthritis and Enthesitis-Related Arthritis Dosage
Children (2 years and older for JPsA; 4 years and older for ERA):
– 15 kg to less than 50 kg: 75 mg
– 50 kg or more: 150 mg
Give at weeks 0, 1, 2, 3, and 4, then every 4 weeks.
IV Infusion (Into a Vein)
Only for adults. Must be given by a healthcare professional in a healthcare setting.
Loading dose: 6 mg/kg at week 0
Maintenance dose: 1.75 mg/kg every 4 weeks
Infusion takes about 30 minutes. Maximum dose is 300 mg per infusion.
Preparing the Injection
Remove from refrigerator and let warm to room temperature:
– 15-30 minutes for Sensoready pen and prefilled syringes
– 30-45 minutes for UnoReady pen and 300 mg syringe
Check the liquid. It should be clear to slightly yellow. Do not use if cloudy or has particles.
Preparing IV Infusion
Healthcare provider will:
1. Calculate dose based on your weight
2. Mix Cosentyx with salt water (0.9% Sodium Chloride)
3. Give through a special filter into your vein over 30 minutes
Use within 4.5 hours at room temperature or 24 hours if refrigerated.
2.1 Testing and Procedures Prior to Treatment Initiation
Perform the following evaluations prior to COSENTYX initiation:
Evaluate for active or latent tuberculosis (TB). COSENTYX initiation is not recommended in patients with active TB infection. Initiate treatment of latent TB prior to initiation of COSENTYX [see Warnings and Precautions (5.3)] .
Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with COSENTYX [see Warnings and Precautions (5.7)] .
2.2 Important Administration Instructions
COSENTYX is for use under the guidance and supervision of a healthcare provider.
UnoReady pen, Sensoready pen, and prefilled syringes are for subcutaneous use only.
Solution in vials is for intravenous use in adult patients only.
Important Subcutaneous Administration Instructions
Adult patients may self-administer COSENTYX or be injected by a caregiver after proper training in subcutaneous injection technique.
Pediatric patients should not self-administer COSENTYX. An adult caregiver should prepare and inject COSENTYX after proper training in subcutaneous injection technique.
Administer each subcutaneous injection at a different anatomic location (such as upper arms, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Administration of subcutaneous COSENTYX in the upper, outer arm may be performed by a caregiver or healthcare provider.
The COSENTYX “Instructions for Use” for each presentation and strength contains more detailed instructions on the preparation and administration of COSENTYX for patients and caregivers [see Instructions for Use] .
Important Intravenous Infusion Instructions
Intravenous infusion is only for use by a healthcare professional in a healthcare setting. Prepare COSENTYX intravenous infusion by diluting COSENTYX injection in vial(s) and administering based on patient body weight [see Dosage and Administration (2.11)] . Intravenous infusion may be administered only in adults with PsA, AS, and nr-axSPA.
2.3 Recommended Dosage in Plaque Psoriasis
Recommended Subcutaneous Dosage in Adults
The recommended dosage in adults with PsO is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. Each 300 mg dosage is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
For some patients, a dosage of 150 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter may be acceptable.
The recommended weight-based dosage in pediatric patients 6 years of age and older with PsO is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
For patients < 50 kg, the recommended dose is 75 mg.
For patients ≥ 50 kg, the recommended dose is 150 mg.
2.4 Recommended Dosage in Adults with Psoriatic Arthritis
COSENTYX may be administered with or without methotrexate.
Recommended Subcutaneous Dosage
For adult patients with PsA and with coexistent moderate to severe PsO, use the dosage and administration recommendations for adults with PsO [see Dosage and Administration (2.3)] .
For other adult patients with PsA, administer COSENTYX with or without a loading dosage by subcutaneous injection.
The recommended dosage in adults with PsA:
With a loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
Without a loading dosage is 150 mg every 4 weeks.
If a patient continues to have active PsA, consider increasing the dosage to 300 mg by subcutaneous injection every 4 weeks. Each 300 mg dosage is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
Recommended Intravenous Dosage
COSENTYX injection for intravenous use (solution in vials) requires dilution prior to intravenous administration. The recommended intravenous dosage regimen in adults with PsA:
With a loading dosage is 6 mg/kg loading dose given at Week 0, followed by 1.75 mg/kg every 4 weeks thereafter (maintenance dosage).
Without a loading dosage is 1.75 mg/kg every 4 weeks.
Administer as an intravenous infusion over a period of 30 minutes [see Dosage and Administration (2.11)] .
Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in adults with PsA [see Dosage and Administration (2.11)] .
COSENTYX may be administered with or without methotrexate.
The recommended weight-based subcutaneous dosage in pediatric patients 2 years of age and older with PsA at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter is as follows:
For patients ≥ 15 kg and < 50 kg, the recommended dose is 75 mg.
For patients ≥ 50 kg, the recommended dose is 150 mg.
2.6 Recommended Dosage in Adults with Ankylosing Spondylitis
Recommended Subcutaneous Dosage
Administer COSENTYX with or without a loading dosage by subcutaneous injection in adult patients with active AS. The recommended dosage:
With a loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
Without a loading dosage is 150 mg every 4 weeks.
If a patient continues to have active AS, consider increasing the dosage to 300 mg every 4 weeks by subcutaneous injection. Each 300 mg dosage is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
Recommended Intravenous Dosage
COSENTYX injection for intravenous use (solution in vials) requires dilution prior to intravenous administration. The recommended intravenous dosage regimen in adult patients with active AS:
With a loading dosage is 6 mg/kg loading dose given at Week 0, followed by 1.75 mg/kg every 4 weeks thereafter (maintenance dosage).
Without a loading dosage is 1.75 mg/kg every 4 weeks.
Administer as an intravenous infusion over a period of 30 minutes [see Dosage and Administration (2.11)] .
Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in patients with AS [see Dosage and Administration (2.11)] .
2.7 Recommended Dosage in Adults with Non-Radiographic Axial Spondyloarthritis
Recommended Subcutaneous Dosage
Administer COSENTYX with or without a loading dosage by subcutaneous injection in adult patients with active nr-axSpA.
The recommended dosage:
With a loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
Without a loading dosage is 150 mg every 4 weeks.
Recommended Intravenous Dosage
COSENTYX injection for intravenous use (solution in vials) requires dilution prior to intravenous administration. The recommended intravenous dosage regimen in adult patients with active nr-axSpA:
With a loading dosage is 6 mg/kg loading dose given at Week 0, followed by 1.75 mg/kg every 4 weeks thereafter (maintenance dosage).
Without a loading dosage is 1.75 mg/kg every 4 weeks.
Administer as an intravenous infusion over a period of 30 minutes [see Dosage and Administration (2.11)] .
Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in patients with nr-axSpA [see Dosage and Administration (2.11)] .
2.8 Recommended Dosage in Enthesitis-Related Arthritis
COSENTYX may only be administered as a subcutaneous injection in pediatric patients aged 4 years and older with active ERA.
The recommended weight-based dosage in pediatric patients 4 years of age and older with ERA is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter:
For patients ≥ 15 kg and < 50 kg, the recommended dose is 75 mg.
For patients ≥ 50 kg, the recommended dose is 150 mg.
2.9 Recommended Dosage in Hidradenitis Suppurativa
Recommended Subcutaneous Dosage in Adults
The recommended dosage in adult patients with moderate to severe HS is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
If an adult patient does not adequately respond, consider increasing the dosage to 300 mg every 2 weeks. Each 300 mg dosage is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
The recommended weight-based dosage in pediatric patients 12 years of age and older with moderate to severe HS is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter [see Clinical Pharmacology (12.3)] .
For patients ≥ 30 kg and < 90 kg, the recommended dose is 150 mg.
For patients ≥ 90 kg, the recommended dose is 300 mg.
2.10 Preparation for Use of COSENTYX UnoReady Pen, Sensoready Pen, and Prefilled Syringes
COSENTYX UnoReady pen, Sensoready pen, and prefilled syringes are for subcutaneous injection only.
Before subcutaneous injection, remove COSENTYX from the refrigerator and allow COSENTYX to reach room temperature (15 to 30 minutes for the Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL)); 30 to 45 minutes for the UnoReady pen and prefilled syringe (300 mg/2 mL)) without removing the needle cap.
The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex and should not be handled by latex-sensitive individuals [see Warnings and Precautions (5.6)] .
Inspect COSENTYX visually for particulate matter and discoloration prior to administration. COSENTYX injection is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles, is discolored or cloudy. Discard any unused product.
2.11 Preparation and Administration of COSENTYX for Intravenous Use
COSENTYX (for intravenous use) must be diluted prior to infusion. Using aseptic technique, prepare COSENTYX (for intravenous use) as follows:
Step 1. Volume Calculation
Calculate the total volume of COSENTYX for intravenous use solution (in mL) required based on the patient’s actual body weight as follows:
Loading dose (6 mg/kg) is 0.24 mL/kg
Maintenance dose (1.75 mg/kg) is 0.07 mL/kg
Use the number of vials based on total volume needed (one vial contains 5 mL of COSENTYX solution).
Step 2. Dilution
Parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulates or discolorations are noted.
* If a 50 mL infusion bag is unavailable, then use a 100 mL infusion bag and withdraw and discard 50 mL of saline using aseptic technique and continue to follow the preparation and administration steps.
Body weight at time of dosing For the loading dose (6 mg/kg) recommended infusion bag For maintenance dose (1.75 mg/kg) recommended infusion bag
Greater than 52 kg 100 mL 100 mL
Less than or equal to 52 kg 100 mL 50 mL *
From the infusion bag, withdraw and discard a volume of 0.9% Sodium Chloride Injection, USP, equal to the calculated volume of the COSENTYX solution required for the patient’s dose [see Dosage and Administration (2.4, 2.6, 2.7)] .
From the vial(s), withdraw the calculated volume (mL) of COSENTYX solution and add slowly into the 0.9% Sodium Chloride Injection, USP infusion bag. To mix the solution, gently invert the bag to avoid foaming. Do not shake.
Discard unused COSENTYX product in vials because it does not contain preservatives.
Allow the diluted COSENTYX solution for infusion to warm to room temperature prior to the start of the intravenous infusion. Administer the diluted COSENTYX solution for infusion as soon as possible. If not administered immediately, store the diluted solution either:
At room temperature 20ºC to 25ºC (68ºF to 77ºF) for no more than 4.5 hours from the start of the preparation (piercing the first vial) to the completion of infusion.
Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours, from the start of the time of the preparation (piercing the first vial) to the completion of infusion. This time includes the refrigeration of the diluted solution and the time to allow the diluted solution to warm to room temperature. Protect the diluted solution from light during storage under refrigeration.
Step 3. Administration
Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
Administer the infusion at a flow rate of about 3.3 mL/minute for a 100 mL bag or 1.7 mL/min for a 50 mL bag (total administration time: 30 minutes).
When administration is complete, flush the line with 0.9% Sodium Chloride Injection, USP to guarantee that all the COSENTYX solution for infusion in the line has been administered.
Do not infuse COSENTYX concomitantly in the same intravenous line with other drugs. No physical or biochemical compatibility studies have been conducted to evaluate the IV coadministration of COSENTYX with other drugs.
Dosage Forms and Strengths
Shot given under the skin (subcutaneous):
– 300 mg/2 mL in a single-dose UnoReady pen
– 300 mg/2 mL in a single-dose prefilled syringe
– 150 mg/mL in a single-dose Sensoready pen
– 150 mg/mL in a single-dose prefilled syringe
– 75 mg/0.5 mL in a single-dose prefilled syringe (for children under 50 kg)
Medicine given in the vein (intravenous):
– 125 mg/5 mL in a single-dose vial, mixed before use (for healthcare professional use only)
Injection for subcutaneous use:
300 mg/2 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose UnoReady pen
300 mg/2 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose prefilled syringe
150 mg/mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose Sensoready pen
150 mg/mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose prefilled syringe
75 mg/0.5 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose prefilled syringe (for pediatric patients less than 50 kg)
Injection for intravenous use:
125 mg/5 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose vial for dilution prior to intravenous infusion (for healthcare professional use only).
Contraindications
When NOT to Use COSENTYX
Do not use COSENTYX if you have had a serious allergic reaction to secukinumab or any ingredients in this medicine. Serious allergic reactions like anaphylaxis and swelling have been reported during treatment.
COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX [see Warnings and Precautions (5.2)] .
Warnings and Precautions
Infections
COSENTYX may raise your chance of getting infections. In studies, more people taking COSENTYX got infections like colds, throat infections, and yeast infections compared to people taking placebo (a fake treatment).
In some cases, serious infections have happened. These infections can sometimes be fatal. Tell your doctor if you have had infections that keep coming back. Call your doctor right away if you have signs of an infection such as fever, cough, or painful skin areas. If you get a serious infection, you may need to stop taking COSENTYX until it gets better.
COSENTYX may also cause Hepatitis B to come back. If you have had Hepatitis B, tell your doctor.
Allergic Reactions
Serious allergic reactions can happen with COSENTYX. These include anaphylaxis (severe allergic reaction), swelling, and hives. If you have signs of a severe allergic reaction like trouble breathing, swelling, or dizziness, get medical help right away and stop using COSENTYX.
Tuberculosis (TB) Test
Your doctor should test you for TB (a lung infection) before you start COSENTYX. Do not take COSENTYX if you have active TB. If you have had TB in the past, tell your doctor. Your doctor will watch you for signs of TB during and after treatment.
Inflammatory Bowel Disease
COSENTYX may make inflammatory bowel disease (IBD) worse. IBD includes ulcerative colitis and Crohn’s disease. Tell your doctor if you have IBD. Your doctor will check for symptoms like stomach pain, diarrhea, or bleeding.
Skin Rashes
Severe skin rashes have been reported in some patients taking COSENTYX. These can include eczema, blisters, or widespread redness. Some patients needed to go to the hospital. Tell your doctor if you get a severe rash. You may need to stop taking COSENTYX.
Latex Allergy
The cap of the COSENTYX pen and prefilled syringes contains natural rubber latex. If you are allergic to latex, tell your doctor before using this medicine.
Vaccines
Get all needed vaccines before starting COSENTYX. Do not get live vaccines (like measles or mumps) while taking COSENTYX. Ask your doctor about which vaccines are safe for you.
5.1 Infections
COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials in subjects with moderate to severe PsO, higher rates of common infections, such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%) and mucocutaneous infections with candida (1.2% versus 0.3%) were observed in subjects treated with COSENTYX compared to placebo-treated subjects. A similar increase in risk of infection in subjects treated with COSENTYX was seen in placebo-controlled trials in subjects with PsA, AS and nr-axSpA. The incidence of some types of infections, including fungal infections, appeared to be dose-dependent in clinical trials [see Adverse Reactions (6.1)] .
In the postmarketing setting, serious bacterial, viral, and fungal opportunistic infections, and some fatal infections have been reported in patients receiving IL-17 inhibitors including COSENTYX. Cases of Hepatitis B virus reactivation have been reported [see Adverse Reactions (6.2)] .
Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, monitor the patient closely and discontinue COSENTYX until the infection resolves.
If signs of Hepatitis B virus reactivation occur, consult a hepatitis specialist. COSENTYX is not recommended for use in patients with active viral hepatitis.
5.2 Hypersensitivity Reactions
Serious hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in COSENTYX treated subjects in clinical trials and in the post-marketing setting [see Adverse Reactions (6.1, 6.2)] . If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of COSENTYX and initiate appropriate therapy [see Contraindications (4)] .
5.3 Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for active or latent TB infection prior to initiating treatment with COSENTYX. Avoid administration of COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients closely for signs and symptoms of active TB during and after treatment.
In the postmarketing setting, cases were reported where patients with a history of latent tuberculosis (TB) who were treated with COSENTYX developed active TB.
5.4 Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD) exacerbations, in some cases serious and/or leading to discontinuation of COSENTYX, occurred in COSENTYX treated subjects during clinical trials in PsO, PsA, AS, nr-axSpA, and HS. In adult subjects with HS, the incidence of IBD was higher in subjects who received COSENTYX 300 mg every 2 weeks (Ulcerative Colitis [UC] 1 case, EAIR 0.2/100 subject-years; Crohn`s Disease [CD] 1 case, EAIR 0.2/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (IBD 1 case, EAIR 0.2/100 subject-years). In addition, new onset IBD cases occurred in subjects treated with COSENTYX in clinical trials. In an exploratory trial in 59 subjects with active Crohn’s disease [COSENTYX is not approved for the treatment of Crohn`s disease], there were trends toward greater disease activity and increased adverse reactions in subjects treated with COSENTYX as compared to placebo-treated subjects.
Exercise caution when prescribing COSENTYX to patients with IBD. Patients treated with COSENTYX should be monitored for signs and symptoms of IBD [see Adverse Reactions (6.1)] .
5.5 Eczematous Eruptions
In postmarketing reports, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving COSENTYX; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of COSENTYX.
Treatment may need to be discontinued to resolve the eczematous eruption. Some patients were successfully treated for eczematous eruptions while continuing COSENTYX.
5.6 Risk of Hypersensitivity in Latex-Sensitive Individuals
The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex, which may cause a hypersensitivity reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringes (150 mg/mL, 75 mg/0.5 mL) in latex-sensitive individuals has not been studied.
5.7 Immunizations
Prior to initiating therapy with COSENTYX, consider completion of all age-appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX [see Clinical Pharmacology (12.2)] .
Adverse Reactions
Adverse Reactions Discussed Elsewhere in This Label
– Infections
– Allergic reactions
– Inflammatory bowel disease
– Skin rash outbreaks
6.1 Clinical Trial Experience
Common Side Effects in Adults With Psoriasis
The table below shows side effects that happened in at least 1% of people taking COSENTYX and more often than in people taking placebo during 12 weeks:
| Side Effect | COSENTYX 300 mg | COSENTYX 150 mg | Placebo |
|————-|—————–|—————–|———|
| Common cold (nasopharyngitis) | 11.4% | 12.3% | 8.6% |
| Diarrhea | 4.1% | 2.6% | 1.4% |
| Upper respiratory infection | 2.5% | 3.2% | 0.7% |
| Runny nose | 1.4% | 1.4% | 0.7% |
| Cold sores | 1.3% | 0.1% | 0.3% |
| Sore throat | 1.2% | 1.0% | 0% |
| Hives | 0.6% | 1.2% | 0.1% |
Infections
– During the first 12 weeks: 28.7% of COSENTYX patients got infections vs. 18.9% of placebo patients
– Over 52 weeks: 47.5% of COSENTYX patients got infections. Serious infections happened in 1.2% of patients.
– More infections occurred with higher amounts of drug in the blood
Low White Blood Cell Count (Neutropenia)
– Some patients developed low white blood cell counts. Most cases were temporary and got better.
– No serious infections were linked to these cases
Inflammatory Bowel Disease
– In psoriasis studies, some patients had flare-ups of Crohn’s disease or ulcerative colitis
Side Effects in Children With Psoriasis
– Side effects were similar to those in adults
– One child had a serious staph infection (MRSA)
Side Effects in Adults With Psoriatic Arthritis
– About 59% of COSENTYX patients and 58% of placebo patients had side effects
– Common side effects: common cold, upper respiratory infection, headache, nausea, high cholesterol
– More infections occurred with COSENTYX (29%) vs. placebo (26%)
Side Effects in Adults With Ankylosing Spondylitis
– 66% of COSENTYX patients and 59% of placebo patients had side effects
– Common side effects: common cold, nausea, upper respiratory infection
Side Effects in Adults With Non-Radiographic Axial Spondyloarthritis
– More infections occurred with COSENTYX loading dose (92 per 100 patient-years) vs. without loading dose (72 per 100 patient-years)
Side Effects in Children With Juvenile Psoriatic Arthritis and Enthesitis-Related Arthritis
– Similar to adults
Side Effects in Adults With Hidradenitis Suppurativa
– Fungal infections were more common with COSENTYX 300 mg every 2 weeks (5.3%) vs. placebo (2.8%)
6.2 Postmarketing Experience
These side effects have been reported after the drug was approved. Because these reports come from patients voluntarily, we don’t always know how often they happen:
Immune System Reactions
– Severe allergic reactions (anaphylaxis)
– Swelling (angioedema)
– Blood vessel inflammation
Skin Reactions
– Skin rash outbreaks (including eczema-like and blistering rash)
– Skin blood vessel inflammation
– Severe skin ulcers (pyoderma gangrenosum)
Infections
– Serious bacterial, viral, and fungal infections
– These included lung infections, herpes infections, and reactivation of hepatitis B
The following adverse reactions are discussed in greater detail elsewhere in the labeling:
Infections [see Warnings and Precautions (5.1)]
Hypersensitivity Reactions [see Warnings and Precautions (5.2)]
Inflammatory Bowel Disease [see Warnings and Precautions (5.4)]
Eczematous Eruptions [see Warnings and Precautions (5.5)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Clinical Trials of Subcutaneous COSENTYX
Adverse Reactions from Clinical Trials in Adults with PsO
A total of 3,430 adult subjects with PsO were treated with COSENTYX in controlled and uncontrolled clinical trials. Of these, 1,641 subjects were treated with COSENTYX for at least 1 year.
Four placebo-controlled Phase 3 trials in PsO subjects (Trials PsO1, PsO2, PsO3, and PsO4) were pooled to evaluate the safety of COSENTYX in comparison to placebo up to 12 weeks after treatment initiation. In total, 2,077 subjects were evaluated (691 in the COSENTYX 300 mg group, 692 in the COSENTYX 150 mg group, and 694 in the placebo group). Subjects randomized to COSENTYX received 300 mg or 150 mg doses subcutaneously at Weeks 0, 1, 2, 3, and 4 followed by the same dose every 4 weeks [see Clinical Studies (14)] .
COSENTYX
Adverse reactions 300 mg (N = 691) n (%) 150 mg (N = 692) n (%) Placebo (N = 694) n (%)
Nasopharyngitis 79 (11.4) 85 (12.3) 60 (8.6)
Diarrhea 28 (4.1) 18 (2.6) 10 (1.4)
Upper respiratory tract infection 17 (2.5) 22 (3.2) 5 (0.7)
Rhinitis 10 (1.4) 10 (1.4) 5 (0.7)
Oral herpes 9 (1.3) 1 (0.1) 2 (0.3)
Pharyngitis 8 (1.2) 7 (1.0) 0 (0)
Urticaria 4 (0.6) 8 (1.2) 1 (0.1)
Rhinorrhea 8 (1.2) 2 (0.3) 1 (0.1)
Adverse reactions that occurred in subjects treated with COSENTYX at rates less than 1% in the placebo-controlled period of Trials PsO1, PsO2, PsO3, and PsO4 through Week 12 included: sinusitis, tinea pedis, conjunctivitis, tonsillitis, oral candidiasis, impetigo, otitis media, otitis externa, IBD, increased liver transaminases, and neutropenia.
Infections
In the placebo-controlled period of the clinical trials in PsO (a total of 1,382 subjects treated with COSENTYX and 694 subjects treated with placebo up to 12 weeks), infections were reported in 28.7% of subjects treated with COSENTYX compared with 18.9% of subjects treated with placebo.
Over the entire treatment period (a total of 3,430 PsO subjects treated with COSENTYX for up to 52 weeks for the majority of subjects), infections were reported in 47.5% of subjects treated with COSENTYX (0.9 per subject-year of follow-up) and serious infections were reported in 1.2% of subjects treated with COSENTYX (0.015 per subject-year of follow-up).
Phase 3 data showed an increasing trend for some types of infection with increasing serum secukinumab concentrations. Candida infections, herpes viral infections, staphylococcal skin infections, and infections requiring treatment increased as serum secukinumab concentration increased.
In the PsO open-label extension of Trials PsO1 and PsO2 (median follow-up of 3.9 years), representing 3,582 subject-years of exposure, 74% of COSENTYX treated subjects reported infections (55 per 100 subject-years) and serious infections were reported in 4.5% of COSENTYX treated subjects (1.4 per 100 subject-years). Sepsis was reported in 5 COSENTYX treated subjects (0.2 per 100 subject-years).
Neutropenia was observed in controlled portion of clinical trials. Most cases of COSENTYX associated neutropenia were transient and reversible. No serious infections were associated with cases of neutropenia.
In the open-label extension of Trials PsO1 and PsO2, neutropenia (ANC < 1 x 10 9 /L) was reported in 1% of COSENTYX treated subjects (0.3 per 100 subject-years). Some cases of serious infections were associated with neutropenia; however, the causal relationship was not established.
Inflammatory Bowel Disease
Cases of IBD, in some cases serious, were observed in subjects treated with COSENTYX in clinical trials. In the PsO program, with 3,430 subjects exposed to COSENTYX over the entire treatment period for up to 52 weeks (2,725 subject-years), there were 3 cases (0.11 per 100 subject-years) of exacerbation of CD, 2 cases (0.08 per 100 subject-years) of exacerbation of UC, and 2 cases (0.08 per 100 subject-years) of new onset UC. There were no IBD cases in placebo-treated subjects (N = 793; 176 subject-years) during the 12-week placebo-controlled period.
One case of exacerbation of Crohn’s disease in a subject treated with COSENTYX subject was reported in open-label portions of clinical trials in PsO.
Adverse Reactions from Clinical Trials in Pediatric Subjects with PsO
The safety of COSENTYX was assessed in two Phase 3 trials in pediatric subjects with PsO.
The first was a randomized, double-blind, placebo and active-controlled, 236-week trial (Trial PsO8) that enrolled 162 pediatric subjects 6 years of age and older, with severe PsO (defined by PASI score ≥ 20, an IGA modified 2011 score of 4, and involving ≥ 10% of the body surface area [BSA]) who were candidates for systemic therapy. The 162 subjects were randomized to receive placebo, a biologic active control, or COSENTYX. In the COSENTYX groups, subjects with body weight (BW) less than 25 kg received 75 mg, subjects with BW 25 to less than 50 kg received either 75 mg or 150 mg (2 times the recommended dose), and subjects with BW of at least 50 kg received either 150 mg or 300 mg (2 times the recommended dose). Subjects were dosed at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
The second trial was a randomized, open-label, 208-week trial (Trial PsO9; NCT03668613) of 84 pediatric subjects 6 years of age and older with moderate to severe PsO (defined by a PASI score ≥ 12, IGA mod 2011 score of ≥ 3, and BSA involvement of ≥ 10% at randomization) who were randomized into two COSENTYX arms [Arm 1: 75 mg for BW < 50 kg or 150 mg for ≥ 50 kg; and Arm 2: 75 mg for BW < 25 kg, 150 mg for BW ≥ 25 kg and < 50 kg, or 300 mg for BW ≥ 50 kg]. Subjects were dosed at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
The safety profile of COSENTYX reported in these trials was consistent with the safety profile reported in adult PsO trials.
Infections
One case of methicillin-resistant Staphylococcus aureus (MRSA) toxic shock syndrome (TSS) was reported in a COSENTYX treated pediatric subject during the placebo-controlled period.
Adverse Reactions from Clinical Trials in Adults with PsA
COSENTYX was studied in two placebo-controlled PsA trials with 1,003 adult patients (703 patients on COSENTYX and 300 patients on placebo). Of the 703 patients who received COSENTYX, 299 patients received a subcutaneous loading dose of COSENTYX (PsA1) and 404 patients received an intravenous loading dose of secukinumab (PsA2) followed by COSENTYX administered by subcutaneous injection every 4 weeks. During the 16-week placebo-controlled period of the trials in patients with PsA, the overall proportion of patients with adverse events was similar in the secukinumab and placebo-treatment groups (59% and 58%, respectively). The adverse events that occurred at a proportion of at least 2% and at a higher proportion in the COSENTYX groups than the placebo groups during the 16-week placebo-controlled period were nasopharyngitis, upper respiratory tract infection, headache, nausea, and hypercholesterolemia. The safety profile observed in adult patients with PsA treated with COSENTYX is consistent with the safety profile in the PsO trials in adults.
Similar to the clinical trials in patients with PsO, there was an increased proportion of patients with infections in the COSENTYX groups (29%) compared to placebo group (26%).
There were cases of CD and UC in the secukinumab group that included patients who experienced either exacerbations or the development of new disease. There were three cases of IBD, of which two patients received secukinumab and one received placebo.
Adverse Reactions from Clinical Trials in Adults with AS
COSENTYX was studied in two placebo-controlled AS trials with 590 adult patients (394 patients on COSENTYX and 196 patients on placebo). Of the 394 patients who received COSENTYX, 145 patients received a subcutaneous load of COSENTYX (study AS1), and 249 received an intravenous loading dose of secukinumab (study AS2) followed by COSENTYX administered by subcutaneous injection every 4 weeks. During the 16-week placebo-controlled period of the trials in patients with AS, the overall proportion of patients with adverse events was higher in the secukinumab groups than the placebo-treatment groups (66% and 59%, respectively). The adverse events that occurred at a proportion of at least 2% and at a higher proportion in the COSENTYX groups than the placebo groups during the 16-week placebo-controlled period were nasopharyngitis, nausea, and upper respiratory tract infection. The safety profile observed in patients with AS treated with COSENTYX is consistent with the safety profile in PsO clinical trials. In a third controlled trial of AS (study AS3), the safety profile of the 300 mg dose of COSENTYX was consistent with the safety profile of the 150 mg dose of COSENTYX.
Similar to clinical trials in patients with PsO, there was an increased proportion of patients with infections in the COSENTYX groups (31%) compared to the placebo group (18%).
In the original AS program, with 571 patients exposed to COSENTYX, there were 8 cases of IBD during the entire treatment period [5 cases of Crohn’s (0.7 per 100 patient-years) and 3 cases of UC (0.4 per 100 patient-years)]. During the placebo-controlled 16-week period, there were 2 Crohn’s disease exacerbations and 1 new onset UC case that was a serious adverse event in patients treated with COSENTYX compared to none of the patients treated with placebo. During the remainder of the trial when all patients received COSENTYX, 1 patient developed Crohn’s disease, 2 patients had Crohn’s exacerbations, 1 patient developed UC, and 1 patient had an UC exacerbation.
Adverse Reactions from Clinical Trials in Adults with nr-axSpA
COSENTYX was studied in one randomized, double-blind, placebo-controlled nr-axSpA trial with 555 adult patients (185 patients received a loading COSENTYX dose, 184 patients did not receive a loading COSENTYX dose, and 186 patients received placebo). The safety profile for patients with nr-axSpA treated with COSENTYX was overall similar to the safety profile seen in patients with AS and other previous experience with COSENTYX. Patients in nr-axSpA1 trial who received the loading dosing regimen compared to those without the loading regimen, had higher incidence of infections and infestations (92 per 100 patient-years versus 72 per 100 patient-years), including nasopharyngitis, upper respiratory tract infection and urinary tract infection, and gastrointestinal disorders (27 per 100 patient-years versus 22 per 100 patient-years), including gastritis, lower abdominal pain, colitis, diarrhea, and hematochezia.
Adverse Reactions from Clinical Trials in Pediatric Patients with Juvenile Psoriatic Arthritis (JPsA) and ERA
COSENTYX was studied in one double-blind, placebo-controlled, event-driven, randomized trial in 86 pediatric patients aged 2 to less than 18 years old with JPsA and ERA. The safety profile reported in this trial was consistent with the safety profile of secukinumab.
Adverse Reactions from Clinical Trials in Adults with HS
COSENTYX was studied in two 52-week, randomized, double-blind, placebo-controlled HS trials with 1,084 adult subjects (361 subjects received COSENTYX 300 mg every 2 weeks, 360 subjects received COSENTYX 300 mg every 4 weeks, and 363 subjects received placebo) with a total of 901 subject-years of COSENTYX exposure (the median duration of exposure for subjects treated with COSENTYX was 360 days). The safety profile of COSENTYX observed in these HS trials was consistent with the known safety profile of COSENTYX observed in the PsO trials.
Infections
During the 16-week placebo-controlled period, subjects who received COSENTYX 300 mg every 2 weeks had the highest incidence of fungal infections (5.3%), compared to subjects who received COSENTYX 300 mg every 4 weeks (4.2%) and subjects who received placebo (2.8%). With longer exposure, the rate of fungal infections remained higher for subjects who received COSENTYX 300 mg every 2 weeks (14.7/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (10.1/100 subject-years). The majority of the cases were reported as non-serious, non-severe, and resolved with anti-fungal treatment.
Inflammatory Bowel Disease
In the open-labeled portion of HS clinical trials, five (0.7%) IBD adverse reactions were reported, all of which were serious and led to withdrawal of trial drug, and occurred only in subjects treated with COSENTYX 300 mg every 2 weeks. There were no IBD cases in subjects treated with COSENTYX 300 mg every 4 weeks.
Adverse Reactions of Intravenous COSENTYX
The safety of intravenous COSENTYX is based on the pharmacokinetic exposure and extrapolation of the established safety of subcutaneous COSENTYX in PsA, AS and nr-axSpA patients [see Clinical Pharmacology (12.3)] .
6.2 Postmarketing Experience
The following adverse reactions have been reported during post-approval use of COSENTYX. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune system disorders : anaphylaxis, angioedema, systemic vasculitis
Skin and subcutaneous tissue disorders : eczematous eruptions (atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma), cutaneous vasculitis, pyoderma gangrenosum
Infections : bacterial, viral, and fungal opportunistic infections, including esophageal candidiasis, tracheobronchial candidiasis, cutaneous aspergillosis, cytomegalovirus gastroenteritis/colitis, herpes simplex encephalitis, herpes simplex keratitis, Pneumocystis jiroveci pneumonia, Hepatitis B virus reactivation, histoplasmosis, toxoplasmosis
Drug Interactions
Drug Interactions
Some diseases (PsO, PsA, AS, nr-axSpA, ERA, HS) can lower the amount of certain enzymes in your body. These enzymes help process many medicines.
When you start or stop COSENTYX, tell your doctor about all other medicines you take. Your doctor may need to:
– Check how well your other medicines are working
– Adjust the dose of your other medicines if needed
This helps make sure your other medicines keep working properly and don’t cause new side effects.
Certain CYP450 Substrates
Increased concentrations of cytokines (e.g., IL-17) during chronic inflammation associated with certain diseases including PsO, PsA, AS, nr-axSpA, ERA, and HS may suppress the formation of CYP enzymes.
Upon initiation or discontinuation of COSENTYX in patients who are receiving concomitant CYP450 substrates, particularly those where minimal decreases in the concentration may reduce CYP substrate effectiveness or minimal increases in the concentration may increase CYP substrate adverse reactions, consider monitoring for therapeutic effect or concentration of the CYP substrate and consider dosage adjustment of the CYP substrate as needed [see Clinical Pharmacology (12.3)] .
Pregnancy
Risk Summary
There is not enough information from pregnant women to know if this medicine causes birth problems. Studies in monkeys did not show harm to babies when the mother received the medicine during pregnancy. The dose was up to 30 times the usual human dose.
In the United States, about 2 to 4 out of 100 pregnancies have birth defects. About 15 to 20 out of 100 pregnancies end in miscarriage.
Animal Data
Studies were done in pregnant monkeys and mice. No birth defects or development problems were found in the babies. The highest doses tested were 30 times the recommended human dose in monkeys and similar in mice.
Risk Summary
Limited available human data with COSENTYX use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In an embryo-fetal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the maximum recommended human dose (MRHD)(see Data).
The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Data
Animal Data
An embryo-fetal development study was performed in cynomolgus monkeys with secukinumab. No malformations or embryo-fetal toxicity were observed in fetuses from pregnant monkeys that were administered secukinumab weekly by the subcutaneous route during the period of organogenesis at doses up to 30 times the MRHD (on a mg/kg basis at a maternal dose of 150 mg/kg).
A pre- and post-natal development toxicity study was performed in mice with a murine analog of secukinumab. No treatment-related effects on functional, morphological, or immunological development were observed in fetuses from pregnant mice that were administered the murine analog of secukinumab on gestation days 6, 11, and 17 and on postpartum days 4, 10, and 16 at doses up to 150 mg/kg/dose.
Lactation
Breastfeeding
Doctors do not know if COSENTYX passes into breast milk. There is no information about how this medicine affects babies who breastfeed. The benefits of breastfeeding for your baby should be considered. Also think about why you need this medicine and if it could harm your baby.
Risk Summary
It is not known whether secukinumab is excreted in human milk or absorbed systemically after ingestion. There are no data on the effects of COSENTYX on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for COSENTYX and any potential adverse effects on the breastfed child from COSENTYX or from the underlying maternal condition.
Pediatric Use
Plaque Psoriasis in Children
COSENTYX is approved for children 6 years and older with moderate to severe plaque psoriasis who need systemic therapy or phototherapy.
COSENTYX is not approved for children under 6 years old with plaque psoriasis.
Juvenile Psoriatic Arthritis
COSENTYX is approved for children 2 years and older with active juvenile psoriatic arthritis who weigh 15 kg or more.
COSENTYX is not approved for children under 2 years old or children weighing less than 15 kg with this condition.
Enthesitis-Related Arthritis
COSENTYX is approved for children 4 years and older with active enthesitis-related arthritis who weigh 15 kg or more.
COSENTYX is not approved for children under 4 years old or children weighing less than 15 kg with this condition.
Hidradenitis Suppurativa
COSENTYX is approved for children 12 years and older with moderate to severe hidradenitis suppurativa who weigh 30 kg or more.
COSENTYX is not approved for children under 12 years old or children weighing less than 30 kg with this condition.
Intravenous Use in Children
COSENTYX given by IV (intravenous) is not approved for use in children.
Subcutaneous Administration
Pediatric Plaque Psoriasis
The safety and effectiveness of COSENTYX have been established for the treatment of moderate to severe PsO in pediatric patients aged 6 years and older who are candidates for systemic therapy or phototherapy[see Adverse Reactions (6.1)andClinical Studies (14.2)].
The safety and effectiveness of COSENTYX in pediatric patients with PsO below the age of 6 years old have not been established.
Juvenile Psoriatic Arthritis
The safety and effectiveness of COSENTYX have been established for the treatment of active JPsA in pediatric patients aged 2 years and older who weigh 15 kg or more[see Adverse Reactions (6.1)andClinical Studies (14.6)].
The safety and effectiveness of COSENTYX in pediatric patients with JPsA below the age of 2 years old or with a body weight less than 15 kg have not been established.
Enthesitis-Related Arthritis
The safety and effectiveness of COSENTYX have been established for the treatment of active ERA in pediatric patients aged 4 years and older who weigh 15 kg or more[see Adverse Reactions (6.1)andClinical Studies (14.6)].
The safety and effectiveness of COSENTYX in pediatric patients with ERA below the age of 4 years old or with body weight less than 15 kg have not been established.
Hidradenitis Suppurativa
The safety and effectiveness of COSENTYX have been established for the treatment of moderate to severe HS in pediatric patients 12 years of age and older who weigh 30 kg or more. Use of COSENTYX for this indication is supported by safety and efficacy data from adequate and well controlled trials in adult subjects with moderate to severe HS. Additional evidence includes population pharmacokinetic modeling and simulation based on data from adult subjects with PsO and HS and pediatric subjects with PsO, as well as safety data from clinical trials in pediatric subjects with PsO and JIA (JPsA and ERA)[see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.7)].
The safety and effectiveness of COSENTYX in pediatric patients with HS below the age of 12 years old or with a body weight less than 30 kg have not been established.
Intravenous Administration
The safety and effectiveness of intravenous COSENTYX in pediatric patients have not been established.
Geriatric Use
Older Adults with Psoriasis
In psoriasis studies, 3,430 people got COSENTYX. Of these, 230 (7%) were 65 or older, and 32 (1%) were 75 or older. The studies did not find different side effects or benefits in older adults. But there were not enough older people to know for sure if they respond differently.
Older Adults with HS
In HS studies, 1,060 people got COSENTYX. Of these, 14 (1.3%) were 65 or older. The studies did not have enough older people to know if they respond differently.
Of the 1,060 subjects with HS exposed to COSENTYX in clinical trials, a total of 14 (1.3%) were 65 years of age and older. Clinical trials in HS did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
Description
What This Medicine Is
Secukinumab is a biologic medicine that blocks a protein called interleukin-17A. It is made in Chinese hamster ovary cells.
COSENTYX Injection (Under the Skin)
COSENTYX is a clear liquid that you inject under your skin. It comes in:
– UnoReady pen (300 mg)
– Sensoready pen (300 mg or 150 mg)
– Prefilled syringe (300 mg, 150 mg, or 75 mg)
Each pen or syringe has a 27-gauge needle that is 1/2 inch long.
Note: The cap of some pens and syringes contains latex (natural rubber).
Medicine Ingredients
Each 300 mg dose contains: secukinumab, L-histidine, L-methionine, polysorbate 80, trehalose, and sterile water. The pH is 5.8.
Each 150 mg dose contains the same ingredients in smaller amounts.
Each 75 mg dose contains the same ingredients in even smaller amounts.
COSENTYX Injection (Into the Vein)
COSENTYX also comes as a liquid that is given into your vein. Each vial has 125 mg of secukinumab. It contains L-histidine, L-histidine hydrochloride, L-methionine, polysorbate 80, trehalose, and sterile water. The pH is 5.8.
Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains.
COSENTYX Injection for Subcutaneous Use
COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (300 mg/2 mL, 150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex.
Each COSENTYX UnoReady pen or prefilled syringe (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8.
Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8.
Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8.
COSENTYX Injection for Intravenous Use
COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution.
Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.
Mechanism of Action
How This Medicine Works
Secukinumab is a protein-based medicine that attaches to a substance in your body called IL-17A. IL-17A is made by your body and is involved in normal inflammation and immune responses. By attaching to IL-17A, the medicine stops it from working. This reduces the release of other substances that cause inflammation.
Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.
Pharmacodynamics
How This Medicine Works
High levels of a certain protein are found in psoriasis skin patches and in a condition called HS. Cosentyx may lower these protein levels in psoriasis patches. Blood tests showed higher levels of this protein at 4 weeks and 12 weeks after starting Cosentyx. These findings came from small studies. We do not fully know how these changes relate to how well the medicine works.
Protein Levels in Other Conditions
Higher levels of this protein have been found in patients with PsA and AS. Higher levels have also been found in patients with nr-axSpA.
Vaccines During Treatment
In a small study, healthy people who got Cosentyx 2 weeks before certain vaccines had similar protection compared to people who did not get Cosentyx. The actual benefit of these vaccines in patients taking Cosentyx has not been studied [see Warnings and Precautions (5.7)].
Elevated levels of IL-17A are found in psoriatic plaques and in HS lesions. Treatment with COSENTYX may reduce epidermal neutrophils and IL-17A levels in psoriatic plaques. Serum levels of total IL-17A (free and secukinumab-bound IL-17A) measured at Week 4 and Week 12 were increased following secukinumab treatment. These pharmacodynamic activities are based on small exploratory trials. The relationship between these pharmacodynamic activities and the mechanism(s) by which secukinumab exerts its clinical effects is unknown.
Increased numbers of IL-17A producing lymphocytes and innate immune cells and increased levels of IL-17A have been found in the blood of patients with PsA and AS. Increased numbers of IL-17A producing lymphocytes have also been found in patients with nr-axSpA.
Immune Response to Non-Live Vaccines During Treatment
Healthy individuals who received a single 150 mg dose of COSENTYX 2 weeks prior to vaccination with a non-U.S.-approved group C meningococcal polysaccharide conjugate vaccine and a non-U.S.-approved inactivated seasonal influenza vaccine had similar antibody responses compared to individuals who did not receive COSENTYX prior to vaccination. The clinical effectiveness of meningococcal and influenza vaccines has not been assessed in patients undergoing treatment with COSENTYX[see Warnings and Precautions (5.7)].
Pharmacokinetics
How the Body Processes the Medicine
The way the body processes secukinumab is similar in patients with psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. The same is true for children with enthesitis-related arthritis and psoriasis.
The amount of medicine in the blood was about 26% lower in patients with hidradenitis suppurativa compared to patients with psoriasis.
Absorption
After a single injection of 150 mg or 300 mg, the medicine reaches its highest level in the blood after about 6 days. The highest levels were about 13.7 mcg/mL for 150 mg and 27.3 mcg/mL for 300 mg.
After multiple injections, the medicine levels at week 12 ranged from about 22.8 to 45.4 mcg/mL depending on the dose.
Steady levels in the blood are reached by week 24 with monthly dosing. The amount of medicine absorbed into the body ranges from 55% to 77%.
In patients with hidradenitis suppurativa, steady levels were reached by week 24 with monthly dosing and by week 16 with dosing every 2 weeks.
Distribution
The medicine spreads through the body to a volume of about 7 to 9 liters. In skin patches of psoriasis, medicine levels in the skin were about 27% to 40% of blood levels.
Elimination
The medicine is broken down like other antibodies. The time it takes for half the medicine to leave the body ranges from 22 to 31 days. In patients with hidradenitis suppurativa, this time is about 23 days.
Effects of Body Weight
Higher body weight leads to faster removal of the medicine from the body.
Special Groups
No formal studies were done in patients with liver or kidney problems.
In elderly patients, the medicine is processed the same as in younger adults.
In children with psoriasis, steady medicine levels at week 24 were 32.6 mcg/mL for children under 25 kg, 19.8 mcg/mL for children 25-50 kg, and 27.3 mcg/mL for children over 50 kg.
In children with juvenile psoriatic arthritis and enthesitis-related arthritis, steady medicine levels at week 24 were 25.2 mcg/mL for children 15-50 kg and 27.9 mcg/mL for children over 50 kg.
Other Medicines
Secukinumab does not affect how other medicines are processed in the body.
Intravenous Dosing
When given through an IV, the medicine levels in the blood are similar to those achieved with injections of 150 mg or 300 mg given monthly.
Pharmacokinetics Following Subcutaneous Administration
The observed pharmacokinetics (PK) of secukinumab administered subcutaneously in patients with PsO, PsA, AS and nr-axSpA were similar. The secukinumab PK is also similar in pediatric patients with ERA and PsO for the same weight tiered dosing regimen.
The mean steady-state trough concentration of secukinumab was approximately 26% lower in HS subjects than that of PsO subjects.
Absorption
Following a single subcutaneous dose of either 150 mg or 300 mg (administered as two injections of 150 mg) of COSENTYX in PsO subjects, secukinumab reached peak mean (± SD) serum concentrations (Cmax) of 13.7 ± 4.8 mcg/mL and 27.3 ± 9.5 mcg/mL, respectively, by approximately 6 days post dose.
Following multiple subcutaneous doses of COSENTYX (administered as one or two injections of 150 mg), the mean (± SD) serum trough concentrations of secukinumab ranged from 22.8 ± 10.2 mcg/mL (150 mg) to 45.4 ± 21.2 mcg/mL (300 mg) at Week 12. At the 300 mg dose at Week 4 and Week 12, the mean trough concentrations resulted from the Sensoready pen were approximately 30% higher than those from the prefilled syringe. Following multiple subcutaneous doses of 300 mg administered via the 300 mg/2 mL UnoReady pen, the mean serum trough concentrations of secukinumab were generally consistent with those in the previous Sensoready pen study used to deliver 300 mg.
Steady-state concentrations of secukinumab were achieved by Week 24 following the every 4-week dosing regimen. The mean (± SD) steady-state trough concentrations ranged from 16.7 ± 8.2 mcg/mL (150 mg) to 34.4 ± 16.6 mcg/mL (300 mg administered as two injections of 150 mg).
In healthy subjects and subjects with PsO, secukinumab bioavailability ranged from 55% to 77% following subcutaneous COSENTYX dose of 150 mg or 300 mg (administered as two injections of 150 mg).
Following subcutaneous administrations of 300 mg of COSENTYX at Weeks 0, 1, 2, 3, and 4 and then every 4 weeks thereafter, steady-state concentrations of secukinumab were achieved by Week 24 in both HS trials. The mean (± SD) steady-state trough concentrations were 25.7 ± 15.7 mcg/mL and 26.0 ± 13.9 mcg/mL in HS Trial 1 and HS Trial 2, respectively.
Following subcutaneous administrations of 300 mg of COSENTYX at Weeks 0, 1, 2, 3, and 4 and then every 2 weeks thereafter, steady-state concentrations of secukinumab were achieved by Week 16 in both HS trials. The mean (± SD) steady-state trough concentrations were 55.0 ± 26.1 mcg/mL and 58.1 ± 30.1 mcg/mL in HS Trial 1 and HS Trial 2, respectively.
Distribution
The mean volume of distribution during the terminal phase (Vz) following a single intravenous administration ranged from 7.10 to 8.60 L in PsO subjects.
Secukinumab concentrations in interstitial fluid in lesional and non-lesional skin of PsO subjects ranged from 27% to 40% of those in serum at 1 and 2 weeks after a single subcutaneous dose of COSENTYX 300 mg (administered as two injections of 150 mg).
Elimination
Metabolism
The metabolic pathway of secukinumab has not been characterized. As a human IgG1κ monoclonal antibody secukinumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Excretion
The mean systemic clearance (CL) ranged from 0.14 L/day to 0.22 L/day and the mean half-life ranged from 22 to 31 days in PsO subjects following intravenous and subcutaneous administration across all PsO trials.
In a population PK analysis, the mean systemic CL in subjects with HS was 0.26 L/day. The mean elimination half-life, as estimated from population PK analysis, was 23 days in HS subjects.
Dose Linearity
Secukinumab exhibited dose-proportional PK in subjects with PsO over a dose range from 25 mg (approximately 0.083 times the recommended dose) to 300 mg following subcutaneous administrations.
Weight
Secukinumab clearance and volume of distribution increase as body weight increases.
Specific Populations
Patients with Hepatic or Renal Impairment
No formal trial of the effect of hepatic or renal impairment on the PK of secukinumab was conducted.
Geriatric Patients
Population PK analysis indicated that the clearance of secukinumab was not significantly influenced by age in adult subjects with PsO, PsA and AS. Subjects who are 65 years and older had apparent clearance of secukinumab similar to subjects less than 65 years old.
Pediatric Patients
Based on population pharmacokinetic modeling and simulation, secukinumab concentrations for the every 4-week dosing regimen in pediatric patients 12 years of age and older who weigh at least 30 kg with moderate to severe HS are predicted to be similar to exposures observed in adults with moderate to severe HS who received 300 mg of subcutaneous COSENTYX administered every 4 weeks.
Drug Interactions
Cytochrome P450 Substrates
In adult subjects with PsO, midazolam (CYP3A4 substrate) PK was similar when administered alone, or when administered following either a single or five weekly subcutaneous administrations of 300 mg of COSENTYX[see Drug Interactions (7)].
Pharmacokinetics Following Intravenous Administration
Following an intravenous administration of 1.75 mg/kg maintenance dose every 4 weeks, with or without a loading dose of 6 mg/kg at Day 0, the secukinumab concentrations [steady state trough secukinumab concentrations (Cmin,ss), mean secukinumab concentrations (Cavg,ss), and maximum secukinumab concentrations (Cmax,ss)] are estimated to be within the range of the steady state concentrations following subcutaneous administration of 150 mg and 300 mg doses of COSENTYX administered every 4 weeks.
Pharmacogenomics
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies (ADA) in the trials described below with the incidence of ADA in other trials, including those of COSENTYX (secukinumab).
The immunogenicity of COSENTYX was evaluated using an electrochemiluminescence-based bridging immunoassay. Less than 1% of subjects treated with COSENTYX developed antibodies to secukinumab in up to 52 weeks of treatment. However, this assay has limitations in detecting anti-secukinumab antibodies in the presence of secukinumab; therefore, the incidence of antibody development might not have been reliably determined.
In up to 52 weeks of treatment in controlled trials in adult patients with PsO, PsA, AS, nr-axSpA, HS, and in pediatric PsO, JPsA and ERA[see Clinical Studies (14)], the incidence of anti-secukinumab antibodies (referred as ADA) formation was less than 1% (25 of 6268 total of subjects treated with COSENTYX). Of the subjects treated with COSENTYX who developed ADA, approximately 8% developed neutralizing antibodies. Because of the low occurrence of ADA, the effect of these antibodies on pharmacokinetics, pharmacodynamics, safety, or effectiveness of COSENTYX is unknown.
Clinical Studies
Adult Plaque Psoriasis
Four main studies tested COSENTYX in adults with plaque psoriasis. A total of 2,403 adults joined these studies. All had psoriasis covering at least 10% of their body. Their psoriasis was moderate to severe.
In two large studies (PsO1 and PsO2):
– 691 people got COSENTYX 300 mg
– 692 people got COSENTYX 150 mg
– 694 people got placebo (inactive pill)
People got shots at weeks 0, 1, 2, 3, and 4. Then they got shots every 4 weeks after that. They were followed for up to 52 weeks.
Results at week 12:
– PASI 75 (75% skin improvement): 82% with 300 mg vs 4% with placebo (PsO1)
– PASI 75: 76% with 300 mg vs 5% with placebo (PsO2)
– Clear or almost clear skin: 65% with 300 mg vs 2% with placebo (PsO1)
– Clear or almost clear: 62% with 300 mg vs 3% with placebo (PsO2)
At week 52, most people who responded kept their improvement:
– 81% of 300 mg users kept PASI 75 response
– 72% of 150 mg users kept PASI 75 response
Pediatric Plaque Psoriasis
One study tested COSENTYX in children 6 years and older with severe plaque psoriasis. 162 children joined.
Results at week 12:
– Children under 50 kg: 55% achieved PASI 75 with 75 mg vs 10% with placebo
– Children 50 kg and over: 86% achieved PASI 75 with 150 mg vs 19% with placebo
Adult Psoriatic Arthritis
Three studies tested COSENTYX in 1,999 adults with psoriatic arthritis. All had active joint disease.
Results at week 24:
– ACR20 (20% joint improvement): 51% with 150 mg vs 15% with placebo
– ACR20: 54% with 300 mg vs 15% with placebo
COSENTYX also helped psoriasis skin lesions in people who had both conditions.
Ankylosing Spondylitis
Three studies tested COSENTYX in 816 adults with active ankylosing spondylitis.
Results at week 16:
– ASAS20 (20% improvement): 61% with 150 mg vs 28% with placebo
– ASAS40 (40% improvement): 36% with 150 mg vs 11% with placebo
Non-Radiographic Axial Spondyloarthritis
One study tested COSENTYX in 555 adults with this condition.
Results:
– ASAS40 at week 52: 38% with 150 mg vs 19% with placebo
Juvenile Psoriatic Arthritis and Enthesitis-Related Arthritis
One study tested COSENTYX in 86 children ages 2 to under 18 with these conditions.
Results at week 12:
– JIA ACR30: 91% for juvenile psoriatic arthritis, 85% for enthesitis-related arthritis
Hidradenitis Suppurativa
Two studies tested COSENTYX in 1,084 adults with moderate to severe hidradenitis suppurativa.
Results at week 16:
– HiSCR50 (50% reduction in abscesses/nodules): 44.5% with 300 mg every 2 weeks vs 29.4% with placebo (Trial 1)
– HiSCR50: 38.3% with 300 mg every 2 weeks vs 26.1% with placebo (Trial 2)
14.1 Adult Plaque Psoriasis
Four multicenter, randomized, double-blind, placebo-controlled trials of subcutaneous COSENTYX (Trials PsO1, PsO2, PsO3, and PsO4) enrolled 2,403 subjects (691 randomized to COSENTYX 300 mg, 692 to COSENTYX 150 mg, 694 to placebo, and 323 to a biologic active control) 18 years of age and older with PsO who had a minimum BSA involvement of 10%, and Psoriasis Area and Severity Index (PASI) score greater than or equal to 12, and who were candidates for phototherapy or systemic therapy. In these studies, each 300 mg dose was administered as two injections of 150 mg.
Trial PsO1 (NCT01365455) enrolled 738 subjects (245 randomized to COSENTYX 300 mg, 245 to COSENTYX 150 mg, and 248 to placebo). Subjects received subcutaneous treatment at Weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks. Subjects randomized to receive placebo that were non-responders at Week 12 were crossed over to receive COSENTYX (either 300 mg or 150 mg) at Weeks 12, 13, 14, 15, and 16 followed by the same dose every 4 weeks. All subjects were followed for up to 52 weeks following first administration of trial treatment.
Trial PsO2 (NCT01358578) enrolled 1306 subjects (327 randomized to COSENTYX 300 mg, 327 to COSENTYX 150 mg, 326 to placebo, and 323 to a biologic active control). Subjects received subcutaneous treatment at Weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks. Subjects randomized to receive placebo that were non-responders at Week 12 crossed over to receive COSENTYX (either 300 mg or 150 mg) at Weeks 12, 13, 14, 15, and 16 followed by the same dose every 4 weeks. All subjects were followed for up to 52 weeks following first administration of trial treatment.
Trial PsO3 (NCT01555125) enrolled 177 subjects (59 randomized to COSENTYX 300 mg, 59 to COSENTYX 150 mg, and 59 to placebo) and assessed safety, tolerability, and usability of COSENTYX self-administration via prefilled syringe for 12 weeks. Subjects received subcutaneous treatment at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks for up to 12 weeks total.
Trial PsO4 (NCT01636687) enrolled 182 subjects (60 randomized to COSENTYX 300 mg, 61 to COSENTYX 150 mg, and 61 to placebo) and assessed safety, tolerability, and usability of COSENTYX self-administration via Sensoready pen for 12 weeks. Subjects received subcutaneous treatment at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks for up to 12 weeks total.
Endpoints
In all trials, the endpoints were the proportion of subjects who achieved a reduction in PASI score of at least 75% (PASI 75) from baseline to Week 12 and treatment success (clear or almost clear) on the Investigator’s Global Assessment modified 2011 (IGA). Other evaluated outcomes included the proportion of subjects who achieved a reduction in PASI score of at least 90% (PASI 90) from baseline at Week 12, maintenance of efficacy to Week 52, and improvements in itching, pain, and scaling at Week 12 based on the Psoriasis Symptom Diary © .
The PASI is a composite score that takes into consideration both the percentage of BSA affected and the nature and severity of psoriatic changes within the affected regions (induration, erythema, and scaling). The IGA is a 5-category scale, including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = moderate” or “4 = severe” indicating the physician’s overall assessment of the psoriasis severity focusing on induration, erythema, and scaling. Treatment success of “clear” or “almost clear” consisted of no signs of psoriasis or normal to pink coloration of lesions, no thickening of the plaque, and none to minimal focal scaling.
Baseline Disease Characteristics
Across all treatment groups, the baseline PASI score ranged from 11 to 72 with a median of 20 and the baseline IGA score ranged from “moderate” (62%) to “severe” (38%). Of the 2,077 PsO subjects who were included in the placebo-controlled trials, 79% were biologic-naïve (have never received a prior treatment with biologics) and 45% were non-biologic failures (failed to respond to a prior treatment with non-biologic therapies). Of the subjects who received a prior treatment with biologics, over one-third were biologic failures. Approximately 15% to 25% of trial subjects had a history of psoriatic arthritis.
Clinical Response
Trial PsO1 Trial PsO2
COSENTYX 300 mg (N = 245) n (%)
COSENTYX 150 mg (N = 245) n (%)
Placebo (N = 248) n (%)
COSENTYX 300 mg (N = 327) n (%)
COSENTYX 150 mg (N = 327) n (%)
Placebo (N = 326) n (%)
Trial PsO3 Trial PsO4
COSENTYX 300 mg (N = 59) n (%)
COSENTYX 150 mg (N = 59) n (%)
Placebo (N = 59) n (%)
COSENTYX 300 mg (N = 60) n (%)
COSENTYX 150 mg (N = 61) n (%)
Placebo (N = 61) n (%)
Examination of age, sex, and racial subgroups did not identify differences in response to COSENTYX among these subgroups. Based on post-hoc subgroup analyses in subjects with moderate to severe PsO, subjects with lower body weight and lower disease severity may achieve an acceptable response with COSENTYX 150 mg.
PASI 90 response at Week 12 was achieved with COSENTYX 300 mg and 150 mg compared to placebo in 59% (145/245) and 39% (95/245) versus 1% (3/248) of subjects, respectively (Trial PsO1) and 54% (175/327) and 42% (137/327) versus 2% (5/326) of subjects, respectively (Trial PsO2). Similar results were seen in Trials PsO3 and PsO4.
With continued treatment over 52 weeks, subjects in Trial PsO1 who were PASI 75 responders at Week 12 maintained their responses in 81% (161/200) of the subjects treated with COSENTYX 300 mg and in 72% (126/174) of subjects treated with COSENTYX 150 mg. Trial PsO1 subjects who were clear or almost clear on the IGA at Week 12 also maintained their responses in 74% (119/160) of subjects treated with COSENTYX 300 mg and in 59% (74/125) of subjects treated with COSENTYX 150 mg.
Similarly in Trial PsO2, PASI 75 responders maintained their responses in 84% (210/249) of subjects treated with COSENTYX 300 mg and in 82% (180/219) of subjects treated with COSENTYX 150 mg. Trial PsO2 subjects who were clear or almost clear on the IGA also maintained their responses in 80% (161/202) of subjects treated with COSENTYX 300 mg and in 68% (113/167) of subjects treated with COSENTYX 150 mg.
Among the subjects who chose to participate (39%) in assessments of patient reported outcomes, improvements in signs and symptoms related to itching, pain, and scaling at Week 12 compared to placebo (Trials PsO1 and PsO2) were observed using the Psoriasis Symptom Diary © .
Psoriasis Lesions of Scalp
A randomized, placebo-controlled trial (Trial PsO5; NCT02267135) enrolled 102 subjects with moderate to severe psoriasis lesions of scalp, defined as having a Psoriasis Scalp Severity Index (PSSI) score of greater than or equal to 12, an IGA scalp only score of 3 or greater, and at least 30% of the scalp affected. In this trial, 62% of subjects had at least 50% of scalp surface area affected. In this study, each 300 mg dose was administered as two injections of 150 mg. The proportions of subjects achieving an IGA scalp only score of 0 or 1 (clear or almost clear) were 56.9% and 5.9% for the COSENTYX 300 mg and the placebo groups, respectively.
300 mg/2 mL Pre-filled Syringe and 300 mg/2 mL UnoReady Pen
Two randomized, double-blind, placebo-controlled, 52-week trials (PsO6 and PsO7) enrolled 336 subjects at least 18 years of age with moderate to severe PsO who are candidates for systemic therapy or phototherapy to evaluate the safety and efficacy of COSENTYX 300 mg subcutaneously administered with a single 300 mg/2 mL prefilled syringe (Trial PsO6, NCT02748863, 214 patients) or with a single 300 mg/2 mL UnoReady pen (Trial PsO7, NCT03589885, 122 patients) compared to two subcutaneous injections using a 150 mg/1 mL prefilled syringe. The co-primary endpoints for both trials were the proportion of subjects who achieved a PASI 75 response and IGA mod 2011 ‘clear’ or ‘almost clear’ response with at least a two-grade reduction from baseline at Week 12.
Abbreviation: PFS, prefilled syringe. Missing data was imputed using multiple imputation.
Trial PsO6 Trial PsO7
COSENTYX 300 mg COSENTYX 300 mg
2 mL PFS (N = 72) % Two 1 mL PFS (N = 71) % Placebo (N = 71) % 2 mL Pen (N = 41) % Two 1 mL PFS (N = 41) % Placebo (N = 40) %
IGA of clear or almost clear 76 69 1 76 68 8
PASI 75 response 89 82 2 95 83 10
PASI 90 response 67 70 2 76 62 5
14.2 Pediatric Plaque Psoriasis
A 52-week, multicenter randomized, double-blind, placebo and active-controlled trial (Trial PsO8; NCT02471144) enrolled 162 pediatric subjects 6 years of age and older, with severe plaque psoriasis (as defined by a PASI score ≥ 20, an IGA modified 2011 score of 4, and involving ≥ 10% of the BSA) who were candidates for systemic therapy.
Baseline Characteristics
Overall, 60% of the subjects were female, 83% were White, the median BW was 50.6 kg, and the mean age was 13.5 years with 23% of the subjects less than 12 years. At baseline, the median PASI score was 26 (ranged from 17 to 60), and 99% of the subjects had an IGA modified 2011 score of 4 (‘severe’). Approximately 43% of the subjects had prior exposure to phototherapy, 53% to conventional systemic therapy, 3% to biologics, and 9% had concomitant psoriatic arthritis.
Endpoints
The co-primary endpoints were the proportion of subjects who achieved a reduction in PASI score of at least 75% (PASI 75) from baseline to Week 12 and the proportion of subjects who achieved an IGA modified 2011 score of ‘clear’ or ‘almost clear’ (0 or 1) with at least a 2-point improvement from baseline to Week 12. The key secondary endpoint was the proportion of subjects who achieved a reduction in PASI score of at least 90% (PASI 90) from baseline to Week 12.
Clinical Response
Non-responder imputation was used to handle missing values.
a COSENTYX treated subjects received 75 mg for subjects less than 50 kg and 150 mg for subjects at least 50 kg body weight.
Body weight < 50 kg Body weight ≥ 50 kg Total
COSENTYX 75 mg (N = 22) n (%) Placebo
(N = 20) n (%) COSENTYX 150 mg (N = 21) n (%) Placebo
(N = 21) n (%) COSENTYX a
(N = 43) n (%) Placebo
(N = 41) n (%)
2 (5)
6 (15)
1 (2)
14.3 Adult Psoriatic Arthritis
The safety and efficacy of COSENTYX were assessed in 1,999 patients, in 3 randomized, double-blind, placebo-controlled trials (PsA1, PsA2, and PsA3) in adult patients, age 18 years and older with active PsA (greater than or equal to 3 swollen and greater than or equal to 3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease modifying anti-rheumatic drug (DMARD) therapy. Patients in these trials had a diagnosis of PsA of at least 5 years across all trials.
PsA1 Study (NCT 01752634) evaluated 397 patients, who were treated with 75 mg, 150 mg or 300 mg of COSENTYX (administered as two subcutaneous injections of 150 mg) at Weeks 0, 1, 2, 3, and 4, followed by the same subcutaneous dose every 4 weeks. Patients who received placebo were re-randomized to receive subcutaneous COSENTYX (either 150 mg or 300 mg every 4 weeks) at Week 16 or Week 24 based on responder status. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 24.
PsA2 Study (NCT 01392326) evaluated 606 patients, who were treated with intravenous secukinumab 10 mg/kg, or placebo at Weeks 0, 2, and 4, followed by either 75 mg or 150 mg of subcutaneous COSENTYX treatment (or placebo) every 4 weeks. Patients who received placebo were re-randomized to receive subcutaneous COSENTYX (either 75 mg or 150 mg every 4 weeks) at Week 16 or Week 24 based on responder status.
PsA3 Study (NCT 02404350) evaluated 996 patients, who were treated with 150 mg or 300 mg of COSENTYX (administered as two subcutaneous injections of 150 mg) at Weeks 0, 1, 2, 3, and 4 followed by the same subcutaneous dose every 4 weeks, or once every 4 weeks of COSENTYX 150 mg. Patients treated with placebo received subcutaneous COSENTYX, either 150 mg or 300 mg, per baseline randomization, at Week 16 or Week 24 based upon responder status. The primary endpoint was ACR20 response at Week 16 with the key secondary endpoint the change from baseline in modified Total Sharp Score (mTSS) at Week 24.
Baseline Disease Characteristics
At baseline, over 61% and 42% of the patients had enthesitis and dactylitis, respectively. Overall, 31% of patients discontinued previous treatment with anti-TNFα agents due to either lack of efficacy or intolerance. In addition, approximately 53% of patients from both studies had concomitant methotrexate (MTX) use. Patients with different subtypes of PsA were enrolled, including polyarticular arthritis with no evidence of rheumatoid nodules (80%), asymmetric peripheral arthritis (63%), distal interphalangeal involvement (58%), spondylitis with peripheral arthritis (20%), and arthritis mutilans (7%).
Clinical Response
In patients with coexistent PsO receiving COSENTYX (n = 99), the skin lesions of psoriasis improved with treatment, relative to placebo, as measured by the Psoriasis Area Severity Index (PASI).
a Patients who met escape criteria (less than 20% improvement in tender or swollen joint counts) at Week 16 were considered non-responders.
COSENTYX COSENTYX Placebo Difference from placebo (95% CI)
150 mg (N = 100) 300 mg (N = 100)
(N = 98) COSENTYX 150 mg COSENTYX 300 mg
ACR20 response
Week 16 (%) 60 57 18 42 (30, 54) 38 (26, 51)
Week 24 (%) 51 54 15 36 (24, 48) 39 (27, 51)
ACR50 response
Week 16 (%) 37 35 6 31 (21, 42) 28 (18, 39)
Week 24 (%) 35 35 7 28 (18, 38) 28 (17, 38)
ACR70 response
Week 16 (%) 17 15 2 15 (7, 23) 13 (5, 20)
Week 24 (%) 21 20 1 20 (12, 28) 19 (11, 27)
The percentage of patients who achieved a ACR20 response by visit is shown in Figure 1. Patients on placebo who received COSENTYX without a loading regimen achieved similar ACR20 responses over time (data not shown).
a Patients who met escape criteria (less than 20% improvement in tender or swollen joint counts) at Week 16 were considered non-responders.
a Week 16 rather than Week 24 data are displayed to provide comparison between arms prior to placebo escape to COSENTYX.
COSENTYX 150 mg
(N = 100)
COSENTYX 300 mg
(N = 100)
Placebo
(N = 98)
Number of swollen joints
Baseline 12.0 11.2 12.1
Mean change at Week 16 -4.86 -5.83 -3.22
Number of tender joints
Baseline 24.1 20.2 23.5
Mean change at Week 16 -10.70 -10.01 -1.77
Patient’s assessment of pain
Baseline 58.9 57.7 55.4
Mean change at Week 16 -22.91 -23.97 -7.98
Patient global assessment
Baseline 62.0 60.7 57.6
Mean change at Week 16 -25.47 -25.40 -8.25
Physician global assessment
Baseline 56.7 55.0 55.0
Mean change at Week 16 -29.24 -34.71 -14.95
Disability index (HAQ)
Baseline 1.2200 1.2828 1.1684
Mean change at Week 16 -0.45 -0.55 -0.23
CRP (mg/L)
Baseline 14.15 10.88 7.87
Mean change at Week 16 b -8.41 -7.21 0.79
Improvements in enthesitis and dactylitis scores were observed in each COSENTYX group compared to placebo at Week 24.
Radiographic Response
In PsA3 Study, inhibition of progression of structural damage was assessed radiographically and expressed by the modified mTSS and its components, the Erosion Score (ES) and Joint Space Narrowing Score (JSN), at Week 24 compared to baseline. Radiographs of hands, wrists, and feet were obtained at baseline, Week 16 and/or Week 24 and scored independently by at least two readers who were blinded to treatment group and visit number. Treatment with subcutaneous COSENTYX 150 mg without a loading dose, 150 mg with a loading dose and 300 mg with a loading dose significantly inhibited progression of peripheral joint damage compared with treatment with placebo as measured by change from baseline in mTSS at Week 24. The percentage of patients with no disease progression (defined as a change from baseline in mTSS of less than or equal to 0.0) from randomization to Week 24 was 75.7%, 70.9%, and 76.5% for COSENTYX 150 mg without a loading dose, 150 mg, 300 mg, respectively versus 68.2% for placebo.
Results from a linear mixed effects model that excluded data after escape for placebo subjects who received escape therapy at Week 16. The model assumes approximately linear progression over time and estimates a difference in rates (slopes) of progression over 24 weeks to compare treatment arms.
Treatment N Rate of change per 24 weeks Difference from placebo (95% CI)
COSENTYX 150 mg without a loading dose 210 -0.10 -0.61 (-0.95, -0.26)
COSENTYX 150 mg with a loading dose 213 0.14 -0.37 (-0.71, -0.03)
COSENTYX 300 mg with a loading dose 217 0.03 -0.48 (-0.82, -0.14)
Placebo 296 0.51 —
Physical Function
Treatment of Adult Patients with Active Psoriatic Arthritis with Intravenous COSENTYX
The effectiveness of intravenous COSENTYX in the treatment of adult patients with active PsA was extrapolated from the established effectiveness of subcutaneous COSENTYX in adult patients with active PsA based on pharmacokinetic exposure [see Clinical Pharmacology (12.3)] .
14.4 Ankylosing Spondylitis
The safety and efficacy of subcutaneous COSENTYX were assessed in 816 adult patients (18 years of age and older) with active AS in three randomized, double-blind, placebo-controlled trials (AS1, AS2, and AS3). Patients had active disease as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) greater or equal to 4 despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease modifying anti-rheumatic drug (DMARD) therapy.
AS2 Study (NCT01358175) evaluated 371 patients, who were treated with intravenous secukinumab 10 mg/kg at Weeks 0, 2, and 4 (for both treatment arms) or placebo, followed by either 75 mg or 150 mg subcutaneous COSENTYX treatment every 4 weeks or placebo. Patients who received placebo were re-randomized to receive subcutaneous COSENTYX (either 75 mg or 150 mg every 4 weeks) at Week 16 or Week 24 based on responder status.
AS3 Study (NCT02008916) evaluated 226 patients, who were treated with intravenous secukinumab 10 mg/kg at Weeks 0, 2, and 4 (for both treatment arms) or placebo, followed by either 150 mg or 300 mg subcutaneous COSENTYX treatment every 4 weeks or placebo. Patients who received placebo were re-randomized to receive subcutaneous COSENTYX (either 150 mg or 300 mg every 4 weeks) at Week 16. The primary endpoint was the percentage of patients who achieved an ASAS20 response at Week 16. Patients were blinded to the treatment regimen up to Week 52, and the trial continued to Week 156. In this study, each 300 mg dose was administered as two injections of 150 mg.
Baseline Disease Characteristics
At baseline, approximately 13% and 25% used concomitant MTX or sulfasalazine, respectively. Overall, 29% of patients discontinued previous treatment with anti-TNFα agents due to either lack of efficacy or intolerance.
Clinical Response
COSENTYX 150 mg (n = 72) Placebo
(n = 74) Difference from placebo (95% CI)
ASAS20 response, % 61 28 33 (18, 48)
ASAS40 response, % 36 11 25 (12, 38)
Percent of subjects with at least a 20%- and 10-unit improvement measured on a Visual Analog Scale (VAS) with 0 = none, 100 = severe.
Bath Ankylosing Spondylitis Functional Index.
Inflammation is the mean of two patient-reported stiffness self-assessments in BASDAI.
Bath Ankylosing Spondylitis Disease Activity Index.
Bath Ankylosing Spondylitis Metrology Index.
High sensitivity C-reactive protein / mean change based upon observed data.
COSENTYX 150 mg (N = 72) Placebo
(N = 74)
ASAS20 response criteria
-Patient Global Assessment of Disease Activity (0-100 mm) 1 67.5 -27.7 70.5 -12.9
-Total spinal pain (0-100 mm) 66.2 -28.5 69.2 -10.9
-BASFI (0-10) 2 6.2 -2.2 6.1 -0.7
-Inflammation (0-10) 3 6.5 -2.5 6.5 -0.8
BASDAI score 4 6.6 -2.2 6.8 -0.9
BASMI 5 3.6 -0.51 3.9 -0.22
hsCRP 6
(mg/L) mean change at Week 16 27.0 -17.2 15.9 0.8
The percentage of patients who achieved ASAS20 responses by visit is shown in Figure 2. Patients on placebo who received COSENTYX without a loading regimen achieved similar ASAS20 responses over time (data not shown).
Figure 2: ASAS20 Responses in All AS1 Study Patients Over Time Up to Week 16 (Subcutaneous Treatment)
COSENTYX treated patients showed improvement compared to placebo-treated patients in health-related quality of life as assessed by ASQoL at Week 16.
Figure 3: ASAS20 Responses in All AS3 Study Patients Over Time Up to Week 16 (Subcutaneous Treatment)
Treatment of Adult Patients with Active Ankylosing Spondylitis with Intravenous COSENTYX
The effectiveness of intravenous COSENTYX in the treatment of adult patients with active AS was extrapolated from the established effectiveness of subcutaneous COSENTYX in adult patients with active AS based on pharmacokinetic exposure [see Clinical Pharmacology (12.3)] .
14.5 Non-Radiographic Axial Spondyloarthritis
The safety and efficacy of COSENTYX were assessed in 555 adult patients (18 years of age and older) with active nr-axSpA in one randomized, double-blind, placebo-controlled Phase 3 study (nr-axSpA1, NCT02696031). Patients met ASAS criteria for axSpA with objective signs of inflammation and had active disease as defined by a BASDAI greater or equal to 4, a Visual Analogue Scale (VAS) for total back pain greater or equal to 40 (on a scale of 0-100 mm) despite NSAID therapy and no evidence of radiographic changes in the sacroiliac joints that would meet the modified New York criteria for AS. Patients also had to have objective signs of inflammation with a C-reactive protein (CRP) level above the upper limit of normal and/or evidence of sacroiliitis on Magnetic Resonance Imaging (MRI).
Baseline Disease Characteristics
Approximately 10% and 15% of patients used concomitant MTX or sulfasalazine, respectively. Overall, 10% of patients had received previous treatment with anti-TNFα agents and discontinued these due to either lack of efficacy or intolerance.
Clinical Response
Difference in proportions with 95% CI based on normal approximation.
Number of subjects with ASAS40 response (%) COSENTYX 150 mg without load (n = 184) COSENTYX 150 mg with load (n = 185) Difference from placebo (95% CI)
Placebo (n = 186) COSENTYX 150 mg without load COSENTYX 150 mg with load
COSENTYX 150 mg without loading dosage (N = 184) COSENTYX 150 mg with a loading dosage (N = 185) Placebo
(N = 186)
ASAS40 response criteria
-Patient Global Assessment of Disease Activity (0-100 mm) 71.0 -26.2 72.6 -24.1 68.8 -13.8
-Total back pain (0-100 mm) 72.0 -25.5 73.3 -25.0 70.9 -15.6
-BASFI (0-10) 5.9 -1.6 6.2 -1.8 5.9 -1.0
-Inflammation (0-10) 6.8 -2.8 7.2 -2.8 6.6 -1.7
hsCRP (mg/L) mean change at Week 16
9.8 -4.7 13.4 -7.9 9.2 -2.4
BASDAI (0-10) 6.9 -2.4 7.1 -2.4 6.8 -1.5
-Spinal pain 7.6 -3.0 7.8 -3.0 7.5 -2.0
-Peripheral pain and swelling (0-10) 6.6 -2.4 6.3 -2.3 6.1 -1.6
BASMI 2.8 -0.3 2.9 -0.3 2.8 -0.1
The percentage of patients achieving an ASAS40 response by visit is shown in Figure 4.
Figure 4: ASAS40 Responses in nr-axSpA1 Study Over Time up to Week 16 (Subcutaneous Treatment)
Health-Related Quality of Life
COSENTYX treated patients showed improvement in both loading and without loading dosage arms compared to placebo-treated patients at Week 16 in health-related quality of life as measured by ASQoL (LS mean change: Week 16: -3.5 and -3.6 versus -1.8, respectively).
Treatment of Adult Patients with Active Non-radiographic Axial Spondyloarthritis with Intravenous COSENTYX
The effectiveness of intravenous COSENTYX in the treatment of adult patients with active nr-axSpA was extrapolated from the established effectiveness of subcutaneous COSENTYX in adult patients with active nr-axSpA based on pharmacokinetic exposure [see Clinical Pharmacology (12.3)] .
14.6 Juvenile Psoriatic Arthritis and Enthesitis-Related Arthritis
The efficacy and safety of subcutaneous secukinumab were assessed in a two-year, 3-part, double-blind, placebo-controlled, event-driven, randomized, Phase 3 study (NCT03031782) in 86 pediatric patients (2 to less than 18 years of age) with active ERA or JPsA as diagnosed based on a modified International League of Associations for Rheumatology (ILAR) Juvenile Idiopathic Arthritis (JIA) classification criteria. The trial consisted of an open-label portion (Part 1) followed by randomized withdrawal (Part 2) followed by open-label treatment (Part 3). Patients were given subcutaneous doses of 75 mg if they weighed less than 50 kg, or subcutaneous doses of 150 mg if they weighed at least 50 kg or greater, administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter.
The primary endpoint was time to flare in Part 2. Disease flare was defined as at least 30% worsening in at least three of the six JIA ACR response criteria and at least 30% improvement in not more than one of the six JIA ACR response criteria and a minimum of two active joints.
In open-label Part 1, all patients received subcutaneous secukinumab until Week 12. Patients classified as responders (achieving JIA ACR30 response) at Week 12 entered into the Part 2 double-blind phase and were randomized 1:1 to continue treatment with secukinumab or begin treatment with placebo.
Baseline Disease Characteristics
The JIA patient subtypes at study entry were: 60.5% ERA and 39.5% JPsA. In the study, 67.6% of patients with JPsA, and 63.5% of patients with ERA, were treated concomitantly with MTX.
Clinical Response
Number of subjects with response (%) JIA ACR 30 JIA ACR 50 JIA ACR 70 JIA ACR 90
Juvenile Psoriatic Arthritis Results
Figure 5: Kaplan-Meier Estimates of the Time to Disease Flare in Part 2 for JPsA Patients (Subcutaneous Treatment)
Enthesitis-Related Arthritis Results
Figure 6: Kaplan-Meier Estimates of the Time to Disease Flare in Part 2 for ERA Patients (Subcutaneous Treatment)
14.7 Hidradenitis Suppurativa
Baseline Demographics and Disease Characteristics
HS Trials 1 and 2 included 1,084 adult subjects with moderate to severe HS. HS Trial 1 evaluated 541 subjects and HS Trial 2 evaluated 543 subjects, of whom 13% and 11%, respectively, received concomitant stable dose of systemic antibiotics. In HS Trial 1 and HS Trial 2, 24% and 23% of patients, respectively, were previously treated with a biologic (biologic-exposed patients) and discontinued the biologic agent for either lack of efficacy or intolerance.
Endpoints
The primary endpoint in both trials was the proportion of subjects who achieved a Hidradenitis Suppurativa Clinical Response (HiSCR50) defined as at least a 50% decrease in abscesses and inflammatory nodules (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae relative to baseline at Week 16.
Clinical Response
For the primary endpoint, HiSCR50, subjects who received any rescue medication or lesion intervention were considered treatment failures and handled as non-responders (n = 20 in Placebo, 11 in Q4W, and 8 in Q2W in HS Trial 1; n = 23 in Placebo, 17 in Q4W, and 13 in Q2W in HS Trial 2).
Improvements were seen for the primary endpoint in HS subjects regardless of previous or concomitant antibiotic treatment or previous biologic exposure.
1 Multiple imputation was implemented for missing data.
2 Subjects received COSENTYX 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3 and 4, followed by 300 mg every 4 weeks (Q4W) or every 2 weeks (Q2W).
* Statistically significant versus placebo based on the pre-defined hierarchy with overall alpha = 0.05 (two-sided).
HS Trial 1 HS Trial 2
Placebo
(n = 180) COSENTYX 300 mg every 4 weeks 2
(n = 180) COSENTYX 300 mg every 2 weeks 2
(n = 181) Placebo
(n = 183) COSENTYX 300 mg every 4 weeks 2
(n = 180) COSENTYX 300 mg every 2 weeks 2
(n = 180)
HiSCR50
29.4%
41.3%
44.5% *
26.1%
42.5% *
38.3% *
Patient Counseling Information
Reading Your Medicine Information
Read the patient information that comes with your medicine.
Risk of Infections
COSENTYX can lower your body’s ability to fight infections. Serious infections may happen. Tell your doctor about any past infections. Call your doctor if you get any signs of infection like fever, cough, or flu-like symptoms.
Allergic Reactions
Get medical help right away if you have signs of a serious allergic reaction like trouble breathing, swelling, or severe rash.
Skin Reactions
Skin reactions like eczema may happen. Call your doctor if you get a rash or itchy, dry skin.
Latex Allergy Warning
The cap on the medicine pen and syringe contains rubber. If you are allergic to rubber, tell your doctor.
Vaccines
Do not get live vaccines while taking COSENTYX. Tell your doctor or nurse that you are taking this medicine before you get any vaccine.
How to Give Your Shot
If you or a caregiver will give the shot, learn how to do it the right way. Make sure you can inject the medicine under your skin before you try it on your own.
Children and teens should not give themselves the shot. An adult should help them.
Use a new needle each time. Do not reuse needles.
Inject all of the medicine in the dose. Follow the instructions in your patient information sheet.
Storing Your Medicine
Keep COSENTYX in the refrigerator at 36°F to 46°F (2°C to 8°C).
If you take it out of the refrigerator, you can keep it at room temperature (up to 86°F or 30°C) for up to 4 days. Throw it away if it has been out longer than 4 days. Do not use medicine that is expired.
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Infections
Inform patients that COSENTYX may lower the ability of their immune system to fight infections and that serious infections, including opportunistic infections, may occur with the use of COSENTYX. Instruct patients of the importance of communicating any history of infections to the doctor and contacting their doctor if they develop any symptoms of infection [see Warnings and Precautions (5.1, 5.3)] .
Hypersensitivity
Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.2)] .
Eczematous Eruptions
Inform patients that skin reactions resembling eczema may occur with the use of COSENTYX. Instruct patients to seek medical advice if they develop signs or symptoms of eczema [see Warnings and Precautions (5.5)] .
Risk of Hypersensitivity in Latex-Sensitive Individuals
Advise latex-sensitive patients that the removal cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals [see Warnings and Precautions (5.6)] .
Immunization
Advise patients that vaccination with live vaccines is not recommended during COSENTYX treatment. Instruct patients to inform the healthcare practitioner that they are taking COSENTYX prior to a potential vaccination [see Warnings and Precautions (5.7)] .
Instructions on Subcutaneous Injection Technique
If a patient or caregiver is to subcutaneously administer COSENTYX, instruct him/her in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of COSENTYX [see Dosage and Administration (2.2, 2.9), Medication Guide, and Instructions for Use] .
For pediatric patients, inform patients and caregivers that pediatric patients should not self-administer COSENTYX.
Instruct patients or caregivers in the technique of proper syringe and needle disposal and advise them not to reuse these items. Instruct patients to inject the full amount of COSENTYX according to the directions provided in the Medication Guide and Instructions for Use.
Storage
Instruct patients to store COSENTYX in a refrigerator at 2°C to 8°C (36ºF to 46ºF) and to discard expired or unused COSENTYX.
Inform patients that if removed from refrigeration, COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) may be stored for up to 4 days at room temperature not to exceed 86°F (30°C). Instruct patients to discard if kept outside of the refrigerator over 4 days [see How Supplied/Storage and Handling (16)] .
© Novartis
T2026-04
Related Medications
Treats These Conditions
References
COSENTYX (secukinumab) [prescribing information]. March 2026. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77c4b13e-7df3-42d4-81db-3d0cddb7f67a
Accessed: March 27, 2026