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Updated: March 16, 2026 (Published: March 15, 2026)

James Blackmer

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Quick Facts

Used For

For Patients with ITP (Low Platelet Count) Nplate is used to treat low platelet counts...

Common Side Effects

What You Should Know About Side Effects The side effects listed here...

What You Should Know

Read the Medication Guide Read the FDA-approved patient information guide. For Radiation Exposure Patients If...

Prescription

Not Required

Generic Available

Indications and Usage

For Patients with ITP (Low Platelet Count)

Nplate is used to treat low platelet counts in:

Adults with ITP who did not get better with steroids, immunoglobulins, or spleen removal surgery.

Children 1 year and older who have had ITP for at least 6 months and did not get better with steroids, immunoglobulins, or spleen removal surgery.

For Patients Exposed to Radiation

Nplate is used to help adults and children (including newborns) survive after being exposed to high levels of radiation.

When NOT to Use Nplate

Do not use Nplate for low platelet counts caused by MDS or any other reason besides ITP.

Only use Nplate if your low platelet count puts you at risk for bleeding.

Do not use Nplate to make your platelet count normal.

Patients with Immune Thrombocytopenia (ITP)

Nplate is indicated for the treatment of thrombocytopenia in:

Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Patients with Hematopoietic Syndrome of Acute Radiation Syndrome

Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation[seeClinical Studies (14.3)].

Limitations of Use:

Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP[see Warnings and Precautions (5.1)].Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding.Nplate should not be used in an attempt to normalize platelet counts[see Warnings and Precautions (5.2)].

Dosage and Administration

For Patients with ITP (Low Platelet Count)

Your doctor will use the lowest dose of Nplate to keep your platelet count at 50 or higher. This helps reduce bleeding risk. You will get a shot under your skin once a week. Your doctor will adjust your dose based on your platelet count.

The dose may be a very small amount (like 0.15 mL). You must use a special syringe that measures very small amounts (0.01 mL marks).

Your doctor will stop Nplate if your platelet count doesn’t get high enough to prevent bleeding after 4 weeks at the highest dose (10 mcg/kg per week).

You will need blood tests to check your platelet count:
• Weekly while your doctor adjusts your dose
• Monthly once you’re on a stable dose
• Weekly for at least 2 weeks after you stop Nplate

For Adults with ITP

Starting dose: 1 mcg/kg based on your actual body weight.

Most adults who respond to Nplate need 2-3 mcg/kg to keep their platelet count at 50 or higher. The highest dose is 10 mcg/kg per week.

Your doctor will adjust your dose each week:
• If platelet count is below 50: increase dose by 1 mcg/kg
• If platelet count is 200-400 for 2 weeks in a row: decrease dose by 1 mcg/kg
• If platelet count is above 400: skip your dose. Keep checking weekly. When it drops below 200, restart at a dose that’s 1 mcg/kg lower

For Children with ITP

Starting dose: 1 mcg/kg based on actual body weight.

Your child’s doctor will adjust the dose based on platelet count and body weight. Your child will be weighed every 12 weeks.

In studies, children usually needed 5.5 mcg/kg. The highest dose is 10 mcg/kg per week.

Dose adjustments for children:
• If platelet count is below 50: increase dose by 1 mcg/kg
• If platelet count is 200-400 for 2 weeks in a row: decrease dose by 1 mcg/kg
• If platelet count is above 400: skip the dose. Keep checking weekly. When it drops below 200, restart at a dose that’s 1 mcg/kg lower

For Patients Exposed to Radiation

For Adults and Children (including newborns)

Dose: 10 mcg/kg given once as a shot under the skin.

Give the shot as soon as possible after exposure to radiation levels greater than 2 gray (Gy).

Give Nplate even if blood tests can’t be done. Radiation exposure is estimated by public health officials, special tests if available, or symptoms like vomiting or low white blood cell counts.

How to Prepare and Give Nplate

Follow these steps carefully to avoid giving too much or too little medicine. Use clean technique. Give only as a shot under the skin.

Nplate comes as a white powder in single-use vials. It must be mixed before use. Use a syringe with 0.01 mL marks.

Calculate the Dose

Multiply the patient’s weight (kg) by the prescribed dose.

Patient Dose (mcg) = Weight (kg) × Prescribed dose (mcg/kg)

Mix the Medicine

Mix Nplate with Sterile Water for Injection only. Do NOT use Bacteriostatic Water or Bacteriostatic Saline.

If the dose is less than 23 mcg, you must dilute it with 0.9% Sodium Chloride (normal saline). This makes it easier to measure small doses accurately.

Mixing Chart

If dose is 23 mcg or more:
• 125 mcg vial: add 0.44 mL Sterile Water (final strength: 500 mcg/mL)
• 250 mcg vial: add 0.72 mL Sterile Water (final strength: 500 mcg/mL)
• 500 mcg vial: add 1.2 mL Sterile Water (final strength: 500 mcg/mL)

If dose is less than 23 mcg:
• 125 mcg vial: add 0.44 mL Sterile Water, then add 1.38 mL normal saline (final strength: 125 mcg/mL)
• 250 mcg vial: add 0.72 mL Sterile Water, then add 2.25 mL normal saline (final strength: 125 mcg/mL)
• 500 mcg vial: add 1.2 mL Sterile Water, then add 3.75 mL normal saline (final strength: 125 mcg/mL)

Gently swirl and turn the vial upside down to mix. Don’t shake hard. DO NOT SHAKE. The medicine usually dissolves in less than 2 minutes. The mixed solution should be clear and colorless. Look for particles or color changes. Don’t use if you see anything floating in it or if it’s discolored.

Calculate How Much to Give

Divide the Patient Dose (mcg) by the final strength.

If dose is 23 mcg or more:
Volume to give (mL) = Patient Dose ÷ 500 mcg/mL

If dose is less than 23 mcg:
Volume to give (mL) = Patient Dose ÷ 125 mcg/mL

Giving the Shot

Use only a syringe with 0.01 mL marks for accurate dosing. Round to the nearest hundredth mL. Check that the syringe has the correct amount.

Throw away any leftover medicine. Don’t combine leftovers from different vials. Don’t give more than one dose from a vial.

Storage After Mixing

Mixed with Sterile Water only (not diluted):
• Can stay in the vial at room temperature (77°F) or in the refrigerator (36°F to 46°F) for up to 24 hours
• Can stay in a syringe at room temperature for up to 4 hours
• Keep away from light. Don’t shake.

Mixed with Sterile Water and then diluted with normal saline:
• Can stay in a syringe at room temperature or in the vial in the refrigerator for up to 4 hours before giving
• Keep away from light. Don’t shake.

Patients with Immune Thrombocytopenia (ITP)

Use the lowest dose of Nplate to achieve and maintain a platelet count ≥ 50 × 109/L as necessary to reduce the risk for bleeding. Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet count response.

The prescribed Nplate dose may consist of a very small volume (e.g., 0.15 mL). Administer Nplate only with a syringe that contains 0.01 mL graduations.

Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of Nplate therapy at the maximum weekly dose of 10 mcg/kg[see Warnings and Precautions (5.3)].

Obtain complete blood counts (CBCs), including platelet counts, weekly during the dose adjustment phase of Nplate therapy and then monthly following establishment of a stable Nplate dose. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate.

For Adult Patients with ITPThe initial dose of Nplate is 1 mcg/kg. Actual body weight at initiation of treatment should always be used when calculating the initial dose. In adults, future dose adjustments are based on changes in platelet counts only.Adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a platelet count ≥ 50 × 109/L as necessary to reduce the risk for bleeding; do not exceed a maximum weekly dose of 10 mcg/kg. In clinical studies, most adult patients who responded to Nplate achieved and maintained platelet counts ≥ 50 × 109/L with a median dose of 2-3 mcg/kg.Adjust the dose as follows for adult patients:If the platelet count is < 50 × 109/L, increase the dose by 1 mcg/kg.If platelet count is > 200 × 109/L and ≤ 400 × 109/L for 2 consecutive weeks, reduce the dose by 1 mcg/kg.If platelet count is > 400 × 109/L, do not dose. Continue to assess the platelet count weekly. After the platelet count has fallen to < 200 × 109/L, resume Nplate at a dose reduced by 1 mcg/kg.

For Pediatric Patients with ITPThe initial dose of Nplate is 1 mcg/kg. Actual body weight at initiation of treatment should always be used when calculating initial dose. In pediatric patients, future dose adjustments are based on changes in platelet counts and changes in body weight. Reassessment of body weight is recommended every 12 weeks.Adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a platelet count ≥ 50 × 109/L as necessary to reduce the risk for bleeding; do not exceed a maximum weekly dose of 10 mcg/kg. In a pediatric placebo-controlled clinical study, the median of the most frequent dose of Nplate received by patients during weeks 17 through 24 was 5.5 mcg/kg.Adjust the dose as follows for pediatric patients:If the platelet count is < 50 × 109/L, increase the dose by 1 mcg/kg.If platelet count is > 200 × 109/L and ≤ 400 × 109/L for 2 consecutive weeks, reduce the dose by 1 mcg/kg.If platelet count is > 400 × 109/L, do not dose. Continue to assess the platelet count weekly. After the platelet count has fallen to < 200 × 109/L, resume Nplate at a dose reduced by 1 mcg/kg.

Patients with Hematopoietic Syndrome of Acute Radiation Syndrome

For Adult and Pediatric Patients (including term neonates)The recommended dose of Nplate is 10 mcg/kg administered once as a subcutaneous injection. Administer the dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy).Administer Nplate regardless of whether a complete blood count (CBC) can be obtained. Estimate a patient’s absorbed whole body radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics.

Preparation and Administration

To mitigate against medication errors (both overdose and underdose), ensure that these preparation and administration instructions are followed. Use aseptic technique. Only administer subcutaneously[see Overdosage(10)].

Calculation of Patient Dose

Multiply the patient’s weight (kg) by the prescribed dose to obtain the Calculated Patient Dose.

Calculated Patient Dose (mcg) = Weight (kg) × Prescribed dose (mcg/kg)

Reconstitutionand Dilutionof Nplate Single-DoseVials

Reconstitute Nplate with Sterile Water for Injection, USP.Do notreconstitute or dilute with Bacteriostatic Water for Injection, USP or dilute with Bacteriostatic Sodium Chloride Injection, USP. If the Calculated Patient Dose is less than 23 mcg, dilution with 0.9% Sodium Chloride Injection, USP is required to reduce the concentration of Nplate (seeTable 1). This reduced concentration allows for low-doses to be accurately calculated, and consistently measured with a 0.01 mL graduated syringe.

Gently swirl and invert the vial to reconstitute. Avoid excess or vigorous agitation:DO NOT SHAKE. Generally, dissolution of Nplate takes less than 2 minutes. The reconstituted Nplate solution should be clear and colorless. Visually inspect the reconstituted solution for particulate matter and/or discoloration. Do not administer Nplate if particulate matter and/or discoloration is observed.

Administration of Prepared Nplate Solution

Administer Nplate only using a syringe with 0.01 mL graduations for accurate dosage. Round volume to the nearest hundredth mL. Verify that the syringe contains the correct dosage.

Discard any unused portion.Do notpool unused portions from the vials.Do notadminister more than one dose from a vial.

Storage of Reconstituted Solution

Reconstituted product with Sterile Water for Injection, USP that has not been further diluted can remain in the original vial at room temperature 25°C (77°F) or be refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours following reconstitution. Reconstituted product with Sterile Water for Injection, USP may be held in a syringe at room temperature 25°C (77°F) for a maximum of 4 hours following reconstitution. Protect product from light. Do not shake.

Storage of Diluted solution (after initial reconstitution)

Reconstituted and further diluted product with 0.9% Sodium Chloride Injection, USP can be held in a syringe at room temperature 25°C (77°F) or in the original vial refrigerated at 2°C to 8°C (36°F to 46°F) for no longer than 4 hours prior to administration. Protect product from light. Do not shake.

Dosage Forms and Strengths

Shots: Comes as a white powder in single-use vials. Available in 125 mcg, 250 mcg, or 500 mcg strengths.

For injection: 125 mcg, 250 mcg or 500 mcg of Nplate as a sterile, lyophilized, solid white powder in single-dose vials.

Contraindications

None.

Warnings and Precautions

Risk of Blood Cancer (AML) in Patients with MDS

If you have a blood disorder called MDS, Nplate may increase your risk of getting a type of blood cancer called AML.

In one study, doctors stopped the trial early because more people taking Nplate got AML compared to people taking placebo (fake medicine). The study included 250 adults with MDS and low platelet counts. During the first 58 weeks, 10 out of 167 people (6.0%) taking Nplate got AML compared to 4 out of 83 people (4.8%) taking placebo. After 5 years of follow-up, 20 out of 168 people (11.9%) taking Nplate got AML compared to 9 out of 82 people (11.0%) taking placebo. About the same number of people died in both groups.

In another study of 72 patients with MDS taking Nplate, 3 people (4.2%) developed AML. In 3 other patients, abnormal blood cells went back to normal after they stopped taking Nplate.

Nplate is not approved to treat low platelet counts caused by MDS or any other condition except ITP.

Blood Clots

Nplate can cause dangerous blood clots because it raises your platelet count. Blood clots have happened in the legs (1.4%), lungs (1.2%), and heart (0.8%) in people with ITP taking Nplate. Other clots like mini-strokes and liver blood clots have also happened. These can occur even when platelet counts are not too high.

To lower your risk of blood clots, your doctor will not try to make your platelet count completely normal. Your doctor will adjust your dose carefully.

If you are exposed to radiation, do not take Nplate unless your platelet count is very low. Otherwise, your platelet count may get too high and cause blood clots.

When Nplate Stops Working

Nplate may stop working over time. This can happen if your body makes antibodies against it or for other reasons. Your doctor will stop Nplate if your platelet count does not get high enough to prevent serious bleeding after 4 weeks at the highest dose (10 mcg/kg per week).

Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia

Progression from myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML) has been observed in adult clinical trials with Nplate.

A randomized, double-blind, placebo-controlled trial enrolling adult patients with severe thrombocytopenia and International Prognostic Scoring System (IPSS) low or intermediate-1 risk MDS was terminated due to more cases of AML observed in the Nplate arm. This trial consisted of a 58-week study period with a 5-year long-term follow-up phase. The patients were randomized 2:1 to treatment with Nplate or placebo (167 Nplate, 83 placebo). During the 58-week study period, progression to AML occurred in 10 (6.0%) patients in the Nplate arm and 4 (4.8%) patients in the placebo arm (hazard ratio [95%CI] = 1.20 [0.38, 3.84]). Of the 250 patients, 210 (84.0%) entered the long-term follow-up phase of this study. With 5 years of follow-up, 29 (11.6%) patients showed progression to AML, including 20/168 (11.9%) patients in the Nplate arm versus 9/82 (11.0%) patients in the placebo arm (HR [95% CI] = 1.06 [0.48, 2.33]). The incidence of death (overall survival) was 55.7% (93/167) in the Nplate arm versus 54.2% (45/83) in the placebo arm (HR [95% CI] = 1.03 [0.72, 1.47]). In the baseline low IPSS group, there was a higher incidence of death in the Nplate arm [41.3% (19/46)] compared to the placebo arm [30.4% (7/23)] (HR [95% CI] = 1.59 [0.67, 3.80]).

In a single-arm trial of Nplate given to 72 patients with thrombocytopenia-related MDS, 8 (11.1%) patients were reported as having possible disease progression, of which 3 (4.2%) had confirmation of AML during follow-up. In addition, in 3 (4.2%) patients, increased peripheral blood blast cell counts decreased to baseline after discontinuation of Nplate.

Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than ITP.

Thrombotic/Thromboembolic Complications

Thrombotic/thromboembolic complications have resulted from increases in platelet counts with Nplate use secondary to drug-induced thrombocytosis, regardless of the underlying disease. Thrombotic/ thromboembolic events including deep vein thrombosis (1.4%), pulmonary embolism (1.2%) and myocardial infarction (0.8%) have been observed with the use of Nplate in the ITP population. Other thrombotic events including transient ischemic attack have been reported. These events have occurred regardless of platelet counts. Portal vein thrombosis has been reported in patients with and without chronic liver disease receiving Nplate.

In patients with ITP, to minimize the risk for thrombotic/thromboembolic complications, do not use Nplate in an attempt to normalize platelet counts. Follow the dose adjustment guidelines[see Dosage and Administration (2.1)].

In the absence of myelosuppression induced by acute exposure to radiation, Nplate administration might cause excessive increases in platelet counts and may cause thrombotic and thromboembolic complications[seeClinical Pharmacology (12.2)].

Loss of Response to Nplate

Hyporesponsiveness or failure to maintain a platelet response with Nplate may occur due to neutralizing antibodies or other causes[see Adverse Reactions (6.3)]. Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the highest weekly dose of 10 mcg/kg.

Adverse Reactions

What You Should Know About Side Effects

The side effects listed here come from studies where people took Nplate. Side effects in studies may be different from what happens when you take the medicine at home.

Side Effects in Adults

271 adults with ITP took Nplate in studies. They were 18 to 88 years old, and most were women. Some had their spleen removed and some did not. 114 people took Nplate for at least 1 year, and 53 people took it for at least 2 years.

The most common side effect was headache. It happened in 35% of people taking Nplate and 32% of people taking placebo (fake medicine). Most headaches were mild or moderate, but some were severe.

Common Side Effects (happened at least 5% more often with Nplate than placebo):

– Joint pain (26% with Nplate, 20% with placebo)
– Muscle pain (14% with Nplate, 2% with placebo)
– Pain in arms or legs (13% with Nplate, 5% with placebo)
– Shoulder pain (8% with Nplate, 0% with placebo)
– Dizziness (17% with Nplate, 0% with placebo)
– Numbness or tingling (6% with Nplate, 0% with placebo)
– Trouble sleeping (16% with Nplate, 7% with placebo)
– Stomach pain (11% with Nplate, 0% with placebo)
– Upset stomach (7% with Nplate, 0% with placebo)

In a longer study with 291 adults, the side effects were similar.

For people who had ITP for less than 1 year, these side effects also happened: bronchitis, sinus infection, vomiting, cough, diarrhea, cold symptoms, nausea, and sore throat. Too many platelets happened in 2% of these people.

Bone Marrow Problems

Nplate may cause extra fibers to form in your bone marrow. This may get better if you stop taking Nplate. In one study, a patient developed serious scarring in the bone marrow.

In a 3-year study of 169 adults, doctors checked bone marrow changes. Out of 132 people checked, 2 people (2%) developed serious scarring with collagen. In one person, the scarring went away 12 weeks after stopping the medicine. 7% of people had their bone marrow fibers get worse.

Side Effects in Children

59 children (ages 1 to 17) with ITP took Nplate for about 6 months in studies. About half were girls.

Common Side Effects in Children (happened at least 5% more often with Nplate than placebo):

– Bruising (41% with Nplate, 33% with placebo)
– Cold symptoms (31% with Nplate, 25% with placebo)
– Sore throat (25% with Nplate, 4% with placebo)
– Fever (24% with Nplate, 8% with placebo)
– Diarrhea (20% with Nplate, 13% with placebo)
– Rash (15% with Nplate, 8% with placebo)
– Upper stomach pain (14% with Nplate, 4% with placebo)
– Swelling (7% with Nplate, 0% with placebo)
– Purple spots on skin (7% with Nplate, 0% with placebo)
– Hives (5% with Nplate, 0% with placebo)
– Ear infection (5% with Nplate, 0% with placebo)
– Stomach flu (5% with Nplate, 0% with placebo)
– Sinus infection (5% with Nplate, 0% with placebo)

In a longer study with 203 children (average 3 years on Nplate), side effects were similar. Headache happened in 38% of children. Most headaches were mild, but 3% were severe and 1% stopped taking the medicine because of headaches.

Bone Marrow Problems in Children

In a study of 79 children, doctors checked bone marrow changes after 1 or 2 years. Out of 27 children checked after 1 year, 18.5% had more fibers in their bone marrow. Out of 36 children checked after 2 years, 47.2% had more fibers. None of the children developed serious scarring or other bone marrow problems.

Side Effects Reported After Nplate Was Approved

These side effects were reported after Nplate started being sold. We don’t know exactly how often they happen:

– Erythromelalgia (burning pain and redness in hands or feet)
– Allergic reactions including swelling and severe allergic reactions

Antibodies (Your Body’s Reaction to Nplate)

Your body might make antibodies against Nplate or against your natural platelet-making protein (TPO). Doctors tested for this in studies.

In Adults:
– 3.3% had antibodies to Nplate before treatment
– 5.7% developed antibodies to Nplate during treatment
– 3% had antibodies to TPO before treatment
– 3.2% developed antibodies to TPO during treatment
– 4 people had antibodies that stopped Nplate from working
– No one had antibodies that stopped TPO from working
– These antibodies didn’t seem to affect how well Nplate worked or cause safety problems

In Children:
– Out of 282 children, 9.6% developed antibodies to Nplate at some point
– 3.9% still had antibodies at the end of the study
– 2.8% developed antibodies that stopped Nplate from working
– 1.4% still had these antibodies at the end of the study
– 3.9% developed antibodies to TPO at some point
– 0.4% still had antibodies to TPO at the end of the study
– One child had antibodies that stopped TPO from working, but this went away

After Nplate Was Approved:

In a study of 184 adults who stopped responding to Nplate:
– 3.8% developed new antibodies to Nplate
– 2.2% developed antibodies to TPO
– 0.5% had antibodies that stopped Nplate from working

In a study of 19 children who stopped responding to Nplate:
– 16% developed antibodies to Nplate
– 5.3% had antibodies that stopped Nplate from working
– No antibodies to TPO were found

The tests for antibodies can vary, so comparing results between different studies may not be accurate.

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.

Adults

The data described below reflect Nplate exposure to 271 adult patients with ITP, aged 18 to 88, of whom 62% were female. Nplate was studied in two randomized, placebo-controlled, double-blind studies that were identical in design, with the exception that Study 1 evaluated non-splenectomized patients with ITP and Study 2 evaluated splenectomized patients with ITP. Data are also reported from an open-label, single-arm study in which patients received Nplate over an extended period of time. Overall, Nplate was administered to 114 patients for at least 52 weeks and 53 patients for at least 96 weeks.

Among 291 adult patients with ITP who received Nplate in the single-arm extension study, the incidence rates of the adverse reactions occurred in a pattern similar to those reported in the placebo-controlled clinical studies.

The safety profile of Nplate was similar across patients, regardless of ITP duration. The following adverse reactions (at least 5% incidence and at least 5% more frequent with Nplate compared with placebo or standard of care) occurred in Nplate patients with ITP duration up to 12 months: bronchitis, sinusitis, vomiting, arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough, nausea and oropharyngeal pain. The adverse reaction of thrombocytosis occurred with an incidence of 2% in adults with ITP duration up to 12 months.

Bone Marrow Reticulin Formation and Collagen Fibrosis

Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy.

Pediatric Patients

Among 203 pediatric patients with ITP who received Nplate in a single arm, open-label, long-term (median duration of 3 years on therapy) study, the incidence rates of the adverse reactions occurred in a pattern similar to those reported in the placebo-controlled clinical studies. In this single arm, open-label, long-term study, headache occurred in 78 patients (38%), 3% (n=6) being severe and 1% (n=2) resulting in discontinuation of drug.

Bone Marrow Reticulin Formation and Collagen FibrosisThe open-label long-term study also evaluated changes in bone marrow reticulin and collagen formation. The modified Bauermeister grading scale was used for both assessments. Based on cohort assignment at the time of study enrollment, patients were evaluated for bone marrow reticulin and collagen at year 1 (cohort 1) or year 2 (cohort 2) in comparison to the baseline bone marrow at the start of the study. From the total of 79 patients enrolled in the 2 cohorts, 27 (90%) patients in cohort 1 and 36 (73.5%) patients in cohort 2 had evaluable on-study bone marrow biopsies. Increased reticulin fiber formation was reported for 18.5% (5 of 27) of patients in cohort 1 and 47.2% (17 of 36) of patients in cohort 2, with a maximum grade of 2. No patients in either cohort developed collagen fibrosis (defined as grade 4) or a bone marrow abnormality that was inconsistent with an underlying diagnosis of ITP.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Nplate. Because these reactions 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.

ErythromelalgiaHypersensitivity reactions including angioedema and anaphylaxis

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Nplate in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. Patients were screened for immunogenicity to romiplostim using a BIAcore-based biosensor immunoassay. This assay is capable of detecting both high- and low-affinity binding antibodies that bind to romiplostim and cross-react with TPO. The samples from patients that tested positive for binding antibodies were further evaluated for neutralizing capacity using a cell-based bioassay.

In adult clinical studies in adult patients with ITP, the incidence of pre-existing antibodies to romiplostim was 3.3% (35/1046) and the incidence of binding antibody development during treatment with Nplate or a non-US approved romiplostim product was 5.7% (60/1046). The incidence of pre-existing antibodies to endogenous TPO was 3% (31/1046) and the incidence of binding antibody development to endogenous TPO during treatment was 3.2% (33/1046). Of the patients with positive binding antibodies that developed to romiplostim or to TPO, four patients had neutralizing activity to romiplostim and none had neutralizing activity to TPO. No apparent correlation was observed between antibody activity and clinical effectiveness or safety.

In pediatric studies, data on antibody formation was collected from 282 patients (20 from early phase studies, 59 from phase 3 studies with duration of 6 months and 203 from a long-term study with median duration of 3 years). The incidence of binding antibodies to Nplate at any time was 9.6% (27/282), of which 2 patients (0.7%) had pre-existing binding non-neutralizing Nplate antibodies at baseline and 11 patients (3.9%) had persistent binding antibody positivity at end of study. Additionally, 2.8% (8/282) developed neutralizing antibodies to Nplate, with 4 patients (1.4%) having persistent neutralizing antibody positivity at end of study, despite discontinuation of Nplate. The incidence of binding antibodies to TPO at any time was 3.9% (11/282), of which 2 patients (0.7%) had pre-existing binding non-neutralizing antibodies to TPO at baseline and 1 patient (0.4%) had binding persistent antibody positivity at end of study. One patient (0.4%) had a weakly positive postbaseline result for neutralizing antibodies against TPO while on study (with positive non-neutralizing antibodies to Nplate) with a negative result at baseline for both antibodies. The patient showed a transient antibody response for neutralizing antibodies against TPO, with a negative result at the patient’s last timepoint tested within the study period after discontinuation of Nplate.

A postmarketing registry study involving patients with thrombocytopenia on Nplate or a non-US approved romiplostim product was conducted to assess the long-term consequences of the anti-romiplostim antibodies. Adult patients who lacked response or lost response to Nplate or a non-US approved romiplostim product were enrolled. The incidence of new binding antibody development was 3.8% (7/184) to romiplostim and 2.2% (4/184) were positive for binding, non-neutralizing antibodies to TPO; two patients were positive for binding antibodies to both romiplostim and TPO. Of the seven patients with positive binding antibodies to romiplostim, one patient (0.5%; 1/184) was positive for neutralizing antibodies to romiplostim only.

Nineteen confirmed pediatric patients were included in the postmarketing registry study. The incidence of binding antibody post treatment was 16% (3/19) to romiplostim, of which 5.3% (1/19) were positive for neutralizing antibodies to romiplostim. There were no antibodies detected to TPO.

Immunogenicity assay results are highly dependent on the sensitivity and specificity of the assay used in detection and may be influenced by several factors, including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to romiplostim with the incidence of antibodies to other products may be misleading.

Drug Interactions

Nplate can be used with other ITP treatments, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.

Nplate may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin[see Clinical Studies (14.1)].

Pregnancy

If You Are Pregnant

Nplate may harm your unborn baby based on animal studies. We don’t have enough information from pregnant women to know for sure what risks there are. In animal studies, the medicine crossed to the baby and caused problems including high platelet counts, pregnancy loss, and death in newborn animals.

We don’t know the exact risk of birth defects or miscarriage for people who need this medicine. All pregnancies have some risk. In the general U.S. population, about 2-4% of babies have major birth defects and 15-20% of pregnancies end in miscarriage.

Animal Studies

In rats and rabbits, no harm to babies was seen at doses much higher than human doses. In mice at 5 times the human dose, mothers lost weight and more pregnancies were lost.

In rat studies at 11 times the human dose, more newborn pups died. The medicine crossed to the babies in rats and increased their platelet counts.

If You Are Breastfeeding

We don’t know if Nplate gets into breast milk or what it might do to a breastfed baby. Because this medicine could cause serious problems in a breastfed baby, don’t breastfeed while taking Nplate.

Use in Children

Nplate is safe and works for children 1 year and older with ITP who have had it for at least 6 months. This was shown in two studies. Long-term safety was studied in children who used it for about 3 years.

Nplate has not been studied in babies younger than 1 year with ITP.

For radiation exposure, Nplate’s use in children is based on studies in adult animals. We expect it to work the same way in children and adults based on how the medicine works in the body.

Use in Older Adults

Of 271 patients in ITP studies, 55 (20%) were 65 or older and 27 (10%) were 75 or older. The medicine worked the same and had similar side effects in older and younger patients. Older patients may need careful dose adjustments because of other health problems or medicines they take.

Pregnancy

Risk Summary

Based on findings from animal reproduction studies, Nplate may cause fetal harm when administered to a pregnant woman. Available data with Nplate use in pregnant women are insufficient to draw conclusions about any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction and developmental toxicity studies, romiplostim crossed the placenta, and adverse fetal effects included thrombocytosis, postimplantation loss, and an increase in pup mortality(see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

In rat and rabbit embryo-fetal development toxicity studies, no evidence of fetal harm was observed at romiplostim doses up to 11 times (rats) and 82 times (rabbits) the maximum human dose (MHD) based on systemic exposure (AUC). In mice at doses 5 times the MHD, reductions in maternal body weight and increased postimplantation loss occurred.

In a prenatal and postnatal development study in rats, at doses 11 times the MHD, there was an increase in perinatal pup mortality. Romiplostim crossed the placental barrier in rats and increased fetal platelet counts at clinically equivalent and higher doses.

Lactation

Risk Summary

There is no information regarding the presence of romiplostim in human milk, the effects on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to romiplostim are unknown. Due to the potential for serious adverse reactions in a breastfed child from Nplate, advise women not to breastfeed during treatment with Nplate.

Pediatric Use

Safety and effectiveness of Nplate have been established in pediatric patients age 1 year and older with ITP for at least 6 months evaluated in two randomized, placebo-controlled studies. Long-term safety in the same population using Nplate for a median duration of 3 years was also evaluated in a single arm, open-label study[see Adverse Reactions (6.1), Clinical Studies (14.2)].

The pharmacokinetics of romiplostim have been evaluated in pediatric patients 1 year and older with ITP[see Clinical Pharmacology (12.3)]. SeeDosage and Administration (2.1)for dosing recommendations for pediatric patients 1 year and older.

The safety and efficacy of Nplate in pediatric patients younger than 1 year with ITP have not been established. Serum concentrations of romiplostim in pediatric patients with ITP were within the range observed in adult patients with ITP receiving the same dose range of romiplostim.

The use of Nplate to increase survival in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation is based on efficacy studies conducted in adult animals. Efficacy studies of Nplate could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. A similar response to Nplate is expected in the pediatric and adult patients based on the mechanism of action of the drug and pharmacokinetics of Nplate in pediatric patients 1 year and older with ITP[seeDosage and Administration (2.2)andClinical Pharmacology (12.3)].

Geriatric Use

Lactation

Breastfeeding

We don’t know if Nplate passes into breast milk or if it could harm your baby. We also don’t know if it affects how much milk you make.

Because Nplate could cause serious harm to a breastfed baby, do not breastfeed while taking Nplate.

Pregnancy

Risk Summary

Data

Animal Data

Lactation

Risk Summary

Pediatric Use

Geriatric Use

Pediatric Use

Use in Children

Nplate is safe and works well for children 1 year and older with ITP (low platelet count) for at least 6 months. This was shown in two studies. Another study showed it was safe when used for about 3 years.

Nplate has been studied in children 1 year and older with ITP to see how the body handles it. See the dosing section for how much to give children 1 year and older.

Nplate has not been studied in babies younger than 1 year with ITP. The amount of Nplate in children’s blood was similar to adults taking the same dose.

Nplate is also used to help children (including newborns) survive after being exposed to high amounts of radiation. This use is based on studies done in adult animals. Studies could not be done in people for safety and practical reasons. Nplate should work the same way in children and adults based on how the drug works and how children’s bodies handle it.

Use in Older Adults

Of 271 patients who took Nplate in ITP studies, 55 (20%) were 65 or older, and 27 (10%) were 75 or older. No differences in safety or how well it worked were seen between older and younger patients. However, some older people may be more sensitive to the medicine. When adjusting the dose for an older patient, doctors should be careful because older people may have liver, kidney, or heart problems, or take other medicines.

Pregnancy

Risk Summary

Data

Animal Data

Lactation

Risk Summary

Pediatric Use

Geriatric Use

Use in Older Adults

Out of 271 patients who took Nplate in studies, 55 (20%) were age 65 and older, and 27 (10%) were 75 and older. The medicine worked the same and had similar side effects in older and younger patients. However, some older people may be more sensitive to the medicine.

When choosing a dose for an older patient, doctors should be careful. This is because older people are more likely to have liver, kidney, or heart problems. They may also take other medicines or have other health conditions.

Pregnancy

Risk Summary

Data

Animal Data

Lactation

Risk Summary

Pediatric Use

Geriatric Use

Hepatic Impairment

If You Are Pregnant

Nplate may harm your unborn baby. Animal studies showed the medicine crossed to the baby and caused problems like high platelet counts, pregnancy loss, and death in newborn animals.

We don’t have enough information from pregnant women to know all the risks. Every pregnancy has some risk of birth defects (2-4%) or miscarriage (15-20%).

Animal Study Results

In rats and rabbits, no harm to babies was seen at doses much higher than human doses. In mice at 5 times the human dose, mothers lost weight and had more pregnancy losses.

In rat studies, more newborn pups died at 11 times the human dose. The medicine crossed to the babies and raised their platelet counts.

If You Are Breastfeeding

We don’t know if Nplate gets into breast milk or how it might affect your baby. Because of possible serious side effects, do not breastfeed while taking Nplate.

Use in Children

Nplate is safe and works for children 1 year and older with ITP lasting at least 6 months. Studies showed it was safe when used for up to 3 years.

Nplate has not been studied in babies younger than 1 year with ITP.

For radiation exposure, Nplate is expected to work the same in children and adults based on how the medicine works in the body.

Use in Older Adults

In studies, 55 patients (20%) were 65 or older, and 27 (10%) were 75 or older. The medicine worked the same in older and younger patients. Older patients may need careful dose adjustments because of other health problems or medicines they take.

Pregnancy

Risk Summary

Data

Animal Data

Lactation

Risk Summary

Pediatric Use

Geriatric Use

Renal Impairment

If You Are Pregnant

Nplate may harm your unborn baby based on animal studies. We don’t have enough information from pregnant women to know for sure what risks there are. In animal studies, the medicine crossed to the baby and caused problems like high platelet counts, pregnancy loss, and death in newborn animals.

Animal Studies

In rats and rabbits, no harm to babies was seen at doses up to 11 times (rats) and 82 times (rabbits) the highest human dose. In mice at 5 times the human dose, mothers lost weight and more pregnancies were lost.

In rat studies, more newborn pups died at 11 times the human dose. The medicine crossed to the babies and raised their platelet counts.

If You Are Breastfeeding

Use in Children

Nplate is safe and works for children 1 year and older with ITP for at least 6 months. This was shown in two studies. Long-term safety was studied in children who used Nplate for about 3 years.

Nplate has not been studied in babies younger than 1 year with ITP.

For radiation exposure, Nplate’s use in children is based on studies in adult animals. We expect it to work the same way in children and adults based on how the medicine works in the body.

Use in Older Adults

Of 271 patients who took Nplate in studies, 55 (20%) were 65 or older, and 27 (10%) were 75 or older. No differences in safety or how well it worked were seen between older and younger patients, but some older people might be more sensitive. Doctors should be careful with dosing in older patients because they may have liver, kidney, or heart problems, or take other medicines.

Pregnancy

Risk Summary

Data

Animal Data

Lactation

Risk Summary

Pediatric Use

Geriatric Use

Description

What Romiplostim Is

Romiplostim is a man-made protein that helps your body make more platelets (blood cells that help with clotting). It works by attaching to special spots on your cells. Romiplostim does not look like the natural protein your body makes. It is made in a lab using bacteria.

What Nplate Looks Like

Nplate (romiplostim) comes as a white powder in a vial. It must be mixed with sterile water before use. You inject it under your skin. It comes in three sizes: 125 mcg, 250 mcg, or 500 mcg per vial. After mixing, the concentration is 500 mcg/mL.

What’s in Each Vial

125 mcg vial contains: 125 mcg romiplostim, L-histidine (0.7 mg), mannitol (18 mg), polysorbate 20 (0.02 mg), sucrose (9 mg), and acid to adjust pH to 5. Mix with 0.44 mL sterile water to get 125 mcg/0.25 mL.

250 mcg vial contains: 250 mcg romiplostim, L-histidine (1.2 mg), mannitol (30 mg), polysorbate 20 (0.03 mg), sucrose (15 mg), and acid to adjust pH to 5. Mix with 0.72 mL sterile water to get 250 mcg/0.5 mL.

500 mcg vial contains: 500 mcg romiplostim, L-histidine (1.9 mg), mannitol (50 mg), polysorbate 20 (0.05 mg), sucrose (25 mg), and acid to adjust pH to 5. Mix with 1.2 mL sterile water to get 500 mcg/mL.

Romiplostim is a thrombopoietin receptor agonist (TPO-RA). Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody). The peptibody molecule contains two identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain, covalently linked at the C-terminus to a peptide containing two thrombopoietin receptor-binding domains. Romiplostim has no amino acid sequence homology to endogenous TPO. Romiplostim is produced by recombinant DNA technology inEscherichia coli (E.coli).

Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous use. Nplate is supplied as either 125 mcg per vial, 250 mcg per vial or 500 mcg per vial of romiplostim and requires reconstitution with Sterile Water for Injection to obtain a concentration of 500 mcg/mL.

Each single-dose 125 mcg vial of Nplate contains the following: 125 mcg of romiplostim, L-histidine (0.7 mg), mannitol (18 mg), polysorbate 20 (0.02 mg), sucrose (9 mg), and sufficient HCl to adjust the pH to a target of 5. Reconstitution with 0.44 mL of Sterile Water for Injection provides a resulting concentration of 125 mcg/0.25 mL.

Each single-dose 250 mcg vial of Nplate contains the following: 250 mcg romiplostim, L-histidine (1.2 mg), mannitol (30 mg), polysorbate 20 (0.03 mg), sucrose (15 mg), and sufficient HCl to adjust the pH to a target of 5. Reconstitution with 0.72 mL of Sterile Water for Injection provides a resulting concentration of 250 mcg/0.5 mL.

Each single-dose 500 mcg vial of Nplate contains the following: 500 mcg romiplostim, L-histidine (1.9 mg), mannitol (50 mg), polysorbate 20 (0.05 mg), sucrose (25 mg), and sufficient HCl to adjust the pH to a target of 5. Reconstitution with 1.2 mL of Sterile Water for Injection provides a resulting concentration of 500 mcg/mL.

Mechanism of Action

How This Medicine Works

Nplate helps your body make more platelets by attaching to and turning on a specific receptor. This works similar to how your body naturally makes platelets.

What Happens When You Take This Medicine

In studies, Nplate increased platelet counts based on the dose given. After one injection under the skin, platelet counts peaked 1.3 to 14.9 times higher than starting levels over 2 to 3 weeks. Seven out of eight patients who got six weekly doses had platelet counts above 50 × 10⁹/L.

In healthy adults given one IV dose, peak platelet counts increased 4.7 to 7.3 times above starting levels (average: 5.8 times).

Computer models show that one injection under the skin would help reduce how often and how long severe low platelet counts happen in people exposed to high doses of radiation.

How the Body Processes This Medicine

Patients with ITP: In long-term studies of adults getting weekly injections under the skin, the highest blood levels appeared about 7 to 50 hours after the dose (usually around 14 hours). The medicine stayed in the body for 1 to 34 days (usually 3.5 days). Blood levels varied between patients and didn’t match the dose given. The medicine leaves your body partly through platelet receptors. This means patients with high platelet counts have lower blood levels of the medicine and the opposite is also true. In another study, the medicine didn’t build up in the blood after six weekly doses. Whether it builds up at higher doses is unknown.

Patients Exposed to Radiation: No information is available for these patients.

Special Groups

Children: Blood levels in children with ITP were similar to adults getting the same doses. Like adults, blood levels vary a lot between children.

Mechanism of Action

Nplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO.

Pharmacodynamics

In clinical studies, treatment with Nplate resulted in dose-dependent increases in platelet counts. After a single subcutaneous dose of 1 to 10 mcg/kg Nplate in patients with ITP, the peak platelet count was 1.3 to 14.9 times greater than the baseline platelet count over a 2- to 3-week period. The platelet counts were above 50 × 109/L for seven out of eight patients with ITP who received six weekly doses of Nplate at 1 mcg/kg.

In a clinical study, peak platelet count increased 4.7 to 7.3 fold (mean: 5.8 fold) above baseline values in healthy adults (n = 4) administered a single 10 mcg/kg IV dose of Nplate.

Results from population modeling and simulation indicate that a single 10 mcg/kg subcutaneous dose of Nplate would result in clinically relevant effects on incidence rate and duration of severe thrombocytopenia in patients acutely exposed to myelosuppressive doses of radiation.

Pharmacokinetics

Patients with Immune Thrombocytopenia (ITP)In the long-term extension study in adult patients with ITP receiving weekly treatment of Nplate subcutaneously, the pharmacokinetics of romiplostim over the dose range of 3 to 15 mcg/kg indicated that peak serum concentrations of romiplostim were observed about 7 to 50 hours post dose (median: 14 hours) with half-life values ranging from 1 to 34 days (median: 3.5 days). The serum concentrations varied among patients and did not correlate with the dose administered. The elimination of serum romiplostim is in part dependent on the TPO receptor on platelets. As a result, for a given dose, patients with high platelet counts are associated with low serum concentrations and vice versa. In another ITP clinical study, no accumulation in serum concentrations was observed (n = 4) after six weekly doses of Nplate (3 mcg/kg). The accumulation at higher doses of romiplostim is unknown.

Patients Acutely Exposed to Myelosuppressive Doses of RadiationThe pharmacokinetics of romiplostim is not available in patients acutely exposed to myelosuppressive doses of radiation.Specific Populations

Pediatric PatientsSerum concentrations of romiplostim in pediatric patients with ITP were within the range observed in adult patients with ITP receiving the same dose range of romiplostim. Similar to adults with ITP, romiplostim pharmacokinetics are highly variable in pediatric patients with ITP.

Patient Counseling Information

Read the Medication Guide

Read the FDA-approved patient information guide.

For Radiation Exposure Patients

If you were exposed to high levels of radiation, you should know that this medicine could not be tested in humans for ethical reasons. It was approved based on animal studies.

Important Things to Know About Nplate:

• Nplate is given to keep your platelet count at 50 or higher to reduce bleeding risk. It is not used to make your platelet count normal.

• When you stop taking Nplate, your platelet count may drop very low—even lower than before you started the medicine. This increases your risk of bleeding.

• Nplate may cause extra fibers to form in your bone marrow. This may get better after you stop the medicine. If your blood tests show problems, you may need a bone marrow test.

• Too much Nplate can cause your platelet count to get too high. This can lead to dangerous blood clots.

• Nplate makes certain bone marrow cells produce more platelets. In patients with myelodysplastic syndromes, this increases the risk of developing acute myelogenous leukemia.

• You must have platelet counts and complete blood counts done weekly until your Nplate dose is stable. After that, you need these tests done monthly while taking Nplate.

• After you stop Nplate, you must have platelet counts and complete blood counts done weekly for at least 2 weeks.

• Even while taking Nplate, avoid situations or medicines that may increase your risk of bleeding.

Pregnancy:

• Nplate may harm your unborn baby. Tell your doctor if you are pregnant or think you might be pregnant.

Breastfeeding:

• Do not breastfeed while taking Nplate.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) that efficacy studies of Nplate for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals[seeClinical Studies (14.3)].

Inform patients of the following risks and considerations for Nplate:

• Nplate therapy is administered to achieve and maintain a platelet count ≥ 50 × 109/L as necessary to reduce the risk for bleeding; Nplate is not used to normalize platelet counts.

• Following discontinuation of Nplate, thrombocytopenia and risk of bleeding may develop that is worse than that experienced prior to the Nplate therapy.

• Nplate therapy may increase the risk of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation. Detection of peripheral blood cell abnormalities may necessitate a bone marrow examination.

• Too much Nplate may result in excessive platelet counts and a risk for thrombotic/thromboembolic complications.

• Nplate stimulates certain bone marrow cells to make platelets and increases the risk of progression to acute myelogenous leukemia in patients with myelodysplastic syndromes.

• Platelet counts and CBCs must be performed weekly until a stable Nplate dose has been achieved; thereafter, platelet counts and CBCs must be performed monthly while taking Nplate.

• Patients must be closely monitored with weekly platelet counts and CBCs for at least 2 weeks following Nplate discontinuation.

• Even with Nplate therapy, patients should continue to avoid situations or medications that may increase the risk for bleeding.

Pregnancy:

• Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy[see Use in Specific Populations (8.1)].

Lactation:

• Advise women not to breastfeed during treatment with Nplate[see Use in Specific Populations (8.2)].

Nplate®(romiplostim)

Manufactured by:Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799U.S. License No. 1080

Patent: http://pat.amgen.com/nplate/

www.nplate.com

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DailyMed ()) [prescribing information]. March 2026. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c45f9a58-37c1-4f76-8e36-97d38c577037

Accessed: March 27, 2026

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