KISQALI
ribociclib
Cancer medicine that slows cell growth
Quick Facts
Used For
Early Breast Cancer KISQALI is used with another hormone medicine to treat adults after breast...
Common Side Effects
What Happened to Patients in Studies Doctors test medicines in studies with...
What You Should Know
Read the patient information sheet that comes with your medicine. Lung Problems Tell your doctor...
Prescription
Not Required
Generic Available
No
Indications and Usage
Early Breast Cancer
KISQALI is used with another hormone medicine to treat adults after breast cancer surgery. It is for people with hormone-positive, HER2-negative stage II and III early breast cancer that has a high chance of coming back.
Advanced or Metastatic Breast Cancer
KISQALI is used to treat adults with hormone-positive, HER2-negative advanced or metastatic breast cancer. It is used with:
• An aromatase inhibitor as the first hormone treatment
• Fulvestrant as the first hormone treatment or after other hormone treatments stop working
Early Breast Cancer
KISQALI is used with another hormone medicine to treat adults after breast cancer surgery. It is for people with hormone-positive, HER2-negative stage II and III early breast cancer that has a high chance of coming back.
Advanced or Metastatic Breast Cancer
KISQALI is used to treat adults with hormone-positive, HER2-negative advanced or metastatic breast cancer. It is used with:
• An aromatase inhibitor as the first hormone treatment
• Fulvestrant as the first hormone treatment or after other hormone treatments stop working
Dosage and Administration
How Much to Take
Important Instructions for Taking KISQALI
You can take KISQALI with or without food.
Women who still have periods and men taking KISQALI with certain hormone medicines should also get hormone shots. Your doctor will tell you about this.
Take your KISQALI dose at the same time each day. Morning is best.
If you throw up after taking your dose or miss a dose, do not take another pill that day. Just take your next dose at the usual time. Swallow the tablets whole. Do not chew, crush, or break them. Do not take any tablet that is broken or cracked.
Early Breast Cancer
Take 400 mg (two 200 mg tablets) by mouth once a day for 21 days in a row. Then take 7 days off. This makes a 28-day cycle. Take KISQALI with a hormone medicine.
For early breast cancer, keep taking KISQALI for 3 years or until your cancer comes back or you have bad side effects.
Advanced or Spread Breast Cancer
Take 600 mg (three 200 mg tablets) by mouth once a day for 21 days in a row. Then take 7 days off. This makes a 28-day cycle. Take KISQALI with hormone therapy.
Changing Your Dose
Changing Dose for Side Effects
Your doctor may need to lower your dose if you have side effects.
Dose Changes:
Early breast cancer:
• Starting dose: 400 mg/day (two 200 mg tablets)
• Lower dose: 200 mg/day (one 200 mg tablet)
Advanced or spread breast cancer:
• Starting dose: 600 mg/day (three 200 mg tablets)
• First lower dose: 400 mg/day (two 200 mg tablets)
• Second lower dose: 200 mg/day (one 200 mg tablet)
If you need less than 200 mg/day, stop taking KISQALI.
Your doctor will tell you how to change your dose based on side effects like lung problems, heart rhythm changes, liver problems, low white blood cells, and other side effects.
Taking KISQALI with Certain Other Medicines
Do not take KISQALI with strong medicines that change how your body breaks down KISQALI. Ask your doctor about other medicines you can take instead.
If you must take these medicines together:
Early breast cancer: Lower KISQALI to 200 mg once daily
Advanced or spread breast cancer: Lower KISQALI to 400 mg once daily
When you stop the other medicine, your doctor will change your KISQALI dose back after at least 5 days.
Liver Problems
If you have mild liver problems, you do not need to change your dose.
If you have worse liver problems and advanced or spread breast cancer, take 400 mg once daily.
Kidney Problems
If you have bad kidney problems, start with 200 mg KISQALI once daily.
How Much to Take
Important Instructions for Taking KISQALI
You can take KISQALI with or without food.
Women who still have periods and men taking KISQALI with certain hormone medicines should also get hormone shots. Your doctor will tell you about this.
Take your KISQALI dose at the same time each day. Morning is best.
If you throw up after taking your dose or miss a dose, do not take another pill that day. Just take your next dose at the usual time. Swallow the tablets whole. Do not chew, crush, or break them. Do not take any tablet that is broken or cracked.
Early Breast Cancer
Take 400 mg (two 200 mg tablets) by mouth once a day for 21 days in a row. Then take 7 days off. This makes a 28-day cycle. Take KISQALI with a hormone medicine.
For early breast cancer, keep taking KISQALI for 3 years or until your cancer comes back or you have bad side effects.
Advanced or Spread Breast Cancer
Take 600 mg (three 200 mg tablets) by mouth once a day for 21 days in a row. Then take 7 days off. This makes a 28-day cycle. Take KISQALI with hormone therapy.
Changing Your Dose
Changing Dose for Side Effects
Your doctor may need to lower your dose if you have side effects.
Dose Changes:
Early breast cancer:
• Starting dose: 400 mg/day (two 200 mg tablets)
• Lower dose: 200 mg/day (one 200 mg tablet)
Advanced or spread breast cancer:
• Starting dose: 600 mg/day (three 200 mg tablets)
• First lower dose: 400 mg/day (two 200 mg tablets)
• Second lower dose: 200 mg/day (one 200 mg tablet)
If you need less than 200 mg/day, stop taking KISQALI.
Your doctor will tell you how to change your dose based on side effects like lung problems, heart rhythm changes, liver problems, low white blood cells, and other side effects.
Taking KISQALI with Certain Other Medicines
Do not take KISQALI with strong medicines that change how your body breaks down KISQALI. Ask your doctor about other medicines you can take instead.
If you must take these medicines together:
Early breast cancer: Lower KISQALI to 200 mg once daily
Advanced or spread breast cancer: Lower KISQALI to 400 mg once daily
When you stop the other medicine, your doctor will change your KISQALI dose back after at least 5 days.
Liver Problems
If you have mild liver problems, you do not need to change your dose.
If you have worse liver problems and advanced or spread breast cancer, take 400 mg once daily.
Kidney Problems
If you have bad kidney problems, start with 200 mg KISQALI once daily.
Dosage Forms and Strengths
Pill: 200 mg ribociclib (equal to 254.40 mg ribociclib succinate).
Coated pill, light purple-gray color, round with slanted edges. Has “RIC” printed on one side and “NVR” on the other side.
Pill: 200 mg ribociclib (equal to 254.40 mg ribociclib succinate).
Coated pill, light purple-gray color, round with slanted edges. Has “RIC” printed on one side and “NVR” on the other side.
Contraindications
None known
None known
Warnings and Precautions
Lung Problems
KISQALI can cause serious lung problems that can kill you. This happens in about 1-2 out of 100 people who take this medicine.
Watch for these lung problem signs:
• Hard to breathe
• New cough that won’t go away
• Not getting enough air
Tell your doctor right away if you have any new breathing problems. Your doctor will stop KISQALI right away and check your lungs. If you have serious lung problems, you will need to stop taking KISQALI forever.
Serious Skin Problems
KISQALI can cause very bad skin problems that can kill you. These include bad rashes that can cover your whole body.
If you get a serious skin rash, your doctor will stop KISQALI until they find out what’s causing it. You may need to see a skin doctor right away.
If the skin problem is very serious, you will need to stop taking KISQALI forever. Do not take KISQALI again if you had a skin problem that could kill you.
Heart Beat Problems
KISQALI can change how your heart beats and make it beat in a dangerous way.
Do not take KISQALI if you have:
• Born with long QT syndrome
• Serious heart disease, recent heart attack, or heart failure
• Low levels of important minerals in your blood
• Taking other medicines that change heart beat
Your doctor will do a heart test (ECG) before you start KISQALI and again after 2 weeks. You can only start KISQALI if your heart test shows it’s safe.
Your doctor will check the mineral levels in your blood before you start treatment and during your first 6 treatment cycles. Any problems must be fixed before starting KISQALI.
In one study, one patient died suddenly who had low potassium and heart beat problems.
Taking KISQALI with Tamoxifen Makes Heart Problems Worse
Liver Problems
KISQALI can hurt your liver. This happened in about 4 out of 1000 people taking this medicine.
Some people had very serious liver damage. Most people got better after stopping KISQALI.
Your doctor will do blood tests to check your liver before you start KISQALI. You will get liver tests every 2 weeks for the first 2 months, then at the start of the next 4 months.
If your liver tests show problems, your doctor may lower your dose, stop KISQALI for a while, or have you stop taking it completely.
Low White Blood Cells
KISQALI lowers your white blood cells, which help fight germs. This happens in most people who take this medicine.
In people with early breast cancer, 94 out of 100 people had low white blood cells. About 45 out of 100 people had very low counts. Less than 1 out of 100 people got a fever from low white blood cells.
It usually takes about 18 days for white blood cells to get low. It takes about 10 days for very low counts to get better.
Your doctor will do blood tests before you start KISQALI, every 2 weeks for the first 2 months, then at the start of the next 4 months.
If your white blood cells get too low, your doctor may lower your dose, stop KISQALI for a while, or have you stop taking it completely.
Harm to Unborn Babies
KISQALI can harm an unborn baby. Animal studies showed this medicine caused birth defects and pregnancy loss.
If you are pregnant, do not take KISQALI. If you can get pregnant, use birth control while taking KISQALI and for at least 3 weeks after your last dose.
Lung Problems
KISQALI can cause serious lung problems that can kill you. This happens in about 1-2 out of 100 people who take this medicine.
Watch for these lung problem signs:
• Hard to breathe
• New cough that won’t go away
• Not getting enough air
Tell your doctor right away if you have any new breathing problems. Your doctor will stop KISQALI right away and check your lungs. If you have serious lung problems, you will need to stop taking KISQALI forever.
Serious Skin Problems
KISQALI can cause very bad skin problems that can kill you. These include bad rashes that can cover your whole body.
If you get a serious skin rash, your doctor will stop KISQALI until they find out what’s causing it. You may need to see a skin doctor right away.
If the skin problem is very serious, you will need to stop taking KISQALI forever. Do not take KISQALI again if you had a skin problem that could kill you.
Heart Beat Problems
KISQALI can change how your heart beats and make it beat in a dangerous way.
Do not take KISQALI if you have:
• Born with long QT syndrome
• Serious heart disease, recent heart attack, or heart failure
• Low levels of important minerals in your blood
• Taking other medicines that change heart beat
Your doctor will do a heart test (ECG) before you start KISQALI and again after 2 weeks. You can only start KISQALI if your heart test shows it’s safe.
Your doctor will check the mineral levels in your blood before you start treatment and during your first 6 treatment cycles. Any problems must be fixed before starting KISQALI.
In one study, one patient died suddenly who had low potassium and heart beat problems.
Taking KISQALI with Tamoxifen Makes Heart Problems Worse
Liver Problems
KISQALI can hurt your liver. This happened in about 4 out of 1000 people taking this medicine.
Some people had very serious liver damage. Most people got better after stopping KISQALI.
Your doctor will do blood tests to check your liver before you start KISQALI. You will get liver tests every 2 weeks for the first 2 months, then at the start of the next 4 months.
If your liver tests show problems, your doctor may lower your dose, stop KISQALI for a while, or have you stop taking it completely.
Low White Blood Cells
KISQALI lowers your white blood cells, which help fight germs. This happens in most people who take this medicine.
In people with early breast cancer, 94 out of 100 people had low white blood cells. About 45 out of 100 people had very low counts. Less than 1 out of 100 people got a fever from low white blood cells.
It usually takes about 18 days for white blood cells to get low. It takes about 10 days for very low counts to get better.
Your doctor will do blood tests before you start KISQALI, every 2 weeks for the first 2 months, then at the start of the next 4 months.
If your white blood cells get too low, your doctor may lower your dose, stop KISQALI for a while, or have you stop taking it completely.
Harm to Unborn Babies
KISQALI can harm an unborn baby. Animal studies showed this medicine caused birth defects and pregnancy loss.
If you are pregnant, do not take KISQALI. If you can get pregnant, use birth control while taking KISQALI and for at least 3 weeks after your last dose.
Adverse Reactions
What Happened to Patients in Studies
Doctors test medicines in studies with many patients. The side effects seen in one study may be different from another study. The side effects you have may also be different.
NATALEE Study: KISQALI with Hormone-Blocking Medicine for Early Breast Cancer
Doctors studied 5,101 patients with early breast cancer that could come back. Patients took KISQALI for about 33 months on average.
Serious Side Effects:
• 14 out of 100 patients had serious side effects
• Most common serious problems: COVID-19, lung infection, blood clot in lung
Deaths:
• 6 out of 1,000 patients died from side effects
• Main causes: COVID-19 or blood clots in lungs
Most Common Side Effects (happened to 20 or more patients out of 100):
• Low white blood cell count
• Infections
• Feeling sick to stomach
• Headache
• Feeling very tired
• Liver problems
Table: Side Effects in NATALEE Study
Side effects that happened to 10 or more patients out of 100:
• Infections: 37 out of 100 patients
• Headache: 22 out of 100 patients
• Feeling sick to stomach: 22 out of 100 patients
• Loose stools: 21 out of 100 patients
• Hard to have bowel movements: 21 out of 100 patients
• Stomach pain: 21 out of 100 patients
• Feeling very tired: 22 out of 100 patients
• Feeling weak: 21 out of 100 patients
• Fever: 21 out of 100 patients
• Hair loss: 15 out of 100 patients
• Cough: 21 out of 100 patients
Blood Test Changes:
• Low white blood cells: 97 out of 100 patients
• Low infection-fighting cells: 94 out of 100 patients
• Low red blood cells: 47 out of 100 patients
• Low platelets: 28 out of 100 patients
• Liver changes: 44-45 out of 100 patients
• Kidney changes: 33 out of 100 patients
MONALEESA-2 Study: KISQALI with Letrozole for Advanced Breast Cancer
Doctors studied 668 women after menopause with advanced breast cancer. Patients took KISQALI for about 13 months on average.
Serious Side Effects:
• 21 out of 100 patients had serious side effects
• Most common: stomach pain, throwing up, hard bowel movements, feeling sick, low red blood cells, fever with low white blood cells, trouble breathing, liver problems
Most Common Side Effects (happened to 20 or more patients out of 100):
• Low white blood cells, low red blood cells
• Feeling sick to stomach
• Loose stools
• Hair loss
• Throwing up
• Hard bowel movements
• Feeling very tired
• Headache
• Back pain
Table: Side Effects in MONALEESA-2 Study
Side effects that happened to 10 or more patients out of 100:
• Feeling sick to stomach: 52 out of 100 patients
• Loose stools: 35 out of 100 patients
• Throwing up: 29 out of 100 patients
• Hard bowel movements: 25 out of 100 patients
• Mouth sores: 12 out of 100 patients
• Stomach pain: 11 out of 100 patients
• Feeling very tired: 37 out of 100 patients
• Fever: 13 out of 100 patients
• Swelling: 12 out of 100 patients
• Hair loss: 33 out of 100 patients
• Skin rash: 17 out of 100 patients
• Itchy skin: 14 out of 100 patients
• Headache: 22 out of 100 patients
• Trouble sleeping: 12 out of 100 patients
• Back pain: 20 out of 100 patients
• Not wanting to eat: 19 out of 100 patients
• Trouble breathing: 12 out of 100 patients
• Bladder infections: 11 out of 100 patients
Blood Test Changes:
• Low white blood cells: 93 out of 100 patients
• Low infection-fighting cells: 93 out of 100 patients
• Low red blood cells: 57 out of 100 patients
• Low lymphocytes: 51 out of 100 patients
• Low platelets: 29 out of 100 patients
• Liver changes: 44-46 out of 100 patients
• Kidney changes: 20 out of 100 patients
• Low phosphorus: 35 out of 100 patients
• Low potassium: 11 out of 100 patients
MONALEESA-7 Study: KISQALI for Younger Women with Advanced Breast Cancer
Doctors studied 672 women before menopause with advanced breast cancer. Patients took KISQALI for about 15 months on average.
Serious Side Effects:
• 17 out of 100 patients had serious side effects
• Most common: liver injury, stomach pain, trouble breathing, fever with low white blood cells, back pain
Most Common Side Effects:
• Low white blood cells
• Infections
• Joint pain
• Feeling sick to stomach
• Hair loss
Table: Side Effects in MONALEESA-7 Study
Side effects that happened to 10 or more patients out of 100:
• Infections: 36 out of 100 patients
• Joint pain: 34 out of 100 patients
• Feeling sick to stomach: 32 out of 100 patients
• Hard bowel movements: 16 out of 100 patients
• Mouth sores: 10 out of 100 patients
• Hair loss: 21 out of 100 patients
• Skin rash: 17 out of 100 patients
• Itchy skin: 11 out of 100 patients
• Fever: 17 out of 100 patients
• Pain in arms or legs: 10 out of 100 patients
• Cough: 15 out of 100 patients
Blood Test Changes:
• Low white blood cells: 93 out of 100 patients
• Low infection-fighting cells: 92 out of 100 patients
• Low red blood cells: 84 out of 100 patients
• Low lymphocytes: 55 out of 100 patients
• Low platelets: 26 out of 100 patients
• Liver changes: 33-42 out of 100 patients
• Low phosphorus: 14 out of 100 patients
• Low potassium: 11 out of 100 patients
• Low blood sugar: 10 out of 100 patients
• Kidney changes: 8 out of 100 patients
MONALEESA-3 Study: KISQALI with Fulvestrant for Advanced Breast Cancer
Doctors studied 724 women after menopause with advanced breast cancer. Patients took KISQALI for about 16 months on average.
Serious Side Effects:
• 29 out of 100 patients had serious side effects
• Most common: lung infection, feeling sick, throwing up, low red blood cells, trouble breathing, low white blood cells
• 1 patient died from lung infection
Most Common Side Effects:
• Low white blood cells
• Feeling sick to stomach
• Infections
• Loose stools
• Throwing up
• Hard bowel movements
• Cough
• Skin rash
• Itchy skin
Blood Test Changes:
• Low white blood cells: 95 out of 100 patients
• Low infection-fighting cells: 92 out of 100 patients
• Low lymphocytes: 69 out of 100 patients
• Low red blood cells: 60 out of 100 patients
• Low platelets: 33 out of 100 patients
• Kidney changes: 65 out of 100 patients
• Liver changes: 44-52 out of 100 patients
• Low blood sugar: 23 out of 100 patients
• Low phosphorus: 18 out of 100 patients
• Low albumin: 12 out of 100 patients
COMPLEEMENT-1 Study: KISQALI for Men with Advanced Breast Cancer
Doctors studied 39 men with advanced breast cancer. Patients took KISQALI for about 21 months on average.
Men had similar side effects as women who took KISQALI with hormone medicines.
Side Effects Reported After the Medicine Was Approved
Some patients have reported these problems after KISQALI was approved:
Lung Problems:
• Lung swelling
Skin Problems:
• Bad skin reactions that can be life-threatening
• Bad allergic reactions affecting the whole body
What Happened to Patients in Studies
Doctors test medicines in studies with many patients. The side effects seen in one study may be different from another study. The side effects you have may also be different.
NATALEE Study: KISQALI with Hormone-Blocking Medicine for Early Breast Cancer
Doctors studied 5,101 patients with early breast cancer that could come back. Patients took KISQALI for about 33 months on average.
Serious Side Effects:
• 14 out of 100 patients had serious side effects
• Most common serious problems: COVID-19, lung infection, blood clot in lung
Deaths:
• 6 out of 1,000 patients died from side effects
• Main causes: COVID-19 or blood clots in lungs
Most Common Side Effects (happened to 20 or more patients out of 100):
• Low white blood cell count
• Infections
• Feeling sick to stomach
• Headache
• Feeling very tired
• Liver problems
Table: Side Effects in NATALEE Study
Side effects that happened to 10 or more patients out of 100:
• Infections: 37 out of 100 patients
• Headache: 22 out of 100 patients
• Feeling sick to stomach: 22 out of 100 patients
• Loose stools: 21 out of 100 patients
• Hard to have bowel movements: 21 out of 100 patients
• Stomach pain: 21 out of 100 patients
• Feeling very tired: 22 out of 100 patients
• Feeling weak: 21 out of 100 patients
• Fever: 21 out of 100 patients
• Hair loss: 15 out of 100 patients
• Cough: 21 out of 100 patients
Blood Test Changes:
• Low white blood cells: 97 out of 100 patients
• Low infection-fighting cells: 94 out of 100 patients
• Low red blood cells: 47 out of 100 patients
• Low platelets: 28 out of 100 patients
• Liver changes: 44-45 out of 100 patients
• Kidney changes: 33 out of 100 patients
MONALEESA-2 Study: KISQALI with Letrozole for Advanced Breast Cancer
Doctors studied 668 women after menopause with advanced breast cancer. Patients took KISQALI for about 13 months on average.
Serious Side Effects:
• 21 out of 100 patients had serious side effects
• Most common: stomach pain, throwing up, hard bowel movements, feeling sick, low red blood cells, fever with low white blood cells, trouble breathing, liver problems
Most Common Side Effects (happened to 20 or more patients out of 100):
• Low white blood cells, low red blood cells
• Feeling sick to stomach
• Loose stools
• Hair loss
• Throwing up
• Hard bowel movements
• Feeling very tired
• Headache
• Back pain
Table: Side Effects in MONALEESA-2 Study
Side effects that happened to 10 or more patients out of 100:
• Feeling sick to stomach: 52 out of 100 patients
• Loose stools: 35 out of 100 patients
• Throwing up: 29 out of 100 patients
• Hard bowel movements: 25 out of 100 patients
• Mouth sores: 12 out of 100 patients
• Stomach pain: 11 out of 100 patients
• Feeling very tired: 37 out of 100 patients
• Fever: 13 out of 100 patients
• Swelling: 12 out of 100 patients
• Hair loss: 33 out of 100 patients
• Skin rash: 17 out of 100 patients
• Itchy skin: 14 out of 100 patients
• Headache: 22 out of 100 patients
• Trouble sleeping: 12 out of 100 patients
• Back pain: 20 out of 100 patients
• Not wanting to eat: 19 out of 100 patients
• Trouble breathing: 12 out of 100 patients
• Bladder infections: 11 out of 100 patients
Blood Test Changes:
• Low white blood cells: 93 out of 100 patients
• Low infection-fighting cells: 93 out of 100 patients
• Low red blood cells: 57 out of 100 patients
• Low lymphocytes: 51 out of 100 patients
• Low platelets: 29 out of 100 patients
• Liver changes: 44-46 out of 100 patients
• Kidney changes: 20 out of 100 patients
• Low phosphorus: 35 out of 100 patients
• Low potassium: 11 out of 100 patients
MONALEESA-7 Study: KISQALI for Younger Women with Advanced Breast Cancer
Doctors studied 672 women before menopause with advanced breast cancer. Patients took KISQALI for about 15 months on average.
Serious Side Effects:
• 17 out of 100 patients had serious side effects
• Most common: liver injury, stomach pain, trouble breathing, fever with low white blood cells, back pain
Most Common Side Effects:
• Low white blood cells
• Infections
• Joint pain
• Feeling sick to stomach
• Hair loss
Table: Side Effects in MONALEESA-7 Study
Side effects that happened to 10 or more patients out of 100:
• Infections: 36 out of 100 patients
• Joint pain: 34 out of 100 patients
• Feeling sick to stomach: 32 out of 100 patients
• Hard bowel movements: 16 out of 100 patients
• Mouth sores: 10 out of 100 patients
• Hair loss: 21 out of 100 patients
• Skin rash: 17 out of 100 patients
• Itchy skin: 11 out of 100 patients
• Fever: 17 out of 100 patients
• Pain in arms or legs: 10 out of 100 patients
• Cough: 15 out of 100 patients
Blood Test Changes:
• Low white blood cells: 93 out of 100 patients
• Low infection-fighting cells: 92 out of 100 patients
• Low red blood cells: 84 out of 100 patients
• Low lymphocytes: 55 out of 100 patients
• Low platelets: 26 out of 100 patients
• Liver changes: 33-42 out of 100 patients
• Low phosphorus: 14 out of 100 patients
• Low potassium: 11 out of 100 patients
• Low blood sugar: 10 out of 100 patients
• Kidney changes: 8 out of 100 patients
MONALEESA-3 Study: KISQALI with Fulvestrant for Advanced Breast Cancer
Doctors studied 724 women after menopause with advanced breast cancer. Patients took KISQALI for about 16 months on average.
Serious Side Effects:
• 29 out of 100 patients had serious side effects
• Most common: lung infection, feeling sick, throwing up, low red blood cells, trouble breathing, low white blood cells
• 1 patient died from lung infection
Most Common Side Effects:
• Low white blood cells
• Feeling sick to stomach
• Infections
• Loose stools
• Throwing up
• Hard bowel movements
• Cough
• Skin rash
• Itchy skin
Blood Test Changes:
• Low white blood cells: 95 out of 100 patients
• Low infection-fighting cells: 92 out of 100 patients
• Low lymphocytes: 69 out of 100 patients
• Low red blood cells: 60 out of 100 patients
• Low platelets: 33 out of 100 patients
• Kidney changes: 65 out of 100 patients
• Liver changes: 44-52 out of 100 patients
• Low blood sugar: 23 out of 100 patients
• Low phosphorus: 18 out of 100 patients
• Low albumin: 12 out of 100 patients
COMPLEEMENT-1 Study: KISQALI for Men with Advanced Breast Cancer
Doctors studied 39 men with advanced breast cancer. Patients took KISQALI for about 21 months on average.
Men had similar side effects as women who took KISQALI with hormone medicines.
Side Effects Reported After the Medicine Was Approved
Some patients have reported these problems after KISQALI was approved:
Lung Problems:
• Lung swelling
Skin Problems:
• Bad skin reactions that can be life-threatening
• Bad allergic reactions affecting the whole body
Drug Interactions
Drugs That May Increase KISQALI Levels in Your Body
CYP3A4 Blockers
Some medicines can stop your body from breaking down KISQALI. This makes more KISQALI stay in your blood. Too much KISQALI can cause more side effects, including heart problems.
Do not take strong CYP3A blocker medicines with KISQALI. Ask your doctor about other medicines that are safer to use.
If you have early breast cancer and must take a strong CYP3A blocker, your doctor will lower your KISQALI dose to 200 mg once a day. If you have advanced breast cancer and must take a strong CYP3A blocker, your doctor will lower your KISQALI dose to 400 mg once a day.
Drugs That May Decrease KISQALI Levels in Your Body
CYP3A Boosters
Some medicines can make your body break down KISQALI faster. This makes less KISQALI stay in your blood. When there is less KISQALI, it may not work as well.
Do not take strong CYP3A booster medicines with KISQALI. Ask your doctor about other medicines that will not affect KISQALI.
How KISQALI Affects Other Drugs
CYP3A Medicines
KISQALI can make some other medicines stronger in your body. If you take medicines that are easily changed by CYP3A, your doctor will watch you closely for side effects. You may need a lower dose of those other medicines.
Medicines That Affect Heart Rhythm
Do not take KISQALI with medicines that can cause heart rhythm problems. This includes some heart medicines and other drugs that affect the QT interval.
If you must take these medicines together, your doctor will check your heart with an ECG test. They will do this when you start treatment and during treatment as needed.
Drugs That May Increase KISQALI Levels in Your Body
CYP3A4 Blockers
Some medicines can stop your body from breaking down KISQALI. This makes more KISQALI stay in your blood. Too much KISQALI can cause more side effects, including heart problems.
Do not take strong CYP3A blocker medicines with KISQALI. Ask your doctor about other medicines that are safer to use.
If you have early breast cancer and must take a strong CYP3A blocker, your doctor will lower your KISQALI dose to 200 mg once a day. If you have advanced breast cancer and must take a strong CYP3A blocker, your doctor will lower your KISQALI dose to 400 mg once a day.
Drugs That May Decrease KISQALI Levels in Your Body
CYP3A Boosters
Some medicines can make your body break down KISQALI faster. This makes less KISQALI stay in your blood. When there is less KISQALI, it may not work as well.
Do not take strong CYP3A booster medicines with KISQALI. Ask your doctor about other medicines that will not affect KISQALI.
How KISQALI Affects Other Drugs
CYP3A Medicines
KISQALI can make some other medicines stronger in your body. If you take medicines that are easily changed by CYP3A, your doctor will watch you closely for side effects. You may need a lower dose of those other medicines.
Medicines That Affect Heart Rhythm
Do not take KISQALI with medicines that can cause heart rhythm problems. This includes some heart medicines and other drugs that affect the QT interval.
If you must take these medicines together, your doctor will check your heart with an ECG test. They will do this when you start treatment and during treatment as needed.
Pregnancy
Risk Summary
KISQALI can harm your unborn baby if you take it while pregnant. We know this from how the medicine works and from animal studies.
We don’t have information about pregnant women taking this medicine. In animal studies, pregnant rats and rabbits were given ribociclib during pregnancy. This caused more pregnancy losses and smaller babies in rats. It caused birth defects in rabbits. The animals got doses like what humans take.
If you are pregnant, you should know about the possible risk to your unborn baby.
For all women, the normal risk of major birth defects is 2% to 4%. The normal risk of miscarriage is 15% to 20% of known pregnancies in the U.S.
Animal Study Details
Pregnant rats and rabbits were given ribociclib by mouth during pregnancy. Rats got up to 1000 mg per kg of body weight per day. Rabbits got up to 60 mg per kg of body weight per day.
In rats, 300 mg per kg per day made mother rats gain less weight. Baby rats weighed less and had bone changes because of their smaller size. There were no major problems with baby survival or body shape at 50 or 300 mg per kg per day.
In rabbits at 30 mg per kg per day or higher, there were harmful effects on baby development. This included more birth defects and smaller babies. Birth defects included:
• Small or missing parts of lungs
• Extra blood vessels near the heart
• Small eyes
• Holes in the muscle that helps with breathing
• Missing or joined lung parts
• Extra or incomplete ribs
• Bent or misshapen throat bones
• Missing finger bones
There was no increase in baby deaths. Mother rabbits showed no harmful effects at 30 mg per kg per day.
At 300 mg per kg per day in rats and 30 mg per kg per day in rabbits, the amount of medicine in the mother’s blood was about 0.6 and 1.5 times what patients get at the highest recommended dose of 600 mg per day.
Risk Summary
KISQALI can harm your unborn baby if you take it while pregnant. We know this from how the medicine works and from animal studies.
We don’t have information about pregnant women taking this medicine. In animal studies, pregnant rats and rabbits were given ribociclib during pregnancy. This caused more pregnancy losses and smaller babies in rats. It caused birth defects in rabbits. The animals got doses like what humans take.
If you are pregnant, you should know about the possible risk to your unborn baby.
For all women, the normal risk of major birth defects is 2% to 4%. The normal risk of miscarriage is 15% to 20% of known pregnancies in the U.S.
Animal Study Details
Pregnant rats and rabbits were given ribociclib by mouth during pregnancy. Rats got up to 1000 mg per kg of body weight per day. Rabbits got up to 60 mg per kg of body weight per day.
In rats, 300 mg per kg per day made mother rats gain less weight. Baby rats weighed less and had bone changes because of their smaller size. There were no major problems with baby survival or body shape at 50 or 300 mg per kg per day.
In rabbits at 30 mg per kg per day or higher, there were harmful effects on baby development. This included more birth defects and smaller babies. Birth defects included:
• Small or missing parts of lungs
• Extra blood vessels near the heart
• Small eyes
• Holes in the muscle that helps with breathing
• Missing or joined lung parts
• Extra or incomplete ribs
• Bent or misshapen throat bones
• Missing finger bones
There was no increase in baby deaths. Mother rabbits showed no harmful effects at 30 mg per kg per day.
At 300 mg per kg per day in rats and 30 mg per kg per day in rabbits, the amount of medicine in the mother’s blood was about 0.6 and 1.5 times what patients get at the highest recommended dose of 600 mg per day.
Lactation
What We Know About Breastfeeding
We don’t know if this medicine gets into breast milk. We don’t have information about how it affects nursing babies or how much milk you make. In animal studies, the medicine did pass into breast milk. Because this medicine could harm nursing babies, don’t breastfeed while taking KISQALI and for at least 3 weeks after your last dose.
Animal Study Results
In rat studies, the medicine was found in breast milk at levels 3.56 times higher than in the mother’s blood.
What We Know About Breastfeeding
We don’t know if this medicine gets into breast milk. We don’t have information about how it affects nursing babies or how much milk you make. In animal studies, the medicine did pass into breast milk. Because this medicine could harm nursing babies, don’t breastfeed while taking KISQALI and for at least 3 weeks after your last dose.
Animal Study Results
In rat studies, the medicine was found in breast milk at levels 3.56 times higher than in the mother’s blood.
Pediatric Use
KISQALI has not been tested to see if it is safe or works in children.
KISQALI has not been tested to see if it is safe or works in children.
Geriatric Use
Studies tested KISQALI in older adults to see if it works the same way as in younger people.
In the NATALEE study, 2,549 adults with early breast cancer took KISQALI. Of these patients, 407 people (16%) were 65 years old or older and 123 people (2.4%) were 75 years old or older. KISQALI worked the same and had the same side effects in older and younger adults with early breast cancer.
In the MONALEESA-2 study, 334 patients with advanced breast cancer took KISQALI. Of these, 150 patients (45%) were 65 or older and 35 patients (11%) were 75 or older. In the MONALEESA-3 study, 484 patients with advanced breast cancer took KISQALI. Of these, 226 patients (47%) were 65 or older and 65 patients (14%) were 75 or older. In the MONALEESA-7 study, 248 patients with advanced breast cancer took KISQALI, but none were 65 or older. KISQALI worked the same and had the same side effects in older and younger adults with advanced breast cancer.
Studies tested KISQALI in older adults to see if it works the same way as in younger people.
In the NATALEE study, 2,549 adults with early breast cancer took KISQALI. Of these patients, 407 people (16%) were 65 years old or older and 123 people (2.4%) were 75 years old or older. KISQALI worked the same and had the same side effects in older and younger adults with early breast cancer.
In the MONALEESA-2 study, 334 patients with advanced breast cancer took KISQALI. Of these, 150 patients (45%) were 65 or older and 35 patients (11%) were 75 or older. In the MONALEESA-3 study, 484 patients with advanced breast cancer took KISQALI. Of these, 226 patients (47%) were 65 or older and 65 patients (14%) were 75 or older. In the MONALEESA-7 study, 248 patients with advanced breast cancer took KISQALI, but none were 65 or older. KISQALI worked the same and had the same side effects in older and younger adults with advanced breast cancer.
Hepatic Impairment
If you have mild liver problems, you don’t need to change your dose. If you have moderate or severe liver problems, your doctor will start you on a lower dose of 400 mg.
Your doctor uses a scoring system called Child-Pugh to check how well your liver works. This helps them decide the right dose for you.
If you have mild liver problems, you don’t need to change your dose. If you have moderate or severe liver problems, your doctor will start you on a lower dose of 400 mg.
Your doctor uses a scoring system called Child-Pugh to check how well your liver works. This helps them decide the right dose for you.
Renal Impairment
If you have breast cancer and mild to moderate kidney problems, you don’t need to change your dose. Your doctor can check how well your kidneys work with a blood test.
If you have breast cancer and severe kidney problems, your doctor will start you on a lower dose of 200 mg.
If you have breast cancer and mild to moderate kidney problems, you don’t need to change your dose. Your doctor can check how well your kidneys work with a blood test.
If you have breast cancer and severe kidney problems, your doctor will start you on a lower dose of 200 mg.
Description
KISQALI (ribociclib) is a type of cancer medicine called a kinase inhibitor.
The full chemical name of ribociclib succinate is: Butanedioic acid—7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1/1).
Ribociclib succinate is a light yellow to light brown powder that forms crystals. The chemical formula is C23H30N8O·C4H6O4 and it weighs 552.64 g/mol (Free base: 434.55 g/mol).
The chemical structure of ribociclib is shown below:
KISQALI tablets are coated pills that you take by mouth. Each tablet has 200 mg of ribociclib free base (equal to 254.40 mg ribociclib succinate). The tablets also have other ingredients that help hold the pill together: colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate and microcrystalline cellulose. The coating on the outside of the pill has iron oxide black, iron oxide red, lecithin (soya), polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide, and xanthan gum. These coating ingredients do not change how the medicine works.
KISQALI (ribociclib) is a type of cancer medicine called a kinase inhibitor.
The full chemical name of ribociclib succinate is: Butanedioic acid—7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1/1).
Ribociclib succinate is a light yellow to light brown powder that forms crystals. The chemical formula is C23H30N8O·C4H6O4 and it weighs 552.64 g/mol (Free base: 434.55 g/mol).
The chemical structure of ribociclib is shown below:
KISQALI tablets are coated pills that you take by mouth. Each tablet has 200 mg of ribociclib free base (equal to 254.40 mg ribociclib succinate). The tablets also have other ingredients that help hold the pill together: colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate and microcrystalline cellulose. The coating on the outside of the pill has iron oxide black, iron oxide red, lecithin (soya), polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide, and xanthan gum. These coating ingredients do not change how the medicine works.
Mechanism of Action
Ribociclib blocks two proteins called CDK 4 and 6. These proteins help cells grow and multiply when they attach to other proteins called D-cyclins. The CDK4/6 proteins control how cells grow by changing another protein called pRb.
In lab tests, ribociclib stopped pRb from working properly. This caused breast cancer cells to stop growing and dividing.
In animal tests, ribociclib alone made tumors smaller by blocking pRb. In tests using breast cancer cells from patients, ribociclib worked better when used with hormone-blocking medicines like letrozole. The combination of ribociclib and fulvestrant also stopped tumor growth in breast cancer that needs estrogen to grow.
Ribociclib blocks two proteins called CDK 4 and 6. These proteins help cells grow and multiply when they attach to other proteins called D-cyclins. The CDK4/6 proteins control how cells grow by changing another protein called pRb.
In lab tests, ribociclib stopped pRb from working properly. This caused breast cancer cells to stop growing and dividing.
In animal tests, ribociclib alone made tumors smaller by blocking pRb. In tests using breast cancer cells from patients, ribociclib worked better when used with hormone-blocking medicines like letrozole. The combination of ribociclib and fulvestrant also stopped tumor growth in breast cancer that needs estrogen to grow.
Pharmacodynamics
Doctors don’t fully understand how KISQALI affects the body over time or how much medicine works best for safety and effectiveness.
Heart Rhythm Effects
Studies show that KISQALI can change your heart rhythm. Higher amounts of the medicine in your blood cause bigger changes to your heart’s electrical activity.
In patients with early breast cancer, KISQALI 400 mg taken with hormone therapy caused the heart rhythm to change by an average of 10.0 milliseconds.
In patients with advanced breast cancer, KISQALI 600 mg caused bigger heart rhythm changes:
• 22.0 milliseconds when taken with aromatase inhibitors
• 23.7 milliseconds when taken with fulvestrant
• 34.7 milliseconds when taken with tamoxifen
These changes happened when the medicine reached steady levels in the blood.
Doctors don’t fully understand how KISQALI affects the body over time or how much medicine works best for safety and effectiveness.
Heart Rhythm Effects
Studies show that KISQALI can change your heart rhythm. Higher amounts of the medicine in your blood cause bigger changes to your heart’s electrical activity.
In patients with early breast cancer, KISQALI 400 mg taken with hormone therapy caused the heart rhythm to change by an average of 10.0 milliseconds.
In patients with advanced breast cancer, KISQALI 600 mg caused bigger heart rhythm changes:
• 22.0 milliseconds when taken with aromatase inhibitors
• 23.7 milliseconds when taken with fulvestrant
• 34.7 milliseconds when taken with tamoxifen
These changes happened when the medicine reached steady levels in the blood.
Pharmacokinetics
How KISQALI Works in Your Body
KISQALI levels in your blood increase more than expected as the dose goes up. When you take 600 mg once daily, it takes about 8 days to reach steady levels in your body. The medicine builds up over time.
How Your Body Absorbs KISQALI
KISQALI reaches its highest level in your blood 1 to 4 hours after you take it. Your body absorbs about 66% of each dose.
Taking KISQALI with a high-fat meal does not change how much gets into your blood.
How KISQALI Spreads in Your Body
About 70% of KISQALI sticks to proteins in your blood. The medicine spreads throughout your body.
How Your Body Breaks Down KISQALI
Your liver breaks down KISQALI using an enzyme called CYP3A4. The medicine gets changed into other substances called metabolites. KISQALI itself does most of the work to treat your cancer.
Your body gets rid of KISQALI mainly through bowel movements and urine.
How Long KISQALI Stays in Your Body
KISQALI stays in your blood for about 32 hours on average. Your body removes the medicine at a steady rate.
Most of the medicine leaves your body within 22 days. About 69% comes out in bowel movements and 23% in urine.
Special Patient Groups
People with Liver Problems
• Mild liver problems: No change in KISQALI levels
• Moderate liver problems: Slightly higher KISQALI levels
• Severe liver problems: Slightly higher KISQALI levels
People with Kidney Problems
• Mild or moderate kidney problems: No change in KISQALI levels
• Severe kidney problems: Much higher KISQALI levels
• End stage kidney disease: Much higher KISQALI levels
Age, Weight, Gender, and Race
Your age, weight, gender, or race do not change how KISQALI works in your body.
Drug Interactions
Medicines That Increase KISQALI Levels
Strong medicines that block CYP3A (like ritonavir) can make KISQALI levels much higher. Moderate blockers cause smaller increases.
Medicines That Decrease KISQALI Levels
Strong medicines that speed up CYP3A (like rifampicin) can make KISQALI levels much lower. This may make KISQALI less effective.
Medicines That KISQALI Affects
KISQALI can increase levels of some other medicines that use CYP3A4. This includes medicines like midazolam.
KISQALI does not affect stomach acid medicines.
Cancer Hormone Medicines
KISQALI works well with these medicines:
• Letrozole: No interaction
• Anastrozole: No interaction
• Exemestane: No interaction
• Fulvestrant: No interaction
KISQALI should not be used with tamoxifen. It makes tamoxifen levels too high.
How KISQALI Works in Your Body
KISQALI levels in your blood increase more than expected as the dose goes up. When you take 600 mg once daily, it takes about 8 days to reach steady levels in your body. The medicine builds up over time.
How Your Body Absorbs KISQALI
KISQALI reaches its highest level in your blood 1 to 4 hours after you take it. Your body absorbs about 66% of each dose.
Taking KISQALI with a high-fat meal does not change how much gets into your blood.
How KISQALI Spreads in Your Body
About 70% of KISQALI sticks to proteins in your blood. The medicine spreads throughout your body.
How Your Body Breaks Down KISQALI
Your liver breaks down KISQALI using an enzyme called CYP3A4. The medicine gets changed into other substances called metabolites. KISQALI itself does most of the work to treat your cancer.
Your body gets rid of KISQALI mainly through bowel movements and urine.
How Long KISQALI Stays in Your Body
KISQALI stays in your blood for about 32 hours on average. Your body removes the medicine at a steady rate.
Most of the medicine leaves your body within 22 days. About 69% comes out in bowel movements and 23% in urine.
Special Patient Groups
People with Liver Problems
• Mild liver problems: No change in KISQALI levels
• Moderate liver problems: Slightly higher KISQALI levels
• Severe liver problems: Slightly higher KISQALI levels
People with Kidney Problems
• Mild or moderate kidney problems: No change in KISQALI levels
• Severe kidney problems: Much higher KISQALI levels
• End stage kidney disease: Much higher KISQALI levels
Age, Weight, Gender, and Race
Your age, weight, gender, or race do not change how KISQALI works in your body.
Drug Interactions
Medicines That Increase KISQALI Levels
Strong medicines that block CYP3A (like ritonavir) can make KISQALI levels much higher. Moderate blockers cause smaller increases.
Medicines That Decrease KISQALI Levels
Strong medicines that speed up CYP3A (like rifampicin) can make KISQALI levels much lower. This may make KISQALI less effective.
Medicines That KISQALI Affects
KISQALI can increase levels of some other medicines that use CYP3A4. This includes medicines like midazolam.
KISQALI does not affect stomach acid medicines.
Cancer Hormone Medicines
KISQALI works well with these medicines:
• Letrozole: No interaction
• Anastrozole: No interaction
• Exemestane: No interaction
• Fulvestrant: No interaction
KISQALI should not be used with tamoxifen. It makes tamoxifen levels too high.
Nonclinical Toxicology
Cancer, Gene Changes, and Fertility Effects
In a 2-year cancer study, rats were given ribociclib by mouth in cycles of 3 weeks on and 1 week off. Ribociclib did not cause cancer at doses up to 50 mg/kg in male rats and 600 mg/kg in female rats. The amount in the rats’ bodies was 1.3 to 1.8 times higher than what humans get at the highest recommended dose of 600 mg/day.
Ribociclib did not cause gene changes in lab tests using bacteria, human cells, or rat bone marrow.
In a fertility study, female rats got ribociclib by mouth for 14 days before mating through the first week of pregnancy. Ribociclib did not affect their ability to get pregnant or early pregnancy at doses up to 300 mg/kg/day. This was about 0.6 times the amount humans get at 600 mg/day.
A fertility study in male rats was not done with ribociclib. In other studies where rats and dogs got ribociclib daily for 3 weeks on and 1 week off for up to 26-39 weeks, there were harmful changes in the testicles. These included damage to sperm-making cells in rats and dogs and other problems with sperm production. These changes happened at doses of 75 mg/kg or higher in rats and 1 mg/kg or higher in dogs. The drug amounts in their bodies were 1.4 times higher in rats and 0.03 times higher in dogs compared to humans taking 600 mg/day. These effects were caused by the drug stopping cell growth in the testicles and started to get better after stopping the drug for four weeks.
Animal Heart Safety Studies
Heart safety studies in dogs showed that ribociclib caused changes in heart rhythm at drug levels similar to patients taking 600 mg. At higher drug levels (about 5 times higher than expected in patients), it may cause irregular heartbeats.
Cancer, Gene Changes, and Fertility Effects
In a 2-year cancer study, rats were given ribociclib by mouth in cycles of 3 weeks on and 1 week off. Ribociclib did not cause cancer at doses up to 50 mg/kg in male rats and 600 mg/kg in female rats. The amount in the rats’ bodies was 1.3 to 1.8 times higher than what humans get at the highest recommended dose of 600 mg/day.
Ribociclib did not cause gene changes in lab tests using bacteria, human cells, or rat bone marrow.
In a fertility study, female rats got ribociclib by mouth for 14 days before mating through the first week of pregnancy. Ribociclib did not affect their ability to get pregnant or early pregnancy at doses up to 300 mg/kg/day. This was about 0.6 times the amount humans get at 600 mg/day.
A fertility study in male rats was not done with ribociclib. In other studies where rats and dogs got ribociclib daily for 3 weeks on and 1 week off for up to 26-39 weeks, there were harmful changes in the testicles. These included damage to sperm-making cells in rats and dogs and other problems with sperm production. These changes happened at doses of 75 mg/kg or higher in rats and 1 mg/kg or higher in dogs. The drug amounts in their bodies were 1.4 times higher in rats and 0.03 times higher in dogs compared to humans taking 600 mg/day. These effects were caused by the drug stopping cell growth in the testicles and started to get better after stopping the drug for four weeks.
Animal Heart Safety Studies
Heart safety studies in dogs showed that ribociclib caused changes in heart rhythm at drug levels similar to patients taking 600 mg. At higher drug levels (about 5 times higher than expected in patients), it may cause irregular heartbeats.
Clinical Studies
Early Breast Cancer
NATALEE: KISQALI Combined with Another Hormone Medicine (with or without Goserelin)
Adults with HR-positive, HER2-negative Stage II and III Early Breast Cancer at High Risk of Cancer Coming Back
NATALEE was a study with 5,101 adults who had a specific type of early breast cancer. This cancer was HR-positive and HER2-negative.
The study included people whose cancer was:
• Stage IIB-III, or
• Stage IIA that was either node positive or node negative with high-grade cancer or other high-risk features
Using cancer staging rules, the study included patients with cancer in their lymph nodes, or if no lymph node cancer, then either tumor size bigger than 5 cm, or tumor size 2 to 5 cm with high-risk features.
People in the study got either KISQALI 400 mg plus a hormone medicine or just the hormone medicine alone. Some also got goserelin shots. The main goal was to see how long people stayed cancer-free.
KISQALI was taken by mouth once daily for 21 days, then 7 days off. This was combined with letrozole or anastrozole taken daily. Goserelin shots were given once every 28 days. KISQALI was given for up to 3 years. The hormone medicine was given for at least 5 years.
The average age was 52 years old. Almost all patients were women. Most had cancer in their lymph nodes and had received chemotherapy before.
The study showed that KISQALI helped people stay cancer-free longer compared to hormone medicine alone.
Advanced or Metastatic Breast Cancer
MONALEESA-2: KISQALI Combined with Letrozole
Women After Menopause with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer
MONALEESA-2 was a study with 668 women after menopause who had advanced breast cancer. This was their first treatment for advanced disease.
Women got either KISQALI plus letrozole or fake pills plus letrozole. Letrozole 2.5 mg was taken daily. KISQALI 600 mg was taken daily for 21 days, then 7 days off, until the cancer got worse.
The main goal was to see how long the cancer stayed controlled. The study showed that adding KISQALI helped control the cancer longer than letrozole alone.
MONALEESA-7: KISQALI Combined with Hormone Medicine and Goserelin
Women Before Menopause with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer
MONALEESA-7 was a study with 672 women before menopause who had advanced breast cancer. This was their first hormone treatment for advanced disease.
Women got KISQALI or fake pills, plus hormone medicine and goserelin shots. The hormone medicines were letrozole, anastrozole, or tamoxifen taken daily. Goserelin shots were given every 28 days. KISQALI 600 mg was taken daily for 21 days, then 7 days off.
The study showed that adding KISQALI helped control the cancer longer in women who got it with letrozole or anastrozole plus goserelin.
MONALEESA-3: KISQALI Combined with Fulvestrant
Women After Menopause with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer
MONALEESA-3 was a study with 726 women after menopause who had advanced breast cancer. They had received no treatment or only one hormone treatment before.
Women got either KISQALI 600 mg and fulvestrant or fake pills and fulvestrant. Fulvestrant 500 mg was given as shots into the muscle on days 1, 15, 29, then monthly. KISQALI was taken daily for 21 days, then 7 days off.
The study showed that adding KISQALI helped control the cancer longer than fulvestrant alone.
COMPLEEMENT-1: KISQALI Combined with Letrozole and Goserelin or Leuprolide
Men with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer
COMPLEEMENT-1 was a study with 39 men who had advanced breast cancer. This was their first hormone treatment for advanced disease.
Men got KISQALI 600 mg daily for 21 days, then 7 days off. They also got letrozole 2.5 mg daily and either goserelin or leuprolide shots every 28 days.
In men with measurable cancer, about 47% saw their tumors shrink. Most men who responded had their cancer controlled for at least 12 months.
Early Breast Cancer
NATALEE: KISQALI Combined with Another Hormone Medicine (with or without Goserelin)
Adults with HR-positive, HER2-negative Stage II and III Early Breast Cancer at High Risk of Cancer Coming Back
NATALEE was a study with 5,101 adults who had a specific type of early breast cancer. This cancer was HR-positive and HER2-negative.
The study included people whose cancer was:
• Stage IIB-III, or
• Stage IIA that was either node positive or node negative with high-grade cancer or other high-risk features
Using cancer staging rules, the study included patients with cancer in their lymph nodes, or if no lymph node cancer, then either tumor size bigger than 5 cm, or tumor size 2 to 5 cm with high-risk features.
People in the study got either KISQALI 400 mg plus a hormone medicine or just the hormone medicine alone. Some also got goserelin shots. The main goal was to see how long people stayed cancer-free.
KISQALI was taken by mouth once daily for 21 days, then 7 days off. This was combined with letrozole or anastrozole taken daily. Goserelin shots were given once every 28 days. KISQALI was given for up to 3 years. The hormone medicine was given for at least 5 years.
The average age was 52 years old. Almost all patients were women. Most had cancer in their lymph nodes and had received chemotherapy before.
The study showed that KISQALI helped people stay cancer-free longer compared to hormone medicine alone.
Advanced or Metastatic Breast Cancer
MONALEESA-2: KISQALI Combined with Letrozole
Women After Menopause with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer
MONALEESA-2 was a study with 668 women after menopause who had advanced breast cancer. This was their first treatment for advanced disease.
Women got either KISQALI plus letrozole or fake pills plus letrozole. Letrozole 2.5 mg was taken daily. KISQALI 600 mg was taken daily for 21 days, then 7 days off, until the cancer got worse.
The main goal was to see how long the cancer stayed controlled. The study showed that adding KISQALI helped control the cancer longer than letrozole alone.
MONALEESA-7: KISQALI Combined with Hormone Medicine and Goserelin
Women Before Menopause with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer
MONALEESA-7 was a study with 672 women before menopause who had advanced breast cancer. This was their first hormone treatment for advanced disease.
Women got KISQALI or fake pills, plus hormone medicine and goserelin shots. The hormone medicines were letrozole, anastrozole, or tamoxifen taken daily. Goserelin shots were given every 28 days. KISQALI 600 mg was taken daily for 21 days, then 7 days off.
The study showed that adding KISQALI helped control the cancer longer in women who got it with letrozole or anastrozole plus goserelin.
MONALEESA-3: KISQALI Combined with Fulvestrant
Women After Menopause with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer
MONALEESA-3 was a study with 726 women after menopause who had advanced breast cancer. They had received no treatment or only one hormone treatment before.
Women got either KISQALI 600 mg and fulvestrant or fake pills and fulvestrant. Fulvestrant 500 mg was given as shots into the muscle on days 1, 15, 29, then monthly. KISQALI was taken daily for 21 days, then 7 days off.
The study showed that adding KISQALI helped control the cancer longer than fulvestrant alone.
COMPLEEMENT-1: KISQALI Combined with Letrozole and Goserelin or Leuprolide
Men with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer
COMPLEEMENT-1 was a study with 39 men who had advanced breast cancer. This was their first hormone treatment for advanced disease.
Men got KISQALI 600 mg daily for 21 days, then 7 days off. They also got letrozole 2.5 mg daily and either goserelin or leuprolide shots every 28 days.
In men with measurable cancer, about 47% saw their tumors shrink. Most men who responded had their cancer controlled for at least 12 months.
Patient Counseling Information
Read the patient information sheet that comes with your medicine.
Lung Problems
Tell your doctor right away if you have new or worse trouble breathing.
Serious Skin Problems
Watch for signs of serious skin problems like skin pain or burning, rash that spreads quickly, or mouth sores with fever or feeling like you have the flu. Call your doctor right away if you have these symptoms.
Heart Beat Problems
Learn the signs of heart beat problems. Call your doctor right away if you have symptoms of heart beat changes.
Liver Problems
Learn the signs of liver problems. Call your doctor right away if you have symptoms of liver problems.
Low White Blood Cells
This medicine can lower your white blood cells, which fight germs. Call your doctor right away if you get a fever, especially if you think you might have an infection.
Risk to Unborn Babies
• This medicine can harm an unborn baby. Tell your doctor if you are pregnant or think you might be pregnant.
• If you can get pregnant, use birth control while taking KISQALI and for at least 3 weeks after your last dose.
Breastfeeding
Do not breastfeed while taking KISQALI and for at least 3 weeks after your last dose.
Other Medicines
• Stay away from certain medicines that can interfere with KISQALI or cause heart beat problems.
How to Take Your Medicine
• Take KISQALI at about the same time each day. Swallow the pills whole. Do not chew, crush, or break them.
• If you throw up or miss a dose, just take your next dose at the usual time.
• You can take KISQALI with or without food.
Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936
© Novartis
T2025-57
Read the patient information sheet that comes with your medicine.
Lung Problems
Tell your doctor right away if you have new or worse trouble breathing.
Serious Skin Problems
Watch for signs of serious skin problems like skin pain or burning, rash that spreads quickly, or mouth sores with fever or feeling like you have the flu. Call your doctor right away if you have these symptoms.
Heart Beat Problems
Learn the signs of heart beat problems. Call your doctor right away if you have symptoms of heart beat changes.
Liver Problems
Learn the signs of liver problems. Call your doctor right away if you have symptoms of liver problems.
Low White Blood Cells
This medicine can lower your white blood cells, which fight germs. Call your doctor right away if you get a fever, especially if you think you might have an infection.
Risk to Unborn Babies
• This medicine can harm an unborn baby. Tell your doctor if you are pregnant or think you might be pregnant.
• If you can get pregnant, use birth control while taking KISQALI and for at least 3 weeks after your last dose.
Breastfeeding
Do not breastfeed while taking KISQALI and for at least 3 weeks after your last dose.
Other Medicines
• Stay away from certain medicines that can interfere with KISQALI or cause heart beat problems.
How to Take Your Medicine
• Take KISQALI at about the same time each day. Swallow the pills whole. Do not chew, crush, or break them.
• If you throw up or miss a dose, just take your next dose at the usual time.
• You can take KISQALI with or without food.
© Novartis
T2025-57
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References
KISQALI (ribociclib) [prescribing information]. February 2026. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aaeaef94-f3f5-4367-8ea2-b181d7be2da8
Accessed: March 27, 2026