Uses

What is Kisqali used for?

Kisqali (ribociclib) is commonly used for treating breast cancer that is hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative and is advanced or has spread to other parts of the body (metastatic). Kisqali may also be used to treat HR-positive, HER2-negative breast cancer that is early, meaning it has not spread beyond the breast or nearby lymph nodes. Kisqali is usually used in combination with another medicine.

Kisqali may also be used for other conditions as determined by your healthcare provider.

How does Kisqali work (mechanism of action)?

Kisqali is a specific kind of medicine called a kinase inhibitor. Kinases are enzymes that are responsible for sending and receiving signals in the body. These signals help your cells do important functions, such as grow properly. Kisqali blocks the action of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). These kinases send signals to cancer cells that help them grow and multiply. When Kisqali blocks the signals sent by CDK4 and CDK6, it helps to stop cancer cells from growing and multiplying and makes tumors shrink in size. 

How is Kisqali supplied (dosage forms)?

Kisqali is available as 200 mg oral tablets that are taken by mouth. 

How should I store Kisqali?

Kisqali should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep Kisqali in its original container.

Side Effects

What are the most common side effects of Kisqali?

The most common side effects of Kisqali are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

There may be other side effects of Kisqali that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Kisqali?

While less common, the most serious side effects of Kisqali are described below, along with what to do if they happen.

Severe Allergic Reactions. Kisqali may cause allergic reactions, which can be serious. Stop taking Kisqali and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Lung Inflammation. Kisqali can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. This can be serious or even life-threatening. Get emergency help if you have trouble breathing. You may also have a cough, fever, or chest pain. 

Severe Skin Reactions. Kisqali can cause severe skin reactions, called Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that can lead to death if not treated. DRESS is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body including your liver, kidneys, and heart. If you develop a rash, stop Kisqali and call your healthcare provider right away. Get emergency help right away if you have any of the following symptoms of SJS, TEN, or DRESS.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Breathing problems or wheezing
  • Racing heart
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Swelling in your feet, ankles, or legs
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Heart Rhythm Changes. Kisqali may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take some medicines that can cause QT prolongation. Tell your healthcare provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Kisqali. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Low Neutrophil Levels (Neutropenia). Kisqali may cause low levels of a type of white blood cell (called neutrophils), which is known as neutropenia. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection. Tell your healthcare provider right away if you have any of the following symptoms of low neutrophil levels.

  • Fever, chills, or sweats
  • Tiredness
  • Sore throat, cough, or shortness of breath
  • Mouth or throat sores
  • Swollen lymph nodes

Warnings & Precautions

Who should not use Kisqali?

Allergies to Ingredients. People who are allergic to any of the following should not take Kisqali.

  • Ribociclib
  • Kisqali
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Kisqali.

What should I know about Kisqali before using it?

Do not take Kisqali unless it has been prescribed to you by a healthcare provider. Take it as prescribed. 

Your dose should be taken at the same time every day, preferably in the morning. Do not chew, cut, or crush Kisqali. Do not take the tablets if they are broken, cracked, or damaged. Contact your pharmacist to learn how to get these replaced. 

Do not share Kisqali with other people, even if they have the same condition as you. It may harm them.

Keep Kisqali out of the reach of children.

You will need to have your heart checked and regular blood work done before and while taking Kisqali. It is important that you attend all appointments so your healthcare provider can make sure it is safe for you to take Kisqali.

What should I tell my healthcare provider before using Kisqali?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Kisqali is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Heart problems, including a prior heart attack, heart failure, irregular or slow heartbeats, or QT prolongation
  • Electrolyte problems (potassium, calcium, phosphorus, or magnesium)
  • Current signs of an infection, including fever or chills
  • Liver problems
  • Kidney problems

Other Medicines and Supplements. Kisqali may interact with other medicines and supplements. Before taking Kisqali, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Kisqali may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. You must not be pregnant before starting Kisqali. If you can become pregnant, use effective birth control while taking Kisqali and for at least 3 weeks after your last dose. 

Infertility. Kisqali may cause fertility problems in people who were assigned male at birth. Talk with your healthcare provider if this is a concern for you. 

Breastfeeding. Do not take Kisqali while you are breastfeeding and for at least 3 weeks after your last dose. It is not known if Kisquali passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Kisqali?

For more information about Kisqali, you can visit the manufacturer’s website www.kisqali.com or call them at 800-282-7630.

Interactions

Does Kisqali interact with foods or drinks?

Grapefruit interacts with Kisqali. It is important to avoid eating grapefruit or drinking grapefruit juice while taking Kisqali. This is because grapefruit can interfere with your body’s ability to break down Kisqali, which can lead to high levels of the medicine and an increased risk of side effects. 

It is unknown if drinking alcohol will affect Kisqali.

Does Kisqali interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

If you take other medicines that can cause QT prolongation, which is a potentially dangerous heart rhythm problem, it can increase your risk of serious heart problems with Kisqali. There are many medicines that may cause QT prolongation. Some examples include clarithromycin (an antibiotic), ondansetron (a medicine commonly used to prevent nausea and vomiting), or a medicine called an antiarrhythmic used to control your heart rate or rhythm, such as amiodarone or sotalol. Also tell your healthcare provider if you are taking a medicine called tamoxifen. 

Many other medicines may alter the blood levels of Kisqali, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.

This is not a complete list of medicines that can interact with Kisqali. Always check with your healthcare provider.

Does Kisqali (ribociclib) interact with other drugs you are taking?
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Overdose/Missed Dose

What should I do if I accidentally use too much Kisqali?

If you or someone else has used too much Kisqali, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Kisqali?

If you miss a dose of Kisqali, skip the dose and take your next dose at the usual time. If you vomit after taking Kisqali, you should skip the dose and take your next dose at the usual time. Do not take double or extra doses.

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