Pronunciation: Kis kah lee
Generic name: ribociclib
Brand names: Kisqali, Kisqali Femara Co-Pack
Dosage form: oral tablet
Drug class: CDK 4/6 inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 8, 2024.

What is Kisqali?

Kisqali is a prescription medicine that may be used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adults:

• in combination with an aromatase inhibitor for stage II and III early breast cancer with a high risk of coming back
• that has gotten worse or has spread to other parts of the body (advanced or metastatic breast cancer). Kisqali is used in combination with:
  • an aromatase inhibitor as the first endocrine-based therapy, or
  • fulvestrant as the first endocrine-based therapy or following disease progression on endocrine therapy.

Kisqali’s mechanism of action involves blocking cyclin-dependent kinases 4 and 6 (CDK4/6), which are key regulators of the cell cycle. By blocking these enzymes, Kisqali slows or stops the growth of cancer cells. Kisqali is not chemotherapy, it is a targeted treatment. Kisqali is usually used in combination with hormone therapies, such as an aromatase inhibitor or fulvestrant (Faslodex).

• Aromatase inhibitors used in combination with Kisqali include letrozole (Femara), anastrozole (Arimidex), and exemestane (Aromasin).
• Kisqali is available co-packaged with Femara as the Kisqali Femara Co-Pack. See What are the benefits of taking Kisqali and Femara together? for more information.

Kisqali first gained FDA approval on March 13, 2017. Kisqali belongs to the drug class kinase inhibitors.

Kisqali side effects

The most common side effects of Kisqali in people with early breast cancer include:

• Changes in laboratory test results, such as decreased white blood cell counts, decreased red blood cell counts, increased liver function tests, decreased platelet counts, or increased kidney function tests
• infections
• nausea
• headache
• tiredness.

Other common side effects of Kisqali reported in people with advanced or metastatic breast cancer include:

• diarrhea
• vomiting
• constipation
• hair loss.

Serious side effects and warnings

Kisqali may cause the following serious side effects.

Lung problems. Kisqali may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including:

• trouble breathing or shortness of breath
• cough with or without mucus
• chest pain

Severe skin reactions. Tell your healthcare provider or get medical help right away if you get severe rash or rash that keeps getting worse, reddened skin, flu-like symptoms, skin pain or burning, blistering of the lips, eyes, or mouth, blisters on the skin or skin peeling, with or without fever.

Heart rhythm problems (QT prolongation). Kisqali can cause a heart problem known as QT prolongation This condition can cause an abnormal heartbeat and may lead to death. Your healthcare provider should check your heart and do blood tests before and during treatment with Kisqali.

• Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint.

Liver problems. Kisqali can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment with Kisqali. Tell your healthcare provider right away if you get any of the following signs and symptoms of liver problems:

• yellowing of your skin or the whites of your eyes (jaundice)
• dark or brown (tea-colored) urine
• feeling very tired
• loss of appetite
• pain on the upper right side of your stomach area (abdomen)
• bleeding or bruising more easily than normal.

Low white blood cell counts (neutropenia). Low white blood cell counts are very common during treatment with Kisqali and may result in infections that may be severe. Your healthcare provider should check your white blood cell counts before and during treatment with Kisqali. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills.

Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking Kisqali if you develop certain serious side effects during treatment with Kisqali.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Kisqali. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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Before taking

Before taking Kisqali, tell your healthcare provider about all of your medical conditions, including if you:

• have any heart problems, including heart failure, irregular heartbeats, and QT prolongation
• have ever had a heart attack
• have a slow heartbeat (bradycardia)
• have high blood pressure that is not controlled
• have decreased thyroid gland function (hypothyroidism)
• have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood
• have a fever, chills, or any other signs or symptoms of infection
• have liver problems
• have kidney problems
• are pregnant, or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Kisqali can harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Kisqali.

Females who are able to become pregnant and who take Kisqali should use effective birth control during treatment and for at least 3 weeks after the last dose of Kisqali.

Talk to your healthcare provider about birth control methods that may be right for you during this time.

If you become pregnant or think you are pregnant, tell your healthcare provider right away.

Breastfeeding

It is not known if Kisqali passes into your breast milk. Do not breastfeed during treatment with Kisqali and for at least 3 weeks after the last dose of Kisqali.

Fertility in males

Kisqali may cause fertility problems in males, which may affect your ability to father a child. Talk to your healthcare provider if this is a problem for you.

How should I take Kisqali?

Take Kisqali exactly as your healthcare provider tells you. Do not change your dose or stop taking Kisqali without talking to your healthcare provider.

• Kisqali is usually taken 1 time a day for 21 days followed by 7 days of treatment.
  • This is called a cycle of treatment.
• Kisqali may be taken with or without food.
• Kisqali is usually taken in combination with an aromatase inhibitor or fulvestrant.
• Swallow Kisqali tablets whole. Do not chew, crush, or split Kisqali tablets before swallowing them.
• Take Kisqali each day at about the same time, preferably in the morning.
• Do not take any Kisqali tablets that are broken, cracked, or that look damaged.
• See How do you take Kisqali? for more information.

Kisqali dosing

Kisqali Dosing for Early Breast Cancer

Kisqali dosing for Early Breast Cancer: Kisqali 400 mg orally (two 200 mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.

Kisqali dosing for Advanced or Metastatic Breast Cancer: Recommended starting dose: Kisqali 600 mg orally (three 200 mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days without treatment.

Dose interruption, reduction, and/or discontinuation may be required based on individual safety and tolerability.

What happens if I miss a dose of Kisqali?

 If you miss a dose of Kisqali or vomit after taking a dose of Kisqali, do not take another dose on that day. Take your next dose at your regular time.

What other drugs will affect Kisqali?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Kisqali and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:

• CYP3A Inhibitors: Avoid concomitant use of Kisqali with strong CYP3A inhibitors, such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, and grapefruit. If strong inhibitors cannot be avoided, reduce the dose of Kisqali.
• CYP3A4 inducers, such as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids. Avoid concomitant use.
• CYP3A Substrates, such as midazolam, felodipine, buspirone, lovastatin, eletriptan, sildenafil, simvastatin, triazolam, dexamethasone, antipyrine, quinine: The dose of CYP3A substrates may need to be reduced when given concurrently with Kisqali.
• Drugs known to prolong the QT interval, such as haloperidol, ziprasidone, quetiapine, thioridazine, olanzapine, risperidone, droperidol, amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide, macrolides, fluoroquinolones. Avoid concomitant use of drugs known to prolong QT interval with Kisqali.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. See the Kisqali Prescribing Information for a full list of interactions.

Kisqali storage

Before use, Kisqali should be kept in a refrigerator at 2°C to 8°C (36°F to 46°F).

After dispensing, patients can store Kisqali at room temperature in its original pack between 68°F to 77°F (20°C to 25°C) for up to 2 months.

Keep out of the reach of children.

Kisqali ingredients

Active ingredient: ribociclib

Inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide red, lecithin (soya), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, and xanthan gum.

Available as Kisqali 200 mg tablets.

Who makes Kisqali?

Novartis Pharmaceuticals Corporation makes Kisqali.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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