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Generic Name: ribociclib
Dosage Form: Tablets
Date of Approval: March 13, 2017
Company: Novartis Pharmaceuticals Corporation

Treatment for: Breast Cancer

FDA Approves Kisqali

The U.S. Food and Drug Administration (FDA) has approved Kisqali (ribociclib), a selective cyclin-dependent kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

Patient Information

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Kisqali may cause serious side effects, including:

  • Heart rhythm problems (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. 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. Your healthcare provider should do blood tests to check your liver before and during treatment. 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 when taking Kisqali and may result in infections that may be severe. Your healthcare provider should check your white blood cell counts before and during treatment. 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.

See Kisqali side effects for more information about side effects.

What is Kisqali?

Kisqali is a prescription medicine used in combination with a certain type of medicine as the first hormonal based therapy to treat women who have gone through menopause with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic).

It is not known if Kisqali is safe and effective in children.

Before taking Kisqali

Before you start treatment, tell your healthcare provider 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 problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood
  • have fever, chills, or any other signs or symptoms of infection
  • have liver problems
  • have any other medical conditions
  • are pregnant, or plan to become pregnant. 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.
    • 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.
    • 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.
  • are breastfeeding or plan to breastfeed. It is not known if Kisqali passes into your breast milk. Do not breastfeed during treatment, and for at least 3 weeks after the last dose.

Tell your healthcare provider about all of 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.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take Kisqali?

  • Take this medicine exactly as your healthcare provider tells you.
  • Do not change your dose or stop treatment unless your healthcare provider tells you.
  • Take the tablets each day at about the same time, preferably in the morning.
  • You may take Kisqali with or without food.
  • Swallow the tablets whole. Do not chew, crush, or split the tablets before swallowing them.
  • Do not take any tablets that are broken, cracked, or that look damaged. If you miss a dose, or vomit after taking a dose, do not take another dose on that day. Take your next dose at your regular time.
  • If you take too much, or overdose, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid while taking Kisqali?

  • Avoid eating pomegranate or grapefruit and avoid drinking pomegranate or grapefruit juice during treatment since these may increase the amount of Kisqali in your blood.

Kisqali side effects

Kisqali may cause serious side effects, including:

  • See Important information.

The most common side effects include:

  • nausea
  • tiredness
  • diarrhea
  • hair loss
  • vomiting
  • constipation
  • headache
  • back pain

Kisqali may cause fertility problems if you are male. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

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. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Kisqali?

  • Store the tablets at 68°F to 77°F (20°C to 25°C).
  • Keep the tablets in the original container.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Kisqali.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information that is written for health professionals.

What are the ingredients in Kisqali?

Active ingredient: ribociclib

Inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, 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.