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What is Kisqali® ? (ribociclib)

Kisqali is an oral kinase inhibitor used in combination with certain hormone therapies to treat women with advanced or metastatic breast cancer that are hormone receptor positive and human epidermal growth factor receptor 2 (HER2) negative. Depending on where a patient is in their treatment, Kisqali may be used in women who are premenopausal, perimenopausal, or postmenopausal. Kisqali is a prescription medication manufactured by Novartis Pharmaceuticals.1,2

What is the ingredient in Kisqali?

The active ingredient in Kisqali is ribociclib, a kinase inhibitor that targets cyclin dependent kinase (CDK) 4 and 6.1

How does Kisqali work?

Kisqali is a kinase inhibitor. Kinase inhibitors block certain proteins which control cellular functions like signaling, cell division, and survival. Kisqali is a CDK4/6 inhibitor. CDK4 and CDK6 are proteins that are important during a cell’s growth and replication cycles. These two proteins may be overactive in breast cancer cells, particularly those which are hormone receptor positive. Breast cancer cells that are hormone receptor positive are stimulated by the presence of hormones like estrogen, which can increase the activity of CDK4/6. Overactivity of CDK4 and CDK6 can cause the cancer cells to grow uncontrollably. By blocking CDK4/6, Kisqali can help slow the growth and division of breast cancer cells, but it may also interfere with the normal growth and division of healthy cells.1,3

What are some of the possible side effects of Kisqali?

Kisqali can cause serious side effects, including:

  • A heart rhythm condition called QT prolongation, which may potentially be life threatening
  • Liver toxicity, which can cause yellowing of the skin or whites of the eyes (jaundice), darkened or brown urine, fatigue, loss of appetite, abdominal pain on the right side, and/or more bleeding or bruising than normal – any of these symptoms should be reported immediately to a doctor
  • Lowered white blood cell counts (neutropenia), which may lead to serious infections1,4

The most common side effects experienced by patients taking Kisqali in clinical trials included lowered white blood cell counts, nausea, fatigue, diarrhea, hair loss, vomiting, constipation, headache, and back pain.1

Things to know about Kisqali

Before starting treatment with Kisqali, patients should talk to their doctor about all their medications (prescription and over-the-counter), herbal supplements, and vitamins they are taking. Some medications or supplements may interfere with each other and may cause side effects.1,4

Before starting treatment with Kisqali, patients should discuss with their doctor all their medical conditions, especially:

  • Any heart problems, such as heart failure, previous heart attack, irregular heartbeats, bradycardia (slow heartbeat), and/or QT prolongation
  • Any problems with the amount of calcium, potassium, phosphorus, or magnesium in the blood
  • Liver problems
  • Symptoms of infection, such as fever or chills
  • If patients are pregnant or planning to become pregnant
  • If patients are breastfeeding or planning to breastfeed1,4

Kisqali can cause harm to an unborn fetus and should not be used in pregnant women. Women who can become pregnant are advised to use effective contraception while taking Kisqali and for at least three weeks after stopping treatment with Kisqali.1,4

It is not known if Kisqali passes through breastmilk. Women should not breastfeed while taking Kisqali.1,4

Kisqali may cause fertility problems in men, which could affect the ability to conceive a child.1,4

People taking Kisqali should not eat grapefruit or drink grapefruit juice, as grapefruit products may increase the levels of Kisqali in the body, which can increase the potential for side effects.1,4

Dosing information

Kisqali is an oral medication that comes in 200 mg tablets. It can be taken with or without food and should be taken in combination with hormone therapy agents Femara® (letrozole) or Faslodex® (fulvestrant). The recommended starting dose is 600 mg (3 tablets) taken once daily for 21 consecutive days, followed by 7 days off treatment. Depending on the individual’s response to Kisqali, the dosage may be reduced, paused, or discontinued as needed.1,2

Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their ribociclib regimen.

For more information, read the full prescribing information of Kisqali.

  1. Kisqali prescribing information. Novartis Pharmaceuticals. Available at https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/kisqali.pdf. Accessed 7/12/18.
  2. Ribociclib approval expanded for some women with advanced breast cancer. Available at https://www.cancer.gov/news-events/cancer-currents-blog/2018/ribociclib-fda-expanded-approval-breast-cancer. Accessed 8/21/18.
  3. CDK4/6 inhibitors: where they are now and where they are headed in the future. ASCO Post. Available at http://www.ascopost.com/issues/may-10-2017-supplement-cdk46-inhibitors/cdk46-inhibitors-where-they-are-now-and-where-they-are-headed-in-the-future/. Accessed 7/12/18.
  4. Kisqali product website. Novartis Pharmaceuticals. Available at https://www.us.kisqali.com/metastatic-breast-cancer/. Accessed 7/12/18.