Class: Biological Therapy

Generic Name: ribociclib

Trade Name: Kisqali®

For which conditions is this drug approved? Kisqali is used in combination with another medicine as the first hormonal-based therapy to treat post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body.

What is the mechanism of action? Kisqali is a kinase inhibitor. A kinase is a type of protein in the body that helps control cell division. Cancer cells grow in an uncontrolled fashion, and Kisqali works by interfering with the kinase to stop cancer cells from dividing and growing.

How is Kisqali typically given (administered)? Kisqali is taken orally with or without food in combination with letrozole.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Kisqali. Typically, blood will be drawn before and after treatment to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans, or other measures to assess side effects and response to therapy.

What are the most common side effects of treatment with Kisqali?

• Nausea
• Tiredness
• Diarrhea
• Hair loss
• Vomiting
• Constipation
• Headache
• Back pain

What are some of the less common but potentially serious side effects of Kisqali?

• Heart rhythm problems (QT prolongation)
• Liver problems
• Low white blood cell counts

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

 Are there any special precautions patients should be aware of before starting treatment?

• Patients should avoid eating pomegranates or grapefruits and their juices during treatment with Kisqali.

What should you tell your healthcare provider before starting treatment with Kisqali?

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.
• Have problems with the amount of potassium, calcium, phosphorous, or magnesium in your blood.
• Have fever, chills, or any other sign of infection.
• Have liver problems.
• Have any other medical conditions.
• Are pregnant or plan to become pregnant.
• Are breastfeeding or plan to breastfeed.
• If you are male, Kisqali may cause fertility problems.

Tell your health care 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 health care provider or pharmacist when you get a new medicine.

When should patients notify their physician?

Contact your healthcare professional immediately in case of any of the following:

• You have symptoms of QT prolongation. These include: a fast or irregular heartbeat, or feeling faint or dizzy.
• You have symptoms of liver problems. These include: yellowing of the skin or the whites of your eyes, dark or brown colored urine, feeling very tired, loss of appetite, pain on the right side of your stomach area, bleeding or bruising more easily than usual.
• You have symptoms of low white blood cell counts. These include: signs of infections such as fever of chills.
• You become pregnant.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 05/17.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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