Brand name: Kisqali
Generic name: ribociclib
Medication Class: Cyclin-dependent kinase (CDK) 4 and 6 inhibitor
Similar Drugs: Ibrance (palbociclib)
Manufacturer: Novartis
FDA Approval Date: March 13, 2017

What is Kisqali and how does it work?

Kisqali (ribociclib) is a cyclin-dependent kinase (CDK) inhibitor approved for the treatment of postmenopausal women with hormone receptor positive (HR-positive), human epidermal growth factor receptor 2 negative (HER2-negative) advanced or metastatic breast cancer. It is used in combination with Femara (letrozole).

Under normal conditions, CDK4 and CDK6 help regulate cell division in the human body. However, these proteins can become over-activated in certain breast cancer patients, leading to uncontrolled cell division. These breast cancer cells can continue to divide and spread rapidly if left untreated. Kisqali slows the growth of breast cancer cells and prevents their spread by blocking the action of CDK4 and CDK6.

What is Kisqali used for treating?

Kisqali (ribociclib) is used in combination with an aromatase inhibitor to treat postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 (HER2)-negative advanced or metastatic breast cancer

How effective is Kisqali?

A randomized, double-blind, placebo-controlled, multicenter study evaluated the effects of Kisqali plus letrozole versus placebo plus letrozole in 668 postmenopausal women with HR-positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced cancer. The dose of Kisqali was 600 mg daily for 21 days followed by 7 days off. Letrozole 2.5 mg was given the entire 28-day cycle.

Kisqali plus letrozole reduced the risk of cancer progression or death by 44% compared to letrozole alone. The median progression-free survival was 25.3 months for patients who received Kisqali plus letrozole and 16 months for the placebo plus letrozole group.

What are the side effects of Kisqali?

Common Side Effects

• Nausea
• Vomiting
• Diarrhea
• Constipation
• Fatigue
• Headache
• Back pain
• Alopecia (hair loss)
• Rash
• Itching
• Stomatitis
• Pyrexia
• Decreased appetite
• Peripheral edema
• Insomnia

Shortness of breath

• Serious Side Effects
• QT  prolongation (heart rhythm problems)
• Liver and biliary problems
• Neutropenia (low white blood cell count)
• Anemia

What is the dosage of Kisqali?

Kisqali is supplied as 200 mg film-coated tablets.

The recommended dose is 600 mg taken orally once daily for 21 consecutive days followed by 7 days without treatment. This results in a complete 28-day cycle. 

Kisqali can be taken with or without food, but it must be taken in combination with letrozole.

The recommended Letrozole dose is 2.5 mg taken orally once daily through the entire 28-day cycle. Kisqali and letrozole should be taken at the same time each day, preferably in the morning.

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