What is Kisqali and what is Ribociclib used for?
Kisqali is a cancer medicine used for the treatment of advanced or metastatic breast cancer (ie that has spread to other parts of the body) in post-menopausal women.
Kisqali can only be used when tumor cells have receptors for some hormones on their surface (HR-positive) and do not have large amounts of another receptor called HER2 (HER2-negative). Kisqali is used in combination with an aromatase inhibitor (an anticancer medicine that reduces estrogen).
Kisqali contains the active ingredient ribociclib.
How is Kisqali - Ribociclib used?
Kisqali can only be obtained with a prescription and treatment must be started by a doctor experienced in the use of anticancer therapies.
Kisqali is available as 200 mg tablets. The usual recommended dose is 3 tablets (600 mg) once a day for 21 days, followed by a 7-day break to complete a 28-day treatment cycle. The patient should take the tablets at about the same time each day, usually in the morning. Treatment cycles should continue until the medicine continues to work and the patient has no unacceptable side effects. If the patient has serious side effects, your doctor may reduce the dose of Kisqali, or stop or stop treatment with the medicine.
For more information, see the package leaflet.
How does Kisqali - Ribociclib work?
The active ingredient in Kisqali, ribociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which are important in regulating the way cells grow and divide. By blocking CDK4 and CDK6, Kisqali slows the growth of HR-positive breast cancer cells.
What benefit has Kisqali - Ribociclib shown during the studies?
The efficacy of Kisqali was demonstrated in a main study involving 668 women with HER2-negative HR-positive breast cancer. The average measure of effectiveness was the survival period of women without disease worsening (progression-free survival).
In this study, women received Kisqali with letrozole (an aromatase inhibitor) or placebo (a dummy treatment) with letrozole. Women taking Kisqali with letrozole lived on average 25.3 months without their disease getting worse compared to 16.0 months for those taking placebo with letrozole.
What are the risks associated with Kisqali - Ribociclib?
The most common side effects of Kisqali (which may affect more than 1 in 5 people) are low levels of white blood cells, headache, back pain, nausea, vomiting, diarrhea, constipation, fatigue, hair loss and a rash.
The most common serious side effects of Kisqali (which may affect more than 1 in 50 people) are low levels of white blood cells, nausea, vomiting, fatigue, back pain, abnormal blood values with regard to liver function and low phosphate levels in the blood (hypophosphataemia).
Kisqali should not be used in patients who are hypersensitive (allergic) to any of the components or to peanuts or soy.
For the full list of side effects and limitations, see the package leaflet.
Why has Kisqali - Ribociclib been approved?
The European Medicines Agency has decided that Kisqali's benefits are greater than its risks and recommended that it be approved for use in the EU. Kisqali used in combination with an aromatase inhibitor increased the time necessary for a worsening of the disease in postmenopausal women with advanced or metastatic HR-positive and HER2-negative breast cancer. The Agency considered that the pattern of side effects of Kisqali was fairly well established and that the side effects appear to be manageable.
What measures are being taken to ensure the safe and effective use of Kisqali - Ribociclib?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kisqali have been included in the summary of product characteristics and the package leaflet.
More information on Kisqali - Ribociclib
For the full version of the EPAR and the summary of the Kisqali risk management plan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Kisqali therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
