Kisqali (ribociclib) is a medicine used for certain types of breast cancer. Kisqali is used to treat breast cancer that is hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative. It can be used to treat breast cancer that is advanced or has spread to other parts of the body (metastatic). Kisqali is usually used in combination with another medicine to treat breast cancer. It is combined with a type of medicine called hormone therapy. These include a medicine called fulvestrant or a type of medicine known as an aromatase inhibitor.
How Does Kisqali Work for Breast Cancer?
Kisqali is a specific kind of medicine called a kinase inhibitor. Kinases are enzymes that are responsible for sending and receiving signals in the body. These signals help your cells do important functions such as grow properly. Kisqali blocks the action of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). These kinases send signals to cancer cells that help them grow and multiply. When Kisqali blocks the signals sent by CDK4 and CDK6, it helps to stop cancer cells from growing and multiplying and makes tumors shrink in size.
How Do I Take Kisqali?
Kisqali is taken as a tablet that you swallow. You take Kisqali once a day for 21 days in a row, and then have 7 days where you do not take Kisqali. This means that in every 28 days, you will take Kisqali once a day for 21 days and then not take any Kisqali for 7 days. You can take Kisqali with or without food, and you should try to take your dose around the same time every day. Kisqali should be taken whole, and you should not crush or chew it. Do not take tablets that are broken, cracked, or damaged, and contact your pharmacy about getting them replaced. If you vomit after taking a dose of Kisqali, skip the dose and do not take an extra dose. Take your next Kisqali dose as scheduled.
You will continue taking Kisqali for as long as possible. This means you will take it until your cancer progresses or you have side effects that make it not safe for you to take. If you have certain side effects, your health care provider may change or pause your doses of Kisqali. In some cases, they may need to have you stop taking Kisqali completely.
If you have problems with your liver or kidneys, your dose of Kisqali will likely be lowered to make sure it is safe for you. Talk with your health care provider about your medical history so they can decide what the best dose of Kisqali is for you.
How Well Does Kisqali Work for Breast Cancer?
The FDA approved Kisqali for HR-positive, HER2-negative metastatic breast cancer based on multiple clinical trials.
In the MONALEESA-2 clinical trial, women and people who were assigned female at birth and were postmenopausal (menopause had already occurred) took Kisqali combined with an aromatase inhibitor hormone therapy called letrozole or a placebo with letrozole for HR-positive, HER2-negative advanced breast cancer that had not been treated for the advanced cancer. A placebo is used in clinical trials as a control so that a new medicine in a group of people can be compared in a similar group of people who did not receive the new medicine. Letrozole is an aromatase inhibitor that blocks estrogen in the body. The clinical trial included 668 people, with 334 people taking Kisqali. They were followed to see how long it took for their breast cancer to progress, meaning that the cancer grew or spread. This measurement is called progression-free survival. The median progression-free survival was 25.3 months for Kisqali plus letrozole compared to 16 months for placebo plus letrozole. This means that half of the people who took Kisqali did not have their cancer progress for at least 25.3 months compared to 16 months for people who took placebo. This study also looked at median overall survival, which measured how long half of the people in the study who received a certain medicine survived after starting to use the medicine. People who took Kisqali plus letrozole in the study had a median overall survival of 63.9 months, while people who took a placebo plus letrozole had a median overall survival of 51.4 months. This means that half of the people who took Kisqali survived for at least 63.9 months compared to 51.4 months for the people who took placebo.
In the MONALEESA-7 clinical trial, women and people who were assigned female at birth and had not experienced menopause took Kisqali combined with goserelin and an aromatase inhibitor or a medicine called tamoxifen or a placebo with goserelin and an aromatase inhibitor or tamoxifen for HR-positive, HER2-negative advanced breast cancer that had not been treated for the advanced cancer. Goserelin is a type of hormone therapy that lowers estrogen along with the aromatase inhibitor or tamoxifen. The clinical trial included 672 people, with 335 people taking Kisqali. The median progression-free survival was 23.8 months for people who took Kisqali compared to 13 months for people who took placebo. This means that half of the people who took Kisqali did not have their cancer progress for at least 23.8 months. The overall survival was measured after 42 months of starting treatment. When this was measured, 70.2% of people who took Kisqali were still alive compared to 46% of the people who took a placebo.
In the MONALEESA-3 clinical trial, women and people who were assigned female at birth and were postmenopausal took Kisqali combined with fulvestrant or placebo combined with fulvestrant for HR-positive, HER2-negative advanced or metastatic breast cancer that had previously been treated with a hormone therapy. Fulvestrant is a type of hormone therapy that decreases estrogen. The clinical trial included 726 people, with 484 people taking Kisqali. The median progression-free survival was 20.5 months for people who took Kisqali compared to 12.8 months for people who took placebo. This means that half of the people who took Kisqali did not have their cancer progress for at least 20.5 months. The overall survival was measured after 42 months of starting treatment. When this was measured, 57.8% of the people who took Kisqali were still alive, compared to 45.9% of the people who took placebo.
In the COMPLEEMENT-1 clinical trial, men and people who were assigned male at birth and had HR-positive, HER2-negative advanced or metastatic breast cancer took Kisqali in combination with the medicines letrozole and either goserelin or leuprolide. These additional medicines work to decrease estrogen. The clinical trial included 39 people. This study looked at how many people had a partial or complete response, and 46.9% of the people who took Kisqali had a response. Of these people who had a response, 80% of them were still having a response to the treatment at 12 months or longer. This study will continue to be followed, and updated results may be available in the future.
The manufacturer of Kisqali also looked at how well the medicine worked in older people. In people who were ages 65 to 74, the median overall survival was 72.6 months when they took Kisqali along with other hormone therapies. This was compared to 59.8 months for people who took placebo. This means that half of the people aged 65 to 75 who took Kisqali were alive for at least 72.6 months. In people who were 75 or older, the median overall survival was 62.1 months when they took Kisqali along with other hormone therapies. This was compared to 52.8 months for people who took placebo. This means that half of the people 75 years of age or older who took Kisqali were alive for at least 62.1 months.
How Will My Progress Be Monitored?
Kisqali will start working as soon as you start taking the medicine. Your health care provider will usually do a scan to see how your cancer is responding to the treatment 6 weeks after you start your medicine. They may choose to do the scan earlier or later than 6 weeks.
Your health care provider will also do regular blood tests to monitor how Kiswali is working in your body. These tests will monitor your blood counts such as white blood cells, neutrophils, and platelets so that your health care provider knows that you can continue to take Kisqali safely. If you have certain side effects such as a cough, your health care provider may do additional tests to make sure it is safe for you to continue to take Kisqali.
How Can I Prevent and Manage Side Effects?
Side effects are common with medicines that treat cancer, including Kisqali. It is important to tell your health care provider about any side effects you have during or after taking Kisqali. They can help to determine if your side effects are serious or provide more information to help you manage the side effects.
Your health care provider will have you do bloodwork regularly while taking Kisqali. It’s important to attend all of your appointments for blood tests so that your health care provider can make sure Kisqali is safe for you. These tests will look at your blood cell counts to make sure you do not have any problems with your blood cell counts that would make it unsafe for you to take Kisqali. This is because Kisqali can cause low white blood cell counts, also called neutropenia. If not treated, neutropenia can cause serious infections that can be dangerous and even life-threatening.
You can ask your health care provider what else you can do to prevent or treat common side effects. For example, you can help to prevent and treat nausea, vomiting, and diarrhea by eating bland foods and having multiple small meals throughout the day instead of three large meals. They may also recommend you keep certain over-the-counter medicines on hand to treat common side effects like diarrhea and what to do if you have severe diarrhea. They will also tell you how to watch for severe side effects such as lung problems or heart problems and what to do if you have these side effects.
If you have certain side effects while you take Kisqali, your health care provider may need to change your dose of medicine, pause your doses, or even stop your medicine altogether. This will depend on the side effect you experience, how severe it is, and what treatment it needs. If your Kisqali dose needs to be lowered, the medicine will continue to work in your body. If your medicine is paused, your health care provider might restart the medication at the same dose or at a lower dose once your side effect gets better.
What Are Some Other Considerations to Be Aware Of?
While taking Kisqali, you will need to avoid grapefruit. You should not eat grapefruit or drink any juice that has grapefruit. This is because grapefruit can block your body’s ability to break down (metabolize) Kisqali and cause too much of the medicine to stay in your body and increase your risk for side effects.
If you have certain health conditions such as liver or kidney problems, your dose of Kisqali may need to be lowered. Talk with your health care provider about your health history and any issues you’ve had in the past.
Is There Any Cost Assistance Available?
The manufacturer of Kisqali has a program to help support financial assistance and may be able to offer coupons or savings for Kisqali.
