Kisqali (ribociclib) is a medicine used for certain types of breast cancer. It is used to treat breast cancer that is hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative. Kisqali can be used to treat early breast cancer, which is cancer that has not spread to other parts of the body. It can also be used to treat breast cancer that has spread to other parts of the body (metastatic breast cancer). You can read more about Kisqali for metastatic breast cancer here.
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 growing 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 stop cancer cells from growing and multiplying, shrinkingtumors. In people with early breast cancer, Kisqali helps lower the risk of the cancer coming back.
How Do I Take Kisqali?
Kisqali is a tablet that you swallow. You must swallow the tablet whole and should not crush or chew it. Do not take tablets that are broken, cracked, or damaged, and contact your pharmacy about getting them replaced.
You can take Kisqali with or without food. Try to take your dose around the same time every day. If you throw up after taking a dose of Kisqali, skip the dose and take your next dose at the usual time.
You take Kisqali once a day for 21 days in a row, and then take seven days off (without taking 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 seven days.
Kisqali is taken with another type of medicine known as an aromatase inhibitor, a type of hormone therapy. The aromatase inhibitor will usually be taken every day for about five years.
Is Kisqali Right for Me?
Kisqali may be right for you if you have HR-positive and HER2-negative early (stage II or III) breast cancer and are at high risk of recurrence. Cancer recurrence is when your cancer comes back after a period of time when it was not detectable. Your health care provider will decide your risk of recurrence based on certain factors, including those listed below:
- Your age at the time of diagnosis
- The size of your tumor
- The number of lymph nodes with cancer
- Any gene mutation or abnormal gene activity that can cause cancer to grow
How Was Kisqali Studied for Early Breast Cancer?
In the NATALEE clinical study, adult women and men with HR-positive, HER2-negative early breast cancer who were at high risk of recurrence were treated with either Kisqali plus an aromatase inhibitor or placebo (containing no medicine) plus an aromatase inhibitor. Two types of aromatase inhibitors were used in the study: anastrozole and letrozole. Goserelin was added for men and premenopausal women to temporarily stop their bodies from making sex hormones (testosterone in men and estrogen in women). This process is called gonadal suppression, and it helps slow the growth of certain cancers that depend on these hormones to grow.
The trial included a total of 5,101 people; 2,549 got Kisqali plus an aromatase inhibitor, while 2,552 were treated with an aromatase inhibitor alone. Kisqali was continued for three years, and the aromatase inhibitor was continued for at least five years.
People in the study were 24-90 years old with a median (middle) age of 52. Most people were White (73.4%); 13.2% were Asian, 1.7% were Black, and race was not reported for 11.7% of people. Most of them were postmenopausal women (55.7%); 0.4% of people were men, and 43.9% were premenopausal women. Most people had received previous chemotherapy (88.1%) or endocrine therapy (71.1%).
Over half of the people (59.6%) had stage III breast cancer, 19.6% had stage IIA, and 20.5% had stage IIB. Less than 1% of patients had stage I breast cancer or had missing data. A total of 28.1% of people did not have cancer in their lymph nodes, while 41.1% had cancer in one lymph node, 18.6% of people had cancer in two or three lymph nodes, and 10.5% of people had lymph nodes that could not be examined.
The researchers measured how well Kisqali treated early breast cancer by looking at invasive disease-free survival. They looked at the time to the first occurrence of any invasive cancer (except basal and squamous cell carcinomas of the skin), cancer recurrence, or death.
What Benefits Were Seen in the NATALEE Study?
After three years, people taking Kisqali with an aromatase inhibitor had better invasive disease-free survival than those taking the aromatase inhibitor alone.
- Invasive disease-free survival was 90.7% with Kisqali plus an aromatase inhibitor and 87.6% with an aromatase inhibitor alone, a difference of about 3%.
This means Kisqali lowers the risk of invasive disease, cancer recurrence, or death by about 25% compared to taking only an aromatase inhibitor. Benefit was seen in patients regardless of disease stage.
Your results may differ from what was seen in the study.
What Are the Common Side Effects of Kisqali, and How Can I Manage Them?
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. Some common side effects of Kisqali include:
- Low white blood cells, low red blood cells, and low platelets
- Infections
- Nausea
- Tiredness
- Headache
Not all side effects can be prevented, but here are things you can do to help:
- To help prevent tiredness and headaches, consider taking rest breaks and getting enough sleep. Drink enough fluid to avoid dehydration. Avoid caffeine or alcohol in the evening, as these may affect sleep patterns.
- If you have nausea, you should eat small, frequent meals. Snacking on bland foods, such as dry toast or crackers, may be helpful. Avoid fatty, fried, or spicy foods. Sipping cold, clear liquids throughout the day may help with nausea and prevent dehydration.
- The most important way to prevent infection is to always wash your hands with soap and water or use hand sanitizer. You should also avoid large crowds and people who are sick. Wash fruits and vegetables thoroughly and cook meats properly to help prevent infection.
- Follow instructions from your health care provider. You will likely need blood tests to check for blood disorders and liver or kidney problems. Your health care provider will likely also check your heart with an electrocardiogram before and during Kisquali treatment.
How Long Will I Continue Treatment With Kisqali?
You will continue to take Kisqali for up to three years. Your health care provider may change your dose, have you pause treatment, or tell you to stop Kisqali treatment if you have side effects. Do not stop Kisqali without contacting your health care provider.
What Are Other Considerations to Be Aware Of?
Many medicines and over-the-counter (OTC) products interact with Kisqali. Tell your health care provider of all medicines, vitamins, herbal products, or other supplements you are using before you start taking Kisqali. Once you start taking Kisqali, do not start or stop any medicine or OTC product until you check with your pharmacist.
Is There Any Cost Assistance Available?
The drugmaker has a program to help support financial assistance and may be able to offer coupons or savings for Kisqali.
