Frequently Asked Questions | mBC | KISQALI® (ribociclib)

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Frequently asked questions about KISQALI for metastatic breast cancer (mBC)

KISQALI is a treatment for HR+, HER2- metastatic breast cancer. This page answers common questions about how KISQALI works, dosing, safety, and what to expect when starting treatment.

About Metastatic Breast Cancer (mBC)

What is HR+, HER2- metastatic breast cancer?

HR+, HER2- metastatic breast cancer is a type of breast cancer that grows with hormones and has low or no HER2 protein.

“Metastatic” means the cancer has spread beyond the breast to other parts of the body, such as bones, liver, lungs, or brain. To learn more, go to Understanding mBC

HER2-, human epidermal growth factor receptor 2-negative.
HR+, hormone receptor-positive.

What does hormone-receptor positive (HR+) cancer mean?

Hormone receptor-positive (HR+) cancer has cells that grow with the help of hormones like estrogen and/or progesterone. Knowing if you have HR+ cancer is important because it means your cancer can be treated with hormone therapy.

HR+, hormone receptor-positive.

Why is knowing my (HER2) status important?

HER2 is a protein that helps cancer cells grow. Knowing your HER2 status helps your doctor choose the right treatment for your cancer type.

HER2, human epidermal growth factor receptor 2.

Why is my menopausal status important?

Your menopausal status affects hormone levels. This helps your doctor decide which hormone therapy works best for you.

About KISQALI

What is KISQALI?

KISQALI is a prescription medicine for HR+, HER2- metastatic breast cancer. KISQALI is taken in combination with:

an aromatase inhibitor (AI) as the first endocrine-based therapy, or
fulvestrant as the first endocrine-based therapy or following disease progression on endocrine therapy

Learn more about the clinical results of KISQALI + hormone therapy

HER2-, human epidermal growth factor receptor 2-negative.
HR+, hormone receptor-positive.

How does KISQALI work?

KISQALI is a targeted treatment for HR+, HER2- metastatic breast cancer that blocks proteins called CDK4 and CDK6 which help cancer cells grow. KISQALI affects cancer cells but can also affect healthy cells.

To learn how KISQALI + an aromatase inhibitor (AI) or fulvestrant work together to help delay disease progression, go to How KISQALI Works

CDK4/6, cyclin-dependent kinase 4 and 6.
HER2-, human epidermal growth factor receptor 2-negative.
HR+, hormone receptor-positive.

What do experts say about ribociclib (KISQALI)?

Leading cancer experts at the National Comprehensive Cancer Network^® (NCCN^®) recommend ribociclib (KISQALI) + an aromatase inhibitor (AI) as an effective and established treatment option for eligible people with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer.

What results were seen in the clinical trials of KISQALI?

Clinical trials show that KISQALI with hormone therapy helps people live longer without their cancer getting worse compared to hormone therapy alone.

In a clinical trial, at 80 months, women taking KISQALI + letrozole lived over a year longer (63.9 months) vs letrozole alone (51.4 months).

To learn more about KISQALI clinical results, go to Proven Results

KISQALI is not approved with tamoxifen.

How is KISQALI taken?

KISQALI is taken

600 mg (three 200 mg pills) orally, once a day
With or without food
3 weeks on, followed by a 1-week break

Taking KISQALI

How should I take KISQALI?

Take KISQALI once a day at the same time, with or without food. The initial starting dose is 600 mg (three 200 mg pills) 3 weeks on, followed by a 1-week break. Follow your doctor’s instructions and do not change your dose unless told to. For more information, go to How to Take KISQALI

How long do I take KISQALI?

For people with HR+, HER2- metastatic breast cancer, KISQALI is taken as long as it is still effective at preventing cancer growth and side effects are manageable.

What if I miss a dose of KISQALI?

If you miss a dose of KISQALI or vomit after taking a dose of KISQALI, do not take another dose on the same day. Take your next dose at the usual time you take KISQALI.

What should I avoid while taking KISQALI?

Avoid eating grapefruit and avoid drinking grapefruit juice. Give your doctor a list of all medications, vitamins, or herbal supplements you are currently taking. It's important to make sure all of your medications work safely together.

What tests will I need during treatment?

As part of your treatment, your doctor will perform heart monitoring and blood monitoring tests to make sure KISQALI is right for you. Heart monitoring would occur during your first 2 weeks of treatment, and blood monitoring would occur during your first 6 months of treatment.

Understanding Overall Survival & Progression-Free Survival

What is overall survival (OS)?

Time spent living with cancer is called overall survival, or OS. Research studies sometimes look at OS to learn if a treatment works. Median OS is the length of time after starting a study when half of the patients are still living.*

What is progression-free survival (PFS)?

Time spent living without cancer getting worse is called progression-free survival, or PFS. Research studies sometimes look at PFS to learn if a treatment works. Median PFS is the length of time after starting a study when half of the patients are living without their cancer getting worse.*

How are PFS and OS different?

Overall survival (OS) is the entire time since starting treatment that a patient spends living with breast cancer. Progression-free survival (PFS) is the time spent living without cancer getting worse.

KISQALI Safety & Side Effects

What are the most common side effects of KISQALI?

In clinical trials, the most common side effects of KISQALI were generally mild to moderate and included:

Decreased white blood cell counts
Increased liver function tests
Decreased red blood cell counts
Infections
Increased kidney function test
Decreased platelet counts
Nausea
Headache
Tiredness
Diarrhea

These are not all the side effects of KISQALI. KISQALI can also cause more serious side effects, including lung problems, severe skin reactions, and heart rhythm problems (also known as QT prolongation), liver problems and low white blood cell counts. Tell your doctor if you are breastfeeding, pregnant or planning to be, as it can harm an unborn baby. To learn more, go to Understanding and Managing Side Effects

What should I do if I notice any side effects?

If you experience any side effects, the most important thing you can do is talk to your doctor or care team. And while not all side effects can be managed, for many cases your care team will have suggestions on how best to manage them. Staying hydrated, getting proper sleep, and avoiding alcohol are among the additional things you can do to help manage some of the more common side effects. To learn more, go to Understanding and Managing Side Effects

Savings & Support

How can I save on my KISQALI prescription?

Novartis Patient Support™ offers savings programs for eligible patients based on your insurance and financial situation. Learn more about Savings & Support

Where can I sign up for support?

You can sign up for Novartis Patient Support™ at support.kisqali.com or at the following link: Sign up for Novartis Patient Support

Is Novartis Patient Support™ free?

Yes, Novartis Patient Support is completely free for people prescribed KISQALI.

What other support exists for people taking KISQALI?

There are many organizations that can help with other aspects of living with metastatic breast cancer, including travel, nutrition, workplace support, and more. To learn more about these different organizations which are independent from Novartis, visit mBC Support Resources

Partnering With Your Doctor

How can I make the most out of my doctor appointments?

One of the best ways to get the most out of your doctor appointments is to take an active role in your care.

Coming prepared with questions, sharing how you are feeling, and communicating openly with your care team about any side effects can help your care team understand what you need. To help you navigate every step of treatment with KISQALI, review these Support Resources

What questions should I ask my doctor and care team?

The questions you ask your doctor and care team should help you better understand your diagnosis and help you know what to expect from your treatment.

Here are a few questions to help you get started.

What are the clinical trial results, and how do they compare to other treatment options?
How does KISQALI help treat my type of cancer?
What are the side effects, and are they manageable?

To learn more about making the most out of your doctor’s appointments, download the Appointment Guide

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