Question 1

What is Kisqali?

Accepted Answer

Kisqali is a targeted therapy medication that contains the active ingredient ribociclib. It works as a kinase inhibitor by targeting specific proteins that help control how cells grow and divide.

By blocking these proteins, the medication helps to slow or stop the growth and division of cancer cells. This process is intended to help slow the spread of the disease.

Question 2

What is Kisqali used for?

Accepted Answer

Kisqali is used to treat hormone receptor (HR)-positive , HER2-negative breast cancer.

Question 3

How does Kisqali work?

Accepted Answer

Kisqali belongs to a class of drugs known as kinase inhibitors. Specifically, it is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor. These proteins are found in both normal and cancer cells, but they play a critical role in controlling how fast cells grow and divide.

In certain types of breast cancer, the CDK4 and CDK6 proteins become overactive, which causes cancer cells to multiply rapidly. Kisqali works by:

Blocking protein signals: It attaches to the CDK4 and CDK6 proteins to prevent them from signaling the cell to divide.

Slowing cancer progression: By interfering with these signals, the medication helps slow the growth of the tumor and may stop the cancer cells from dividing altogether.

Kisqali is typically used in combination with hormone therapies, such as aromatase inhibitors or fulvestrant. While hormone therapy works by reducing or blocking estrogen that fuels the cancer, Kisqali works at a different stage by directly targeting the cell division cycle. Using these treatments together provides a dual approach to stopping cancer cell growth.

Question 4

What are the active ingredients in Kisqali?

Accepted Answer

The active ingredient in Kisqali is ribociclib .

Question 5

What are the side effects of Kisqali?

Accepted Answer

Common side effects of Kisqali may include:

Neutropenia

Nausea

Fatigue

and others.

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Kisqali?

Accepted Answer

Kisqali belongs to the CDK4/6 inhibitor drug class.

Question 7

What is the dosage of Kisqali and how do I take it?

Accepted Answer

How to Take Kisqali

Kisqali comes as a tablet to be taken by mouth. It is usually taken once daily, with or without food, at approximately the same time each day. It is recommended to take the dose in the morning. The tablets should be swallowed whole and should not be crushed, chewed, or broken. Do not take any tablet that is cracked, broken, or otherwise damaged.

Dosing Schedule

This medication is typically prescribed in cycles. A common pattern involves taking the medication daily for three weeks, followed by one week off. This cycle is then repeated as directed by a healthcare provider. Kisqali is often used in combination with other medications, such as an aromatase inhibitor or fulvestrant.

Missed Doses and Vomiting

If you miss a dose or if you vomit after taking your dose, skip the missed dose for that day. Take your next dose at the regular time. Do not take two doses at once to make up for a missed or vomited dose.

Storage and Handling

Keep the tablets in their original blister pack until you are ready to take them to protect them from moisture. Store the medication at room temperature away from excess heat.

Question 8

Is Kisqali safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy Considerations

Kisqali can cause fetal harm if taken during pregnancy. Based on findings from animal studies, the medication may lead to birth defects or pregnancy loss. Healthcare providers typically require a pregnancy test to ensure a patient is not pregnant before starting treatment.

Individuals who can become pregnant should use effective birth control during treatment and for at least 3 weeks after the final dose. If a patient becomes pregnant while taking this medication, they should contact their healthcare provider immediately to discuss the potential risks.

Breastfeeding

It is not known whether Kisqali passes into human breast milk. Because of the potential for serious adverse reactions in a nursing infant, breastfeeding is not recommended during treatment and for at least 3 weeks after the last dose.

Fertility

Based on animal studies, Kisqali may impair fertility in males. Patients should discuss any concerns regarding reproductive health and future family planning with their healthcare team before starting treatment.

Question 9

What forms and strengths does Kisqali come in?

Accepted Answer

Available Forms

Kisqali is provided as film-coated tablets for oral administration. The tablets are typically packaged in blister cards to help track the treatment cycle.

The medication is available in the following formats:

Kisqali: A package containing only ribociclib tablets.

Kisqali Femara Co-Pack: A combination package that contains both Kisqali tablets and letrozole tablets for use together.

Question 10

What is the FDA approval status of Kisqali?

Accepted Answer

FDA Approval Status

Kisqali (ribociclib) was first approved by the U.S. Food and Drug Administration (FDA) in March 2017. It belongs to a class of drugs known as kinase inhibitors. Since its initial release, the FDA has expanded its approved uses to include various stages of breast cancer treatment.

Approved Uses

Kisqali is FDA-approved for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in the following scenarios:

Advanced or Metastatic Cancer: It is used in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy or after the cancer has progressed on other hormonal treatments.

Early-Stage Cancer: In 2024, the FDA approved Kisqali for use with an aromatase inhibitor to treat patients with early-stage breast cancer who have a high risk of the cancer coming back (recurrence).

Regulatory Warnings and Safety Communications

The FDA has issued safety alerts for the class of drugs Kisqali belongs to (CDK4/6 inhibitors). This includes a warning about the potential for rare but serious lung inflammation, such as interstitial lung disease or pneumonitis. Healthcare providers are advised to monitor patients for new or worsening respiratory symptoms.

There are currently no Boxed Warnings or Risk Evaluation and Mitigation Strategy (REMS) programs required for Kisqali. However, the FDA continues to monitor its safety through post-marketing surveillance, particularly regarding its effects on heart rhythm (QT prolongation) and liver function.

Question 11

What should I know about Kisqali and cost?

Accepted Answer

Insurance and Out-of-Pocket Costs

Kisqali is a specialty medication, and its price can vary significantly based on the patient's insurance plan. Most commercial insurance and Medicare Part D plans provide coverage, but patients may still be responsible for co-pays, deductibles, or co-insurance. Because it is a specialty drug, it is often dispensed through specific specialty pharmacies rather than standard retail locations.

Financial Assistance Programs

There are several resources available to help manage the cost of Kisqali treatment:

Co-pay Savings Cards: Patients with commercial (private) insurance may be eligible for manufacturer programs that reduce out-of-pocket costs to a minimal amount per prescription.

Patient Assistance Programs: For individuals without insurance or those who are underinsured, the manufacturer may provide the medication at no cost or a reduced rate based on financial need.

Independent Foundations: Some non-profit organizations offer financial grants to help cancer patients cover the costs of their medications and insurance premiums.

Patients should consult with their healthcare team or a financial counselor at their treatment center to explore these options and determine the most accurate cost for their specific situation.

Kisqali

Medication Quick Facts

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Price Information

FAQ

Found an Error?