Kisqali is a brand-name tablet prescribed for advanced breast cancer. Kisqali contains the active ingredient ribociclib and belongs to the kinase inhibitor drug class.

Specifically, the Food and Drug Administration (FDA) has approved Kisqali to treat breast cancer that’s HR-positive and HER2-negative. Kisqali can be used for early, advanced, or metastatic breast cancer. It’s taken with certain hormone therapies.

Drug details

You’ll find key information about Kisqali here:

  • Drug class: a type of targeted therapy called a kinase inhibitor
  • Drug form: tablet
  • Generic available? no
  • Prescription required? yes
  • Controlled substance? no

Kisqali is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of a brand-name medication. The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs. And generics tend to cost less than brand-name drugs.

Kisqali can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Kisqali with hormone therapies. These lists do not include all possible side effects.

For more information on the possible side effects of Kisqali, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Kisqali, you can do so through MedWatch.

More common side effects

The more common side effects of Kisqali can include:

  • diarrhea
  • constipation
  • headache
  • cough
  • infections
  • rash
  • abnormal results of liver function tests, which could be a sign of liver problems
  • hair thinning or hair loss
  • fatigue and asthenia (feeling weak)
  • nausea and vomiting
  • anemia (low level of red blood cells)
  • mild allergic reaction

For more information about some of these side effects, see the “Side effect details” section.

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Kisqali are rare, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

For more information about some of these side effects, see the “Side effect details” section.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Hair loss

Hair loss or thinning can be a side effect of Kisqali. Hair loss could also be a side effect of hormone therapies that you take with Kisqali. These may include fulvestrant (Faslodex) and aromatase inhibitors such as letrozole (Femara).

Talk with your doctor if you’re concerned about hair loss.

Blood disorders

Taking Kisqali could cause problems with your blood cell counts. Kisqali commonly causes:

  • leukopenia (low levels of white blood cells)
  • neutropenia (low levels of a type of white blood cell)
  • anemia (low levels of red blood cells)
  • reduced platelet levels

Leukopenia and neutropenia

White blood cells help your body fight infections. Leukopenia occurs when your white blood cell count gets low. This raises your risk of getting infections. Some infections can be serious or life threatening.

Neutrophils are the most common type of white blood cell. Neutropenia occurs when your neutrophil levels become low.

To help protect yourself from infections, try to minimize your exposure to germs. Wash your hands often. If possible, try to avoid crowds and people who are sick.

See your doctor right away if you get symptoms of a low white blood cell count. These include fever, chills, or other signs of infection such as a sore throat or cough.

Anemia

Red blood cells carry oxygen through your body. If your red blood cell count gets low, it’s called anemia. This may make you feel unusually tired or cold. You may also notice your skin or gums looking pale.

Reduced platelet level

Platelets are blood cells that help your blood to clot (for example, if you injure yourself). If your platelet level falls too low, it’s called thrombocytopenia. It can make you bruise or bleed more easily than usual.

While taking Kisqali, you’ll need to get blood tests done regularly to check your blood cell levels. If your blood cells are affected, your doctor may lower your Kisqali dose. Or they may ask you to stop taking Kisqali until your blood cell levels recover. If you get severe problems with your blood cells, you may need to stop taking Kisqali and switch to another treatment.

Nausea and vomiting

Kisqali may cause nausea. Nausea can also be a side effect of hormone therapies that you take with Kisqali.

Nausea and vomiting were common in clinical studies of Kisqali.

If you’re having problems with nausea or vomiting, talk with your doctor about ways to manage these side effects. Other tips for managing nausea include eating small amounts throughout the day (instead of having three main meals) and avoiding greasy or fatty foods. It can also be helpful to sip fluids often, instead drinking a lot at once.

ALLERGIC REACTION

For some people, Kisqali can cause an allergic reaction. In general, symptoms of an allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Kisqali, your doctor may recommend a different medication instead.

Kisqali is FDA approved to treat breast cancer that’s HR-positive and HER2-negative. It’s specifically used for:

  • Early breast cancer, which refers to stage 2 or stage 3: Kisqali is used in people who have a high risk of their cancer recurring (coming back after treatment). It’s used with an aromatase inhibitor drug, which is a type of hormone therapy (see the “Kisqali use with other drugs” section for details).
  • Advanced or metastatic HER2-negative breast cancer: This means the cancer has spread to other parts of the body, such as the bones, liver, lungs, or brain. For this use, Kisqali is prescribed with hormone therapy (see the “Kisqali use with other drugs” section for details).

Hormone receptor-positive (HR-positive) means the cancer cells have tested positive for hormone receptors. Cells with hormone receptors are encouraged to multiply by the hormones estrogen, progesterone, or both. These hormones stimulate the growth and spread of the cancer.

Human epidermal growth factor receptor 2-negative (HER2-negative) means the cancer cells don’t have abnormally high levels of a protein called HER2, which promotes cell growth.

Kisqali use with other drugs

Kisqali is prescribed with certain hormone therapies for breast cancer. Hormone therapies are drugs that stop the hormone estrogen from stimulating the growth of cancer cells. Kisqali makes these therapies more effective at slowing the growth and spread of the cancer. You’ll take Kisqali with one of the following hormone therapies:

If you’re female and premenopausal or perimenopausal or if you’re male and you’re taking hormone therapy with Kisqali, you’ll take another type of hormone therapy called a luteinizing hormone-releasing hormone (LHRH) agonist. This type of therapy stops the ovaries from making estrogen. An example of an LHRH agonist is goserelin acetate (Zoladex). LHRH agonists are given by injection.

Note: Sex and gender exist on spectrums. The use of the terms “female” and “male” in this article refers to sex assigned at birth.

As with all medications, the price of Kisqali can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require you to get prior authorization before approving coverage for Kisqali. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Kisqali.

If you’re not sure if you’ll need to get prior authorization for Kisqali, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Kisqali, or if you need help understanding your insurance coverage, help is available. The manufacturer of Kisqali offers a patient support program that includes:

  • a copay program for people with private health insurance
  • a free trial offer
  • a patient support team, which is available at 866-433-8000

To learn more and see if you’re eligible for support, visit the Kisqali website.

This section compares Kisqali with some similar medications.

Kisqali vs. Ibrance

Ibrance and Kisqali are both approved to treat HR-positive and HER2-negative breast cancer. Both drugs are approved for advanced or metastatic HER2-negative breast cancer, and Kisqali is also approved for early breast cancer (stage 2 or stage 3). Both are prescribed with hormone therapy, specifically an aromatase inhibitor drug or fulvestrant (Faslodex).

Kisqali comes as oral tablets, and Ibrance comes as capsules and tablets. These drugs belong to the same class of drugs, which means they work in the same way in your body.

If you’re interested in taking Kisqali or Ibrance, talk with your doctor about which drug might be a better fit for you.

Can I use Kisqali after Ibrance?

Possibly. It depends on the reason you want to switch from Ibrance to Kisqali. For example, if you experience certain side effects from Ibrance that aren’t associated with Kisqali, it might be reasonable to switch.

However, if your cancer started to get worse or spread while taking Ibrance, it’s not known if switching to Kisqali would have any benefit. This is currently being researched in clinical studies.

Talk with your doctor if you want to try Kisqali because Ibrance has stopped working for you. This would be an off-label (non-approved) use for Kisqali.

Kisqali vs. Afinitor

Kisqali and Afinitor are both approved to treat advanced or metastatic breast cancer that is HR-positive and HER2-negative. But Afinitor is specifically approved for use in females who have gone through menopause.

Afinitor is also approved to treat certain tumors and a type of kidney cancer called renal cell carcinoma.

Kisqali is also approved to treat early breast cancer (stage 2 or stage 3) that’s HR-positive and HER2-negative.

Both drugs come as oral tablets, and Afinitor also comes as a tablet that you dissolve into water. Both drugs are targeted therapies for breast cancer, but they work in different ways.

If you’re interested in taking Kisqali or Afinitor, talk with your doctor about which drug is better for you.

Kisqali vs. Verzenio

Both Kisqali and Verzenio are used in certain situations for early, advanced, or metastatic breast cancer that’s HR-positive and HER2-negative.

Kisqali and Verzenio are both used in combination with other drugs, but Verzenio is also sometimes used alone.

Both drugs come as tablets that are taken by mouth. But Kisqali is taken once per day, while Verzenio is taken twice per day.

Your doctor can recommend which drug is the best choice for your treatment.

No, Kisqali is not chemotherapy. Chemotherapy treatments work by attacking all cells in the body that are multiplying rapidly. This includes healthy cells as well as cancer cells. This is why chemotherapy can cause many side effects.

Kisqali is a targeted therapy for cancer. It works on specific proteins inside the cancer cells that are overactive. These proteins are called CDK 4 and 6. They make the cancer cells grow and multiply quickly. Kisqali stops these proteins from working, so it slows or stops the growth and spread of the cancer.

CDK 4 and 6 are also involved in making healthy cells grow and multiply. However, because these proteins aren’t overactive in healthy cells, Kisqali affects healthy cells less than the cancer cells.

Kisqali can still affect some healthy cells, and can cause some serious side effects. But targeted therapies like Kisqali tend to have fewer side effects than chemotherapy.

The Kisqali dosage your doctor prescribes will depend on several factors. These include:

  • how well your liver works
  • other medications you take
  • any serious side effects you have

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Note: If you have certain serious side effects from Kisqali, your doctor may adjust your dosage of the drug. In some cases, they may have you stop taking Kisqali, either temporarily or permanently. For more information on possible serious side effects of this drug, see the “Kisqali side effects” section.

Drug forms and strengths

Kisqali comes as 200-milligram (mg) oral tablets.

Note: Your doctor may prescribe the Kisqali Femara Co-Pack if you take Femara with Kisqali. The co-pack contains enough Kisqali and Femara tablets for one cycle. (The dose of Kisqali in this package is the same as the dose you’d typically take if you were taking Kisqali by itself.)

Dosage for early breast cancer

For early breast cancer, Kisqali’s dosage is 400 mg (2 tablets) once per day for 21 days. This is followed by 7 days of not taking the drug. This 28-day cycle is continued for as long as your doctor recommends.

You’ll take an aromatase inhibitor drug, such as Femara, with Kisqali for early breast cancer. (See the “Kisqali use with other drugs” section for details.)

Dosage for advanced or metastatic breast cancer

To treat advanced or metastatic HER2-negative breast cancer the usual dosage of Kisqali is 600 mg (3 tablets) once per day for 21 days. This is followed by 7 days of not taking the drug. This 28-day cycle is continued for as long as your doctor recommends.

You might take an aromatase inhibitor drug or fulvestrant with Kisqali for advanced or metastatic breast cancer. (See the “Kisqali use with other drugs” section for details.)

About taking Kisqali

You’ll find information about key dosage issues here:

  • When to take: Kisqali’s manufacturer recommends taking the drug at the same time each day, preferably in the morning. Taking the medication around the same time of day helps keep a steady level of the drug in your body. This helps Kisqali work effectively.
  • If you miss a dose: If you forget to take a dose of Kisqali at your usual time, skip that dose. Take your next dose at your usual time. Never take two doses together to make up for a missed dose. (If you vomit after taking Kisqali, don’t take another dose that day. Just take your next dose when it’s time. If you often vomit while taking Kisqali, talk with your doctor about ways to manage this side effect.)
  • Taking Kisqali with food: Kisqali can be taken with or without food. But try to be consistent and take your dose either with or without food each day. This helps make sure the drug is absorbed at a consistent rate.
  • Crushing, splitting, or chewing Kisqali: You should swallow Kisqali tablets whole. Do not crush, split, or chew them. Don’t take a tablet if it looks broken, cracked, or damaged.
  • Length of use: Kisqali is meant to be a long-term treatment. If you and your doctor determine that Kisqali is safe and effective for you, you’ll likely take it long term.
  • How long it takes to work: Kisqali starts to work as soon as you start taking it, although you probably won’t notice any changes. You’ll have various tests throughout your treatment to check that Kisqali is working for you.

Why is it recommended to take Kisqali in the morning?

Kisqali’s manufacturer recommends taking the drug in the morning, but a specific reason for this recommendation isn’t given.

You should take Kisqali around the same time of day. This helps keep a steady level of the drug in your body, which helps it work effectively.

Overdose

Do not take more Kisqali than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Kisqali

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number or go to the nearest emergency room right away.

Kisqali is approved to treat breast cancer that’s HR-positive and HER2-negative.

Breast cancer happens when cells in your breast start to grow and multiply rapidly. The hormone estrogen sometimes encourages breast cancer cells to do this. If this is the case, tests will show that your breast cancer is hormone receptor-positive (HR-positive).

In HR-positive breast cancer, estrogen makes certain proteins in the cancer cells more active than usual. These proteins are called CDK 4 and 6. They are involved in regulating how cells grow and multiply. When these proteins become overactive in breast cancer cells, the cells grow and multiply faster than usual.

Kisqali mechanism of action

Kisqali’s mechanism of action (how it works) is to block the action of CDK 4 and 6. This stops the breast cancer cells from growing and multiplying, and this slows the growth and spread of the cancer.

Kisqali is a targeted therapy for breast cancer because it acts on this specific feature of the cancer cells.

Kisqali is taken with hormone therapies that reduce the action of estrogen on the cancer cells.

When you take both treatments, they work together to slow the growth of the cancer more than either one used alone.

Other drugs are available that can treat breast cancer. Some may be a better fit for you than others. If you’re interested in finding an alternative to Kisqali, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat this specific condition. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

The following drugs are similar to Kisqali:

Kisqali can interact with several other medications. It can also interact with certain supplements and foods.

Before taking Kisqali, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions with Kisqali.

Interactions with medications, foods, and supplements

This section lists medications, supplements, and foods that can interact with Kisqali. But, this section does not list all substances that may interact with Kisqali. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Kisqali and other medications

  • certain antibiotics, such as:
    • clarithromycin (Biaxin)
    • rifampin (Rifadin)
  • certain antifungals, such as:
    • itraconazole (Sporanox, Onmel, Tolsura)
    • ketoconazole
    • voriconazole (Vfend)
  • certain HIV drugs, such as:
    • atazanavir (Reyataz)
    • lopinavir/ritonavir (Kaletra)
    • ritonavir (Norvir)
  • certain seizure drugs, such as:
    • carbamazepine (Carbatrol, Equetro, Tegretol)
    • oxcarbazepine (Trileptal)
    • phenobarbital
    • phenytoin (Dilantin, Phenytek)
  • certain drugs to treat irregular heartbeats, such as:
    • amiodarone (Pacerone)
    • sotalol (Sotylize, Betapace, Betapace AF, Sorine)
  • certain antipsychotic drugs, such as:
    • haloperidol (Haldol)
    • quetiapine (Seroquel, Seroquel XR)
    • ziprasidone (Geodon)
  • certain antimicrobials, such as moxifloxacin (Avelox)
  • tamoxifen
  • cyclosporine (Neoral, Gengraf, Sandimmune, Restasis)
  • everolimus (Afinitor, Zortress)
  • sirolimus (Rapamune)
  • midazolam (Versed, Nayzilam)
  • tacrolimus (Prograf, Astagraf XL)

Kisqali and herbs and supplements

You should not take St. John’s wort (Hypericum perforatum) with Kisqali. St. John’s wort can lower the amount of Kisqali in your body. It could make Kisqali less effective.

Check with your doctor or pharmacist before using any herbs or supplements while taking Kisqali.

Kisqali and grapefruit

You should not drink grapefruit juice or eat grapefruit while taking Kisqali. Eating grapefruit or drinking grapefruit juice while taking Kisqali can make Kisqali build up in your body. This can raise your risk of side effects from Kisqali.

Alcohol interaction

There are no known interactions between alcohol and Kisqali. However, if you have side effects from Kisqali such as fatigue, nausea, diarrhea, or headache, drinking alcohol could make these side effects worse.

Drinking large amounts of alcohol can also damage your liver. Kisqali can cause liver problems as well. If you drink excessively while taking Kisqali, this might raise your risk for liver problems.

Alcohol has been reported to raise your riskTrusted Source of developing breast cancer. However, the amount of alcohol that may put you at risk is not currently known. It’s also not known if drinking alcohol while you have breast cancer will make it worse.

If you drink alcohol and are concerned about how it might affect your breast cancer or your Kisqali treatment, talk with your doctor. They can tell you how much is safe for you to drink.

This drug comes with several precautions. Before taking Kisqali, talk with your doctor about your health history. Kisqali may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • heart problems or risk factors for heart problems, such as:
  • liver problems
  • pregnancy
  • breastfeeding
  • previous allergic reaction to this or a similar drug

Note: For more information about the potential negative effects of Kisqali, see the “Kisqali side effects” section.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.