Kisqali (ribociclib)

What is Kisqali?

Kisqali is a brand-name prescription medication. It’s used to treat a form of advanced breast cancer in women. Kisqali treats breast cancer that is:

• metastatic (it’s spread to other parts of the body, such as the bones, liver, brain, or lungs)
• hormone receptor-positive (HR-positive), which means the cancer’s growth is stimulated by the hormones estrogen, progesterone, or both
• HER2-negative (the cancer cells don’t have abnormally high levels of a protein called HER2, which promotes cell growth)

Drug details

Kisqali is a targeted therapy for this type of breast cancer. It targets and blocks specific proteins within the breast cancer cells that make them multiply.

Kisqali is used 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:

• an aromatase inhibitor, such as letrozole (Femara)
• fulvestrant (Faslodex)

Kisqali comes as a tablet you take by mouth.

FDA approval

Kisqali was first approved by the Food and Drug Administration (FDA) in March 2017 to treat postmenopausal* women. It was approved to treat HR-positive, HER2-negative breast cancer that is advanced or has spread to other parts of the body. In July 2018, the FDA expanded this approval to include premenopausal* and perimenopausal* women.

Kisqali is approved for use with either an aromatase inhibitor or fulvestrant.

* Postmenopausal women have already gone through menopause. Premenopausal women haven’t started menopause yet, and perimenopausal women are in the stage right before menopause.

Effectiveness

For more information on Kisqali’s effectiveness, see the “Kisqali uses” section below.

Kisqali generic

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. Generics tend to cost less than brand-name drugs.

Kisqali contains one active drug ingredient: ribociclib.

Kisqali cost

As with all medications, the cost 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.

Novartis Pharmaceuticals Corp., the manufacturer of Kisqali, offers the following:

• Free treatment vouchers. Visit the voucher website or call 800-282-7630.
• The Novartis Oncology Universal Co-pay Program. Refer to the program information or call 877-577-7756.
• Kisqali Care Patient Navigators. Call 800-282-7630.

For general information about these services and to see if you’re eligible for support, visit the Kisqali website.

Kisqali side effects

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 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 (lack of energy) and asthenia (feeling weak)*
• nausea and vomiting*
• anemia (low level of red blood cells)*

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.

* This common side effect is discussed in the “Side effect details” section below.

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:

• Liver problems. Symptoms can include:
  • jaundice (yellowing of your skin or the whites of your eyes)
  • dark urine
  • loss of appetite
  • pain in your upper-right abdomen (belly)
  • bruising or bleeding easily
  • feeling very tired
• Interstitial lung disease or pneumonitis (severe, life threatening lung inflammation). Symptoms can include:
  • trouble breathing
  • feeling short of breath
  • cough
  • chest pain
• QT prolongation (a problem with your heart rhythm that can lead to a life threatening abnormal heartbeat). Symptoms can include:
  • fast heartbeat
  • irregular heartbeat
  • dizziness
  • feeling faint
• Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug-induced hypersensitivity syndrome/drug reaction. Symptoms can include:
  • red or flushed skin
  • peeling skin
  • blisters
  • fever and body aches
• Leukopenia (low levels of white blood cells) and neutropenia (low levels of a type of white blood cell).*
• Allergic reaction.*

* This serious side effect is discussed in the “Side effect details” section below.

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

In clinical studies, hair loss was reported in:

• 19% of women who took Kisqali with fulvestrant, compared with 5% of women who took a placebo (a treatment with no active drug) with fulvestrant
• 21% of women who took Kisqali with an aromatase inhibitor and goserelin acetate (Zoladex), compared with 13% of women who took a placebo with an aromatase inhibitor and goserelin acetate
• 33% of women who took Kisqali with letrozole, compared with 16% of women who took a placebo with letrozole

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 for 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.

In clinical studies, leukopenia occurred in:

• 27% of people taking Kisqali + fulvestrant
• < 1% of people taking a placebo* + fulvestrant
• 29% of people taking Kisqali + aromatase inhibitor + goserelin acetate
• 3% of people taking a placebo + aromatase inhibitor + goserelin acetate
• 33% of people taking Kisqali + letrozole
• 1% of people taking a placebo + letrozole

And neutropenia occurred in:

• 69% of people taking Kisqali + fulvestrant
• 2% of people taking a placebo* + fulvestrant
• 78% of people taking Kisqali + aromatase inhibitor + goserelin acetate
• 7% of people taking a placebo + aromatase inhibitor + goserelin acetate
• 75% of people taking Kisqali + letrozole
• 5% of people taking a placebo + letrozole

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.

* A placebo is a treatment with no active drug.

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.

In clinical studies, anemia was reported in:

• 17% of women who took Kisqali with fulvestrant, compared with 5% of women who took a placebo with fulvestrant
• 19% of women who took Kisqali with an aromatase inhibitor and goserelin acetate, compared with 8% of women who took a placebo with an aromatase inhibitor and goserelin acetate
• 18% of women who took Kisqali with letrozole, compared with 5% of women who took a placebo with letrozole

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.

In clinical studies, reduced platelet levels were reported in:

• 33% of women who took Kisqali with fulvestrant, compared with 11% of women who took a placebo with fulvestrant
• 26% of women who took Kisqali with an aromatase inhibitor and goserelin acetate, compared with 9% of women who took a placebo with an aromatase inhibitor and goserelin acetate
• 29% of women who took Kisqali with letrozole, compared with 6% of women who took a placebo with letrozole

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. In these studies:

• of the women who took Kisqali with fulvestrant, 45% reported nausea and 27% reported vomiting
• of the women who took a placebo with fulvestrant, 28% reported nausea and 13% reported vomiting
• of the women who took Kisqali with an aromatase inhibitor and goserelin acetate, 31% reported nausea
• of the women who took a placebo with an aromatase inhibitor and goserelin acetate, 20% reported nausea
• of the women who took Kisqali with letrozole, 52% reported nausea and 29% reported vomiting
• of the women who took a placebo with letrozole, 29% reported nausea and 16% reported vomiting

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.

Fatigue and weakness

Fatigue (lack of energy) and asthenia (feeling weak) are common side effects of many cancer treatments, including Kisqali.

In clinical studies, these effects varied depending on which drug Kisqali was used with:

• fatigue was reported by 37% of women who took Kisqali with letrozole, compared with 30% of women who took a placebo with letrozole
• asthenia was reported by 12% of women who took Kisqali with an aromatase inhibitor and goserelin acetate
• asthenia was reported by 14% of women who took Kisqali with fulvestrant

Tips for managing fatigue include staying active, resting after physical activities, and taking short naps when needed. Talk with your doctor about how much activity is right for you and the best way to manage your fatigue.

Allergic reaction

Allergic reactions weren’t reported in clinical studies of Kisqali. But hypersensitivity (allergic) reactions have occurred in people taking Kisqali since the medication was approved for use. And some of these reactions may be severe and, rarely, even life threatening.

You should call your doctor right away if you think you’re having a severe allergic reaction to Kisqali. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Symptoms of severe allergic reactions can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Common questions about Kisqali

Here are answers to some frequently asked questions about Kisqali.

How is Kisqali different from Verzenio?

Both Kisqali and Verzenio are used in certain situations for breast cancer that’s:

• metastatic, which means that it’s spread to other parts of the body, such as the bones, liver, brain, or lungs
• hormone receptor-positive, which means that the cancer’s growth is stimulated by the hormones estrogen, progesterone, or both
• HER2-negative, meaning that the cancer cells don’t have abnormally high levels of a protein called HER2, which promotes cell growth

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.

For more information about the types of breast cancer that Kisqali is used to treat, see the “Kisqali uses” section below. And to learn more about Verzenio, view the drug’s prescribing information or talk with your doctor.

Can I use Kisqali after Ibrance?

Possibly. It depends on the reason you want to switch from Ibrance to Kisqali. For example, if you got 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.

Does Kisqali cause hair loss?

Kisqali can cause hair loss or hair thinning in some women. Kisqali is taken with hormone therapies such as letrozole (Femara) or fulvestrant (Faslodex), and these can also cause hair loss. In clinical studies, hair loss was reported in:

• 19% of women who took Kisqali with fulvestrant, compared with 5% of women who took a placebo (a treatment with no active drug) with fulvestrant
• 21% of women who took Kisqali with an aromatase inhibitor and goserelin acetate (Zoladex), compared with 13% of women who took a placebo with an aromatase inhibitor and goserelin acetate
• 33% of women who took Kisqali with letrozole, compared with 16% of women who took a placebo with letrozole

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

Is Kisqali able to shrink tumors?

Yes, Kisqali can shrink tumors. This is one of the effects of treatment that was reported in clinical studies. Of the women whose tumors could be measured in these studies, tumors shrunk partially or completely in:

• 40.9% of women who took Kisqali with fulvestrant, compared with 28.7% of women who took a placebo with fulvestrant
• 50.5% of women who took Kisqali with an aromatase inhibitor and goserelin acetate, compared with 36.2% of women who took a placebo with an aromatase inhibitor and goserelin acetate
• 52.7% of women who took Kisqali with letrozole, compared with 37.1% of women who took a placebo with letrozole

Are there certain foods I should avoid during Kisqali treatment?

Yes, you should avoid eating grapefruit or drinking grapefruit juice while taking Kisqali. Grapefruit can make Kisqali build up in your body. This can raise your risk for getting side effects.

What if I vomit after taking a dose of Kisqali? Should I take another dose right away?

No. 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.

Alternatives to Kisqali

Other drugs are available that can treat advanced 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.

Alternatives for breast cancer

Examples of other drugs that may be used to treat advanced or metastatic breast cancer that is hormone receptor-positive (HR-positive) and HER2-negative include:

• Hormone therapies, such as:
  • anastrozole (Arimidex)
  • exemestane (Aromasin)
  • fulvestrant (Faslodex)
  • aromatase inhibitors, such as letrozole (Femara)
  • tamoxifen
  • toremifene (Fareston)
• Targeted therapies, such as:
  • abemaciclib (Verzenio)
  • everolimus (Afinitor)
  • palbociclib (Ibrance)

Kisqali vs. Ibrance

You may wonder how Kisqali compares with other medications that are prescribed for similar uses. Here we look at how Kisqali and Ibrance are alike and different.

Ingredients

Kisqali contains the active drug ribociclib. Ibrance contains the active drug palbociclib. They belong to the same class of drugs, which means they both work in the same way in your body.

Uses

Kisqali and Ibrance are both approved to treat advanced or metastatic breast cancer that is hormone receptor-positive (HR-positive) and HER2-negative.

Kisqali is approved for use in:

• women who haven’t started or are going through menopause, and who haven’t already had hormone therapy for their advanced cancer (these women will take Kisqali with a hormone therapy called an aromatase inhibitor)
• postmenopausal women who haven’t already had hormone therapy for their advanced cancer (these women will take Kisqali with an aromatase inhibitor or another hormone therapy called fulvestrant)
• postmenopausal women whose advanced cancer has gotten worse or spread after hormone therapy (these women will take Kisqali with fulvestrant)

Ibrance is approved for:

• men and postmenopausal women who haven’t already had hormone therapy for their advanced cancer (in this case, Ibrance is used with an aromatase inhibitor)
• men and women whose advanced cancer has gotten worse or spread after hormone therapy (in this case, Ibrance is used with fulvestrant)

Drug forms and administration

Kisqali comes as tablets that you take by mouth. Ibrance comes as capsules that you take by mouth.

Both drugs are usually taken once a day for 21 days, followed by 7 days without taking the drug. This 28-day cycle is repeated for as long as your doctor recommends.

Side effects and risks

Kisqali and Ibrance both contain the same type of drug. Therefore, these medications can cause similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Kisqali or with both drugs (when taken separately). Both Kisqali and Ibrance are taken with other drugs.

• Can occur with Kisqali:
  • cough
  • constipation
  • headache
  • asthenia (feeling weak)
• Can occur with Ibrance:
  • no unique more common side effects
• Can occur with both Kisqali and Ibrance:
  • fatigue (lack of energy)
  • nausea and vomiting
  • diarrhea
  • infections
  • hair thinning or hair loss
  • rash
  • abnormal results of liver function tests, which could be a sign of liver problems
  • anemia (low level of red blood cells)

Serious side effects

These lists contain examples of serious side effects that can occur with Kisqali, or with both Kisqali and Ibrance (when taken individually).

• Can occur with Kisqali:
  • liver problems
  • QT prolongation (a problem with your heart rhythm that can lead to a life threatening abnormal heartbeat)
  • severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug-induced hypersensitivity syndrome/drug reaction
• Can occur with Ibrance:
  • no unique serious side effects
• Can occur with both Kisqali and Ibrance:
  • leukopenia (low levels of white blood cells) and neutropenia (low levels of a type of white blood cell), which can raise your risk for serious and life threatening infections
  • interstitial lung disease or pneumonitis (severe, life threatening lung inflammation)

Effectiveness

The only condition both Ibrance and Kisqali are approved to treat is advanced or metastatic breast cancer that is hormone receptor-positive (HR-positive) and HER2-negative.

These drugs haven’t been directly compared in clinical studies. But studies have found both Kisqali and Ibrance to be effective for treating advanced or metastatic breast cancer that’s HR-positive and HER2-negative.

One review of studies with these drugs found that Kisqali and Ibrance were equally effective for treating this type of advanced breast cancer.

Guidelines by the National Comprehensive Cancer Network for HER2-negative metastatic breast cancer recommend both Kisqali and Ibrance as preferred first-line treatments.

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

Costs

Kisqali and Ibrance are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Kisqali vs. Afinitor

Like Ibrance (above), the drug Afinitor has uses similar to those of Kisqali. Here’s a comparison of how Kisqali and Afinitor are alike and different.

Ingredients

Kisqali contains the active drug ribociclib. Afinitor contains the active drug everolimus. Both drugs are targeted therapies for breast cancer, but they work in different ways.

Uses

Kisqali and Afinitor are both approved to treat advanced or metastatic breast cancer that is hormone receptor-positive (HR-positive) and HER2-negative.

Kisqali is approved for:

• women who haven’t started or are going through menopause, who haven’t already had hormone therapy for their advanced cancer (these women will take Kisqali with a hormone therapy called an aromatase inhibitor)
• postmenopausal women who haven’t already had hormone therapy for their advanced cancer (these women will take Kisqali with an aromatase inhibitor or another hormone therapy called fulvestrant)
• postmenopausal women whose advanced cancer has gotten worse or spread after hormone therapy (these women will take Kisqali with fulvestrant)

Afinitor is approved for use in postmenopausal women whose cancer has got worse or has spread while taking letrozole (Femara) or anastrozole (Arimidex). It’s used with a hormone therapy called exemestane (Aromasin).

Afinitor is also approved to treat:

• neuroendocrine tumors (tumors that produce certain hormones)
• renal cell carcinoma (a type of kidney cancer)
• tuberous sclerosis complex (a rare genetic condition in which tumors develop in various parts of the body)

Drug forms and administration

Kisqali comes as tablets that you take by mouth. It’s taken once a day for 21 days, followed by 7 days of not taking the drug. This 28-day cycle is repeated for as long as your doctor recommends.

Afinitor comes as tablets that you take by mouth. For breast cancer, it’s taken once a day for as long as your doctor recommends.

Side effects and risks

Kisqali and Afinitor have some similar side effects and others that differ. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Kisqali (when used with other drugs), with Afinitor, or with both drugs (when taken separately).

• Can occur with Kisqali:
  • constipation
  • vomiting
  • hair thinning or hair loss
  • abnormal results of liver function tests, which could be a sign of liver problems
• Can occur with Afinitor:
  • abdominal (belly) pain
  • fever
  • swelling of your arms, hands, feet, ankles, or face
  • mouth sores or pain
• Can occur with both Kisqali and Afinitor:
  • infections
  • rash
  • fatigue (lack of energy)
  • diarrhea
  • headache
  • nausea
  • cough
  • asthenia (feeling weak)
  • anemia (low level of red blood cells)*

* This is considered a serious side effect for Afinitor.

Serious side effects

These lists contain examples of serious side effects that can occur with Kisqali (when used with other drugs), with Afinitor, or with both drugs (when taken separately).

• Can occur with Kisqali:
  • liver problems
  • QT prolongation (a problem with your heart rhythm that can lead to a life threatening abnormal heartbeat)
  • severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug-induced hypersensitivity syndrome/drug reaction
• Can occur with Afinitor:
  • severe allergic reaction
  • kidney failure
  • wounds healing slower than normal
  • increased blood sugar levels
  • increased cholesterol or triglyceride levels
  • thrombocytopenia (low platelet level)
• Can occur with both Kisqali and Afinitor:
  • leukopenia (low levels of white blood cells) and neutropenia (low levels of a type of white blood cell), which can raise your risk for serious and life threatening infections
  • interstitial lung disease or pneumonitis (severe, life threatening lung inflammation)

Effectiveness

Kisqali and Afinitor have different Food and Drug Administration (FDA)-approved uses, but they’re both used to treat hormone advanced or metastatic breast cancer that’s HR-positive and HER2-negative.

These drugs haven’t been directly compared in clinical studies. But studies have found both Kisqali and Afinitor to be effective for treating this type of breast cancer.

An indirect comparison of studies found that using a CDK4/5 inhibitor such as Kisqali may improve progression-free survival more so than using Afinitor would. This is the case when either drug is used with other drugs for treating breast cancer.

Guidelines by the National Comprehensive Cancer Network for HER2-negative metastatic breast cancer recommend Kisqali as a preferred first-line treatment option. These same guidelines also recommend both Kisqali and Afinitor as preferred second-line treatment options.

Costs

Kisqali and Afinitor are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Kisqali and Afinitor generally cost about the same. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Is Kisqali chemotherapy?

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 down 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.

Kisqali dosage

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

• how well your liver works
• other medications you take
• if you get certain side effects

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 above.

Drug forms and strengths

Kisqali comes as tablets that you take by mouth. They are available in one strength: 200 mg.

Dosage with an aromatase inhibitor for breast cancer

To treat advanced or metastatic breast cancer that’s HR-positive and HER2-negative, the usual dosage of Kisqali is 600 mg (three tablets) once a 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.

An aromatase inhibitor is usually taken once every day, including on the days that you don’t take Kisqali.

Dosage with fulvestrant for breast cancer

To treat advanced or metastatic breast cancer that’s HR-positive and HER2-negative, the usual dosage of Kisqali is 600 mg (three tablets) once a 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.

Fulvestrant injections are usually given on days 1, 15, and 29 of your first month of taking Kisqali. After that, you’ll get injections once a month.

What if I 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.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Kisqali is meant to be used as 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.

Kisqali interactions

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

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Kisqali and other medications

Below is a list of medications that can interact with Kisqali. This list does not contain all drugs that may interact with Kisqali.

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.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Kisqali and certain antibiotic drugs

Antibiotics are drugs that treat infections caused by bacteria. Taking certain antibiotics with Kisqali can cause Kisqali to build up in your body. This can raise your risk for getting side effects from Kisqali.

Examples of antibiotics that can make Kisqali build up in your body include:

• clarithromycin
• telithromycin (Ketek)

These antibiotics should usually be avoided while you take Kisqali. If you need to take one, your doctor will temporarily lower your Kisqali dosage.

Taking Kisqali with certain other antibiotics can lower the amount of Kisqali in your body. This could make Kisqali less effective, so these drugs should not be taken with Kisqali.

Examples of antibiotics that can make Kisqali less effective include:

• rifabutin (Mycobutin)
• rifampin (Rifadin)
• rifapentine (Priftin)

Kisqali and certain antifungal drugs

Antifungal drugs treat fungal infections. Taking certain antifungal drugs with Kisqali can cause Kisqali to build up in your body. This can raise your risk for getting side effects from Kisqali.

Examples of antifungals that can make Kisqali build up in your body include:

• itraconazole (Sporanox, Onmel, Tolsura)
• ketoconazole
• posaconazole (Noxafil)
• voriconazole (Vfend)

These antifungals should usually be avoided while you take Kisqali. If you need to take one of them, your doctor will temporarily lower your Kisqali dosage.

Kisqali and certain drugs for HIV

Taking Kisqali with certain HIV treatments can cause Kisqali to build up in your body. This can raise your risk for getting side effects from Kisqali.

Examples of HIV drugs that can cause Kisqali to build up in your body include:

• atazanavir (Reyataz)
• cobicistat (Tybost)
• darunavir (Prezista)
• fosamprenavir (Lexiva)
• indinavir (Crixivan)
• lopinavir/ritonavir (Kaletra)
• nelfinavir (Viracept)
• ritonavir (Norvir)
• saquinavir (Invirase)

If possible, Kisqali should not be taken with these HIV drugs. If you need to take one of them, your doctor will prescribe a lower dose of Kisqali.

Kisqali and certain seizure medications

Taking certain seizure medications with Kisqali can lower the amount of Kisqali in your body. This could make Kisqali less effective, so you shouldn’t take these drugs with Kisqali.

Examples of seizure medications that can make Kisqali less effective include:

• carbamazepine (Carbatrol, Equetro, Tegretol)
• fosphenytoin (Cerebyx)
• oxcarbazepine (Trileptal)
• phenobarbital
• phenytoin (Dilantin, Phenytek)
• primidone (Mysoline)

Kisqali and drugs that can cause an abnormal heart rhythm

Kisqali can sometimes cause an abnormal heart rhythm called QT prolongation. This can lead to a life threatening abnormal heartbeat.

Certain other drugs can also cause this side effect. If you take Kisqali with one of these other drugs, this can raise your risk for QT prolongation. You should avoid taking these drugs with Kisqali.

Examples of drugs that can raise your risk for QT prolongation when taken with Kisqali include:

• certain drugs to treat irregular heartbeats, such as:
  • amiodarone (Pacerone)
  • quinidine
  • procainamide
  • sotalol (Sotylize, Betapace, Betapace AF, Sorine)
  • disopyramide (Norpace)
• certain antipsychotic drugs, such as:
  • pimozide (Orap)
  • haloperidol
  • quetiapine (Seroquel, Seroquel XR)
  • ziprasidone (Geodon)
• certain antimicrobials, such as:
  • clarithromycin
  • moxifloxacin (Avelox)
• methadone (Methadose, Dolophine)
• ondansetron (Zuplenz, Zofran ODT)
• tamoxifen

Kisqali and drugs metabolized by CYP3A4

Certain drugs are metabolized (broken down) by an enzyme in your liver called CYP3A4. Kisqali can stop this enzyme from working. If you take Kisqali with a drug that’s usually broken down by CYP3A4, Kisqali can cause the drug to build up in your body. This can raise your risk for getting side effects.

Examples of drugs that can build up in your body when taken with Kisqali include:

• cyclosporine (Neoral, Gengraf, Sandimmune, Restasis)
• dihydroergotamine (DHE-45, Migranal)
• ergotamine (Ergomar)
• ergotamine/caffeine (Cafergot, Migergot, Wigraine)
• everolimus (Afinitor, Zortress)
• fentanyl (Duragesic, Subsys, Lazanda, Abstral, others)
• midazolam (Nayzilam)
• sirolimus (Rapamune)
• tacrolimus (Prograf, Astagraf XL)

Kisqali and herbs and supplements

Don’t 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

Don’t 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 for getting side effects from Kisqali.

Kisqali and alcohol

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 risk for 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.

Kisqali uses

The Food and Drug Administration (FDA) approves prescription drugs such as Kisqali to treat certain conditions.

Kisqali is FDA-approved to treat a certain type of breast cancer in women. It’s approved for breast cancer that is:

• Advanced or metastatic. This means the cancer has spread to other parts of the body, such as the bones, liver, lungs, or brain.
• Hormone receptor-positive (HR-positive). This 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.
• HER2-negative. This means the cancer cells don’t have abnormally high levels of a protein called HER2, which promotes cell growth.

Kisqali is used with certain hormone therapies to treat this type of breast cancer. Hormone therapies stop estrogen from stimulating the growth of cancer cells. Kisqali targets other processes in the cancer cells that are making them multiply. Kisqali helps make the hormone therapies more effective at slowing the growth and spread of the cancer. (See “Kisqali use with other drugs” below for more information.)

Effectiveness for breast cancer

In three clinical studies, Kisqali slowed the progression (worsening or spreading) of advanced breast cancer that was HR-positive and HER2-negative.

Studies in postmenopausal women

One study looked at postmenopausal women (those who’ve gone through menopause) who hadn’t had any hormone therapy for their advanced breast cancer. Some women took Kisqali with letrozole (Femara). The others took letrozole with a placebo (a treatment with no active drug). Women who took Kisqali with letrozole had a 44% lower risk of their cancer progressing than women who took letrozole with a placebo.

Another study looked at postmenopausal women who hadn’t already been treated with hormone therapy or whose cancer had progressed with previous hormone therapy. Some of the women took Kisqali with fulvestrant (Faslodex), and the others took fulvestrant with a placebo. Those who took Kisqali with fulvestrant had a 41% lower risk of their cancer progressing than the women who took fulvestrant with a placebo.

Studies in premenopausal and perimenopausal women

One study looked at premenopausal women (those who hadn’t started menopause) and perimenopausal women (who were in the stage right before menopause). These women hadn’t already had hormone therapy for their advanced breast cancer. Some women took Kisqali with an aromatase inhibitor (such as letrozole) and another type of hormone therapy called goserelin acetate (Zoladex). The others took an aromatase inhibitor with a placebo and goserelin acetate.

Women who took Kisqali with an aromatase inhibitor and goserelin acetate had a 43% lower risk of their cancer progressing than women who took an aromatase inhibitor with a placebo and goserelin.

A further analysis of this study found that women who took Kisqali with these hormone therapies lived significantly longer than women who took a placebo with the hormone therapies. Of those taking Kisqali, 70% were still alive after 42 months, compared with 46% of those who took a placebo. The women who took Kisqali were 30% less likely to die at 42 months than the women who took a placebo.

Kisqali use with other drugs

You’ll take Kisqali with one of the hormone therapies listed below to treat your breast cancer.

Kisqali with an aromatase inhibitor for breast cancer

Aromatase inhibitors include letrozole (Femara), anastrozole (Arimidex), and exemestane (Aromasin). They come as tablets that you take by mouth.

Aromatase inhibitors stop an enzyme called aromatase from working. The aromatase enzyme normally makes estrogen from other hormones called androgens. After you’ve gone through menopause, this process is the main way your body makes estrogen. Before and during menopause, most of your estrogen is made by your ovaries (with a small amount being made by the aromatase enzyme).

Estrogen stimulates breast cancer cells to grow and multiply. Aromatase inhibitors lower the amount of estrogen in your body. This slows the growth and spread of the cancer.

You might take Kisqali with an aromatase inhibitor if you haven’t had any hormone therapy for your breast cancer yet and you are:

• premenopausal (haven’t started menopause yet)
• perimenopausal (are in the stage right before menopause)
• postmenopausal (have gone through menopause)

If you’re premenopausal or perimenopausal, you’ll also take another type of hormone therapy called a luteinizing hormone-releasing hormone (LHRH) agonist. These stop your ovaries from making estrogen. An example of an LHRH agonist is goserelin acetate (Zoladex). LHRH agonists are given by injection.

Kisqali with fulvestrant for breast cancer

Fulvestrant (Faslodex) is a drug that acts on your estrogen receptors. Estrogen receptors are special docking stations inside cells that the hormone estrogen can attach to. When estrogen attaches to estrogen receptors in breast cancer cells, it makes the cancer cells multiply. Fulvestrant stops estrogen from attaching to estrogen receptors. It also lowers the number of estrogen receptors in the cancer cells. Both actions slow the growth and spread of breast cancer.

You might take Kisqali with fulvestrant if you are postmenopausal and:

• you haven’t had any hormone therapy for advanced breast cancer yet, or
• your breast cancer has gotten worse or spread after hormone therapy

Fulvestrant is given by injection.

How to take Kisqali

You should take Kisqali according to your doctor’s or healthcare provider’s instructions.

When to take

You’ll usually take Kisqali once a day for 21 days, followed by 7 days of not taking the drug. Repeat this 28-day cycle for as long as your doctor recommends.

Always take your dose of Kisqali at about the same time of day, ideally in the morning.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Taking Kisqali with food

You can take Kisqali either with or without food.

Don’t drink grapefruit juice or eat grapefruit while you’re taking Kisqali. Grapefruit can make Kisqali build up in your body, which can raise your risk for getting side effects.

Can Kisqali be crushed, split, or chewed?

No, you should swallow Kisqali tablets whole. Don’t crush, split, or chew them. Don’t take a tablet if it looks broken, cracked, or damaged.

How Kisqali works

Kisqali is approved by the Food and Drug Administration (FDA) to treat advanced or metastatic breast cancer that is hormone receptor-positive (HR-positive) and HER2-negative.

What happens in breast cancer

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.

What Kisqali does

Kisqali works by blocking the action of CDK 4 and 6. This stops the breast cancer cells from growing and multiplying, and this slows down 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.

How long does it take 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.

Kisqali and pregnancy

You shouldn’t take Kisqali if you’re pregnant or planning to become pregnant. Kisqali could harm a developing fetus. Before you start taking Kisqali, you’ll need to have a pregnancy test done to make sure you’re not pregnant.

Tell your doctor right away if you think you could be pregnant while taking Kisqali.

Kisqali and birth control

If you’re sexually active and can become pregnant, you need to use an effective of method of birth control while taking Kisqali. Keep using birth control for at least 3 weeks after you stop taking Kisqali.

Talk with your doctor about your birth control needs while taking Kisqali.

Kisqali and breastfeeding

It’s not known if Kisqali passes into breast milk. You shouldn’t breastfeed while taking Kisqali, or for at least 3 weeks after you stop taking it.

If you’re currently breastfeeding, talk with your doctor. You’ll need to decide if you want to continue breastfeeding or start taking Kisqali.

Kisqali precautions

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. Kisqali can sometimes cause an abnormal heart rhythm called QT prolongation. You may not be able to take Kisqali if you already have a heart rhythm problem called long QT syndrome. Also, you may not be able to take Kisqali if you have an uncontrolled or severe heart problem. These include a slow or irregular heartbeat, heart failure, recent heart attack, or unstable angina (chest pain that happens while you’re resting). Your doctor will check your heart before you start Kisqali. If you can take Kisqali, your heart will be monitored throughout your treatment.
• Low levels of electrolytes in your blood. Electrolytes include chemicals such as potassium, magnesium, calcium, and phosphorous. If you have low levels of these chemicals in your blood, it raises your risk for getting an abnormal heart rhythm with Kisqali. You’ll get blood tests to check your levels of electrolytes before you start taking Kisqali. If your electrolyte levels are low, you may need treatment to correct this before you can take Kisqali.
• Liver problems. If your liver is not working well, you may be prescribed a lower dosage of Kisqali. Kisqali can sometimes cause serious problems with how well your liver works. You’ll have regular blood tests to monitor your liver function while you take Kisqali.
• Pregnancy. Don’t take Kisqali if you’re pregnant or planning to become pregnant. Kisqali could harm a developing fetus. For more information, see the “Kisqali and pregnancy” section above.
• Breastfeeding. Don’t take Kisqali if you’re breastfeeding. For more information, see the “Kisqali and breastfeeding” section above.

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

Kisqali overdose

Do not use more Kisqali than your doctor recommends.

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Kisqali expiration, storage, and disposal

When you get Kisqali from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Kisqali tablets should be stored at room temperature (68°F to 77°F/20°C to 25°C), away from light, in their original packaging. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Kisqali and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.