Ibrance (palbociclib)

What is Ibrance?

Ibrance is a brand-name prescription medication. It’s used to treat a type of advanced breast cancer in adults. Specifically, Ibrance treats breast cancer that’s:

• advanced (severe) or metastatic (has spread to other parts of the body)
• hormone receptor-positive (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)

For this use, Ibrance is given in combination with certain hormone therapies. (Hormone therapies stop estrogen, a hormone your body produces, from making the cancer cells grow and multiply.)

In certain cases, Ibrance can be used by either males or females.* For more information about when Ibrance may be prescribed, see the “Ibrance for breast cancer” section below.

* Use of the terms “female” and “male” within this article refer to a person’s sex assigned at birth.

Drug details

Ibrance contains the active drug palbociclib. It comes as both capsules and tablets that are taken by mouth. And it’s available in three strengths: 75 milligrams (mg), 100 mg, and 125 mg.

Ibrance is a targeted therapy for these types type of breast cancer. It targets and helps slow key processes within the breast cancer cells. These processes make the cells grow and multiply uncontrollably.

Effectiveness

For information on Ibrance’s effectiveness, see the “Ibrance for breast cancer” section below.

Ibrance generic

Ibrance contains the active drug palbociclib. It’s available only as a brand-name medication. It’s not currently available in generic form. (A generic drug is an exact copy of the active drug in a brand-name medication.)

Ibrance side effects

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

For more information on the possible side effects of Ibrance or help managing certain side effects, 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 it has approved. If you’d like to notify the FDA about a side effect you’ve had with Ibrance, you can do so through MedWatch.

More common side effects

The more common side effects of Ibrance can include:

• anemia (low levels of red blood cells)
• thrombocytopenia (low levels of platelets)
• infections
• fatigue (low energy levels)
• nausea and vomiting
• diarrhea
• hair thinning or hair loss
• mouth sores or pain
• headache
• reduced appetite
• rash
• changes in results of liver function tests (may be a sign of liver damage)
• asthenia* (a general feeling of weakness)
• fever*

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 side effect was reported as common in people taking Ibrance tablets during clinical trials. It wasn’t reported as common in people taking Ibrance capsules during clinical trials.

Serious side effects

Serious side effects can occur with Ibrance. 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 the following.

• Inflammation or scarring in your lungs.* Symptoms may include:
  • trouble breathing
  • cough
• Pulmonary embolism (a blood clot that blocks blood flow in your lungs).† Symptoms may include:
  • trouble breathing
  • chest pain
• Neutropenia (low levels of certain white blood cells).‡
• Allergic reaction.‡

* This side effect was reported in clinical trials of Ibrance tablets. It wasn’t reported in clinical trials of Ibrance capsules.
† This side effect was reported in clinical trials of Ibrance capsules. It wasn’t reported in clinical trials of Ibrance tablets.
‡ For more information about this side effect, see the “Side effect details” section below.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause.

Neutropenia

Neutropenia is a very common side effect of Ibrance. With this condition, you have low levels of certain white blood cells. Having neutropenia can increase your risk for serious or life threatening infections. Call your doctor right away if you experience any of the following symptoms:

• fever
• chills
• any signs of infection, such as a sore throat or cough

In clinical studies, neutropenia occurred in:

• 75% to 83%* of people taking Ibrance capsules
• 80% to 83%* of people taking Ibrance tablets
• 4% to 6%* of people taking a placebo† with either letrozole or fulvestrant

To help protect yourself from infections, wash your hands often. If possible, try to stay away from people who’ve got an infection.

* This percentage range varied depending on the condition being treated and other drugs used with either Ibrance or the placebo.
† A placebo is a treatment with no active drug.

Hair loss

Ibrance may cause hair loss. However, in most cases, the effect was hair thinning rather than total hair loss.

Ibrance is often used with the hormone therapies letrozole or fulvestrant, both of which may also cause hair loss.

In clinical studies, hair loss occurred in:

• 18% to 22%* of people taking Ibrance capsules
• 18% to 33%* of people taking Ibrance tablets
• 3% to 16%* of people taking a placebo† with either letrozole or fulvestrant

Most of these people reported hair loss or thinning that wasn’t obvious from far away. If you’re concerned about hair loss, talk with your doctor.

* This percentage range varied depending on the condition being treated and other drugs used with either Ibrance or the placebo.
† A placebo is a treatment with no active drug.

Rash

Rashes of various types, including itchy rashes, bumpy rashes, and dermatitis, can occur with Ibrance.

Ibrance is often used with the hormone therapies letrozole or fulvestrant. Both letrozole and fulvestrant may also cause a rash.

In clinical studies, rash occurred in:

• 17% of people taking Ibrance capsules
• 17% to 18% of people taking Ibrance tablets
• 6% to 12%* of people taking a placebo† with either letrozole or fulvestrant

If you get a rash, ask your pharmacist if they can recommend any creams that could help.

* This percentage range varied depending on the condition being treated and other drugs used with either Ibrance or the placebo.
† A placebo is a treatment with no active drug.

Fatigue

It’s very common to have fatigue (low energy levels) while taking Ibrance. Taking short naps may help, and so can taking time to rest after being physically active.

Ibrance is often used with the hormone therapies letrozole or fulvestrant. Letrozole and fulvestrant may also cause fatigue.

In clinical studies, fatigue occurred in:

• 41% of people taking Ibrance capsules
• 37% to 41%* of people taking Ibrance tablets
• 23% to 29%* of people taking a placebo† with either letrozole or fulvestrant

The American Cancer Society notes that staying active is important in managing fatigue. Talk with your doctor about how much activity is right for you. They can give advice about the best ways to manage fatigue.

* This percentage range varied depending on the condition being treated and other drugs used with either Ibrance or the placebo.
† A placebo is a treatment with no active drug.

Nausea

Nausea and vomiting was common with Ibrance in clinical studies. Ibrance is often used with the hormone therapies letrozole or fulvestrant. Letrozole and fulvestrant may also cause upset stomach.

In clinical studies, nausea occurred in:

• 25% to 34%* of people taking Ibrance capsules
• 34% to 35%* of people taking Ibrance tablets
• 13% to 28%* of people taking a placebo† with either letrozole or fulvestrant

In clinical studies, vomiting occurred in:

• 15% to 19%* of people taking Ibrance capsules
• 16% to 19%* of people taking Ibrance tablets
• 4% to 17%* of people taking a placebo† with either letrozole or fulvestrant

Nausea can often be relieved if you eat small amounts throughout the day instead of having three main meals. This also helps if you’ve lost your appetite, and it can help keep your energy levels up as well.

There are other ways you can manage nausea. If you’re having a lot of problems with nausea, talk with your doctor. They may be able to prescribe anti-nausea medication.

* This percentage range varied depending on the condition being treated and other drugs used with either Ibrance or the placebo.
† A placebo is a treatment with no active drug.

Diarrhea

Diarrhea is common with Ibrance. Ibrance is often used with the hormone therapies letrozole or fulvestrant. Letrozole and fulvestrant can also cause diarrhea.

In clinical studies, diarrhea occurred in:

• 21% to 24%* of people taking Ibrance capsules
• 24% to 26%* of people taking Ibrance tablets
• 10% to 19%* of people taking a placebo† with either letrozole or fulvestrant

If you get diarrhea, drink plenty of fluids to avoid getting dehydrated (when your body has lost too much fluid). Talk with your doctor if the diarrhea doesn’t go away after a few days.

* This percentage range varied depending on the condition being treated and other drugs used with either Ibrance or the placebo.
† A placebo is a treatment with no active drug.

Headache

You may get headaches while you’re having breast cancer treatment. Headaches are a side effect that may be associated with taking hormone therapies for breast cancer. Hormone therapies include fulvestrant and aromatase inhibitors such as letrozole. You’ll take Ibrance along with one of these therapies.

In one clinical study, headache was reported in more than 20% of people taking Ibrance capsules with fulvestrant. Headache wasn’t reported as a side effect in clinical trials of people taking Ibrance tablets.

If you get headaches while taking Ibrance, ask your pharmacist what pain relievers you could take.

Allergic reaction

Allergic reactions weren’t reported in clinical studies of people taking either Ibrance tablets or capsules. However, you should call your doctor right away if you think you are having a severe allergic reaction to Ibrance. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Symptoms of a severe allergic reaction can include:

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

Back pain (not a side effect)

Back pain was not reported in clinical studies of Ibrance. However, some people taking fulvestrant have back pain. Fulvestrant is a hormone therapy that may be prescribed along with Ibrance. Talk to your doctor if you get back pain while having treatment for your breast cancer.

Weight gain (not a side effect)

Weight gain was not reported in clinical studies of Ibrance. However, some people do gain weight while taking letrozole. Letrozole is a hormone therapy that some people are prescribed to take with Ibrance. Talk to your doctor if you’re worried about weight gain.

Ibrance cost

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

Financial and insurance assistance

If you need financial support to pay for Ibrance, or if you need help understanding your insurance coverage, assistance is available.

Pfizer Inc., the manufacturer of Ibrance, offers a program called Pfizer Oncology Together. For more information and to find out if you’re eligible for support, call 844-9-IBRANCE (844-942-7262) or visit the program website.

Ibrance dosage

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

• other medications you take
• your liver function
• 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 suit your needs.

Drug forms and strengths

Ibrance comes as capsules and tablets. It’s available in three strengths: 75 milligrams (mg), 100 mg, and 125 mg.

Dosage for advanced or metastatic breast cancer

The typical dosage of Ibrance is 125 mg taken once a day for 21 days. This is followed by 7 days with no drug treatment. This 28-day cycle is repeated for as long as your doctor recommends.

Your doctor may prescribe a lower dosage if you have problems with your liver function or if you’re taking certain other medications. Your doctor may also lower your dosage or have you take a break from treatment if you get certain side effects, including low blood cell counts. Always take Ibrance exactly as your doctor prescribes.

What if I miss a dose?

If you forget to take a dose, skip that dose and take your next dose at your usual time. Do not take an extra dose to make up for a missed dose.

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

Will I need to use this drug long term?

Ibrance is meant to be used as a long-term treatment. If you and your doctor determine that Ibrance is safe and effective for you, you’ll likely take it long term.

Alternatives to Ibrance

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

Examples of other drugs that may be used to treat hormone receptor-positive (HR+), HER2-negative, metastatic breast cancer* include:

• Hormone therapies such as:
  • tamoxifen
  • letrozole (Femara)
  • anastrazole (Arimidex)
  • exemestane
  • fulvestrant (Faslodex)
  • toremifene (Fareston)
• Targeted therapies such as:
  • ribociclib (Kisqali)
  • abemaciclib (Verzenio)
  • everolimus (Afinitor)

* For more information about this type of breast cancer, see the “Ibrance for breast cancer” section below.

Ibrance vs. Verzenio

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

Ingredients

Ibrance contains palbociclib, and Verzenio contains abemaciclib. These medications are from the same drug class, so they work in the same way in the body.

Uses

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

Verzenio is used for:

• postmenopausal females* who haven’t yet had hormone therapy for their breast cancer (in this case, Verzenio is used with a hormone therapy called an aromatase inhibitor)
• females whose breast cancer has come back or spread after hormone therapy (in this case, Verzenio is used with a hormone therapy called fulvestrant)
• males and females whose breast cancer has come back or spread after hormone therapy and chemotherapy (in this case, Verzenio is used on its own)

Ibrance tablets are used for:

• males and postmenopausal females who haven’t yet had hormone therapy for their breast cancer (in this case, Ibrance is used with a hormone therapy called an aromatase inhibitor)
• males and females whose breast cancer has come back or spread after hormone therapy (in this case, Ibrance is used with a hormone therapy called fulvestrant)

Ibrance capsules are used for:

• postmenopausal females who haven’t yet had hormone therapy for their breast cancer (in this case, Ibrance is used with a hormone therapy called letrozole)†
• females whose breast cancer has come back or spread after hormone therapy (in this case, Ibrance is used with a hormone therapy called fulvestrant)

* Use of the terms “female” and “male” within this article refer to a person’s sex assigned at birth.
† For this use, Ibrance received accelerated approval from the Food and Drug Administration (FDA). Accelerated approval is based on information from early clinical trials. The FDA’s decision for full approval will be made after additional clinical trials are completed.

Drug forms and administration

Ibrance comes as capsules and tablets that you take by mouth. You’ll usually take a dose once a day for 21 days, followed by seven days off treatment. This 28-day cycle is repeated for as long as your doctor recommends.

Verzenio comes as tablets that you take by mouth. You’ll usually take a dose twice a day, every day, for as long as your doctor recommends.

Side effects and risks

Ibrance and Verzenio both contain drugs from the same class. Therefore, these medications can cause very 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 Verzenio or with both Ibrance and Verzenio (when taken individually as part of a breast cancer treatment plan).

• Can occur with Ibrance:
  • fever*
• Can occur with Verzenio:
  • abdominal pain
• Can occur with both Ibrance and Verzenio:
  • anemia (low levels of red blood cells)
  • changes in results of liver function tests
  • thrombocytopenia (low levels of platelets)
  • diarrhea
  • headache
  • infections
  • mouth sores or pain
  • nausea
  • vomiting
  • rash
  • reduced appetite
  • hair thinning or hair loss
  • fatigue (low energy levels) and asthenia* (a general feeling of weakness)

* This side effect was reported as common in people taking Ibrance tablets during clinical trials. It wasn’t reported as common in people taking Ibrance capsules during clinical trials.

Serious side effects

These lists contain examples of serious side effects that can occur with Verzenio or with both Ibrance and Verzenio (when taken individually as part of a breast cancer treatment plan).

• Can occur with Ibrance:
  • no unique serious side effects
• Can occur with Verzenio:
  • serious problems with your liver function
  • blood clots in your veins or lungs
• Can occur with both Ibrance and Verzenio:
  • severe diarrhea
  • neutropenia (low levels of certain white blood cells) that can increase the risk of serious or life-threatening infections
  • inflammation and scarring in your lungs*
  • pulmonary embolism†

* This side effect was reported in clinical trials of Ibrance tablets. It wasn’t reported in clinical trials of Ibrance capsules.
† This side effect was reported in clinical trials of Ibrance capsules. It wasn’t reported in clinical trials of Ibrance tablets.

Effectiveness

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

These drugs haven’t been directly compared in clinical studies, but studies have found both Ibrance and Verzenio to be effective for treating advanced or metastatic HR+, HER2-negative breast cancer.

One review of studies on these drugs found that Ibrance and Verzenio were equally effective for treating this type of advanced breast cancer. The researchers also found that Ibrance caused less diarrhea than did Verzenio.

Costs

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

Ibrance and Verzenio 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.

Ibrance vs. Kisqali

Ibrance and Kisqali are prescribed for similar uses. Below are details of how these medications are alike and different.

Ingredients

Ibrance contains palbociclib, and Kisqali contains ribociclib. These medications are from the same drug class, so they work in the same way in the body.

Uses

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

Kisqali is used for:

• females* who haven’t started menopause (or who are going through menopause) who haven’t yet had hormone therapy for their breast cancer (in this case, Kisqali is used with a hormone therapy called an aromatase inhibitor)
• postmenopausal females who haven’t yet had hormone therapy for their breast cancer (in this case, Kisqali is used either with an aromatase inhibitor or with another hormonal therapy called fulvestrant)
• postmenopausal females whose breast cancer has come back or spread after hormone therapy (in this case, Kisqali is used with fulvestrant)

Ibrance tablets are used for:

• males and postmenopausal females who haven’t yet had hormone therapy for their breast cancer (in this case, Ibrance is used with a hormone therapy called an aromatase inhibitor)
• males and females whose breast cancer has come back or spread after hormone therapy (in this case, Ibrance is used with a hormone therapy called fulvestrant)

Ibrance capsules are used for:

• postmenopausal females who haven’t yet had hormone therapy for their breast cancer (in this case, Ibrance is used with a hormone therapy called letrozole)†
• females whose breast cancer has come back or spread after hormone therapy (in this case, Ibrance is used with a hormone therapy called fulvestrant)

* Use of the terms “female” and “male” within this article refer to a person’s sex assigned at birth.
† For this use, Ibrance received accelerated approval from the Food and Drug Administration (FDA). Accelerated approval is based on information from early clinical trials. The FDA’s decision for full approval will be made after additional clinical trials are completed.

Drug forms and administration

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

With both drugs, you’ll usually take a dose once a day for 21 days. This is followed by seven days off treatment. This 28-day cycle is repeated for as long as your doctor recommends.

Side effects and risks

Ibrance and Kisqali both contain drugs from the same class. Therefore, both medications can cause very 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 Ibrance and Kisqali (when taken individually as part of a breast cancer treatment plan).

• Can occur with Kisqali:
  • cough
  • fever*
  • asthenia* (a general feeling of weakness)
• Can occur with both Ibrance and Kisqali:
  • anemia (low levels of red blood cells)
  • thrombocytopenia (low levels of platelets)
  • reduced appetite
  • mouth sores or pain
  • changes in results of liver function tests
  • constipation
  • headache
  • infections
  • nausea
  • vomiting
  • diarrhea
  • rash
  • hair thinning or hair loss
  • fatigue (low energy levels)

* This side effect was reported as common in people taking Ibrance tablets during clinical trials. It wasn’t reported as common in people taking Ibrance capsules during clinical trials.

Serious side effects

These lists contain examples of serious side effects that can occur with Kisqali or with both Ibrance and Kisqali (when taken individually as part of a breast cancer treatment plan).

• Can occur with Ibrance:
  • pulmonary embolism*
• Can occur with Kisqali:
  • problems with your heart rhythm
  • serious problems with your liver function
  • severe skin reactions
• Can occur with both Ibrance and Kisqali:
  • neutropenia (low levels of certain white blood cells) that can increase the risk of serious or life-threatening infections
  • inflammation and scarring in your lungs†

* This side effect was reported in clinical trials of Ibrance capsules. It wasn’t reported in clinical trials of Ibrance tablets.
† This side effect was reported in clinical trials of Ibrance tablets. It wasn’t reported in clinical trials of Ibrance capsules.

Effectiveness

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

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

One review of studies with these drugs found that Ibrance and Kisqali were equally effective for treating this type of advanced breast cancer. The researchers also found that Ibrance caused less QTc prolongation (a type of abnormal heart rhythm) than did Kisqali.

Costs

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

Ibrance is much more expensive than Kisqali. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Ibrance and alcohol

Alcohol doesn’t affect how Ibrance works, and there aren’t any warnings about avoiding alcohol while you’re taking it. However, if you find that Ibrance makes you feel nauseous or tired, or if it gives you diarrhea, drinking alcohol could worsen these side effects.

Mouth sores or pain in the mouth are also side effects of Ibrance. Drinking alcohol can irritate these sores and make the pain worse.

Another point to consider is that alcohol is known to increase your risk of breast cancer. But it’s not known if drinking alcohol after you’re diagnosed will worsen your cancer.

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

Ibrance interactions

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

Ibrance and other medications

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

Before taking Ibrance, 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.

Ibrance and certain antifungals

Antifungals are drugs that treat fungal infections. Taking certain antifungal drugs with Ibrance can increase the levels of Ibrance in your body. This can raise your risk of side effects from Ibrance.

Examples of antifungals that increase Ibrance levels include:

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

If possible, you should avoid taking these antifungals while you’re taking Ibrance. However, if you need to take one of these drugs, your doctor will likely lower your dosage of Ibrance for a period of time.

Ibrance and certain antibiotics

Antibiotics are drugs that treat bacterial infections. Taking certain antibiotics with Ibrance can increase the levels of Ibrance in your body. This can increase your risk of getting side effects from Ibrance.

Examples of antibiotics that can increase Ibrance levels include:

• clarithromycin
• telithromycin (Ketek)

If possible, you should avoid taking these antibiotics while you’re taking Ibrance. However, if you have to take one of these antibiotics, your doctor will temporarily lower your dose of Ibrance.

Ibrance and drugs for HIV

If you take Ibrance with certain HIV medications, you are more at risk of getting side effects from Ibrance. This is because some HIV drugs can increase the levels of Ibrance in your body.

Examples of HIV drugs that increase Ibrance levels include:

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

If possible, you should avoid taking Ibrance if you’re taking one of these HIV drugs. However, if you have to take them, your doctor will prescribe you a low dosage of Ibrance.

Ibrance and certain drugs for tuberculosis

Taking Ibrance with certain treatments for tuberculosis can lower the levels of Ibrance in your body. This could make Ibrance less effective. You should avoid taking Ibrance with any of these drugs.

Examples of these drugs include:

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

Ibrance and certain drugs for seizures

Taking Ibrance with certain seizure medications can lower the levels of Ibrance in your body. This could make Ibrance less effective. You should avoid taking Ibrance with any of these drugs.

Examples of these drugs include:

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

Ibrance and certain heart medications

Taking Ibrance with certain heart medications may increase the levels of the heart medication in your body. This could raise your risk of side effects from the heart medication. Your doctor may need to lower your dosage of the heart medication to avoid this interaction.

Examples of heart drugs that could be affected by Ibrance include:

• pimozide (Orap)
• quinidine (Cin-Quin, Cardioquin, Quinact, Duraquin)

Ibrance and certain immunosuppressants

Immunosuppressant drugs reduce the activity of your immune system. Taking certain immunosuppressant drugs with Ibrance may increase the levels of those drugs in your body. This could raise your risk of side effects from the immunosuppressant.

Your doctor may need to lower your dose of the immunosuppressant to avoid this interaction. Examples of immunosuppressants that could be affected by Ibrance include:

• cyclosporine (Neoral, Gengraf, Sandimmune, Restasis)
• everolimus (Afinitor, Zortress)
• sirolimus (Rapamune)
• tacrolimus (Prograf, Astagraf XL)

Ibrance and certain drugs for migraine

Taking Ibrance with certain migraine medications may increase the levels of the migraine medication in your body. This could raise your risk of side effects from the migraine drug. Your doctor may need to lower your dose of the migraine medication to avoid this interaction.

Examples of migraine drugs that could be affected by Ibrance include:

• dihydroergotamine (DHE-45, Migranal)
• ergotamine (Ergomar)
• ergotamine and caffeine (Cafergot, Migergot, Wigraine)

Ibrance and certain strong pain relievers

Taking Ibrance with fentanyl (Duragesic, Subsys, Lazanda, Abstral, others) or alfentanil (Alfenta, which is used as anesthesia during surgery) may increase the levels of these strong pain relievers in your body. This could raise your risk of side effects from the pain relievers.

To avoid this interaction, your doctor will lower your dosage of fentanyl or alfentanil.

Ibrance and herbs and supplements

Always check with your doctor or pharmacist before using any herbs or supplements with Ibrance.

Ibrance and turmeric

It’s not known for sure whether turmeric interacts with Ibrance. However, some research suggests that turmeric may change the way that Ibrance is broken down in your body. This may lead to higher levels of Ibrance in your body and increase your risk of side effects.

Talk with your doctor first if you want to take turmeric while taking Ibrance.

Ibrance and St. John’s wort

Don’t take St. John’s wort (also called Hypericum perforatum) while you’re taking Ibrance. This herbal remedy can lower the levels of Ibrance in your body and make it less effective.

Ibrance and foods

Ibrance capsules should be taken with food, while Ibrance tablets can be taken with or without food.

But with either form of the drug, you should avoid drinking grapefruit juice or eating grapefruit. This is because grapefruit can increase your risk for side effects from Ibrance by making the drug build up in your body.

Ibrance for breast cancer

The Food and Drug Administration (FDA) approves prescription drugs such as Ibrance to treat certain conditions. Ibrance may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Ibrance is FDA-approved to treat breast cancer that is:

• Advanced or metastatic. With advanced or metastatic cancer, the cancer is severe or has spread to other parts of the body, such as the bones, liver, lungs, or brain.
• Hormone receptor-positive (HR+). This means the cancer cells have receptors on them for the hormones estrogen, progesterone, or both. Hormone receptors are special areas on cells that hormones attach to. The hormones tell the cells what to do. The hormones estrogen and progesterone tell HR+ breast cancer cells to grow and divide.
• HER2-negative. With HER2-negative cancer, the cancer cells don’t have abnormally high levels of a protein called HER2. High levels of HER2 make breast cancer cells grow and multiply more quickly.

Ibrance tablets are approved for use in:

• males* and postmenopausal females* who haven’t yet had hormone therapy for their breast cancer (in this case, Ibrance is used with a hormone therapy called an aromatase inhibitor)
• males and females whose breast cancer has come back or spread after hormone therapy (in this case, Ibrance is used with a hormone therapy called fulvestrant)

Ibrance capsules are approved for use in:

• postmenopausal females who haven’t yet had hormone therapy for their breast cancer (in this case, Ibrance is used with a hormone therapy called letrozole)†
• females whose breast cancer has come back or spread after hormone therapy (in this case, Ibrance is used with a hormone therapy called fulvestrant)

* Use of the terms “female” and “male” within this article refer to a person’s sex assigned at birth.
† For this use, Ibrance received accelerated approval from the Food and Drug Administration (FDA). Accelerated approval is based on information from early clinical trials. The FDA’s decision for full approval will be made after additional clinical trials are completed.

Effectiveness for breast cancer

Ibrance has been studied as a breast cancer treatment in combination with two different hormone therapies: fulvestrant (an estrogen receptor down regulator) and letrozole (an aromatase inhibitor). Below, we describe the results of these studies.

Effectiveness of Ibrance with letrozole

One clinical study looked at postmenopausal females who had HR+, HER2-negative, advanced breast cancer. These females hadn’t yet taken systemic treatment for the advanced cancer. (Systemic treatment affects your whole body.)

Some females were given Ibrance plus letrozole, while other females were given letrozole alone. Females in this study are still being followed, but so far, the following results have been seen:

• 50% of females taking Ibrance plus letrozole didn’t have their cancer worsen for at least 24.8 months
• 50% of females taking letrozole alone didn’t have their cancer worsen for at least 14.5 months

Another clinical study looked at postmenopausal females who had HR+, HER2-negative, advanced breast cancer. These females hadn’t yet taken systemic treatment for the advanced cancer. (Systemic treatment affects your whole body.)

Some females were given Ibrance plus letrozole, while other females were given letrozole alone. Over about 40 months of treatment, the following results were seen:

• 50% of females taking Ibrance plus letrozole didn’t have their cancer worsen for at least 20 months
• 50% of females taking letrozole alone didn’t have their cancer worsen for at least 10 months

Effectiveness of Ibrance with fulvestrant

One clinical study looked at 521 females whose cancer had come back or spread after hormone therapy. They were split into two groups. One group took Ibrance with fulvestrant. The other group took fulvestrant with a placebo.

Females who took Ibrance with fulvestrant had a 54% lower risk of their cancer progressing compared with females who took fulvestrant plus the placebo. In this study, Ibrance was twice as effective as the placebo in delaying cancer progression.

Another clinical study looked at females with HR+, HER2-negative, advanced breast cancer. These females had had their cancer worsen with hormone treatments in the past.

Some females were given Ibrance plus fulvestrant, while other females were given fulvestrant alone. Over about 14 months of treatment, the following results were seen:

• 50% of females taking Ibrance plus fulvestrant went at least 9.5 months without having their cancer worsen
• 50% of females taking fulvestrant alone went at least 4.6 months without having their cancer worsen

Other uses for Ibrance

Ibrance has been approved by the Food and Drug Administration (FDA) to treat some forms of breast cancer. You may wonder if the drug is used for other conditions.

Off-label use for Ibrance

In addition to the type of breast cancer listed above, Ibrance may be used off-label for other uses. Off-label drug use is when a drug that’s approved for one use is used for a different one that’s not approved.

Ibrance for liposarcoma

Ibrance is used off-label to treat a rare type of cancer called liposarcoma. Liposarcoma is a type of soft tissue sarcoma. Sarcoma is cancer that develops in your bones or soft tissues, such as your tendons, muscles, fat, or nerves.

Liposarcoma affects fat cells, most often in the limbs or abdomen. Ibrance is included in current guidelines for treating this type of cancer.

Ibrance for lung cancer

Ibrance is being investigated as a treatment for several other types of cancer, including lung cancer and multiple myeloma. Multiple myeloma is a type of cancer that affects plasma cells (white blood cells made in your bone marrow).

Ibrance use with other drugs

Ibrance is always used with certain hormone therapies. These treatments work in different ways.

The hormone therapies stop the hormone estrogen from making breast cancer cells multiply. Ibrance, on the other hand, targets other processes inside the cancer cells that are making them multiply. The combined treatments slow down the growth and spread of the cancer.

Ibrance is used with the hormone therapies described below.

Ibrance with Faslodex

Faslodex is the brand name for a drug called fulvestrant. Faslodex works by blocking estrogen receptors and reducing the number of estrogen receptors in cancer cells. Estrogen receptors are special areas found inside certain cells in the body. The hormone estrogen attaches to these receptors.

When estrogen attaches to estrogen receptors in breast cancer cells, it makes these cells multiply. By blocking the estrogen receptors, Faslodex stops estrogen from attaching to them. Faslodex also reduces the number of estrogen receptors in the cancer cells. Both of these actions slow the growth of the cancer.

You’ll take Ibrance with Faslodex if your breast cancer has come back or spread after having a different type of hormone therapy. With Ibrance tablets, this combination is suitable for males* and females*. And with Ibrance capsules, this combination is suitable for females.

* Use of the terms “male” and “female” within this article refer to a person’s sex assigned at birth.

Ibrance with letrozole

Letrozole (Femara) is a type of hormone therapy called an aromatase inhibitor. It works by blocking the action of the aromatase enzyme. In females,* this enzyme makes estrogen after you have gone through menopause. It’s also responsible for producing the majority of estrogen in males.* (In males, small amounts of estrogen are also produced by the testicles.)

By blocking the aromatase enzyme, letrozole stops estrogen production in postmenopausal females. It reduces estrogen production in males. Males may also be given another drug called an LHRH agonist (see below) to stop their testicles from producing estrogen.

You’ll take Ibrance with letrozole if haven’t yet tried hormone therapy for your breast cancer. With Ibrance capsules, this combination is suitable for females. With Ibrance tablets, this combination is suitable for postmenopausal females and for males.

* Use of the terms “male” and “female” within this article refer to a person’s sex assigned at birth.

Ibrance with other aromatase inhibitors

While Ibrance capsules are approved for use with letrozole specifically, Ibrance tablets can be used with other aromatase inhibitors besides letrozole. Other aromatase inhibitors include:

• anastrazole (Arimidex)
• exemestane (Aromasin)

You’ll take Ibrance tablets with an aromatase inhibitor if haven’t yet tried hormone therapy for your breast cancer. With Ibrance tablets, this combination is suitable for postmenopausal females* and for males.*

* Use of the terms “male” and “female” within this article refer to a person’s sex assigned at birth.

Ibrance with LHRH agonists

Luteinizing hormone-releasing hormone (LHRH) agonists are hormone therapies that are sometimes used with Ibrance. They include goserelin (Zoladex) and leuprolide (Eligard, Lupron, Viadur, Lupron Depot). (Leuprolide is used off-label to treat breast cancer.)

In females,* LHRH agonists stop your ovaries from producing estrogen. In males,* LHRH agonists stop your testicles from producing testosterone and estrogen.

If you’re a female taking Ibrance with fulvestrant (Faslodex), you’ll also be prescribed an LHRH agonist unless you have gone through menopause.

If you’re a male taking Ibrance with an aromatase inhibitor such as letrozole (Femara), you may also be prescribed an LHRH agonist.

* Use of the terms “male” and “female” within this article refer to a person’s sex assigned at birth.

Ibrance overdose

Taking more than the recommended dosage of Ibrance can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose may include an increase in any of the possible side effects of Ibrance. These increased side effects can include:

• anemia (low numbers of red blood cells)
• thrombocytopenia (low numbers of blood cells called platelets)
• infections
• fatigue (low energy)
• nausea
• vomiting
• diarrhea
• hair thinning or hair loss
• rash
• changes in results of liver function tests (may be a sign of liver damage)

What to do in case of overdose

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.

How to take Ibrance

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

When to take

You’ll usually take Ibrance once a day for 21 days, followed by seven days without taking the drug. You can take your dose at any time of day, but try to always take it around the same time.

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

Taking Ibrance with food

Ibrance capsules should be taken with food, as this helps your body absorb the drug. It’s best to take Ibrance with a meal. However, if you don’t feel like eating much, it’s fine to take it with a snack.

Ibrance tablets, on the other hand, can be taken with or without food.

You should avoid eating grapefruit or drinking grapefruit juice while you’re taking Ibrance. Grapefruit can make Ibrance build up in your body, which can raise your risk of side effects.

Can Ibrance be crushed, split, or chewed?

No, you must swallow Ibrance capsules and tablets whole. Don’t chew, crush, or open the pills. And don’t take Ibrance pills that are cracked, broken, or damaged in any other way.

How Ibrance works

Breast cancer happens when cells in your breast start to grow and divide uncontrollably. If your breast cancer is found to be hormone receptor positive (HR+), this means that hormones in your body are involved in making the cancer cells grow and multiply.

Estrogen is a hormone that affects certain processes inside the cancer cells. It causes two enzymes (proteins that help chemical reactions happen) to become overactive. These enzymes are called cyclin-dependent kinases 4 and 6 (CDK 4 and 6).

CDK 4 and 6 are involved in regulating how all cells grow and multiply. When they become overactive in cancer cells, they make the cancer cells grow and divide more rapidly.

What Ibrance does

Ibrance is a targeted therapy for breast cancer. Targeted therapies for cancer work on particular features inside the cancer cells that make them grow and multiply uncontrollably. Ibrance targets the CDK 4 and 6 enzymes that are overactive in HR-positive breast cancer.

Ibrance blocks the action of CDK 4 and 6. This stops the breast cancer cells from growing and dividing, which slows the growth and spreading of the cancer.

How long does it take to work?

Ibrance starts to work soon after you take your first dose. It keeps building up its effect over the first week of treatment. You won’t notice if Ibrance is working. Your doctor will do various tests throughout your treatment to monitor how well it’s working for you.

Ibrance and pregnancy

You shouldn’t take Ibrance if you are pregnant or planning a pregnancy. Taking Ibrance while pregnant can harm the fetus.

If you’re taking Ibrance and think you could be pregnant, tell your doctor right away.

Ibrance and birth control

Both females and males need to use birth control while taking Ibrance.

• For females:* If you could get pregnant, use an effective method of birth control while taking Ibrance. You must continue to use birth control for 3 weeks after taking your last dose of Ibrance.
• For males:* If your sexual partner could get pregnant, use effective birth control while taking Ibrance. You must keep using birth control for 3 months after taking your last dose of Ibrance.

* Use of the terms “male” and “female” within this article refer to a person’s sex assigned at birth.

Ibrance and breastfeeding

It’s not known if Ibrance passes into breast milk. Therefore, you shouldn’t breastfeed while taking Ibrance. You should avoid breastfeeding for 3 weeks after taking your last dose of Ibrance.

If you’re breastfeeding, talk with your doctor. You’ll need to decide whether you want to take Ibrance or continue breastfeeding.

Common questions about Ibrance

Here are answers to some frequently asked questions about Ibrance.

Will Ibrance treatment lead to cancer remission?

No, taking Ibrance won’t lead to cancer remission.

With cancer remission, there aren’t any signs of cancer in your body. Clinical trials of Ibrance haven’t studied whether or not the drug causes remission. Instead, they looked at whether or not the drug helped people live longer without their cancer getting worse. For more information and results from these trials, see the “Ibrance for breast cancer” section above.

If you have additional questions about cancer treatment options and their possible outcomes, talk with your doctor.

Is Ibrance a type of chemotherapy?

Ibrance is not a traditional chemotherapy treatment. Chemotherapy attacks all rapidly dividing cells in the body, including healthy cells as well as cancer cells. This is why it can have such serious side effects.

Ibrance, on the other hand, is a targeted therapy for cancer. Targeted therapies work on specific features inside cancer cells that make these particular cells grow, divide, and spread. Because targeted therapies only affect cancer cells, they tend to cause fewer side effects.

Ibrance targets two enzymes (proteins that help chemical reactions happen) called cyclin-dependent kinases 4 and 6 (CDK 4 and 6). These enzymes are overactive in hormone receptor-positive (HR+) breast cancer cells. They make the cancer cells multiply rapidly. By blocking CDK 4 and 6, Ibrance slows down the growth and spread of cancer cells.

CDK 4 and 6 are also involved in the growth of healthy cells. This means Ibrance can affect some healthy cells and can cause side effects, some of which are serious. However, side effects are much less likely with Ibrance than with traditional “untargeted” chemotherapy.

If I throw up after taking Ibrance, should I take another pill?

No. If you vomit after taking a dose of Ibrance, don’t take another dose that day. Just take your next dose when it’s time. If you often throw up while taking Ibrance, tell your doctor. They can give you advice on managing nausea, or they may prescribe an anti-nausea medication.

Can Ibrance cure my breast cancer?

Metastatic breast cancer can’t be cured. However, taking Ibrance with a hormone therapy (fulvestrant or an aromatase inhibitor) can slow the growth and spreading of your cancer for a significant amount of time.

Will I need any tests while I take Ibrance?

Yes, you’ll need to have regular blood tests to monitor your blood cells and your liver function while you take Ibrance.

Ibrance can cause your white blood cell count to fall, which can increase your risk of infections. Very low white blood cell counts can put you at risk of serious, potentially life-threatening infections.

Your doctor will want you to have regular blood tests to check your white blood cell counts, so any problems can be found early. If your white blood cell counts start to fall, your doctor may lower your dosage of Ibrance. They may also have you take a break from treatment until your blood cells recover.

Ibrance can also cause your red blood cell count to fall. This is called anemia. It can make you look pale and feel tired, cold, or lightheaded. Your platelet count may also fall, which can make you bruise or bleed more easily. (Platelets are blood cells that help your blood to clot.) Your blood tests will also check your red blood cell and platelet counts.

Ibrance can sometimes damage your liver, causing certain liver enzymes to be released into your blood. Your doctor will want to regularly test your blood for this. These tests are called liver function tests. If your liver function tests show damage to your liver, your doctor may lower your dose of Ibrance.

If you’re a female* who can get pregnant, your doctor will also give you a pregnancy test before starting Ibrance. You shouldn’t take Ibrance if you are pregnant or planning a pregnancy.

* Use of the terms “male” and “female” within this article refer to a person’s sex assigned at birth.

Will I lose my hair when I take Ibrance?

You may lose some hair while taking Ibrance. Some hair loss occurred in about a third of people taking Ibrance in clinical studies. However, your hair is more likely to get thinner rather than fall out completely.

Ibrance precautions

Before taking Ibrance, talk with your doctor about your health history. Ibrance may not be right for you if you have certain medical conditions or other situations. These include:

• Liver disease. If you have severe problems with the way your liver works, you’ll be prescribed a lower dosage of Ibrance. Ibrance can also cause problems with how well your liver works. You’ll have blood tests regularly to monitor your liver function while you take Ibrance.
• Lung problems. Ibrance may cause new or worsening lung disease. Tell your doctor if you have any new or worsening breathing problems while you’re using Ibrance. In some cases, your doctor may have you stop using this drug.
• Pregnancy. Ibrance shouldn’t be taken during pregnancy. For more information, please see the “Ibrance and pregnancy” section above.

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

Ibrance expiration, storage, and disposal

When you get Ibrance from the pharmacy, the pharmacist will add an expiration date to the bottle’s label. This date is typically one year from the date they dispensed the medication.

The expiration date helps guarantee the medication will be effective during this time. The current stance of the Food and Drug Administration 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.

Ibrance tablets should be stored at a room temperature of 68°F to 77°F (20°C to 25°C). The drug should be kept in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as in the bathroom.

Disposal

If you no longer need to take Ibrance 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.