Important Safety Information & Use

IBRANCE may cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are very common when taking IBRANCE and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment.

If you develop low white blood cell counts during treatment with IBRANCE, your healthcare provider may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.

Lung problems (pneumonitis). IBRANCE may cause severe inflammation of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including:

• chest pain
• cough with or without mucus
• trouble breathing or shortness of breath

Your healthcare provider may interrupt or stop treatment with IBRANCE completely if your symptoms are severe.

What should I tell my healthcare provider before taking IBRANCE?

Before taking IBRANCE, tell your healthcare provider about all of your medical conditions, including if you:

• have fever, chills, or any other signs or symptoms of infection.
• have liver or kidney problems.
• are pregnant or plan to become pregnant; IBRANCE can harm your unborn baby.
  • Females who are able to become pregnant should use effective birth control during treatment and for at least 3 weeks after the last dose of IBRANCE. Your healthcare provider may ask you to take a pregnancy test before you start treatment with IBRANCE.
  • Males with female partners who can become pregnant should use effective birth control during treatment with IBRANCE for at least 3 months after the last dose of IBRANCE.
• are breastfeeding or plan to breastfeed. It is not known if IBRANCE passes into your breast milk. Do not breastfeed during treatment with IBRANCE and for 3 weeks after the last dose.

The most common side effects of IBRANCE include:

• Low red blood cell counts and low platelet counts. Call your healthcare provider right away if you develop any of these symptoms during treatment:
  • dizziness
  • shortness of breath
  • weakness
  • bleeding or bruising more easily
  • nosebleeds
• infections
• tiredness
• nausea
• sore mouth
• abnormalities in liver blood tests
• diarrhea
• hair thinning or hair loss
• vomiting
• rash
• loss of appetite

IBRANCE may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider about family planning options before starting IBRANCE if this is a concern for you.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of IBRANCE. Call your doctor for medical advice about side effects.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IBRANCE and other medicines may affect each other, causing side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

Do not drink grapefruit juice or eat grapefruit products while taking IBRANCE as they may increase the amount of IBRANCE in your blood.

Tell your healthcare provider if you start a new medicine. Take IBRANCE exactly as your healthcare provider tells you.

If you take too much IBRANCE, call your healthcare provider right away or go to the nearest hospital emergency room.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is IBRANCE?

IBRANCE (palbociclib) 125 mg capsules and tablets are a prescription medicine used in adults to treat HR+, HER2- breast cancer that has spread to other parts of the body (metastatic) in combination with an aromatase inhibitor as the first hormonal based therapy, or fulvestrant in people with disease progression following hormonal therapy.

It is not known if IBRANCE is safe and effective in children.