IMPORTANT SAFETY INFORMATION & INDICATIONS
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 doctor should check your white blood cell counts before and during treatment.
If you develop low white blood cell counts during treatment with IBRANCE, your doctor may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your doctor 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 doctor right away if you have any new or worsening symptoms, including:
- trouble breathing or shortness of breath
- cough with or without mucus
- chest pain
Before you take IBRANCE, tell your doctor if you:
- have fever, chills, or any other signs or symptoms of infection.
- have liver or kidney problems.
- have any other medical conditions.
- 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.
- 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.
Common side effects of IBRANCE include:
- Low red blood cell counts and low platelet counts. Call your doctor right away if you develop any of these symptoms during treatment:
- shortness of breath
- bleeding or bruising more easily
- sore mouth
- abnormalities in liver blood tests
- hair thinning or hair loss
- 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.
These are not all of the possible side effects of IBRANCE. For more information, ask your doctor. Tell your doctor if you have any side effect that bothers you or does not go away.
Tell your doctor 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.
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 doctor if you start a new medicine. Take IBRANCE exactly as your doctor tells you.
If you take too much IBRANCE, call your doctor right away or go to the nearest hospital emergency room.
IBRANCE is a prescription medicine used in adults to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (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 in postmenopausal women or in men, or
- fulvestrant with disease progression following hormonal therapy.