HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use IBRANCE safely and effectively. See full prescribing information for IBRANCE. IBRANCE® (palbociclib) capsules, for oral use Initial U.S. Approval: 2015 INDICATIONS AND USAGEIBRANCE is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: DOSAGE AND ADMINISTRATIONIBRANCE capsules are taken orally with food in combination with an aromatase inhibitor or fulvestrant. (2) DOSAGE FORMS AND STRENGTHSCapsules: 125 mg, 100 mg, and 75 mg. (3) CONTRAINDICATIONSNone. (4) WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost common adverse reactions (incidence ≥10%) were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia, rash, vomiting, decreased appetite, asthenia, and pyrexia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 12/2022 |

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IBRANCE® capsules Highlights (palbociclib)
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To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
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