HIGHLIGHTS OF PRESCRIBING INFORMATION
These 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
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
IBRANCE 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 ADMINISTRATION
IBRANCE capsules are taken orally with food in combination with an aromatase inhibitor or fulvestrant. (2)
DOSAGE FORMS AND STRENGTHS
Capsules: 125 mg, 100 mg, and 75 mg. (3)
WARNINGS AND PRECAUTIONS
Most 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.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.