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IBRANCE® (palbociclib) Highlights

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 (1) 4/2019

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:

  • an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or
  • fulvestrant in patients with disease progression following endocrine therapy. (1)

DOSAGE AND ADMINISTRATION

IBRANCE capsules are taken orally with food in combination with an aromatase inhibitor or fulvestrant. (2)

  • Recommended starting dose: 125 mg once daily taken with food for 21 days followed by 7 days off treatment. (2.1)
  • Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability. (2.2)

DOSAGE FORMS AND STRENGTHS

Capsules: 125 mg, 100 mg, and 75 mg. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

  • Neutropenia: Monitor complete blood count prior to start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. (2.2, 5.1)
  • Embryo-Fetal Toxicity: IBRANCE can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (5.2, 8.1, 8.3)

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

  • CYP3A Inhibitors: Avoid concurrent use of IBRANCE with strong CYP3A inhibitors. If the strong inhibitor cannot be avoided, reduce the IBRANCE dose. (2.2, 7.1)
  • CYP3A Inducers: Avoid concurrent use of IBRANCE with strong CYP3A inducers. (7.2)
  • CYP3A Substrates: The dose of sensitive CYP3A4 substrates with narrow therapeutic indices may need to be reduced when given concurrently with IBRANCE. (7.3)

USE IN SPECIFIC POPULATIONS

  • Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 4/2019

What's New

No Current Announcements.

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You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch

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