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IBRANCE® tablets (palbociclib)
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IBRANCE® tablets Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
IBRANCE is 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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose and Schedule
The recommended dose of IBRANCE is a 125 mg tablet taken orally once daily for 21 consecutive days...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
125 mg tablets: Oval, light purple, film-coated tablets debossed with "Pfizer" on one side and "PBC 125" on the other side.
100 mg tablets: Oval, green, film-coated tablets debossed with "...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Neutropenia
Neutropenia was the most frequently reported adverse reaction in Study 1 (PALOMA-2) with an incidence of 80% and Study 2 (...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- •
- Neutropenia [see Warnings and Precautions (5.1)...
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Drug Interactions
7 DRUG INTERACTIONS
Palbociclib is primarily metabolized by CYP3A and sulfotransferase (SULT) enzyme SULT2A1. In vivo, palbociclib is a time-dependent inhibitor of CYP3A.
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
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Overdosage
10 OVERDOSAGE
There is no known antidote for IBRANCE. The treatment of overdose of IBRANCE should consist of general supportive measures.
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Description
11 DESCRIPTION
IBRANCE tablets for oral administration contain 125 mg, 100 mg, or 75 mg of palbociclib, a kinase inhibitor. The molecular formula for palbociclib is C24H29N...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Palbociclib is an inhibitor of cyclin-dependent kinases (CDK) 4 and 6. Cyclin D1 and CDK4/6 are downstream of...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Palbociclib was assessed for carcinogenicity in a 6-month transgenic mouse study...
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Clinical Studies
14 CLINICAL STUDIES
Study 1: IBRANCE plus Letrozole
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
IBRANCE is supplied in the following strengths and package configurations:
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
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Other
This product's label may have been updated. For full prescribing information, please visit www.Pfizer.com. For medical information about...
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Resources
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Report Adverse Event
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:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.