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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 PALOMA-2 with an incidence of 80% and PALOMA-3 with an...
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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
PALOMA-2: 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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