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IBRANCE is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-...
The recommended dose of IBRANCE is a 125 mg capsule taken orally once daily for 21 consecutive...
125 mg capsules: opaque, hard gelatin capsules, size 0, with caramel cap and body, printed with white ink "Pfizer" on the cap, "PBC 125" on the body.
100 mg capsules: opaque, hard gelatin...
Neutropenia was the most frequently reported adverse reaction in Study 1 (PALOMA-2) with an incidence of 80% and...
The following clinically significant adverse reactions are described elsewhere in the labeling:
Palbociclib is primarily metabolized by CYP3A and sulfotransferase (SULT) enzyme SULT2A1. In vivo, palbociclib is a time-dependent inhibitor of CYP3A.
Based on findings from...
There is no known antidote for IBRANCE. The treatment of overdose of IBRANCE should consist of general supportive measures.
IBRANCE capsules for oral administration contain 125 mg, 100 mg, or 75 mg of palbociclib, a kinase inhibitor. The molecular formula for palbociclib is C24H29N...
Palbociclib is an inhibitor of cyclin-dependent kinases (CDK) 4 and 6. Cyclin D1 and CDK4/6 are downstream of...
Palbociclib was assessed for carcinogenicity in a 6-month transgenic mouse study...
Study 1: IBRANCE plus Letrozole
IBRANCE is supplied in the following strengths and package configurations:
Advise the patient to read the FDA-approved patient labeling (Patient Information).
This product's label may have been updated. For full prescribing information, please visit www.IBRANCE.com.
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To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
Pfizer Safety Reporting Site
*If you are involved in a clinical trial for this 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 https://vaers.hhs.gov or call (800) 822-7967.