Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
Not a healthcare professional? Go to the patient or caregiver website.

IBRANCE® tablets (palbociclib)

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

IBRANCE® tablets Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
Did you find an answer to your question? Yes No

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...

Did you find an answer to your question? Yes No

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...

Did you find an answer to your question? Yes No

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 "...

Did you find an answer to your question? Yes No

4 CONTRAINDICATIONS

None.

Did you find an answer to your question? Yes No

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 (...

Did you find an answer to your question? Yes No

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Neutropenia [see

    6.1 Clinical Studies Experience

    ...
Did you find an answer to your question? Yes No

7 DRUG INTERACTIONS

Palbociclib is primarily metabolized by CYP3A and sulfotransferase (SULT) enzyme SULT2A1. In vivo, palbociclib is a time-dependent inhibitor of CYP3A.

...
Did you find an answer to your question? Yes No

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

Did you find an answer to your question? Yes No

10 OVERDOSAGE

There is no known antidote for IBRANCE. The treatment of overdose of IBRANCE should consist of general supportive measures.

Did you find an answer to your question? Yes No

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...

Did you find an answer to your question? Yes No

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...

Did you find an answer to your question? Yes No

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Palbociclib was assessed for carcinogenicity in a 6-month transgenic mouse study...

Did you find an answer to your question? Yes No

14 CLINICAL STUDIES

Study 1: IBRANCE plus Letrozole

...

Did you find an answer to your question? Yes No

16 HOW SUPPLIED/STORAGE AND HANDLING

IBRANCE is supplied in the following strengths and package configurations:

...
IBRANCE Tablets
Did you find an answer to your question? Yes No

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

...

Did you find an answer to your question? Yes No

This product's label may have been updated. For full prescribing information, please visit www.IBRANCE.com.

...

Did you find an answer to your question? Yes No
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event