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?

I am a U.S. Healthcare ProfessionalYes, I am a U.S. Healthcare Professional
SelectI am a U.S. Healthcare ProfessionalYes, I am a U.S. Healthcare Professional
I am a U.S. Patient / CaregiverNo, go back to the patient portal
SelectI am a U.S. Patient / CaregiverNo, go back to the patient portal
Non-US residents click here.

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® capsules Highlights (palbociclib)

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)

12/2022

Dosage and Administration (2.1)

12/2022

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 (1); 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)
•
Interstitial Lung Disease (ILD)/Pneumonitis: Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for pulmonary symptoms of ILD/pneumonitis. Interrupt IBRANCE immediately in patients with suspected ILD/pneumonitis. Permanently discontinue IBRANCE if severe ILD/pneumonitis occurs. (5.2)
•
Embryo-Fetal Toxicity: IBRANCE can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (5.3, 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: 12/2022

Show All Hide All
Show All Hide All
Did you find an answer to your question? Yes No

Resources

website
Ibrance Website for Healthcare Professionals
 
website
Ibrance Website for Consumers and Patients
 
website
Pfizer Oncology together
 
Didn’t find what you were looking for? Contact us.
MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Contact Medical Information.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event
Pfizer Safety

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:

Pfizer Safety Reporting Site

*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.
FDA Medwatch
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.