Medical Information

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 Highlights (palbociclib)


These highlights do not include all the information needed to use IBRANCE safely and effectively. See full prescribing information for IBRANCE.

IBRANCE® (palbociclib) tablets, for oral use
Initial U.S. Approval: 2015


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 in postmenopausal women or in men (1); or
  • fulvestrant in patients with disease progression following endocrine therapy. (1)


IBRANCE tablets are taken orally with or without food in combination with an aromatase inhibitor or fulvestrant. (2)

  • Recommended starting dose: 125 mg once daily taken with or without 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)


Tablets: 125 mg, 100 mg, and 75 mg. (3)


None. (4)


  • 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)


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


  • 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)


  • Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 11/2019

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.

*Contact Medical Information. 9AM-5PM ET Monday to Friday; excluding holidays.

*9AM-5PM ET Monday to Friday; excluding holidays.

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or