IBRANCE® tablets (palbociclib) HIGHLIGHTS OF PRESCRIBING INFORMATION

(palbociclib)

Prescribing Information

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) tablets, for oral use
Initial U.S. Approval: 2015

RECENT MAJOR CHANGES

Indications and Usage (1)	4/2025
Dosage and Administration (2.1, 2.2)	4/2025

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:

o: an aromatase inhibitor as initial endocrine-based therapy (1); or
o: fulvestrant in patients with disease progression following endocrine therapy. (1)

•

in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. (1)

DOSAGE AND ADMINISTRATION

IBRANCE tablets are taken orally with or without food in combination with an aromatase inhibitor, fulvestrant, or inavolisib and 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)

DOSAGE FORMS AND STRENGTHS

Tablets: 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 ≥20%) in combination with either letrozole or fulvestrant, including laboratory abnormalities, were white blood cell count decreased, neutrophils decreased, blood creatinine increased, hemoglobin decreased, platelets decreased, infections, aspartate aminotransferase increased, alanine aminotransferase increased, fatigue, nausea, stomatitis, diarrhea, and alopecia. (6.1)

The most common adverse reactions (incidence ≥20%) in combination with inavolisib and fulvestrant, including laboratory abnormalities, were neutrophils decreased, hemoglobin decreased, fasting glucose increased, platelets decreased, lymphocytes decreased, stomatitis, diarrhea, calcium decreased, fatigue, potassium decreased, creatinine increased, alanine aminotransferase (ALT) increased, nausea, sodium decreased, magnesium decreased, rash, decreased appetite, COVID-19 infection, and headache. (6.1)

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: 9/2025

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: September 2025
PATIENT INFORMATION IBRANCE® (EYE-brans) (palbociclib) Tablets
What is the most important information I should know about IBRANCE? IBRANCE may cause serious side effects, including: Low white blood cell counts (neutropenia). Low white blood cell counts are very common when taking IBRANCE and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment. If you develop low white blood cell counts during treatment with IBRANCE, your healthcare provider may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills. Lung problems (pneumonitis). IBRANCE may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including: • chest pain • cough with or without mucus • trouble breathing or shortness of breath Your healthcare provider may interrupt or stop treatment with IBRANCE completely if your symptoms are severe. See "What are the possible side effects of IBRANCE?" for more information about side effects.
What is IBRANCE? IBRANCE is a prescription medicine used: In adults to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) in combination with: • an aromatase inhibitor as the first hormonal based therapy, or • fulvestrant in people with disease progression following hormonal therapy. In adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative and with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene breast cancer that has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic) in combination with: • inavolisib and fulvestrant in people with disease progression during or after adjuvant hormonal therapy. It is not known if IBRANCE is safe and effective in children.
What should I tell my healthcare provider before taking IBRANCE? Before taking IBRANCE, tell your healthcare provider about all of your medical conditions, including if you: • have fever, chills, or any other signs or symptoms of infection. • have liver or kidney problems. • have any other medical conditions. • are pregnant, or plan to become pregnant. IBRANCE can harm your unborn baby. o Females who are able to become pregnant should use effective birth control during treatment and for at least 3 weeks after the last dose of IBRANCE. Your healthcare provider may ask you to take a pregnancy test before you start treatment with IBRANCE. o Males with female partners who can become pregnant should use effective birth control during treatment with IBRANCE for at least 3 months after the last dose of IBRANCE. o Talk to your healthcare provider about birth control methods that may be right for you during this time. o If you become pregnant or think you are pregnant, tell your healthcare provider right away. • are breastfeeding or plan to breastfeed. It is not known if IBRANCE passes into your breast milk. Do not breastfeed during treatment with IBRANCE and for 3 weeks after the last dose. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IBRANCE and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
How should I take IBRANCE? • Take IBRANCE exactly as your healthcare provider tells you. • IBRANCE tablets may be taken with or without food. • IBRANCE should be taken at about the same time each day. • Swallow IBRANCE tablets whole. Do not chew, crush or split IBRANCE tablets before swallowing them. • Do not take any IBRANCE tablets that are broken, cracked, or that look damaged. • Avoid grapefruit and grapefruit products during treatment with IBRANCE. Grapefruit may increase the amount of IBRANCE in your blood. • Do not change your dose or stop taking IBRANCE unless your healthcare provider tells you. • If you miss a dose of IBRANCE or vomit after taking a dose of IBRANCE, do not take another dose on that day. Take your next dose at your regular time. • When IBRANCE is used in combination with inavolisib and fulvestrant, or an aromatase inhibitor, also read the Patient Information for the prescribed products.
What are the possible side effects of IBRANCE?
IBRANCE may cause serious side effects. See "What is the most important information I should know about IBRANCE?"
The most common side effects of IBRANCE when used with either letrozole or fulvestrant include: • Low red blood cell counts and low platelet counts are common with IBRANCE. Call your healthcare provider right away if you develop any of these symptoms during treatment:
	o dizziness o shortness of breath o weakness	o bleeding or bruising more easily o nosebleeds
• infections (see "What is the most important information I should know about IBRANCE?") • tiredness • nausea • sore mouth • abnormalities in liver blood tests		• diarrhea • hair thinning or hair loss • increased blood creatinine
The most common side effects when inavolisib is added to IBRANCE plus fulvestrant include: • high blood sugar levels leading to excessive thirst and urination • sore mouth • diarrhea • decreased white blood cell counts, red blood cell counts, and platelet counts • decreased blood levels of calcium, potassium, sodium, and magnesium • increased creatine blood levels • tiredness • abnormalities in liver blood tests • nausea • rash • loss of appetite • COVID-19 infection • headache IBRANCE may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider about family planning options before starting IBRANCE if this is a concern for you. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of IBRANCE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store IBRANCE? • Store IBRANCE at 68 °F to 77 °F (20 °C to 25 °C) in the original blister pack. Keep IBRANCE and all medicines out of the reach of children.
General information about the safe and effective use of IBRANCE Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IBRANCE for a condition for which it was not prescribed. Do not give IBRANCE to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about IBRANCE that is written for health professionals.
What are the ingredients in IBRANCE? Active ingredient: palbociclib Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, succinic acid, HPMC 2910/hypromellose, titanium dioxide, triacetin, and FD&C Blue #2/Indigo Carmine Aluminum Lake. In addition, the 75 mg and 125 mg tablets contain red iron oxide and the 100 mg tablets contain yellow iron oxide. This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com. LAB-1372-7.0 For more information, go to www.pfizer.com or call 1-800-438-1985.

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