(palbociclib)
5 WARNINGS AND PRECAUTIONS
5 WARNINGS AND PRECAUTIONS
5.1 Neutropenia
Neutropenia was the most frequently reported adverse reaction in PALOMA-2 with an incidence of 80% and PALOMA-3 with an incidence of 83%. A Grade ≥3 decrease in neutrophil counts was reported in 66% of patients receiving IBRANCE plus letrozole in PALOMA-2 and 66% of patients receiving IBRANCE plus fulvestrant in PALOMA-3. In PALOMA-2 and PALOMA-3, the median time to first episode of any grade neutropenia was 15 days and the median duration of Grade ≥3 neutropenia was 7 days [see Adverse Reactions (6.1)].
Monitor complete blood counts prior to starting IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia [see Dosage and Administration (2.2)].
Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Physicians should inform patients to promptly report any episodes of fever [see Patient Counseling Information (17)].
5.2 Interstitial Lung Disease (ILD)/Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, including IBRANCE when taken in combination with endocrine therapy.
Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4 and no fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the postmarketing setting, with fatalities reported [see Adverse Reactions (6.2)].
Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis [see Dosage and Administration (2.2)].
5.3 Embryo-Fetal Toxicity
Based on findings from animal studies and its mechanism of action, IBRANCE can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of palbociclib to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at maternal exposures that were ≥4 times the human clinical exposure based on area under the curve (AUC). Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IBRANCE and for at least 3 weeks after the last dose [see Use in Specific Populations (8.1 and 8.3) and Clinical Pharmacology (12.1)].
MEDICATION GUIDE
| This Patient Information has been approved by the U.S. Food and Drug Administration. Revised September 2025 | ||
PATIENT INFORMATION | ||
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:
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:
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:
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:
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?
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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:
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The most common side effects of IBRANCE when used in combination with inavolisib plus fulvestrant include:
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?
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, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and hard gelatin capsule shells. The light orange, light orange/caramel and caramel opaque capsule shells contain: gelatin, red iron oxide, yellow iron oxide, and titanium dioxide. The printing ink contains: shellac, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. 
For more information, go to www.pfizer.com or call 1-800-438-1985. | ||
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