Palbociclib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Overview
Palbociclib is a cyclin-dependent kinase inhibitor that is FDA approved for the treatment of postmenopausal women with estrogen receptor ([ER]])-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease, in combination with letrozole. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Common adverse reactions include neutropenia, leukopenia, fatigue, anemia, upper respiratory infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, asthenia, peripheral neuropathy, and epistaxis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Palbociclib FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Palbociclib in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Palbociclib in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Palbociclib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Palbociclib in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Palbociclib in pediatric patients.
Contraindications
- None
Warnings
Neutropenia
- Decreased neutrophil counts have been observed in clinical trials with IBRANCE. Grade 3 (57%) or 4 (5%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole in the randomized clinical trial (Study 1). Median time to first episode of any grade neutropenia per laboratory data was 15 days (13–117 days). Median duration of Grade ≥3 neutropenia was 7 days.
- Febrile neutropenia events have been reported in the IBRANCE clinical program, although no cases of febrile neutropenia have been observed in Study 1. Monitor complete blood count prior to starting IBRANCE therapy and at the beginning of each cycle, as well as on Day 14 of the first two 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.
Infections
- Infections have been reported at a higher rate in patients treated with IBRANCE plus letrozole compared to patients treated with letrozole alone in Study 1. Grade 3 or 4 infections occurred in 5% of patients treated with IBRANCE plus letrozole whereas no patients treated with letrozole alone experienced a Grade 3 or 4 infection. Monitor patients for signs and symptoms of infection and treat as medically appropriate.
Pulmonary Embolism
- Pulmonary embolism has been reported at a higher rate in patients treated with IBRANCE plus letrozole (5%) compared with no cases in patients treated with letrozole alone in Study 1. Monitor patients for signs and symptoms of pulmonary embolism and treat as medically appropriate.
Embryo-Fetal Toxicity
- Based on findings in animals and mechanism of action, IBRANCE can cause fetal harm. IBRANCE caused embryo-fetal toxicities in rats and rabbits at maternal exposures that were greater than or equal to 4 times the human clinical exposure based on area under the curve (AUC). Advise females of reproductive potential to use effective contraception during therapy with IBRANCE and for at least two weeks after the last dose.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Palbociclib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Palbociclib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Palbociclib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Palbociclib in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Palbociclib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Palbociclib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Palbociclib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Palbociclib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Palbociclib in geriatric settings.
Gender
There is no FDA guidance on the use of Palbociclib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Palbociclib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Palbociclib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Palbociclib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Palbociclib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Palbociclib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Palbociclib Administration in the drug label.
Monitoring
There is limited information regarding Palbociclib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Palbociclib and IV administrations.
Overdosage
There is limited information regarding Palbociclib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Palbociclib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Palbociclib Mechanism of Action in the drug label.
Structure
There is limited information regarding Palbociclib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Palbociclib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Palbociclib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Palbociclib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Palbociclib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Palbociclib How Supplied in the drug label.
Storage
There is limited information regarding Palbociclib Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Palbociclib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Palbociclib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Palbociclib Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Palbociclib Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.