The complete official prescribing information should be consulted before prescribing or administering palbociclib. The following is a structured educational summary and is not a replacement for the official label.
Indications
Current U.S. IBRANCE labeling includes:
- HR-positive/HER2-negative advanced or metastatic breast cancer with an aromatase inhibitor as initial endocrine-based therapy.
- HR-positive/HER2-negative advanced or metastatic breast cancer with fulvestrant after disease progression following endocrine therapy.
- Endocrine-resistant, PIK3CA-mutated HR-positive/HER2-negative locally advanced or metastatic breast cancer with inavolisib and fulvestrant in the specified setting.
- HR-positive/HER2-positive locally advanced or metastatic breast cancer maintenance treatment after induction therapy with trastuzumab, with or without pertuzumab, and endocrine therapy.
Dosage
The labeled starting dose is 125 mg once daily for 21 consecutive days followed by 7 days off.
Capsules are taken with food; tablets are taken with or without food according to current U.S. labeling.
Dosage forms and strengths
Current U.S. IBRANCE labeling lists:
- 75 mg
- 100 mg
- 125 mg
for both capsule and tablet formulations.
Contraindications
The current U.S. IBRANCE label lists no contraindications. This does not mean palbociclib is appropriate for every patient.
Major warnings
The principal warnings and precautions include:
- Neutropenia
- Interstitial lung disease/pneumonitis
- Embryo-fetal toxicity
Drug interactions
Strong CYP3A inhibitors and strong CYP3A inducers should generally be avoided. Sensitive CYP3A substrates with narrow therapeutic indices may require additional consideration.
Monitoring
CBC monitoring is essential, particularly because of the frequency of neutropenia.
Pregnancy and lactation
Palbociclib can cause fetal harm. Current U.S. labeling advises against breastfeeding during treatment and for 3 weeks after the final dose.
Complete label
The official current label should be consulted for complete dosing tables, dose modifications, clinical pharmacology, adverse reactions and patient counseling information.