What are the precautions for Palbociclib?

Patients should pay attention to the occurrence of neutropenia, interstitial lung disease (ILD)/pneumonitis, embryo-fetal toxicity and other events during treatment with palbociclib (Palbociclib).

1. Neutropenia:

Neutropenia was the most commonly reported adverse reaction in the study, and patients had complete blood counts monitored before initiating palbociclib treatment and at the beginning of each cycle, and on Day 15 of the first two cycles, as clinically indicated. For patients who develop grade 3 or 4 neutropenia, dose interruption, dose reduction, or delayed initiation of the treatment cycle is recommended.

2. Interstitial lung disease (ILD)/pneumonia:

Severe, life-threatening, or fatal ILD/pneumonitis may occur in patients receiving cyclin-dependent kinase4/6 (CDK4/6) inhibitors, including palbociclib when used in combination with endocrine therapy. Monitor patients for pulmonary symptoms of ILD/pneumonitis (e.g., hypoxia, cough, dyspnea). If a patient develops new or worsening respiratory symptoms and is suspected of having pneumonia, palbociclib should be discontinued immediately and the patient evaluated. Palbociclib should be permanently discontinued in patients with severe ILD or pneumonia.

3. Embryo-Fetotoxicity:

Based on findings from animal studies and its mechanism of action, palbociclib can cause fetal harm when administered to pregnant women. In animal reproduction studies, administration of palbociclib to pregnant rats and rabbits during organogenesis resulted in maternally exposed embryonic-fetal toxicity ≥ 4 times the human clinical exposure. Doctors recommend that women of reproductive potential use effective contraception during palbociclib treatment and for at least 3 weeks after the last dose.