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Assess left ventricular ejection fraction (LVEF) prior to initiation of Entrectinib. Monitor patients for clinical signs and symptoms of CHF, including shortness of breath and edema. For patients with myocarditis, with or without a decreased ejection fraction, MRI or cardiac biopsy may be required to make the diagnosis. For patients with new onset or worsening CHF, withhold Entrectinib, institute appropriate medical management, and reassess LVEF. Based on the severity of CHF or worsening LVEF, resume Entrectinib at a reduced dose upon recovery to baseline or permanently discontinue.
A broad spectrum of central nervous system (CNS) adverse reactions occurred in patients receiving Entrectinib, including cognitive impairment, mood disorders, dizziness, and sleep disturbances.
Advise patients and caregivers of these risks with Entrectinib. Advise patients not to drive or operate hazardous machinery if they are experiencing CNS adverse reactions. Withhold and then resume at same or reduced dose upon improvement, or permanently discontinue Entrectinib based on severity.
Entrectinib increases the risk of fractures.
Promptly evaluate patients with signs or symptoms (e.g., pain, changes in mobility, deformity) of fractures. There are no data on the effects of Entrectinib on healing of known fractures and risk of future fractures.
Monitor liver tests, including ALT and AST, every 2 weeks during the first month of treatment, then monthly thereafter, and as clinically indicated. Withhold or permanently discontinue Entrectinib based on the severity. If withheld, resume Entrectinib at the same or reduced dose.
Assess serum uric acid levels prior to initiation of Entrectinib and periodically during treatment. Monitor patients for signs and symptoms of hyperuricemia. Initiate treatment with urate-lowering medications as clinically indicated and withhold Entrectinib for signs and symptoms of hyperuricemia. Resume Entrectinib at same or reduced dose upon improvement of signs or symptoms based on severity.
from FDA，2024.01
