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Patients with chronic HBV infection who receive Momelotinib should have their chronic HBV infection treated and monitored according to clinical HBV guidelines.
Assess complete blood counts (CBC), including platelet and neutrophil counts, before initiating treatment and periodically during treatment as clinically indicated. Interrupt dosing or reduce the dose for thrombocytopenia or neutropenia.
Monitor liver tests at baseline, every month for 6 months during treatment, then periodically as clinically indicated. If increases in ALT, AST or bilirubin related to treatment are suspected, modify Momelotinib dosage based upon Table 1.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Momelotinib, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients receiving Momelotinib of the symptoms of serious cardiovascular events and the steps to take if they occur.
Evaluate patients with symptoms of thrombosis and treat appropriately.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Momelotinib, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
from FDA,2023.09
