Precautions of Momelotinib

1. Risk of Infections

Patients with chronic HBV infection who receive Momelotinib should have their chronic HBV infection treated and monitored according to clinical HBV guidelines.

2. Thrombocytopenia and Neutropenia

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.

3. Hepatotoxicity

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.

4. Major Adverse Cardiovascular Events (MACE)

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.

5. Thrombosis

Evaluate patients with symptoms of thrombosis and treat appropriately.

6. Malignancies

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