Tepotinib Disease Interactions

The use of tepotinib may cause interstitial lung disease (ILD)/pneumonitis, sometimes resulting in fatalities. Care should be exercised when using this drug in patients with preexisting pulmonary impairment. Tepotinib should be immediately withheld in patients with suspected ILD/pneumonitis and permanently discontinued if no other potential causes of ILD/pneumonitis are identified. Patients should be monitored for new/worsening pulmonary symptoms indicative of ILD/pneumonitis.

The use of tepotinib may cause hepatotoxicity, sometimes resulting in fatalities. No dosage modification is recommended in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) liver dysfunction. Care should be exercised when using tepotinib in patients with severe liver dysfunction (Child-Pugh C) as its pharmacokinetics and safety have not been studied in this patient population. It is recommended to monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of therapy, every 2 weeks during the first 3 months of therapy, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin. Tepotinib should be withheld, the dose should be reduced, or therapy should be permanently discontinued based on the severity of the adverse reaction.

Care should be exercised when using tepotinib in patients with severe renal dysfunction (CrCl less than 30 mL/min) as the recommended dosage has not been established in this patient population. No dosage adjustment is recommended in patients with mild or moderate renal dysfunction (CrCl 30 to 89 mL/min).