Tepmetko Special Precautions

Interstitial lung disease/Pneumonitis: Interstitial lung disease (ILD) or ILD-like adverse reactions have been reported in 8 patients (2.6%) with advanced NSCLC with METex14 skipping alterations who received tepotinib monotherapy at the recommended dosage regimen (n=313), including 1 case of Grade 3 or higher; serious cases occurred in 4 patients (1.3%), 1 case was fatal.
Patients should be monitored for pulmonary symptoms indicative for ILD-like reactions. TEPMETKO should be withheld and patients should be promptly investigated for alternative diagnosis or specific aetiology of interstitial lung disease. TEPMETKO must be permanently discontinued if interstitial lung disease is confirmed and the patient be treated appropriately.
Hepatotoxicity: Hepatotoxicity occurred in patients treated with TEPMETKO (see Adverse Reactions). Increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST) occurred in 18% of patients treated with TEPMETKO. Grade 3 or 4 increased ALT/AST occurred in 4.7% of patients. Four patients (0.8%) discontinued TEPMETKO due to increased ALT/AST. The median time-to-onset of Grade 3 or higher increased ALT/AST was 47 days (range 1 to 262).
Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of TEPMETKO, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue TEPMETKO (see Dosage & Administration).
Embryo-foetal toxicity: TEPMETKO can cause foetal harm when administered to pregnant women (see Use in Pregnancy & Lactation).
Women of childbearing potential or male patients with female partners of childbearing potential should be advised of the potential risk to a foetus.
Women of childbearing potential should use effective contraception during TEPMETKO treatment and for at least 1 week after the last dose.
Male patients with female partners of childbearing potential should use barrier contraception during TEPMETKO treatment and for at least 1 week after the last dose.
Interpretation of laboratory tests: Nonclinical studies suggest that tepotinib or its main metabolite inhibit the renal tubular transporter proteins organic cation transporter (OCT) 2 and multidrug and toxin extrusion transporters (MATE) 1 and 2 (see Pharmacology: Pharmacokinetics under Actions). Creatinine is a substrate of these transporters, and the observed increases in creatinine (see Adverse Reactions) may be the result of inhibition of active tubular secretion rather than renal injury. Renal function estimates that rely on serum creatinine (creatinine clearance or estimated glomerular filtration rate) should be interpreted with caution considering this effect.
Lactose content: TEPMETKO contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: TEPMETKO has no influence on the ability to drive and use machines.