Tepmetko Special Precautions

Interstitial lung disease: Interstitial lung disease (ILD) or ILD-like adverse reactions (e.g. pneumonitis) have been reported, including a fatal case (see Adverse Reactions).
Patients should be monitored for new or worsening pulmonary symptoms indicative for ILD-like reactions (e.g. dyspnoea, cough, fever). TEPMETKO should be withheld immediately 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 according to local clinical practice.
Hepatotoxicity: Increases in ALT and/or AST have been reported (see Adverse Reactions).
Liver enzymes (ALT and AST) and bilirubin should be monitored prior to the start of TEPMETKO, every 2 weeks during the first 3 months of treatment, then once a month. If grade 3 or higher increases occur, dose adjustment is recommended (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 inhibits 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. In case of blood creatinine increase while on treatment, it is recommended that further assessment of the renal function be performed to exclude renal impairment.
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 may have minor influence on the ability to drive and use machines. During treatment with tepotinib, fatigue and asthenia have been reported.