TEMPETKO

General
Patient selection for METex14 skipping alterations
Patients treated with TEPMETKO must have a documented METex14 skipping alteration based on a validated METex14 assay. Assessment for the presence of METex14 skipping alterations should be performed by laboratories with demonstrated proficiency in the specific technology being utilized (see CLINICAL TRIALS).
Driving and Operating Machinery
No studies on the effects of TEPMETKO on the ability to drive or use machines have been performed. Caution should be exercised when operating a vehicle or potentially dangerous machinery until the patient is reasonably certain that TEPMETKO does not affect them
adversely.
Hepatic
Hepatotoxicity
Hepatotoxicity occurred in patients with advanced NSCLC with METex14 skipping alterations who received TEPMETKO monotherapy at the recommended dosage regimen (n=255) (see ADVERSE REACTIONS). Adverse reactions of increase in alanine aminotransferase (ALT) and/or increase in aspartate aminotransferase (AST) (ALT/AST) were reported in 12.2% of patients treated with TEPMETKO. Grade ≥ 3 adverse reactions were reported in 3.1%. A case of fatal hepatic failure occurred in one patient (0.4%). Nine patients (3.5%) temporarily discontinued TEPMETKO and 2 patients (0.8%) had dose reductions due to increase in
ALT/AST. The median time to first onset of Grade ≥ 3 adverse reactions was 7.3 weeks (range 3.1 to 28.6 weeks).
Liver function tests (ALT and AST, and total bilirubin) should be monitored 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, TEPMETKO should be withheld, dose reduced, or permanently discontinued. See DOSAGE AND ADMINISTRATION, Dose Modification.