Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
TEPMETKO as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
Treatment must be initiated and supervised by a physician experienced in the use of anticancer therapies.
Prior to initiation of treatment with TEPMETKO the presence of METex14 skipping alterations should be confirmed by a validated test method (see sections 4.4 and 5.1).
The recommended dose is 450 mg tepotinib (2 tablets) taken once daily. Treatment should continue as long as clinical benefit is observed.
If a daily dose is missed, it can be taken as soon as remembered on the same day, unless the next dose is due within 8 hours.
The recommended dose reduction level for the management of adverse reactions is 225 mg (1 tablet) daily. Detailed recommendations for dose modification are provided in the table hereafter.
| Adverse reaction | Severity | Dose modification |
|---|---|---|
| Interstitial lung disease (ILD) (see section 4.4) | Any grade | Withhold TEPMETKO if ILD is suspected. Permanently discontinue TEPMETKO if ILD is confirmed. |
| Increased ALT and/or AST without increased total bilirubin (see section 4.4) | ALT and/or AST greater than 5 times up to 20 times ULN | Withhold TEPMETKO until recovery to baseline ALT/AST. If recovered to baseline within 7 days, then resume TEPMETKO at the same dose; otherwise resume TEPMETKO at a reduced dose. |
| ALT and/or AST greater than 20 times ULN | Permanently discontinue TEPMETKO. | |
| Increased ALT and/or AST with increased total bilirubin in the absence of cholestasis or haemolysis (see section 4.4) | ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN | Permanently discontinue TEPMETKO. |
| Other adverse reactions (see section 4.8) | Grade 3 or higher | Reduce TEPMETKO to 225 mg until the adverse reaction recovers to ≤ grade 2. A temporary interruption of TEPMETKO treatment for no more than 21 days can also be considered. |
ULN = upper limit of normal
No dose adjustment is recommended in patients with mild or moderate renal impairment (creatinine clearance 30 to 89 mL/min) (see section 5.2). The pharmacokinetics and safety of tepotinib in patients with severe renal impairment (creatinine clearance below 30 mL/min) have not been studied. The use of TEPMETKO in patients with severe renal impairment is therefore not recommended.
Renal function estimates that rely on serum creatinine (creatinine clearance or estimated glomerular filtration rate) should be interpreted with caution (see section 4.4).
No dose adjustment is recommended in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment (see section 5.2). The pharmacokinetics and safety of tepotinib in patients with severe hepatic impairment (Child-Pugh Class C) have not been studied. The use of TEPMETKO in patients with severe hepatic impairment is therefore not recommended.
No dose adjustment is necessary in patients aged 65 years and above (see section 5.2).
Safety and efficacy of tepotinib in paediatric patients below 18 years of age have not been established. No data are available.
TEPMETKO is for oral use. The tablet(s) should be taken with food and should be swallowed whole to ensure that the full dose is administered.
Tepotinib has been investigated at doses up to 1 261 mg, but experience with doses higher than the recommended therapeutic dose is limited.
The symptoms of overdose are expected to be in the range of known adverse reactions (see section 4.8). There is no specific antidote for TEPMETKO. Treatment of overdose is directed to symptoms.
3 years.
This medicinal product does not require special storage conditions.
Aluminium/Polyvinyl chloride-polyethylene-polyvinylidene chloride-polyethylene-polyvinyl chloride (Al/PVC-PE-PVDC-PE-PVC) blister. Pack of 60 film-coated tablets.
This medicinal product may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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