Active Ingredient: Tepotinib
Tepotinib 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.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
450 - 450 mg
From 450 To 450 mg once every day
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) | Any grade | Withhold tepotinib if ILD is suspected. Permanently discontinue tepotinib if ILD is confirmed. |
| Increased ALT and/or AST without increased total bilirubin | ALT and/or AST greater than 5 times up to 20 times ULN | Withhold tepotinib until recovery to baseline ALT/AST. If recovered to baseline within 7 days, then resume tepotinib at the same dose; otherwise resume tepotinib at a reduced dose. |
| ALT and/or AST greater than 20 times ULN | Permanently discontinue tepotinib. | |
| Increased ALT and/or AST with increased total bilirubin in the absence of cholestasis or haemolysis | ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN | Permanently discontinue tepotinib. |
| Other adverse reactions | Grade 3 or higher | Reduce tepotinib to 225 mg until the adverse reaction recovers to ≤ grade 2. A temporary interruption of tepotinib treatment for no more than 21 days can also be considered. |
ULN = upper limit of normal
The tablet(s) should be taken with food and should be swallowed whole to ensure that the full dose is administered.
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