Tepmetko

Treatment must be initiated and supervised by a physician experienced in the use of anticancer therapies. 1). Posology 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. Dose modification for adverse reactions 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. 4) Any grade Withhold TEPMETKO if ILD is suspected. Permanently discontinue TEPMETKO if ILD is confirmed. 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. 4) ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN Permanently discontinue TEPMETKO.

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. 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. 4). 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.

2). Paediatric population Safety and efficacy of tepotinib in paediatric patients below 18 years of age have not been established. No data are available. 4 Method of administration 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.

If the patient is unable to swallow, the tablets can be dispersed in 30 mL of non-carbonated water. No other liquids should be used or added. The tablets should be dropped in a glass with water without crushing, stir until the tablets dispersed into small pieces which may take a few minutes (the tablet will not completely dissolve).

8%). 0%). 9%. 0%). 7%. 6%). 1%. 6%). List of adverse reactions Adverse reactions described in the list below reflect exposure to tepotinib in 506 patients with various solid tumours enrolled in five open-label studies, in which patients received tepotinib as a single agent at a dose of 450 mg once daily.

The frequencies of adverse reactions are based on all-cause adverse event frequencies identified in 313 patients exposed to tepotinib at the recommended dose in the target indication, whereas frequencies for changes in laboratory parameters are based on worsening from baseline by at least 1 grade and shifts to ≥ grade 3.

5 months (range 0 to 72). Frequencies presented may not be fully attributable to tepotinib alone but may contain contributions from the underlying disease or from other medicinal products used concomitantly. The severity of adverse reactions was assessed based on the Common Terminology Criteria for Adverse Events (CTCAE), defining grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening and grade 5 = death.

3%), 1 case was fatal. Treatment was permanently discontinued in 5 patients and temporarily in 3 patients. 4 weeks. 4. 3%) of tepotinib. 1 weeks. 6 weeks, 86% of events resolved. 4. ALP increase did not lead to any dose reductions, temporary treatment discontinuation or permanent discontinuation.

The observed ALP increase was not associated with cholestasis. 1 weeks. 1 weeks, 80% of events resolved. 7%). 1 weeks. 2% of events resolved. 4% had peripheral oedema. 7% of patients had dose reductions due to oedema. Most frequently peripheral oedema led to temporary treatment […]

Assessment of METex14 skipping alterations status When detecting the presence of alterations leading to METex14 skipping using tissue-based or plasma- based specimens, it is important that a well-validated and robust test is chosen to avoid false negative or false positive results.

1. 8). 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. 8). Liver enzymes (ALT and AST) and bilirubin should be monitored prior to the start of TEPMETKO treatment and thereafter as clinically indicated.

2). 8). g. ECG, electrolytes). 5 Embryo-foetal toxicity Tepotinib can cause foetal harm when administered to pregnant women. Pregnancy testing is recommended in women of childbearing potential prior to initiating treatment with TEPMETKO.

6). 2). 8) 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.

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