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Tepmetko

Tepmetko

tepotinib

Manufacturer:

Merck

Distributor:

Apex Pharma Marketing
Concise Prescribing Info
Contents
Tepotinib
Indications/Uses
Metastatic NSCLC harbouring mesenchymal-epithelial transition factor gene exon 14 skipping alterations.
Dosage/Direction for Use
Administration
Should be taken with food: Swallow whole.
Contraindications
Special Precautions
Monitor for pulmonary symptoms indicative of ILD/pneumonitis. W/hold treatment & promptly investigate patients for alternative diagnosis or specific aetiology of ILD; permanently discontinue use if ILD is confirmed. Monitor LFTs (including ALT, AST & total bilirubin) prior to starting treatment, every 2 wk during the 1st 3 mth of treatment, then once mthly or as clinically indicated. Interpretation of renal function estimates that rely on serum creatinine (CrCl or estimated GFR). Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Severe renal (CrCl <30 mL/min) & hepatic (Child-Pugh Class C) impairment. May cause foetal harm. Women of childbearing potential should use effective contraception during treatment & for at least 1 wk after last dose; male patients w/ female partners of childbearing potential should use barrier contraception during treatment & for at least 1 wk after last dose. Pregnancy. Discontinue breastfeeding during treatment & for 1 wk after final dose. Childn <18 yr.
Adverse Reactions
Edema, fatigue; nausea, diarrhea; musculoskeletal pain; dyspnea; decreased lymphocytes, albumin, Na & Hb, increased γ-glutamyltransferase, amylase, ALT & AST; decreased appetite.
Drug Interactions
May inhibit transport of sensitive P-gp & BCRP substrates. May potentially alter exposure to co-administered metformin.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EX21 - tepotinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Tepmetko FC tab 225 mg
Packing/Price
60's
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