Tepmetko Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Tepotinib HCl hydrate

Indications/Uses

Metastatic NSCLC harbouring mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping alterations.

Click to view Tepmetko detailed prescribing information

Dosage/Direction for Use

Adult 2 tab once daily until disease progression or unacceptable toxicity.

Click to view Tepmetko detailed prescribing information

Overdosage

View Tepmetko overdosage for action to be taken in the event of an overdose.

Administration

Should be taken with food: Swallow whole, do not crush/chew.

Contraindications

Hypersensitivity.

Click to view Tepmetko detailed prescribing information

Special Precautions

Permanently discontinue use if ILD is confirmed. Hepatotoxicity. Assess for presence of METex14 skipping alterations prior to initiation. Monitor for new or worsening pulmonary symptoms indicative of ILD-like reactions; liver enzymes & bilirubin prior to, every 2 wk during 1st 3 mth of treatment then once mthly. Interference w/ creatinine & renal function lab tests. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Severe hepatic (Child-Pugh Class C) & renal (CrCl <30 mL/min) impairment. Women of childbearing potential & male patients w/ female partners should use effective contraception during & for at least 1 wk after last dose. Not to be used during pregnancy, lactation & for at least 1 wk after last dose. Paed <18 yr.

Click to view Tepmetko detailed prescribing information

Use In Pregnancy & Lactation

Click to view Tepmetko detailed prescribing information

Adverse Reactions

Decreased albumin; nausea, diarrhoea, increased amylase & lipase, vomiting; increased alkaline phosphatase, ALT & AST; increased creatinine; oedema. QT prolongation; ILD-like reactions.

Click to view Tepmetko detailed prescribing information

Drug Interactions

Decreased exposure w/ strong P-gp (eg, carbamazepine, phenytoin, rifampicin, St. John's wort) & CYP inducers. Increased exposure w/ dual strong CYP3A & P-gp inhibitors eg, itraconazole. Inhibited transport of sensitive P-gp & BCRP substrates. Altered exposure to metformin. Monitor clinical effects of P-gp dependent substrates w/ narrow therapeutic index eg, digoxin.

Click to view Tepmetko detailed prescribing information

Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Tepmetko detailed prescribing information

Storage

View Tepmetko storage conditions for details to ensure optimal shelf-life.

Description

View Tepmetko description for details of the chemical structure and excipients (inactive components).

Action

View Tepmetko mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Targeted Cancer Therapy

ATC Classification

L01EX21 - tepotinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.

Regulatory Classification

Presentation/Packing

Form

Tepmetko FC tab 225 mg

Packing/Price

60's

Tepmetko

tepotinib

Manufacturer:

Merck

Distributor:

Zuellig Pharma