All Names: Tepotinib,Tepmetko
Indications:Non-Small Cell Lung Cancer.
Manufacturer:Merck KgaA
Customs Clearance Procedure:If the customs requires the package for customs clearance, please pay the customs clearance fee according to the content of EMS SMS and customs regulations.
INDICATIONS AND USAGE(适应症)
TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
DOSAGE(服用剂量)
The recommended dosage of TEPMETKO is 450 mg orally once daily with food until disease progression or unacceptable toxicity.
Instruct patients to take their dose of TEPMETKO at approximately the same time every day and to swallow tablets whole. Do not chew, crush or split tablets.
Advise patients not to make up a missed dose within 8 hours of the next scheduled dose.
If vomiting occurs after taking a dose of TEPMETKO, advise patients to take the next dose at the scheduled time.
ADVERSE REACTIONS(不良反应)
Interstitial Lung Disease/Pneumonitis
Hepatotoxicity
For full information, please refer to:
https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/80a0f1b9-071a-47f5-9e67-32d638a669dc/spl-doc?hl=Tepmetko
Tepmetkoinformation
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