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Tepotinib Hydrochloride Tablets (Tepotinib) Instructions
Common Name: Tepotinib
Trade Name: Tepmetko
Full Names: Tepotinib Hydrochloride Tablets, Tepotinib, Tepotinib, Tepmetko
Indications:
MET gene exon 14 skip mutation-positive non-small cell lung cancer with unresectable progression and recurrence
Usage and dosage:
Recommended dose: 500 mg once a day, orally after meals. In phase 1 clinical trials, the maximum dose was ramped up to 1,400 mg once a day, which was still not the maximum tolerated dose.
Dose adjustment: If the dose needs to be reduced due to adverse reactions, the dose can be reduced to 250mg once a day. If still unable to tolerate 250 mg once daily, permanently discontinue treatment.
Adverse reactions:
Common adverse reactions (≥5%): peripheral edema (48.3%), nausea (23%), diarrhea (20.7%), Increased serum creatinine (12.6%), fatigue (9.2%), increased amylase (8%), increased ALT (6.9%), increased AST (5.7%), and hypoalbuminemia (5.7%).
Common grade 3 adverse reactions: peripheral edema (8%), increased amylase (2.3%), increased ALT (2.3%), diarrhea (1.1%), asthenia (1.1%), and increased AST (1.1%).
Other treatment-related adverse reactions: increased lipase (4.6%), fatigue (3.4%), vomiting (3.4%).
Contraindications:
Not clear
Precautions:
Interstitial lung disease/pneumonitis: In the VISON clinical trial, interstitial lung disease/pneumonitis occurred in 3.8% of patients. If a patient is found to have symptoms of interstitial lung disease/pneumonia, such as difficulty breathing, cough and fever, go to the hospital for examination and treatment in time.
Hepatotoxicity: In the VISON clinical trial, 13.1% of patients experienced elevated ALT, AST, γ-GTP, or ALP. Tepotinib is contraindicated in patients with severe hepatic impairment. Liver function needs to be checked before taking the medicine, and rechecked regularly while taking the medicine.
Peripheral edema: In the VISON clinical trial, adverse reactions to fluid retention such as acral edema, hypoalbuminemia and pleural effusion were found. If you find any abnormalities such as significant weight gain or difficulty breathing while taking the medicine, go to the hospital for examination and treatment in time.
Embryo-fetal toxicity: Animal experiments show that Tepotinib has embryo-fetal toxicity. Patients and partners should use effective contraception while taking the drug and for one week after stopping the drug.
Kidney toxicity: In the VISON clinical trial, adverse reactions such as increased serum creatinine (13.8%), renal insufficiency (2.3%) and acute kidney damage (1.5%) were found. Kidney function needs to be checked before taking the medicine and reviewed regularly while taking the medicine.
Storage:
Store at room temperature to avoid moisture. The validity period is 24 months.
Mechanism of action:
Tipotinib hydrochloride is a low molecular compound that inhibits mesenchymal epithelial transition factor (MET) and is a receptor tyrosine kinase. Tepotinib hydrochloride inhibits the phosphorylation of MET and is thought to exhibit tumor growth inhibition by inhibiting downstream signal transduction.