Tepmetko 225mg Tablet

Tepotinib 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. Tepotinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Interstitial Lung Disease (ILD)/Pneumonitis: Immediately withhold Tepotinib in patients with suspected ILD/pneumonitis. Permanently discontinue Tepotinib in patients diagnosed with ILD/pneumonitis of any severity. Hepatotoxicity: Monitor liver function tests. Withhold, dose reduce, or permanently discontinue Tepotinib based on severity. Pancreatic Toxicity: Monitor amylase and lipase. Embryo-fetal toxicity: Tepotinib can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. Interstitial Lung Disease (ILD)/Pneumonitis ILD/pneumonitis, which can be fatal, occurred in patients treated with Tepotinib. ILD/pneumonitis occurred in 2% patients treated with Tepotinib, with one patient experiencing a Grade 3 or higher event; this event resulted in death. Five patients (1%) discontinued Tepotinib due to ILD/pneumonitis. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold Tepotinib in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified. Hepatotoxicity occurred in patients treated with Tepotinib. Increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST) occurred in 18% of patients treated with Tepotinib. Grade 3 or 4 increased ALT/AST occurred in 4.7% of patients. A fatal adverse reaction of hepatic failure occurred in one patient (0.2%). Four patients (0.8%) discontinued Tepotinib due to increased ALT/AST. The median time-to-onset of Grade 3 or higher increased ALT/AST was 47 days (range 1 to 262). Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of Tepotinib, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue Tepotinib. Pancreatic Toxicity Elevations in amylase and lipase levels occurred in patients treated with Tepotinib. Increased amylase and/or lipase occurred in 13% of patients treated with Tepotinib. Grade 3 and 4 increased amylase and/or lipase occurred in 5% and 1.2% of patients, respectively. Monitor amylase and lipase at baseline and regularly during treatment with Tepotinib. Based on the severity of the adverse drug reaction, temporarily withhold, dose reduce, or permanently discontinue Tepotinib. Embryo-Fetal Toxicity Based on findings in animal studies and its mechanism of action Tepotinib can cause fetal harm when administered to a pregnant woman. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following adverse reactions are described in greater detail elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis Hepatotoxicity Pancreatic Toxicity Most common adverse reactions (≥ 20%) were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash. The most common Grade 3 to 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes, decreased albumin, decreased sodium, increased gamma-glutamyltransferase, increased amylase, increased lipase, increased ALT, increased AST, and decreased hemoglobin. 5563 or FDA Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to Tepotinib in 506 patients with solid tumors enrolled in five open-label, single-arm studies receiving Tepotinib as single agent at a dose of 450 mg once daily. This included 313 patients with NSCLC positive for MET ex14 skipping alterations, who received Tepotinib in VISION. Among 506 patients who received Tepotinib, 44% were exposed for 6 months or longer, and 22% were exposed for more than one year. The data described below reflect exposure to Tepotinib 450 mg once daily in 313 patients with metastatic non-small cell lung cancer (NSCLC) with MET ex14 skipping alterations in VISION. Serious adverse reactions occurred in 51% of patients who received Tepotinib. Serious adverse reactions in > 2% of patients included pleural effusion (6%), pneumonia (6%), edema (5%), general health deterioration (3.8%), dyspnea (3.5%), musculoskeletal pain (2.9%), and pulmonary embolism (2.2%). Fatal adverse reactions occurred in 1.9% of patients who received Tepotinib, including pneumonitis (0.3%), hepatic failure (0.3%), dyspnea from fluid overload (0.3%), pneumonia (0.3%), sepsis (0.3%), and death of unknown cause (0.3%). Permanent discontinuation due to an adverse reaction occurred in 25% of patients who received Tepotinib. The most frequent adverse reactions (> 1%) leading to permanent discontinuations of Tepotinib were edema (8%), pleural effusion (1.6%), and general health deterioration (1.6%). Dosage interruptions due to an adverse reaction occurred in 53% of patients who received Tepotinib. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.