Big Bear TEPODX Tepotinib

Product Information

• Product name: TEPODX Tepotinib as shown on package
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Tepotinib
• Current strength: as shown on package
• SKU: BB-ITEM-68
• Site category: MET target, other cancer

Product Summary

TEPODX Tepotinib as shown on package is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Tepotinib is the active ingredient used for this product page. Public prescribing information for Tepotinib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Tepotinib is a kinase inhibitor that targets MET, including variants with exon 14 skipping alterations. Tepotinib inhibits hepatocyte growth factor (HGF)-dependent and -independent MET phosphorylation and MET-dependent downstream signaling pathways. Tepotinib also inhibited melatonin 2 and imidazoline 1 receptors at clinically achievable concentrations.

Reference Indications

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.

Reference Dosage and Administration

Recommended dosage : 450 mg orally once daily with food until disease progression or unacceptable toxicity. take their dose of Tepotinib at approximately the same time every day and to swallow tablets whole.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

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. ( 2.4 , 5.1 ) Hepatotoxicity : Monitor liver function tests. Withhold, dose reduce, or permanently discontinue Tepotinib based on severity. Pancreatic Toxicity : Monitor amylase and lipase. Withhold, dose reduce, or permanently discontinue Tepotinib based on severity. Embryo-fetal toxicity : Tepotinib can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Interstitial Lung Disease (ILD)/Pneumonitis ILD/pneumonitis, which can be fatal, occurred in patients treated with Tepotinib .

Common Adverse Reactions and Monitoring

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. The pooled safety population described in the 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.

Drug Interactions and Special Populations

Certain P-gp substrates : Avoid coadministration of Tepotinib with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Avoid concomitant use of Tepotinib with certain P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling. Lactation : Advise not to breastfeed. There are no available data on the use of Tepotinib in pregnant women. Oral administration of tepotinib to pregnant rabbits during the period of organogenesis resulted in malformations (teratogenicity) and anomalies at maternal exposures less than the human exposure based on area under the curve (AUC) at the 450 mg daily clinical dose (see Data ) .

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: TEPMETKO public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.