Tepotinib-Associated Risk of Liver Function Abnormalities and Liver Failure

Tepotinib-Associated Risk of Liver Function Abnormalities and Liver Failure

Tepotinib may cause abnormalities in liver function blood test results, and one patient in clinical trials died from liver failure. Due to this serious risk, all patients receiving tepotinib must have regular blood tests to monitor liver function parameters (such as transaminases, bilirubin, etc.) before starting treatment and throughout the treatment period. Patients also need to actively recognize the signs and symptoms of potential liver problems, including: yellowing of the skin or whites of the eyes (jaundice), dark or "tea-colored" urine, light-colored or clay-colored stools, confusion, unusual fatigue, loss of appetite lasting several days or longer, nausea and vomiting, pain, soreness or tenderness in the upper right abdomen (liver area), weakness, and abdominal swelling. If any of these symptoms occur, the healthcare provider must be notified immediately. Depending on the severity of liver function test abnormalities, the doctor will decide whether to reduce the dose of tepotinib, temporarily interrupt treatment, or permanently discontinue it. For patients with pre-existing liver disease (e.g., hepatitis, cirrhosis), the doctor should be fully informed before treatment, as these individuals may be at higher risk for hepatotoxicity. Regular monitoring and prompt reporting are key measures to prevent severe liver injury.

Tepotinib-Associated Pancreatic Toxicity and Embryo-Fetal Toxicity

Tepotinib treatment may cause elevated blood levels of amylase and lipase, which typically suggests potential pancreatic problems (such as pancreatitis). Therefore, before starting tepotinib and throughout the treatment period, doctors will regularly arrange blood tests to assess pancreatic function. Patients should also be alert for symptoms of pancreatic issues, including mainly: upper abdominal (stomach area) pain (this pain may sometimes radiate to the back and worsen after eating), unexplained weight loss, nausea, and vomiting. If any of these manifestations occur, the healthcare provider should be contacted immediately for timely diagnosis and intervention. In addition, tepotinib has potential harm to an unborn baby in pregnant women. For females of childbearing potential, a pregnancy test may be performed before starting treatment to rule out pregnancy; effective contraception must be used during treatment and for at least 1 week after the last dose. For male patients with female partners of childbearing potential, effective contraception is also required during treatment and for 1 week after the last dose. It is unknown whether tepotinib passes into breast milk; therefore, breastfeeding is not recommended during treatment and for 1 week after the last dose.

Most Common Side Effects of Tepotinib at a Glance

In the VISION clinical trial, study participants taking tepotinib reported a range of common side effects. Knowing these side effects can help patients better manage their treatment course. The most common side effects include: edema (swelling) on the face or other parts of the body, nausea, fatigue, diarrhea, muscle and joint pain, shortness of breath, decreased appetite, rash, and certain changes in blood test parameters. Please note that this list is not a complete list of all possible side effects; the type and severity of side effects may vary among patients. Most side effects are usually mild to moderate, but some patients may experience more severe reactions. If you experience side effects during treatment that are bothersome or do not go away, do not stop taking the medication or adjust the dose on your own. Instead, contact your healthcare provider promptly. Depending on the specific situation, the doctor can take appropriate measures, such as providing symptomatic supportive care, temporarily interrupting tepotinib treatment, reducing the dose, or permanently discontinuing treatment based on severity.