Medical Information

Not all patients are suitable for using tepotinib. The following three groups of people are clearly classified as contraindicated or require extreme caution due to potential serious risks, and must complete corresponding screening before medication.

1. Patients with severe liver dysfunction (absolute contraindication)

1.1 Definition criteria: Child Pugh C grade or total bilirubin>3 times the upper limit with any elevated transaminase levels.

1.2 Essence of risk: Drugs are mainly metabolized by the liver, and when severely damaged, clearance is significantly slowed down, leading to the accumulation of toxicity.

1.3 Operation requirements: Before medication, a complete set of liver function tests must be conducted. If severe liver damage occurs during treatment, the medication should be stopped immediately and the patient should be referred to a liver specialist.

2. Patients with severe renal insufficiency (relatively contraindicated, requiring evaluation)

2.1 Definition criteria: Estimated glomerular filtration rate (eGFR)<30mL/min/1.73m ², or requiring regular dialysis.

2.2 Essence of risk: Although not the main excretion pathway, severe kidney damage can affect the clearance of metabolites.

2.3 Operation requirements: This type of patient should only be used after the doctor's consideration, and the monitoring interval should be shortened (such as weekly kidney function check). In case of eGFR30-60, no adjustment is required, but fluid retention should be closely observed.

3. Pregnant women and women preparing for pregnancy (absolutely contraindicated)

3.1 Core Basis: Animal studies have shown embryonic fetal toxicity, and human risks are not yet clear but cannot be ignored.

3.2 Contraceptive Requirements: Women with fertility must use highly effective contraceptive measures during treatment and for at least one week after discontinuing medication.

3.3 Pre medication confirmation: A serum pregnancy test must be conducted within 72 hours before initiating treatment, and medication can only be administered if the result is negative.

4. Breastfeeding patients (absolute contraindication)

4.1 Core basis: It is not yet clear whether the drug is secreted into human milk, but potential risks cannot be ruled out.

4.2 Operation requirements: Breastfeeding is prohibited during the treatment period and for at least one week after the last administration. Suggest preparing infant formula in advance.

5. Other alert groups

Individuals allergic to any excipients of this product are prohibited from using it. The efficacy and safety of children and adolescents (<18 years old) have not been established and are not recommended for use. For patients with combined active infections or uncontrolled interstitial lung disease, medication eligibility should be evaluated after correction.