What are the precautions for capmatinib?

Capmatinib (Capmatinib) is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have mutations that cause mesenchymal epithelial transition (MET) exon 14 skipping, according to a U.S. Food and Drug Administration (FDA)-approved test. In its clinical studies, warnings and precautions such as interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, pancreatic toxicity, allergic reactions, photosensitivity risks, embryo-fetal toxicity, etc. have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Interstitial lung disease (ILD)/pneumonia: Patients taking capmatinib developed fatal ILD/pneumonitis. Monitor for new or worsening pulmonary symptoms (e.g., dyspnea, cough, fever) indicating ILD/pneumonitis. In patients with suspected ILD/pneumonitis, capmatinib should be discontinued immediately or permanently if no other underlying cause of ILD/pneumonitis is identified.

2. Hepatotoxicity: Patients receiving treatment developed hepatotoxicity, including elevated alanine aminotransferase(ALT)/aspartate aminotransferase (AST). Before initiating capmatinib, liver function tests (including ALT, AST, and total bilirubin) should be monitored every 2 weeks for the first 3 months of treatment and then monthly or as clinically indicated, or more frequently in patients with elevated transaminases or bilirubin.

3. Pancreatic toxicity: Patients receiving treatment experienced elevated levels of amylase and lipase. Monitor amylase and lipase at baseline and periodically during treatment with capmatinib. .

4. Anaphylaxis: Signs and symptoms of hypersensitivity include fever, chills, itching, rash, drop in blood pressure, nausea and vomiting. Depending on the severity of the adverse reaction, capmatinib may be temporarily or permanently discontinued.

5. Photosensitivity risk: According to the results of animal studies, capmatinib has a potential risk of photosensitivity reaction; it is recommended that patients take measures to prevent ultraviolet exposure during treatment with capmatinib, such as using sunscreen or protective clothing. Patients should limit direct exposure to UV rays during treatment.

6. Embryo-Fetal toxicity: According to the results of animal studies and its mechanism of action, capmatinib taken by pregnant women may cause harm to the fetus. Based on the area under the curve (AUC) at the clinical dose of 400 mg twice daily, oral capmatinib during organogenesis in pregnant rats and rabbits resulted in malformation exposures that were lower than human exposures. Inform pregnant women of potential risks to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 1 week after the last dose; males of female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose.