What does the package insert for capmatinib include?

1. Generic name: Capmatinib,Capmatinib

Product name:Tabrecta

Other names: Capmatinib, Capatinib, Terita

2. Indications:

Capmatinib (Capmatinib) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have mutations causing mesenchymal epithelial transition (MET) exon 14, as detected by a U.S. Food and Drug Administration (FDA)-approved test.

3. Usage and dosage:

1. Before treatment: Doctors will select patients to receive capmatinib based on the presence of mutations that cause MET exon 14 skipping in tumors or plasma specimens. If mutations causing MET exon 14 skipping are not detected in the plasma specimen, test the tumor tissue if available.

2. Recommended dose: The recommended dose of capmatinib is 400 mg orally taken twice daily, which can be taken with or without food. Patients should swallow capmatinib tablets whole and do not break, crush or chew the tablets. If the patient misses a dose or vomits a dose, instruct the patient not to make up the dose but to take the next dose at the scheduled time.

3. Dose adjustment: If the patient experiences adverse reactions during treatment with capmatinib, the doctor may adjust the drug dosage. The first dose needs to be adjusted to 300 mg orally twice a day; the second dose needs to be adjusted to 200 mg orally twice a day; for patients who cannot tolerate 200 mg orally twice a day, capmatinib should be permanently discontinued.

4. Adverse reactions:

In clinical studies of capmatinib, the most common adverse reactions (≥20%) were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite; serious adverse reactions included dyspnea, pneumonia, pleural effusion, musculoskeletal pain, worsening of general health, interstitial lung disease (ILD)/pneumonitis, edema, and vomiting.

5. Storage:

Capmatinib is provided in the form of tablets, and the desiccant needs to be packed in the original packaging and stored inAllowable deviation is 15°C to 30°C (59°F to 86°F) at 20°C to 25°C (68°F to 77°F). Moisture proof. Throw away any unused tablets 6 weeks after first opening.

6. Special groups:

1. Women: Due to the possibility of serious adverse reactions in breastfed children, it is recommended that women of childbearing potential use effective contraception during treatment with capmatinib and within 1 week after the last dose; they should not breastfeed during treatment and within 1 week after the last dose.

2. Men: It is recommended that men with female partners use effective contraception during treatment with capmatinib and within 1 week after the last dose.

7. Mechanism of action:

Capmatinib is a kinase inhibitor that targetsMET, including mutant variants resulting from exon 14 skipping. Skipping of MET exon 14 results in the loss of the regulatory domain of the protein, thereby reducing its negative regulatory effect and resulting in increased downstream MET signaling. At clinically achievable concentrations, capmatinib inhibits the growth of cancer cells driven by mutant MET variants lacking exon 14 and shows antitumor activity in murine tumor xenograft models derived from human lung tumors with mutations leading to MET exon 14 skipping or MET amplification. Capmatinib inhibits MET phosphorylation triggered by hepatocyte growth factor binding or MET amplification, as well as MET-mediated phosphorylation of downstream signaling proteins and MET-dependent cancer cell proliferation and survival.