নির্দেশনা

Capmatinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA approved test.

Composition

ফার্মাকোলজি

Capmatinib is a kinase inhibitor that targets MET, including the mutant variant produced by exon 14 skipping. MET exon 14 skipping results in a protein with a missing regulatory domain that reduces its negative regulation leading to increased downstream MET signaling. Capmatinib inhibited cancer cell growth driven by a mutant MET variant lacking exon 14 at clinically achievable concentrations and demonstrated anti-tumor activity in murine tumor xenograft models derived from human lung tumors with either a mutation leading to MET exon 14 skipping or MET amplification. Capmatinib inhibited the phosphorylation of MET triggered by binding of hepatocyte growth factor or by MET amplification, as well as MET mediated phosphorylation of downstream signaling proteins and proliferation and survival of MET-dependent cancer cells.

মাত্রা ও সেবনবিধি

Patient Selection: Select patients for treatment with Capmatinib based on the presence of a mutation that leads to MET exon 14 skipping in tumor or plasma specimens. If a mutation that leads to MET exon 14 skipping is not detected in a plasma specimen, test tumor tissue if feasible. Recommended Dose: The recommended dosage of Capmatinib is 400 mg orally twice daily with or without food. Swallow Capmatinib tablets whole. Do not break, crush or chew the tablets. If a patient misses or vomits a dose, instruct the patient not to make up the dose, but to take the next dose at its scheduled time.

প্রতিনির্দেশনা

পার্শ্ব প্রতিক্রিয়া

Lung or breathing problems Liver problems. Pancreas problems. Swelling of your hands or feet Nausea Muscle or bone pain Tiredness and weakness Vomiting Trouble breathing Cough Loss of appetite Changes in certain blood tests

গর্ভাবস্থায় ও স্তন্যদানকালে

Pregnancy: Capmatinib can cause fetal harm when administered to a pregnant woman. There are no available data on Capmatinib use in pregnant women. Advise pregnant women of the potential risk to a fetus. Lactation: Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Capmatinib and for 1 week after the last dose. Females and Males of Reproductive Potential: Based on animal data, Capmatinib can cause malformations at doses less than the human exposure based on AUC at the 400 mg twice daily clinical dose. Pregnancy Testing: Verify pregnancy status for females of reproductive potential prior to starting treatment with Capmatinib. Contraception- Females: Advise females of reproductive potential to use effective contraception during treatment with Capmatinib and for 1 week after the last dose. Males: Advise males with female partners of reproductive potential to use effective contraception during treatment with Capmatinib and for 1 week after the last dose.

সতর্কতা

Interstitial Lung Disease (ILD) : Immediately withhold Capmatinib in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified. Hepatotoxicity : Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of Capmatinib, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue Capmatinib. Pancreatic Toxicity : Monitor amylase and lipase at baseline and regularly during treatment with Capmatinib. Based on the severity of the adverse drug reaction, temporarily withhold, dose reduce, or permanently discontinue Capmatinib. Risk of Photosensitivity : Advise patients to limit direct ultraviolet exposure during treatment with Capmatinib. Embryo-Fetal Toxicity : Based on findings from animal studies and its mechanism of action, Capmatinib can cause fetal harm when administered to a pregnant woman.

থেরাপিউটিক ক্লাস

Cytotoxic Chemotherapy

সংরক্ষণ