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Capmatinib is an oral small molecule kinase inhibitor that selectively targets the mesenchymal epithelial transition factor (MET), specifically targeting mutations that cause MET exon 14 skipping.
1. Generic name : Capmatinib (Capmatinib)
2. Trade name : TABRECTA® (US marketing name )
3. Dosage form :Film-coated tablets
4. Main ingredients :Each tablet contains capmatinib 150mg or 200mg (in the form of succinate), and excipients include microcrystalline cellulose, crospovidone, magnesium stearate, etc.
Metastatic non-small cell lung cancer (NSCLC) : For the treatment of adult patients with MET exon 14 skipping mutations confirmed by FDA-approved testing. This indication received accelerated approval based on overall response rate and duration of response, and subsequent verification of clinical benefit may be required.
1. Specifications : 200mg
2. Properties : Film-coated tablets, smooth surface, white to off-white powder content.
1. Recommended dosage of : 400mg orally, twice a day (about 12 hours apart). It can be taken with food or on an empty stomach.
2. How to take : Swallow the tablet whole. Do not break, crush or chew.
3. Treatment of missed doses : If you miss a dose or vomit, there is no need to take a supplementary dose, just take the next dose as originally planned.
1. Adverse reaction adjustment : Reduce the dose to 300mg twice a day for the first time and to 200mg twice a day for the second time. If still not tolerated, permanently discontinue medication.
2. Abnormal liver function : Permanently discontinue the drug when ALT/AST is >3 times the upper limit of normal (ULN) accompanied by an increase in bilirubin; if ALT/AST is simply elevated, the drug can be suspended and the dose reduced after recovery.
3. Renal insufficiency : Mild to moderate does not require adjustment, severe (CrCl<30mL/min) is not studied.
1. Influence of diet : is not affected by food, but avoid taking it with aluminum/magnesium-containing antacids (an interval of 2 hours is required).
2. Photosensitivity reaction : May cause photosensitivity, sun protection is recommended.
3. Pulmonary toxicity : Monitor for new or worsening respiratory symptoms (such as cough, fever, dyspnea), and permanent discontinuation of the drug is required if interstitial lung disease (ILD) is suspected.
1. Pregnant women: : Disabled (animal experiments show teratogenicity).
2. Lactation : Breastfeeding is prohibited during treatment and within 1 week after the last dose.
3. Children : Safety has not been established.
4. U200c for the elderly: No need to adjust the dosage.
1. Common (≥20%) : Peripheral edema (52%), nausea (44%), fatigue (32%), vomiting (28%), dyspnea (24%), decreased appetite (21%).
5. Severe reactions :ILD/pneumonitis (4.5%, can be fatal), liver toxicity (ALT/AST increased by 13%, 6% grade 3-4).
There are no absolute contraindications, but use by people known to be allergic to ingredients should be avoided.
1. Strong/moderate CYP3A inducer (such as rifampicin): Reduce efficacy, avoid combined use.
2. CYP1A2/P-gp/BCRP substrate (such as caffeine, digoxin): may increase its plasma concentration and the dose needs to be adjusted.
1. Store in original packaging, moisture-proof, with built-in desiccant.
2. Storage temperature: 20-25°C (short-term fluctuation of 15-30°C is allowed). Discard if not used within 6 weeks after opening.
Note : Liver function, lung function and MET mutation status need to be monitored regularly during treatment. Avoid coadministration with strong CYP3A inhibitors (such as ketoconazole).