Capmatinib

Capmatinib is an oral, selective MET inhibitor originally developed and produced by Novartis pharmaceutical company.

Capmatinib received accelerated FDA approval for marketing on May 6, 2020.The specification of Camatinib produced by Lucius is 200mg * 60 pieces per box.

Non small cell lung cancer patients carrying MET gene exon 14 jump mutation generally have poor prognosis, are insensitive to chemotherapy, and treatment is not ideal.Capmatinib, as the first targeted therapeutic drug targeting METex14 mutations, can significantly improve the treatment efficacy of this group of patients.

1. Main components

Capmatinib

2. Adapt to the population

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.

3.Medication for special populations

3.1Pregnant

Based on findings from animal studies and its mechanism of action, Capmatinib can cause fetal harm when administered to a pregnant woman.Advise pregnant women of the potential risk to a fetus.

3.2Lactation

There are no data on the presence of Capmatinib or its metabolites in either human or animal milk or its effects on the breastfed child or on milk production. 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.

3.3Females and Males of Reproductive Potential

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.

3.4 Pediatric Use

Safety and effectiveness of Capmatinib in pediatric patients have not been established.

3.5 Geriatric Use

In GEOMETRY mono-1, 61% of the 373 patients were 65 years or older and 18% were 75 years or older. No overall differences in the safety or effectiveness were observed between these patients and younger patients.

3.6 Renal Impairment

No dosage adjustment is recommended in patients with mild (baseline creatinine clearance [CLcr] 60 to 89 mL/min by Cockcroft-Gault) or moderate renal impairment (CLcr 30 to 59 mL/min). Capmatinib has not been studied in patients with severe renal impairment (CLcr 15 to 29 mL/min).

4.Drug overdose

Drug overdose is not yet clear.

5. Drug storage

Dispense in the original package with the desiccant cartridge. Store at 20℃ to 25℃ (68℉to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉). Protect from moisture.Discard any unused Capmatinib remaining after 6 weeks of first opening the bottle.

6.Pharmacokinetics

After administration of Capmatinib 400 mg orally in patients with cancer, Capmatinib peak plasma concentrations (Cmax) were reached in approximately 1 to 2 hours (Tmax). The absorption of Capmatinib after oral administration is estimated to be greater than 70%.

from FDA,2023.03