Capmaxen 200mg

• Strong CYP3A Inhibitors: Closely monitor patients for adverse reactions during coadministration of Capmaxen with strong CYP3A inhibitors.
• Strong and Moderate CYP3A Inducers: Avoid coadministration of Capmaxen with strong and moderate CYP3A inducers.

Effect of Capmaxen on Other Drugs-

• CYP1A2 Substrates: Coadministration of Capmaxen increased the exposure of a CYP1A2 substrate, which may increase the adverse reactions of these substrates.
• P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP) Substrates: Coadministration of Capmaxen increased the exposure of a P-gp substrate and a BCRP substrate, which may increase the adverse reactions of these substrates.
• MATE1 and MATE2K Substrates: Coadministration of Capmaxen may increase the exposure of MATE1 and MATE2K substrates, which may increase the adverse reactions of these substrates.

• 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

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.

Hepatotoxicity: Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of Capmaxen, 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 Capmaxen.

Pancreatic Toxicity: Monitor amylase and lipase at baseline and regularly during treatment with Capmaxen. Based on the severity of the adverse drug reaction, temporarily withhold, dose reduce, or permanently discontinue Capmaxen.

Risk of Photosensitivity: Advise patients to limit direct ultraviolet exposure during treatment with Capmaxen.

Embryo-Fetal Toxicity: Based on findings from animal studies and its mechanism of action, Capmaxen can cause fetal harm when administered to a pregnant woman.

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.

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