Description

Capmaxen tablet: Each film coated tablet contains Capmatinib Hydrochloride INN equivalent to Capmatinib 200 mg.

 

Product Features

Product Name	:	Capmaxen
Generic Name	:	Capmatinib
Formulation	:	Tablet
Available Pack Size	:	56’s Pot
Available Strength	:	200 mg
Registrations	:	Export Only

 

Capmatinib Mechanism of Action

Capmatinib is a type of medication that targets a protein called MET, which includes a specific mutant form produced when a certain part of its genetic code, called exon 14, is skipped. This skipping leads to a MET protein with a missing part that normally helps regulate its activity. Without this regulatory part, MET signaling becomes more active, potentially promoting cancer growth.

 

Studies have shown that Capmatinib can effectively inhibit the growth of cancer cells that rely on this mutant MET variant. In experiments with mice implanted with human lung tumors carrying either met exon 14 skipping mutation or MET amplification, Capmatinib demonstrated the ability to reduce tumor growth.

 

Capmatinib works by blocking the activation of MET caused by its interaction with a protein called hepatocyte growth factor, as well as by inhibiting the effects of increased MET levels. This includes reducing the phosphorylation (a chemical modification) of MET and other proteins involved in signaling pathways downstream of MET, ultimately leading to a decrease in the proliferation and survival of cancer cells dependent on MET activity.

 

Capmaxen Side effects

• 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

 

Use in Specific Populations

Pregnancy: Capmaxen poses a risk of fetal harm when used during pregnancy. There’s a lack of data on its use in pregnant women. Therefore, advise pregnant women about the potential risks to the fetus.

Lactation: Due to the possibility of serious adverse reactions in breastfed infants, it’s recommended that women avoid breastfeeding while receiving Capmatinib treatment and for 1 week after the last dose. Animal studies indicate that Capmatinib can cause malformations even at doses lower than those used in humans (at the clinical dose of 400 mg twice daily).

Pregnancy Testing: Verify the pregnancy status of females of reproductive potential before initiating Capmaxen treatment.

Contraception

Females: Women of reproductive age should use effective contraception during Capmatinib treatment and for 1 week after the last dose.

Males: Men with female partners capable of reproduction should also use effective contraception during treatment and for 1 week after the final dose.

Pediatric Use: The safety and efficacy of Capmaxen in pediatric patients have not been established.

Geriatric Use: In the GEOMETRY mono-1 study, a significant portion of patients (61% of 373) were 65 years or older, with 18% being 75 years or older. No notable differences in safety or efficacy were observed between these older patients and younger ones.

Renal Impairment: There’s no need for dosage adjustment in patients with mild (baseline creatinine clearance [CLcr] 60 to 89 mL/min) or moderate renal impairment (CLcr 30 to 59 mL/min). However, Capmatinib hasn’t been studied in patients with severe renal impairment (CLcr 15 to 29 mL/min).

 

Capmaxen Warnings and Precautions

Interstitial Lung Disease (ILD): Immediate cessation of Capmatinib is necessary if ILD/pneumonitis is suspected, and permanent discontinuation should follow if no other causes are found.

Hepatotoxicity: Regular monitoring of liver function tests, including ALT, AST, and total bilirubin. It’s essential before starting Capmatinib and every 2 weeks for the first 3 months of treatment. Afterward, monitoring should continue monthly or as needed, with increased frequency for patients showing elevated transaminases or bilirubin levels. Adjustments to Capmatinib dosage, temporary withholding, or permanent discontinuation may be required based on the severity of hepatotoxicity.

Pancreatic Toxicity: Monitoring of amylase and lipase levels at baseline and throughout Capmatinib treatment is advised. Management strategies, such as temporary withholding, dose adjustment, or permanent discontinuation, should be implemented based on the severity of pancreatic adverse effects.

Risk of Photosensitivity: Patients should be advised to minimize direct exposure to ultraviolet light while undergoing Capmatinib treatment.

Embryo-Fetal Toxicity: Due to potential fetal harm demonstrated in animal studies and the drug’s mechanism of action, Capmatinib should not be administered to pregnant women.

 

Countries where our service provided

Delivering worldwide including United State (USA), United Kingdom (UK), Saudi Arabia, Dubai, Kuwait, Qatar, Philippines, Nepal, Malaysia, Indonesia, Thailand, Poland, Peru, South Korea, New Zealand, Netherlands, Georgia, France, Egypt, Australia, Germany, Canada, Uzbekistan, Lebanon, Mexico, Singapore, Vietnam,  Pakistan, Russia, Ukraine, Bangladesh, India

 

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