micafungin Vials, lyophilized injection 50 mg, 100 mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
FDA, EU GMP
Comments
Storage conditions: Between 15-25°C (68-77°F)
Manufacturer #1187

Micafungin

Micafungin is used to treat a variety of fungal infections, including infections in patients who are having a stem cell transplant. Micafungin belongs to a class of drugs known as echinocandins whose actions stop the growth of fungi, thus curing the infection. Some of the infections caused by fungus for which Micafungin is indicated include serious fungus infections, such as candidemia, acute disseminated candidiasis, candida peritonitis and abscess without meningo-encephalitis or ocular dissemination, and esophageal candidiasis. Micafungin is most commonly sold under the brand name Mycamine Fujisawa Pharmaceutical Co filed the first patent in 1999 for its stabilized pharmaceutical composition in lyophilized form as antifungal agent. The U.S. FDA approved Micafungin in March 2005. In the USA, Nanobio Corporation, file for patents in 2008 for their methods of treating fungal, yeast and mold infections. Several other companies have also file other patents.

Forms and dose

Micafungin is sold as Powder for solution in 100 mg dose and as powder, lyophilized, for solution for injections. In the treatment of Esophageal Candidiasis, the recommended Adult Dose is 150 mg, once a day, given through an IV. The therapy is expected to last 2 weeks. For Fungal Infection Prophylaxis, the recommended dose is 50 mg, taken once a day. However, In cases of hematopoietic stem cell transplant recipients the therapy can longer, upto 3 weeks to show benefits. In the treatment of Candidemia the dose is 100 mg for 15 days. The Pediatric Dose for Esophageal Candidiasis for infants 4 months or older and Weighing 30 kg or less is 3 mg per kilo of body weight once day. For kids more than30 kgs, the dose is 2.5 mg per day. The dose for Fungal Infection Prophylaxis for infants 4 months or older is 1 mg and 4mg for treating other form of Candidiasis.

The price of Micafungin

In the USA, the consumers have to pay an average retail price of $1,745.16, for nine vials 100mg. in the UK, the price for 100mg is around £341.00. the price is significantly lower in India, where a 50mg vial costs less US$0.5.

How does it work?

Micafungin is a semisynthetic lipopeptide. It is synthesized from a fermentation product of Coleophoma empetri which is a antifungal agent. Micafungin is a glucan synthesis inhibitor of the echinocandin structural class that inhibits enzyme essential for fungal cell-wall synthesis. In focused concentrations, It is fungicidal against some Candida, but is normally a fungistatic against Apergillus.

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