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Mycamine (Micafungin Sodium) - Summary

 
 



MYCAMINE SUMMARY

Mycamine is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1, 3-beta-D-glucan, an integral component of the fungal cell wall. Each single-use vial contains 50 mg or 100 mg micafungin sodium, 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). Mycamine must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5-7.

Mycamine® is indicated in adult and pediatric patients 4 months and older for:

Treatment of Patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses

[see Clinical Studies ]

Mycamine has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to Candida infections.

Treatment of Patients with Esophageal Candidiasis

[see Clinical Studies]

Prophylaxis of Candida Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation

[see Clinical Studies]

NOTE: The efficacy of Mycamine against infections caused by fungi other than Candida has not been established.


See all Mycamine indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Mycamine (Micafungin)

Outcomes with micafungin in patients with candidaemia or invasive candidiasis due to Candida glabrata and Candida krusei. [2011.02]
OBJECTIVES: Infection with Candida glabrata and Candida krusei represents a major challenge. We sought to describe outcomes for patients with candidaemia/invasive candidiasis (C/IC) due to these pathogens who were treated with micafungin... CONCLUSIONS: Micafungin results in similar outcomes to comparators for C/IC due to C. glabrata and C. krusei. The 100 mg/day dose represents an acceptable option in this setting. Patient characteristics and catheter management appear to be more important factors affecting clinical outcomes.

Lack of pharmacokinetic drug interaction between oral posaconazole and caspofungin or micafungin. [2011.01]
The objective of this phase 1, open-label, parallel, randomized study was to determine the effect of posaconazole on the pharmacokinetics of caspofungin and micafungin in 67 healthy subjects. Caspofungin (70 mg on day 1, 50 mg on days 2-14 once daily; 1-hour intravenous infusion) (cohort 1) or micafungin (150 mg once daily days 1-7; 1-hour IV infusion) (cohort 2) was administered alone or with posaconazole oral suspension 400 mg twice daily, on days 1 to 14 (cohort 1) or days 1 to 7 (cohort 2).

Intravenous micafungin versus voriconazole for chronic pulmonary aspergillosis: a multicenter trial in Japan. [2010.11]
Chronic pulmonary aspergillosis (CPA) is slowly progressive inflammatory pulmonary syndrome due to Aspergillus spp...

Factors related to survival and treatment success in invasive candidiasis or candidemia: a pooled analysis of two large, prospective, micafungin trials. [2010.02]
Crude and attributable mortality rates in patients with candidemia and invasive candidiasis remain unacceptably high. It is important to reach a more complete understanding of the risk factors underlying poor outcomes in patients with invasive Candida infections...

[Comparison of micafungin and fosfluconazole as prophylaxis for invasive fungal infection during neutropenia in children undergoing chemotherapy and hematopoietic stem cell transplantation] [2009.12]
Invasive fungal infection (IFI) is a serious complication of chemotherapy for hematological malignancies and autologous/allogeneic hematopoietic stem cell transplantation in children and shows a high mortality rate. We performed a randomized trial comparing micafungin (MCFG), a new anti-fungal agent, with fosfluconazole, a prodrug of fluconazole (FF) conventionally used as a prophylactic agent, for prophylaxis against IFI...

more studies >>

Clinical Trials Related to Mycamine (Micafungin)

A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis [Active, not recruiting]
The purpose of this research study is to examine the pharmacokinetics (the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body) of micafungin when it is given at 5mg/kg dose to immunocompromised children as anti-fungal prophylaxis. These children are at high risk for developing invasive fungal disease due to their compromised immunity and associated variable degree and duration of neutropenia. Currently, children who receive micafungin are given daily or alternate day dosing. The investigators will give a ONE TIME dose of micafungin and draw PK levels up to 96 hours post-infusion. The investigators goal is to obtain comparable micafungin drug concentrations at the end of 96 hours (4 days) as compared to lower dose at every 24 hour dosing. The investigators dosing proposal is likely to be effective prophylaxis for immunocompromised patients and would broaden its applicability to larger populations.

Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation [Recruiting]
Determine proper dosing of micafungin in children supported with extracorporeal membrane oxygenation (ECMO).

A Study to Compare Efficacy and Safety of Mycamine« and Itraconazole for Preventing Fungal Infections [Completed]
The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients

An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates [Completed]
This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection

Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome [Recruiting]
The purpose of this study is to compare the effects, good and/or bad, of posaconazole and micafungin in preventing fungal infections after chemotherapy for acute leukemia or myelodysplastic syndrome. When people take chemotherapy, they are more likely to get infections. Posaconazole has been approved for the prevention of fungal infections in patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome. Posaconazole is available only as an oral suspension and has to be given with food. After chemotherapy, many patients are not able to tolerate food or oral medication because of severe mucositis. Patients unable to tolerate food and oral medications cannot take posaconazole. Micafungin is an antifungal medication that is given only intravenously. Micafungin is approved for the treatment of certain fungal infections and for preventing fungal infections in patients who receive bone marrow transplant. The investigators know that micafungin is safe. Micafungin has not been tested for the prevention of fungal infections in patients receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin is given by vein, it can be given even in patients who cannot take food or medications by mouth after chemotherapy. In this study the investigators want to compare micafungin to posaconazole when given for the prevention of fungal infections in leukemia and myelodysplastic syndrome patients.

more trials >>

Reports of Suspected Mycamine (Micafungin) Side Effects

Death (12)OFF Label USE (6)Drug Ineffective (5)Multi-Organ Failure (4)Candidiasis (3)Rash (3)Sepsis (3)Abdominal Pain (2)Graft Versus Host Disease (2)Chills (2)more >>


Page last updated: 2011-12-09

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