Micafungin

Summary

Micafungin is an echinocandin antifungal agent derived from a fermentation product of Coleophoma empetri. It is approved for treatment of candidemia, invasive candidiasis, esophageal candidiasis, and prophylaxis of Candida infections in hematopoietic stem cell transplant recipients. Administered intravenously.

Mechanism of Action

Non-competitive inhibition of 1,3-beta-D-glucan synthase, an enzyme essential for fungal cell wall synthesis, leading to osmotic instability and fungal cell death. Selective for fungi as mammalian cells lack this enzyme.

Routes of Administration

Goals & Uses

• Treatment of invasive aspergillosisAntifungalLow
• Pediatric candidal infectionsAntifungal TreatmentModerate
• Treatment of candidemia and invasive candidiasisAntifungal TreatmentHigh
• Prophylaxis of Candida infections in HSCT recipientsAntifungal ProphylaxisHigh
• Treatment of esophageal candidiasisAntifungal TherapyHigh

Contraindications

• Known hypersensitivity to micafungin or other echinocandinsAllergyHigh
• Severe hepatic impairment (relative)Organ ImpairmentModerate

Adverse Effects

• Phlebitis/infusion site reactionsLocal/infusionUncommon
• Elevated liver enzymes (AST/ALT)HepatotoxicityCommon
• HeadacheNeurologicCommonPain in the head or upper neck
• Anaphylaxis/hypersensitivityImmunologicRare
• NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
• Hemolytic anemiaHematologicRare

Drug Interactions

• ItraconazoleLow
• NifedipineLow
• Amphotericin B deoxycholateModerate
• SirolimusModerate

Population Constraints

• Pregnancy (Category C)ReproductiveRelative
• Hepatic impairmentOrgan FunctionRelative
• Neonates/premature infantsPediatricRelative
• BreastfeedingReproductiveRelative

Regulatory Status

• European UnionApprovedApproved: Invasive candidiasis in adults and children, Esophageal candidiasis in adults, Prophylaxis of Candida infections in HSCT recipientsEMA approved; hepatotoxicity concerns noted; use in children under 2 years requires benefit-risk assessment
• United StatesApprovedApproved: Candidemia and invasive candidiasis, Esophageal candidiasis, Prophylaxis of Candida infections in HSCT recipientsFDA approved March 2005 (Mycamine); pediatric labeling included; post-marketing hepatotoxicity warnings added
• United KingdomApprovedApproved: Invasive candidiasis, Esophageal candidiasis, Candida prophylaxis in HSCTApproved post-Brexit via MHRA; follows similar labeling to EMA approval

Approved by FDA in 2005 (Mycamine). EMA approved. Post-marketing hepatotoxicity concerns led to restrictions in some jurisdictions. Pediatric indication included in labeling.

Evidence & Sources

No sources recorded yet.