Micafungin

Mechanism-of-action class: Glucan Synthase Inhibitors.

• Micafungin for Injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)] . Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)] .ICD-10: B37.9

• Micafungin for injection is contraindicated in persons with known hypersensitivity to micafungin, any component of micafungin for injection, or other echinocandins. Micafungin for injection is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of micafungin for injection, or other echinocandins.contraindicated

Recommended Dosage Administered by Indication, Weight and Age (2.1, 2.2, 2.3, 8.4) Adult Pediatric Patients 4 Months and Older 30 kg or less Pediatric Patients 4 Months and Older greater than 30 kg Pediatric Patients Younger than 4 Months of Age Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses 100 mg daily 2 mg/kg/day (maximum 100 mg daily) See below Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without Meningoencephalitis and/or Ocular Dissemination See above See above 4 mg/kg/day Treatment of Esophageal Candidiasis 150 mg daily 3 mg/kg/day 2.5 mg/kg/day (maximum 150 mg daily) Not approved Prophylaxis of Candida Infections in HSCT Recipients 50 mg daily 1 mg/kg/day (maximum 50 mg daily) Not approved Infuse over 1 hour. (2.5) See Full Prescribing Information for intravenous (IV) preparation and administration instructions. (2) 2.1 Dosage for Adults The recommended dosage for adult patients based on indications are shown in Table 1. Table 1. Micafungin for Injection Dosage in Adult Patients ​​Indication Recommended Reconstituted Dose Once Daily Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses * 100 mg Treatment of Esophageal Candidiasis † 150 mg Prophylaxis of Candida Infections in HSCT Recipients ‡ 50 mg *In patients treated successfully for candidemia and other Candida infections, the mean duration of treatment was 15 days (range 10 to 47 days).

Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue micafungin for injection and administer appropriate treatment. (5.1) Hematological Effects: Isolated cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria have been reported. Monitor rate of hemolysis. Discontinue if severe. (5.2) Hepatic Effects: Abnormalities in liver tests; isolated cases of hepatic impairment, hepatitis, and hepatic failure have been observed. Monitor hepatic function. Discontinue if severe dysfunction occurs. (5.3) Renal Effects: Elevations in BUN and creatinine; isolated cases of renal impairment or acute renal failure have been reported. Monitor renal function. (5.4) Infusion and Injection Site Reactions can occur including rash, pruritus, facial swelling, and vasodilatation. Monitor infusion closely, slow infusion rate if necessary. (2.5, 5.5) 5.1 Hypersensitivity Reactions Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving micafungin for injection. If these reactions occur, micafungin for injection infusion should be discontinued and appropriate treatment administered. 5.2 Hematological Effects Acute intravascular hemolysis and hemoglobinuria was seen in a healthy volunteer during infusion of micafungin for injection (200 mg) and oral prednisolone (20 mg). Cases of significant hemolysis and hemolytic anemia have also been reported in patients treated with micafungin for injection.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Hematological Effects [see Warnings and Precautions (5.2)] Hepatic Effects [see Warnings and Precautions (5.3)] Renal Effects [see Warnings and Precautions (5.4)] Infusion and Injection Site Reactions [see Warnings and Precautions (5.5)] Most common adverse reactions across adult and pediatric clinical trials for all indications include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache. (6.1) In pediatric patients younger than 4 months of age, the following additional common adverse reactions were reported at an incidence rate of ≥15%: sepsis, acidosis, anemia, oxygen saturation decreased and hypokalemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hisun Pharmaceuticals USA, Inc. at 1-855-554-4786 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of micafungin for injection cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The overall safety of micafungin for injection was assessed in 520 healthy volunteers and 3417 adult and pediatric patients who received single or multiple doses of micafungin for injection across 50 clinical trials, including the invasive candidiasis, esophageal candidiasis and prophylaxis trials.

Pregnancy Risk Summary Based on findings from animal studies, micafungin for injection may cause fetal harm when administered to a pregnant woman (see Data) . There is insufficient human data on the use of micafungin for injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, intravenous administration of micafungin sodium to pregnant rabbits during organogenesis at doses four times the maximum recommended human dose resulted in visceral abnormalities and increased abortion (see Data) . Advise pregnant women of the risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal toxicity study in pregnant rabbits, intravenous administration of micafungin sodium during organogenesis (days 6 to 18 of gestation) resulted in fetal visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to four times the recommended human dose based on body surface area comparisons.

Micafungin for injection is highly protein bound and, therefore, is not dialyzable. No cases of micafungin for injection overdosage have been reported. Repeated daily doses up to 8 mg/kg (maximum total dose of 896 mg) in adult patients, up to 6 mg/kg in pediatric patients 4 months of age and older, and up to 15 mg/kg in pediatric patients younger than 4 months of age have been administered in clinical trials with no reported dose-limiting toxicity [see Adverse Reactions (6.1) and Use in Specific Populations (8.4)] .

• Mar 16, 2005NDANDA021506Astellas
• May 17, 2019ANDAANDA207344Fresenius Kabi Usa
• Jun 16, 2021NDANDA212156Ph Health
• Jul 9, 2021ANDAANDA213261Hikma
• Jul 9, 2021ANDAANDA213363Jiangsu Hansoh Pharm
• Sep 28, 2022ANDAANDA215381Meitheal
• Oct 24, 2022ANDAANDA215241Zydus Pharms
• Sep 29, 2023NDANDA216142Baxter Hlthcare Corp

1. 1Off Label Use1,18914%
2. 2Drug Ineffective1,12214%
3. 3Febrile Neutropenia5396.5%
4. 4Pyrexia5246.3%
5. 5Product Use In Unapproved Indication3934.8%
6. 6Sepsis3494.2%
7. 7Pneumonia3294.0%
8. 8Death3113.8%
9. 9Diarrhoea2943.6%
10. 10Neutropenia2753.3%
11. 11Multiple Organ Dysfunction Syndrome2723.3%
12. 12Acute Kidney Injury2583.1%
13. 13Respiratory Failure2563.1%
14. 14Septic Shock2372.9%
15. 15Aplastic Anaemia2282.8%

Recent PubMed references pinned to Micafungin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Micafungin microevolution in Candida auris reveals resistance development without in vivo fitness compromise.
  Virulence · 2026 · Bohner F, Szilovics Z, Veres É, et al.
  PMID 42051239DOI 10.1080/21505594.2026.2664993
• Twice-Weekly Micafungin as Antifungal Prophylaxis in Children Undergoing Hematopoietic Stem Cell Transplantation.
  Pediatric transplantation · 2026 · Ab Rahman S, Chiew XY, Jawin V, et al.
  PMID 41820822DOI 10.1111/petr.70296
• Micafungin-induced hemolytic anemia: a case report and investigation of anti-micafungin antibody prevalence.
  International journal of hematology · 2026 · Kaya H, Hamada M, Murayama Y, et al.
  PMID 41604063DOI 10.1007/s12185-026-04161-x
• From AUC/MIC to AUCss and Cmin: Optimizing Micafungin Therapy in the Critically Ill through Model-Informed Precision Dosing.
  The AAPS journal · 2025 · Berrah R, Saint-Marcoux F, Monchaud C, et al.
  PMID 41219680DOI 10.1208/s12248-025-01173-z
• Optimizing Micafungin Dosing in Patients with Critically Ill Candidemia and Trends of Candida Species Causing Bloodstream Infections in a Tertiary Hospital in Thailand: A Monte Carlo Simulation Approach.
  Drug design, development and therapy · 2025 · Watcharasuwanseree J, Chueansuwan W, Suwantarat N, et al.
  PMID 41164403DOI 10.2147/DDDT.S549066
• Ultrastructural and Immunohistochemical Study on the Nephrotoxicity Following Intravitreal Administration of the Antifungal Agents Voriconazole and Micafungin in New Zealand White Rabbits.
  International journal of molecular sciences · 2025 · Karachrysafi S, Karakousis VA, Liatsos A, et al.
  PMID 41155421DOI 10.3390/ijms262010129
• SIP-SRS Imaging of Cell Wall Synthesis Identifies a Synergy between Micafungin and Amphotericin B.
  Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025 · Zhang M, Zhan Y, Lin H, et al.
  PMID 41117037DOI 10.1002/advs.202507331
• Successful combination therapy with voriconazole and micafungin for voriconazole-resistant Scedosporium dehoogii pulmonary infection: A case report with in vitro analysis.
  Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2025 · Yamazaki K, Osada M, Maruguchi N, et al.
  PMID 41106552DOI 10.1016/j.jiac.2025.102832

The 10 most recently updated of 71 ClinicalTrials.gov registrations naming Micafungin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole
  Terminated · Phase 3 · Interventional · 68 enrolled · Scynexis, Inc.
  NCT05178862updated 2025-12-19
• Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis (EPI Study)
  Completed · Phase 4 · Interventional · 24 enrolled · Centre Hospitalier Universitaire de Nīmes
  NCT02805049updated 2025-12-10
• Pharmacokinetics of Micafungin in Patients of Intensive Care Units
  Completed · Phase 4 · Interventional · 60 enrolled · University Hospital, Limoges
  NCT02164890updated 2025-11-21
• Fluconazole Versus Micafungin in Neonates With Candidiasis
  Completed · Phase 2 · Phase 3 · Interventional · 100 enrolled · Institut National de la Santé Et de la Recherche Médicale, France
  NCT02145832updated 2025-09-04
• Antibiotic Impregnated Beads in Osteomyelitis
  Not yet recruiting · Phase 4 · Interventional · 100 enrolled · University of Arizona
  NCT07072923updated 2025-07-18
• A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
  Not yet recruiting · Observational · 150 enrolled · Augusta University
  NCT06907992updated 2025-04-04
• Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis
  Terminated · Phase 4 · Interventional · 43 enrolled · Astellas Pharma China, Inc.
  NCT02646774updated 2024-11-20
• A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
  Terminated · Phase 4 · Interventional · 59 enrolled · Astellas Pharma China, Inc.
  NCT01982071updated 2024-11-20
• A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects
  Completed · Phase 2 · Interventional · 252 enrolled · Astellas Pharma Inc
  NCT01122368updated 2024-11-19
• Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis
  Completed · Phase 2 · Interventional · 35 enrolled · Astellas Pharma Global Development, Inc.
  NCT03421002updated 2024-11-18

Frequently asked questions

How does Micafungin work?

Mechanism-of-action class: Glucan Synthase Inhibitors.

What is Micafungin used for?

According to FDA labeling, Micafungin carries indications including: Micafungin for Injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)] . Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Micafungin?

Micafungin is classified as Other antimycotics for systemic use, Echinocandin Antifungal, Glucan Synthase Inhibitors, Decreased Cell Wall Integrity.

What are the brand names for Micafungin?

Micafungin is marketed under brand names including Mycamine.

What are the contraindications for Micafungin?

Micafungin labeling lists contraindications including: Micafungin for injection is contraindicated in persons with known hypersensitivity to micafungin, any component of micafungin for injection, or other echinocandins. Micafungin for injection is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of micafungin for injection, or other echinocandins.. Always consult the full prescribing information and a clinician.