Micafungin sodium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]
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Overview
Micafungin sodium is an echinocandin that is FDA approved for the treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses, and esophageal Candidiasis; prophylaxis of Candida Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation. Common adverse reactions include diarrhea, nausea, vomiting, pyrexia, thrombocytopenia, and headache.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Treatment of patients with candidemia, acute cisseminated candidiasis, candida peritonitis and abscesses
- Dosage: 100 mg once daily
- Treatment of patients with esophageal candidiasis
- Dosage: 150 mg once daily
- Prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation
- Dosage: 50 mg once daily
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Micafungin sodium in adult patients.
Non–Guideline-Supported Use
- Invasive aspergillosis
- Prophylaxis against invasive aspergillosis in high-risk patients
- Candida endophthalmitis
- Candida infection of the cardiovascular system
- Candida osteoarticular infections
- Chronic disseminated candidiasis
- Empiric antifungal therapy for suspected candidiasis in nonneutropenic patients
- Oropharyngeal candidiasis in patients with HIV
- Prophylaxis of invasive fungal infections
- Oropharyngeal candidiasis
- Chronic necrotizing or cavitary pulmonary aspergillosis
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Micafungin sodium is indicated in pediatric patients 4 months and older for:
- Treatment of patients with candidemia, acute cisseminated candidiasis, candida peritonitis and abscesses
- Dosage: 2 mg/kg once daily
- Treatment of patients with esophageal candidiasis
- Dosage for 30 kg or less: 3 mg/kg once daily
- Dosage for greater than 30 kg: 2.5 mg/kg once daily
- Prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation
- Dosage: 1 mg/kg once daily
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Micafungin sodium in pediatric patients.
Non–Guideline-Supported Use
- Invasive aspergillosis
- Prophylaxis of invasive fungal infections
Contraindications
Micafungin sodium is contraindicated in persons with known hypersensitivity to micafungin, any component of micafungin sodium, or other echinocandins.
Warnings
Hypersensitivity Reactions
Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving Mycamine. If these reactions occur, Mycamine infusion should be discontinued and appropriate treatment administered.
Hematological Effects
Acute intravascular hemolysis and hemoglobinuria was seen in a healthy volunteer during infusion of Mycamine (200 mg) and oral prednisolone (20 mg). This reaction was transient, and the subject did not develop significant anemia. Isolated cases of significant hemolysis and hemolytic anemia have also been reported in patients treated with Mycamine. Patients who develop clinical or laboratory evidence of hemolysis or hemolytic anemia during Mycamine therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing Mycamine therapy.
Hepatic Effects
Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with Mycamine. In some patients with serious underlying conditions who were receiving Mycamine along with multiple concomitant medications, clinical hepatic abnormalities have occurred, and isolated cases of significant hepatic impairment, hepatitis, and hepatic failure have been reported. Patients who develop abnormal liver function tests during Mycamine therapy should be monitored for evidence of worsening hepatic function and evaluated for the risk/benefit of continuing Mycamine therapy.
Renal Effects
Elevations in BUN and creatinine, and isolated cases of significant renal impairment or acute renal failure have been reported in patients who received Mycamine. In fluconazole-controlled trials, the incidence of drug-related renal adverse reactions was 0.4% for Mycamine treated patients and 0.5% for fluconazole treated patients. Patients who develop abnormal renal function tests during Mycamine therapy should be monitored for evidence of worsening renal function.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Micafungin sodium Clinical Trials Experience in the drug label.
Postmarketing Experience
The following adverse reactions have been identified during the post-approval use of micafungin sodium for injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
- Blood and lymphatic system disorders: disseminated intravascular coagulation
- Hepatobiliary disorders: hepatic disorder
- Renal and urinary disorders: renal impairment
- Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis
- Vascular disorders: shock
Drug Interactions
A total of 14 clinical drug-drug interaction studies were conducted in healthy volunteers to evaluate the potential for interaction between Mycamine and amphotericin B, mycophenolate mofetil, cyclosporine, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, itraconazole, voriconazole, ritonavir, and rifampin. In these studies, no interaction that altered the pharmacokinetics of Mycamine was observed.
There was no effect of a single dose or multiple doses of Mycamine on mycophenolate mofetil, cyclosporine, tacrolimus, prednisolone, fluconazole, and voriconazole pharmacokinetics.
Sirolimus AUC was increased by 21% with no effect on Cmax in the presence of steady-state Mycamine compared with sirolimus alone. Nifedipine AUC and Cmax were increased by 18% and 42%, respectively, in the presence of steady-state Mycamine compared with nifedipine alone. Itraconazole AUC and Cmax were increased by 22% and 11%, respectively.
Patients receiving sirolimus, nifedipine or itraconazole in combination with Mycamine should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary.
Micafungin is neither a substrate nor an inhibitor of P-glycoprotein and, therefore, would not be expected to alter P-glycoprotein-mediated drug transport activity.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): C
There is no FDA guidance on usage of Micafungin sodium in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Micafungin sodium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Micafungin sodium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Micafungin sodium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Micafungin sodium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Micafungin sodium in geriatric settings.
Gender
There is no FDA guidance on the use of Micafungin sodium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Micafungin sodium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Micafungin sodium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Micafungin sodium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Micafungin sodium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Micafungin sodium in patients who are immunocompromised.
Administration and Monitoring
Administration
Intravenous
Monitoring
There is limited information regarding Micafungin sodium Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Micafungin sodium and IV administrations.
Overdosage
There is limited information regarding Micafungin sodium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Micafungin sodium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Micafungin sodium Mechanism of Action in the drug label.
Structure
There is limited information regarding Micafungin sodium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Micafungin sodium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Micafungin sodium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Micafungin sodium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Micafungin sodium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Micafungin sodium How Supplied in the drug label.
Storage
There is limited information regarding Micafungin sodium Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Micafungin sodium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Micafungin sodium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- Mycamine
Look-Alike Drug Names
There is limited information regarding Micafungin sodium Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.