Micafungin 50 mg/5mL
Micafungin Sodium · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Sagent Pharmaceuticals
Micafungin is a injection, powder, lyophilized, for solution containing micafungin sodium at 50 mg/5mL, taken intravenous. Manufactured by Sagent Pharmaceuticals.
Key Facts
- Brand Name
- Micafungin
- Generic Name
- Micafungin Sodium
- NDC Code (Product)
25021-190- Manufacturer
- Sagent Pharmaceuticals
- Strength
- 50 mg/5mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA213363
- Marketing Start
- 06/15/2021
Recall History
Zydus Pharmaceuticals (USA) Inc
Cross contamination with other products
XELLIA PHARMACEUTICALS USA, LLC
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Zydus Pharmaceuticals (USA) Inc
Cross contamination with other products
XELLIA PHARMACEUTICALS USA, LLC
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Sentara Enterprises
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Astellas Pharma US Inc
Labeling: Label Error on Declared Strength
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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)] . Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)] . Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)] . Limitations of Use The safety and effectiveness of Micafungin for Injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed [see Use in Specific Populations (8.4)] . Micafungin for Injection has not been adequately studied in patients with endocarditis…
Dosage & Administration
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 Candidias…
Contraindications
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. (4)
Drug Interactions
Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary. (7) 7.1 Effect of Other Drugs on Micafungin for Injection CYP3A4, CYP2C9 and CYP2C19 Inhibitors Co-administration of micafungin for injection with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of micafungin for injection. CYP2C19 and CYP3A4 Inducer Co-administration of micafungin for injection with rifampin and ritonavir did not alter the pharmacokinetics of micafungin for injection. Co-administration of Micafungin for Injection with Other Drugs Co-administration of micafungin for injection with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of micafungin for injection. 7.2 Effect of Micafungin for Injection on Other Drug CYP3A4 Substrates There was no effect of single or multiple doses of micafungin for injection on cyclosporine, tacrolimus, prednisolone, voriconazole and fluconazole pharmacokinetics. Sirolimus AUC was increased by 21% with no effect on C max in the presence of steady-state micafungin for injec…
Adverse Reactions
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 clinic…
Frequently Asked Questions
What is Micafungin used for?
Micafungin contains Micafungin Sodium. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Micafungin a controlled substance?
Micafungin is not classified as a controlled substance by the DEA.
What is the generic name for Micafungin?
The generic name for Micafungin is Micafungin Sodium. There are 1 other brand versions of Micafungin Sodium.
What is the NDC code for Micafungin 50 mg/5mL?
The NDC (National Drug Code) for Micafungin 50 mg/5mL is 25021-190, listed by Sagent Pharmaceuticals.