Mycamine 10 mg/mL
Micafungin sodium · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Astellas Pharma US, Inc.
Mycamine is a injection, powder, lyophilized, for solution containing micafungin sodium at 10 mg/mL, taken intravenous. Manufactured by Astellas Pharma US, Inc..
Key Facts
- Brand Name
- Mycamine
- Generic Name
- Micafungin sodium
- NDC Code (Product)
0469-3250- Manufacturer
- Astellas Pharma US, Inc.
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA021506
- Marketing Start
- 03/16/2005
Recall History
Sentara Enterprises
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Sentara Infusion Services
Lack of sterility assurance
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
1 INDICATIONS AND USAGE MYCAMINE ® 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 MYCAMINE 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 )] . • MYCAMINE has not been adequately studied in patients with endocarditi…
Dosage & Administration
2 DOSAGE AND 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. MYCAMINE Dosage in Adult Patients Indication Recommended Reconstituted Dose Once Daily Treatment of Candidemia, Acut…
Contraindications
4 CONTRAINDICATIONS MYCAMINE is contraindicated in persons with known hypersensitivity to micafungin, any component of MYCAMINE, or other echinocandins. MYCAMINE is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of MYCAMINE, or other echinocandins. ( 4 )
Drug Interactions
7 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 MYCAMINE CYP3A4, CYP2C9 and CYP2C19 Inhibitors Co-administration of MYCAMINE with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of MYCAMINE. CYP2C19 and CYP3A4 Inducer Co-administration of MYCAMINE with rifampin and ritonavir did not alter the pharmacokinetics of MYCAMINE. Co-administration of MYCAMINE with Other Drugs Co-administration of MYCAMINE with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of MYCAMINE. 7.2 Effect of MYCAMINE on Other Drugs CYP3A4 Substrates There was no effect of single or multiple doses of MYCAMINE 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 MYCAMINE compared with sirolimus alone. Nifedipine AUC and C max were increased by 18% and 42%, respectively, in the presence of steady-state MYCAMINE compar…
Adverse Reactions
6 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 Astellas Pharma US, Inc. at 1-800-727-7003 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 MYCAMINE cannot be directly c…
Frequently Asked Questions
What is Mycamine used for?
Mycamine contains Micafungin sodium. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Mycamine a controlled substance?
Mycamine is not classified as a controlled substance by the DEA.
What is the generic name for Mycamine?
The generic name for Mycamine is Micafungin sodium. There are 8 other brand versions of Micafungin sodium.
What is the NDC code for Mycamine 10 mg/mL?
The NDC (National Drug Code) for Mycamine 10 mg/mL is 0469-3250, listed by Astellas Pharma US, Inc..