HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------- DOSAGE FORMS AND STRENGTHS -------------------- These highlights do not include all the information needed to use MYCAMINE® safely and effectively. See full prescribing information for For injection: 50 mg single-dose vial. (3) MYCAMINE®. For injection: 100 mg single-dose vial. (3) MYCAMINE® (micafungin for injection), for intravenous use ------------------------------ CONTRAINDICATIONS ----------------------------- Initial U.S. Approval: 2005 MYCAMINE is contraindicated in persons with known hypersensitivity to ---------------------------RECENT MAJOR CHANGES--------------------------- micafungin sodium, any component of MYCAMINE, or other echinocandins. (4) Indications and Usage (1) 12/2019 ----------------------- WARNINGS AND PRECAUTIONS ---------------------- Dosage and Administration, Dosage for Pediatric Patients Younger than 4 Months of Age (2.3) 12/2019 Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue MYCAMINE and Warnings and Precautions, Infusion and Injection Site Reactions (5.5) 12/2019 administer appropriate treatment. (5.1) --------------------------- INDICATIONS AND USAGE -------------------------- Hematological Effects: Isolated cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria have been reported. Monitor rate ® MYCAMINE is an echinocandin indicated in adult and pediatric patients for of hemolysis. Discontinue if severe. (5.2) (1): Hepatic Effects: Abnormalities in liver tests; isolated cases of hepatic Treatment of Candidemia, Acute Disseminated Candidiasis, Candida impairment, hepatitis, and hepatic failure have been observed. Monitor Peritonitis and Abscesses in adult and pediatric patients 4 months of age hepatic function. Discontinue if severe dysfunction occurs. (5.3) and older. Renal Effects: Elevations in BUN and creatinine; isolated cases of renal Treatment of Candidemia, Acute Disseminated Candidiasis, Candida impairment or acute renal failure have been reported. Monitor renal Peritonitis and Abscesses without meningoencephalitis and/or ocular function. (5.4) dissemination in pediatric patients younger than 4 months of age. Infusion and Injection Site Reactions can occur including rash, pruritus, Treatment of Esophageal Candidiasis in adult and pediatric patients 4 facial swelling, and vasodilatation. Monitor infusion closely, slow months of age and older. infusion rate if necessary. (2.5, 5.5) Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell ------------------------------ ADVERSE REACTIONS ----------------------------- Transplantation (HSCT). Most common adverse reactions across adult and pediatric clinical trials Limitations of Use for all indications include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache. (6.1) The safety and effectiveness of MYCAMINE have not been established for the treatment of candidemia with meningoencephalitis and/or ocular In pediatric patients younger than 4 months of age, the following dissemination in pediatric patients younger than 4 months of age as a additional common adverse reactions were reported at an incidence rate of higher dose may be needed. (1, 2.3, 8.4) ≥15%: sepsis, acidosis, anemia, oxygen saturation decreased and hypokalemia. (6.1) MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida. (1) To report SUSPECTED ADVERSE REACTIONS, contact Astellas The efficacy of MYCAMINE against infections caused by fungi other Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or than Candida has not been established. (1) www.fda.gov/medwatch. ---------------------- DOSAGE AND ADMINISTRATION ---------------------- ------------------------------ DRUG INTERACTIONS ----------------------------- Recommended Dosage Administered by Indication, Weight and Age (2.1, Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of 2.2, 2.3, 8.4) sirolimus, itraconazole or nifedipine should be reduced, if necessary. (7) Pediatric Patients Pediatric ----------------------- USE IN SPECIFIC POPULATIONS ---------------------- Pediatric Patients 4 Months and Patients 4 Months and Pregnancy – Based on animal data, MYCAMINE may cause fetal harm. Adult Older Younger than 4 Older Advise pregnant women of the risk to the fetus. (8.1) greater than Months of Age 30 kg or less 30 kg See 17 for PATIENT COUNSELING INFORMATION. Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Revised: 12/2019 Peritonitis and Abscesses 2 mg/kg/day 100 mg daily See below (maximum 100 mg daily) 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 2.5 mg/kg/day 150 mg daily 3 mg/kg/day (maximum Not approved 150 mg daily) Prophylaxis of Candida Infections in HSCT Recipients 1 mg/kg/day 50 mg daily Not approved (maximum 50 mg daily) Infuse over 1 hour. (2.5) See Full Prescribing Information for intravenous (IV) preparation and administration instructions. (2) Reference ID: 4537807 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 8.6 Use in Patients with Renal Impairment 2 DOSAGE AND ADMINISTRATION 8.7 Use in Patients with Hepatic Impairment 2.1 Dosage for Adults 8.8 Race and Gender 2.2 Dosage for Pediatric Patients 4 Months and Older 9 DRUG ABUSE AND DEPENDENCE 2.3 Dosage for Pediatric Patients Younger than 4 Months of Age 10 OVERDOSAGE 2.4 Directions for Reconstitution, Dilution, and Preparation 11 DESCRIPTION 2.5 Infusion Volume and Duration 12 CLINICAL PHARMACOLOGY 3 DOSAGE FORMS AND STRENGTHS 12.1 Mechanism of Action 4 CONTRAINDICATIONS 12.2 Pharmacodynamics 5 WARNINGS AND PRECAUTIONS 12.3 Pharmacokinetics 5.1 Hypersensitivity Reactions 12.4 Microbiology 5.2 Hematological Effects 13 NONCLINICAL TOXICOLOGY 5.3 Hepatic Effects 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.4 Renal Effects 13.2 Animal Toxicology and/or Pharmacology 5.5 Infusion and Injection Site Reactions 14 CLINICAL STUDIES 6 ADVERSE REACTIONS 14.1 Treatment of Candidemia and Other Candida Infections in Adult 6.1 Clinical Trials Experience and Pediatric Patients 4 Months of Age and Older 6.2 Postmarketing Experience 14.2 Treatment of Esophageal Candidiasis in Adult and Pediatric 7 DRUG INTERACTIONS Patients 4 Months of Age and Older 7.1 Effect of Other Drugs on MYCAMINE 14.3 Prophylaxis of Candida Infections in Hematopoietic Stem Cell 7.2 Effect of MYCAMINE on Other Drugs Transplant Recipients 8 USE IN SPECIFIC POPULATIONS 16 HOW SUPPLIED/STORAGE AND HANDLING 8.1 Pregnancy 17 PATIENT COUNSELING INFORMATION 8.2 Lactation *Sections or subsections omitted from the full prescribing information are not 8.4 Pediatric Use listed. 8.5 Geriatric Use Reference ID: 4537807 FULL PRESCRIBING INFORMATION 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 endocarditis, osteomyelitis and meningoencephalitis due to Candida. The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established. 2 DOSAGE AND ADMINISTRATION 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 Recommended Reconstituted Dose Indication Once Daily Treatment of Candidemia, Acute Disseminated Candidiasis, Candida 100 mg Peritonitis and Abscesses* 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). ‡ In patients treated successfully for esophageal candidiasis, the mean duration of treatment was 15 days (range 10 to 30 days). § In hematopoietic stem cell transplant (HSCT) recipients who experienced success of prophylactic therapy, the mean duration of prophylaxis was 19 days (range 6 to 51 days). 2.2 Dosage for Pediatric Patients 4 Months and Older The recommended dosage for pediatric patients 4 months of age and older based on indication and weight are shown in Table 2. Reference ID: 4537807 Table 2. MYCAMINE Dosage in Pediatric Patients (4 Months of Age and Older) Dosage for Pediatric