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Indications And Usage

MYCAMINE® is indicated in adult and pediatric patients 4 months and older for: MYCAMINE® is an echinocandin indicated in adult and pediatric patients 4 months and older for: •Treatment of Patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses (1.1) •Treatment of Patients with Esophageal Candidiasis (1.2) •Prophylaxis of Candida Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation (1.3) 1.1 Treatment of Patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses [see Clinical Studies (14.1)]. MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to Candida infections. 1.2 Treatment of Patients with Esophageal Candidiasis [see Clinical Studies (14.2)]. 1.3 Prophylaxis of Candida Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation [see Clinical Studies (14.3)]. NOTE: The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.

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Dosage And Administration

Indication Dose
Adult Pediatric 30 kg or less Pediatric greater than 30 kg
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses (1.1) 100 mg100 mg micafungin is equivalent to 101.73 mg micafungin sodium. daily 2 mg/kg/day (maximum 100 mg daily)
Treatment of Esophageal Candidiasis (1.2) 150 mg daily 3 mg/kg/day 2.5 mg/kg/day (maximum 150 mg daily)
Prophylaxis of Candida Infections in HSCT Recipients (1.3) 50 mg50 mg micafungin is equivalent to 50.86 mg micafungin sodium. daily 1 mg/kg/day (maximum 50 mg daily)

Dosage Forms And Strengths

50 mg single-dose vial is equivalent to 50.86 mg micafungin sodium 100 mg single-dose vial is equivalent to 101.73 mg micafungin sodium MYCAMINE (micafungin) for injection is supplied in a single-dose vial containing 50 mg micafungin, equivalent to 50.86 mg micafungin sodium (3) MYCAMINE (micafungin) for injection is supplied in a single-dose vial containing 100 mg micafungin, equivalent to 101.73 mg micafungin sodium (3)

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)

Warning and Cautions

Hypersensitivity Reactions •Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue MYCAMINE and administer appropriate treatment (5.1) Hematological Effects •Isolated cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria have been reported (5.2) Hepatic Effects •Abnormalities in liver function tests; isolated cases of hepatic impairment, hepatitis, and hepatic failure have been observed (5.3) Renal Effects •Elevations in BUN and creatinine; isolated cases of renal impairment or acute renal failure have been reported (5.4) Monitor closely patients who develop clinical or laboratory evidence of the above reactions and evaluate risk/benefit of continuing MYCAMINE therapy. (5) 5.1 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. 5.2 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. 5.3 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. 5.4 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

The overall safety of MYCAMINE was assessed in 3227 adult and pediatric patients and 520 volunteers in 46 clinical trials, including the invasive candidiasis, esophageal candidiasis and prophylaxis trials, who received single or multiple doses of MYCAMINE, ranging from 0.75 mg/kg to 10 mg/kg in pediatric patients and 12.5 mg to 150 mg/day or greater in adult patients. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of MYCAMINE cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does provide a basis for identifying adverse events that appear to be related to drug use and for approximating rates. •Most common adverse reactions include diarrhea, nausea, vomiting, pyrexia, thrombocytopenia, and headache (6) •Histamine-mediated symptoms including rash, pruritus, facial swelling, and vasodilatation (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 Infusion Reactions Possible histamine-mediated symptoms have been reported with MYCAMINE, including rash, pruritus, facial swelling, and vasodilatation. Injection site reactions, including phlebitis and thrombophlebitis have been reported, at MYCAMINE doses of 50-150 mg/day. These reactions tended to occur more often in patients receiving MYCAMINE via peripheral intravenous administration. 6.2 Clinical Trials Experience in Adults In all clinical trials with MYCAMINE, 2497/2748 (91%) adult patients experienced at least one treatment-emergent adverse reaction. Candidemia and Other Candida Infections In a randomized, double-blind study for treatment of candidemia and other Candida infections, treatment-emergent adverse reactions occurred in 183/200 (92%), 187/202 (93%) and 171/193 (89%) patients in the MYCAMINE 100 mg/day, MYCAMINE 150 mg/day, and caspofungin (a 70 mg loading dose followed by a 50 mg/day dose) treatment groups, respectively. Selected treatment-emergent adverse reactions, those occurring in 5% or more of the patients and more frequently in a MYCAMINE treatment group, are shown in Table 3. Table 3. SelectedDuring IV treatment + 3 days Treatment-Emergent Adverse Reactions in Adult Patients with Candidemia and Other Candida Infections Patient base: all randomized patients who received at least 1 dose of trial drug System Organ Class MedDRA v5.0 (Preferred Term) Within a system organ class patients may experience more than 1 adverse reaction. MYCAMINE 100 mg n (%) MYCAMINE 150 mg n (%) Caspofungin 70 mg loading dose on day 1 followed by 50 mg/day thereafter (caspofungin) n (%) Number of Patients 200 202 193 Gastrointestinal Disorders 81 (41) 89 (44) 76 (39) Diarrhea 15 (8) 26 (13) 14 (7) Nausea 19 (10) 15 (7) 20 (10) Vomiting 18 (9) 15 (7) 16 (8) Metabolism and Nutrition Disorders 77 (39) 83 (41) 73 (38) Hypoglycemia 12 (6) 14 (7) 9 (5) Hypernatremia 8 (4) 13 (6) 8 (4) Hyperkalemia 10 (5) 8 (4) 5 (3) General Disorders/Administration Site Conditions 59 (30) 56 (28) 51 (26) Pyrexia 14 (7) 22 (11) 15 (8) Investigations 36 (18) 49 (24) 37 (19) Blood Alkaline Phosphatase Increased 11 (6) 16 (8) 8 (4) Cardiac Disorders 35 (18) 48 (24) 36 (19) Atrial Fibrillation 5 (3) 10 (5) 0 In a second, supportive, randomized, double-blind study for treatment of candidemia and other Candida infections, treatment-emergent adverse reactions occurred in 245/264 (93%) and 250/265 (94%) patients in the MYCAMINE (100 mg/day) and AmBisome (3 mg/kg/day) treatment groups, respectively. The following treatment-emergent adverse reactions in the MYCAMINE-treated patients at least 16 years of age were notable: nausea (10% vs. 8%); diarrhea (11% vs. 11%), vomiting (13% vs. 9%), abnormal liver function tests (4% vs. 3%); increased aspartate aminotransferase (3% vs. 2%), and increased blood alkaline phosphatase (3% vs. 2%), in the MYCAMINE and AmBisome treatment groups, respectively. Esophageal Candidiasis In a randomized, double-blind study for treatment of esophageal candidiasis, a total of 202/260 (78%) patients who received MYCAMINE 150 mg/day and 186/258 (72%) patients who received intravenous fluconazole 200 mg/day experienced an adverse reaction. Treatment-emergent adverse reactions resulting in discontinuation were reported in 17 (7%) MYCAMINE-treated patients; and in 12 (5%) fluconazole-treated patients. Selected treatment-emergent adverse reactions, those occurring in 5% or more of the patients and more frequently in the MYCAMINE group, are shown in Table 4. Table 4. SelectedDuring treatment + 3 days. Treatment-Emergent Adverse Reactions in Adult Patients with Esophageal Candidiasis Patient base: all randomized patients who received at least 1 dose of trial drug System Organ Class MedDRA v5.0 (Preferred Term)Within a system organ class patients may experience more than 1 adverse reaction. MYCAMINE 150 mg/day n (%) Fluconazole 200 mg/day n (%) Number of Patients 260 258 Gastrointestinal Disorders 84 (32) 93 (36) Diarrhea 27 (10) 29 (11) Nausea 20 (8) 23 (9) Vomiting 17 (7) 17 (7) General Disorders/Administration Site Conditions 52 (20) 45 (17) Pyrexia 34 (13) 21 (8) Nervous System Disorders 42 (16) 40 (16) Headache 22 (9) 20 (8) Vascular Disorders 54 (21) 21 (8) Phlebitis 49 (19) 13 (5) Skin and Subcutaneous Tissue Disorders 36 (14) 26 (10) Rash 14 (5) 6 (2) Prophylaxis of Candida Infections in Hematopoietic Stem Cell Transplant Recipients A double-blind study was conducted in a total of 882 patients scheduled to undergo an autologous or allogeneic hematopoietic stem cell transplant. The median duration of treatment was 18 days (range 1 to 51 days) in both treatment arms. All adult patients who received MYCAMINE (382) or fluconazole (409) experienced at least one adverse reaction during the study. Treatment-emergent adverse reactions resulting in MYCAMINE discontinuation were reported in 15 (4%) adult patients; while those resulting in fluconazole discontinuation were reported in 32 (8%). Selected adverse reactions, those reported in 15% or more of adult patients and more frequently on the MYCAMINE treatment arm, are shown in Table 5. Table 5. Selected Adverse Reactions in Adult Patients During Prophylaxis of Candida Infection in Hematopoietic Stem Cell Transplant Recipients Patient base: all randomized adult patients who received at least 1 dose of trial drug System Organ Class MedDRA v12.0 (Preferred Term) Within a system organ class patients may experience more than 1 adverse reaction. MYCAMINE 50 mg/day n (%) Fluconazole 400 mg/day n (%) Number of Patients 382 409 Gastrointestinal Disorders 377 (99) 404 (99) Diarrhea 294 (77) 327 (80) Nausea 270 (71) 290 (71) Vomiting 252 (66) 274 (67) Abdominal Pain 100 (26) 93 (23) Blood and Lymphatic System Disorders 368 (96) 385 (94) Neutropenia 288 (75) 297 (73) Thrombocytopenia 286 (75) 280 (69) Skin and Subcutaneous Tissue Disorders 257 (67) 275 (67) Rash 95 (25) 91 (22) Nervous System Disorders 250 (65) 254 (62) Headache 169 (44) 154 (38) Psychiatric Disorders 233 (61) 235 (58) Insomnia 142 (37) 140 (34) Anxiety 84 (22) 87 (21) Cardiac Disorders 133 (35) 138 (34) Tachycardia 99 (26) 91 (22) Other selected adverse reactions reported at less than 5% in adult clinical trials are listed below: • Blood and lymphatic system disorders: coagulopathy, pancytopenia, thrombotic thrombocytopenic purpura • Cardiac disorders: cardiac arrest, myocardial infarction, pericardial effusion • General disorders and administration site conditions: infusion reaction, injection site thrombosis • Hepatobiliary disorders: hepatocellular damage, hepatomegaly, jaundice, hepatic failure • Immune disorders: hypersensitivity, anaphylactic reaction • Nervous system disorders: convulsions, encephalopathy, intracranial hemorrhage • Psychiatric disorders: delirium • Skin and subcutaneous tissue disorders: urticaria 6.3 Clinical Trials Experience in Pediatric Patients The overall safety of MYCAMINE was assessed in 479 patients 3 days through 16 years of age who received at least one dose of MYCAMINE in 11 separate clinical studies. The mean treatment duration was 24.8 days. A total of 246 patients received at least one dose of MYCAMINE 2 mg/kg or higher. Of the 479 pediatric patients, 264 (55%) were male, 319 (67%) were Caucasians, with the following age distribution: 116 (24%) less than 2 years, 108 (23%) between 2 and 5 years, 140 (29%) between 6 years and 11 years, and 115 (24%) between 12 and 16 years of age. In all pediatric studies with MYCAMINE, 439/479 (92%) patients experienced at least one treatment-emergent adverse reaction. Two studies that included pediatric patients were randomized, double-blind, and active-controlled: The invasive candidiasis and candidemia study investigated the efficacy and safety of MYCAMINE (2 mg/kg/day for patients weighing 40 kg or less and 100 mg/day for patients weighing greater than 40 kg) compared to AmBisome (3 mg/kg/day) in 112 pediatric patients. Treatment-emergent adverse reactions occurred in 51/56 (91%) of patients in the MYCAMINE group and 52/56 (93%) of patients in the AmBisome group. Treatment-emergent adverse reactions resulting in MYCAMINE discontinuation were reported in 2 (4%) pediatric patients; while those resulting in AmBisome discontinuation were reported in 9 (16%). The prophylaxis study in patients undergoing HSCT investigated the efficacy of MYCAMINE (1 mg/kg/day for patients weighing 50 kg or less and 50 mg/day for patients weighing greater than 50 kg) as compared to fluconazole (8 mg/kg/day for patients weighing 50 kg or less and 400 mg/day for patients weighing greater than 50 kg). All 91 pediatric patients experienced at least one treatment-emergent adverse reaction. Three (7%) pediatric patients discontinued MYCAMINE due to adverse reaction; while one (2%) patient discontinued fluconazole. The selected treatment-emergent adverse reactions, those occurring in 15% or more of the patients and more frequently in a MYCAMINE group, for all MYCAMINE pediatric studies and for the two comparative studies (candidemia and prophylaxis) described above are shown in Table 6. Table 6. Selected Treatment-Emergent Adverse Reactions in All Pediatric Patients, in Patients with Candidemia and Other Candida Infections (C/IC), and in Hematopoietic Stem-Cell Recipients During Prophylaxis of Candida Infections Patient base: all randomized patients who received at least one dose of trial drug. System Organ Class MedDRA v12.0 (Preferred Term) Within a system organ class, patients may experience more than 1 adverse reaction. All Micafungin-treated Patients n = 479 n (%) C/IC Prophylaxis MYCAMINE n = 56 n (%) AmBisome n = 56 n (%) MYCAMINE n = 43 n (%) Fluconazole n = 48 n (%) Gastrointestinal disorders 285 (60) 22 (40) 18 (32) 43 (100) 45 (94) Vomiting 146 (31) 10 (18) 8 (14) 28 (65) 32 (67) Diarrhea 106 (22) 4 (7) 5 (9) 22 (51) 31 (65) Nausea 91 (19) 4 (7) 4 (7) 30 (70) 25 (52) Abdominal pain 76 (16) 2 (4) 2 (4) 15 (35) 12 (25) Abdominal distension 29 (6) 1 (2) 1 (2) 8 (19) 6 (13) General disorders and administration site conditions 256 (53) 14 (25) 14 (25) 41 (95) 46 (96) Pyrexia 103 (22) 5 (9) 9 (16) 26 (61) 31 (65) Infusion-related reaction 24 (5) 0 3 (5) 7 (16) 4 (8) Skin and subcutaneous tissue disorders 197 (41) 11 (20) 8 (14) 33 (77) 38 (79) Pruritus 54 (11) 0 1 (2) 14 (33) 15 (31) Rash 55 (12) 1 (2) 1 (2) 13 (30) 13 (27) Urticaria 24 (5) 0 1 (2) 8 (19) 4 (8) Respiratory, thoracic and mediastinal disorders 194 (41) 9 (16) 13 (23) 30 (70) 33 (69) Epistaxis 45 (9) 0 0 4 (9) 8 (17) Blood and lymphatic system disorders 161 (34) 17 (30) 13 (23) 40 (93) 44 (92) Thrombocytopenia 70 (15) 5 (9) 3 (5) 31 (72) 37 (77) Neutropenia 61 (13) 3 (5) 4 (7) 33 (77) 34 (71) Anemia 63 (13) 10 (18) 6 (11) 22 (51) 24 (50) Febrile neutropenia 23 (5) 0 0 7 (16) 7 (15) Investigations 191 (40) 12 (21) 8 (14) 24 (56) 25 (52) Alanine aminotransferase increased 45 (10) 0 0 7 (16) 1 (2) Urine output decreased 18 (4) 0 0 10 (23) 8 (17) Cardiac disorders 97 (20) 7 (13) 3 (5) 10 (23) 17 (35) Tachycardia 47 (10) 2 (4) 1 (2) 7 (16) 12 (25) Renal and urinary disorders 78 (16) 4 (7) 4 (7) 16 (37) 15 (31) Hematuria 18 (4) 0 0 10 (23) 7 (15) Psychiatric disorders 80 (17) 3 (5) 1 (2) 20 (47) 9 (19) Anxiety 35 (7) 0 0 10 (23) 3 (6) Other clinically significant adverse reactions reported at less than 15% in pediatric clinical trials are listed below: • Hepatobiliary disorders: hyperbilirubinemia • Investigations: liver function tests abnormal • Renal Disorders: renal failure 6.4 Postmarketing Adverse Reactions 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 [see Clinical Pharmacology (12)]. 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. Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary (7)

Use In Specific Populations

•Pregnancy - No human data. Adverse effects in animals. Use if potential benefits of treatment outweigh potential fetal risk (8.1) •Nursing Mothers - Caution should be exercised if administered to a nursing woman (8.3) •Safety and effectiveness in pediatric patients less than 4 months of age have not been established (8.4) 8.1 Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies of MYCAMINE in pregnant women. Animal reproduction studies in rabbits showed visceral abnormalities and increased abortion at 4 times the recommended human dose. However, animal studies are not always predictive of human response. MYCAMINE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When pregnant rabbits were given 4 times the recommended human dose, there were increased abortion and visceral abnormalities including abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, and dilatation of the ureter [see Nonclinical Toxicology (13.2)]. 8.3 Nursing Mothers It is not known whether micafungin is excreted in human milk. Caution should be exercised when MYCAMINE is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness in pediatric patients younger than 4 months of age have not been established. Safety and effectiveness of MYCAMINE in pediatric patients 4 months of age and older have been demonstrated based on the evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. Two randomized, double-blind, active-control studies investigated the safety and efficacy of MYCAMINE in both adult and pediatric patients: one for the treatment of invasive candidiasis and candidemia and the other for prophylaxis of Candida infections in patients undergoing HSCT [see Dosage and Administration (2), Adverse Reactions (6.3), Clinical Pharmacology (12.3), Clinical Studies (14)]. 8.5 Geriatric Use A total of 418 subjects in clinical studies of MYCAMINE were 65 years of age and older, and 124 subjects were 75 years of age and older. No overall differences in safety and effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The exposure and disposition of a 50 mg MYCAMINE dose administered as a single 1-hour infusion to 10 healthy subjects aged 66-78 years were not significantly different from those in 10 healthy subjects aged 20-24 years. No dose adjustment is necessary for the elderly. 8.6 Use in Patients with Renal Impairment MYCAMINE does not require dose adjustment in patients with renal impairment. Supplementary dosing should not be required following hemodialysis [see Clinical Pharmacology (12.3)]. 8.7 Use in Patients with Hepatic Impairment Dose adjustment of MYCAMINE is not required in patients with mild, moderate, or severe hepatic impairment [see Clinical Pharmacology (12.3)]. 8.8 Race and Gender No dose adjustment of MYCAMINE is required based on gender or race. After 14 daily doses of 150 mg to healthy subjects, micafungin AUC in women was greater by approximately 23% compared with men, due to smaller body weight. No notable differences among white, black, and Hispanic subjects were seen. The micafungin AUC was greater by 19% in Japanese subjects compared to blacks, due to smaller body weight.