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Mycamine

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Mycamine

Side Effects
Interactions

SIDE EFFECTS

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.

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.

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: Selected* Treatment-Emergent Adverse Reactions in Adult Patients with Candidemia and Other Candida Infections

System Organ Class¥ (Preferred Term) † Mycamine 100 mg
n (%)
Mycamine 150 mg
n (%)
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
Patient base: all randomized patients who received at least 1 dose of trial drug
* During IV treatment + 3 days
¥MedDRA v5.0
† Within a system organ class patients may experience more than 1 adverse reaction.
‡ 70 mg loading dose on day 1 followed by 50 mg/day thereafter (caspofungin)

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: Selected* Treatment-Emergent Adverse Reactions in Adult Patients with Esophageal Candidiasis

System Organ Class¥ (Preferred Term)† 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)
Patient base: all randomized patients who received at least 1 dose of trial drug
* During treatment + 3 days.
¥MedDRA v5.0
† Within a system organ class patients may experience more than 1 adverse reaction.

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

System Organ Class¥ (Preferred Term) † 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)
Patient base: all randomized adult patients who received at least 1 dose of trial drug
¥MedDRA v12.0
† Within a system organ class patients may experience more than 1 adverse reaction.

Other selected adverse reactions reported at less than 5% in adult clinical trials are listed below:

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

System Organ Class¥ (Preferred Term) † All Micafungintreated 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)
Patient base: all randomized patients who received at least one dose of trial drug.
¥MedDRA v12.0
†Within a system organ class, patients may experience more than 1 adverse reaction.

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

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

Read the Mycamine (micafungin sodium) Side Effects Center for a complete guide to possible side effects

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].

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.

Drug Abuse And Dependence

There has been no evidence of either psychological or physical dependence or withdrawal or rebound effects with Mycamine.

Read the Mycamine Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 8/26/2013
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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