Mycamine
(Micafungin Sodium)Mycamine Prescribing Information
Indications and Usage (
MYCAMINE®is an echinocandin indicated in adult and pediatric patients for :
• Treatment of Candidemia, Acute Disseminated Candidiasis,CandidaPeritonitis and Abscesses in adult and pediatric patients 4 months of age and older.• Treatment of Candidemia, Acute Disseminated Candidiasis,CandidaPeritonitis and Abscessesmeningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age.without• Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.• Prophylaxis ofCandidaInfections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT).
• The safety and effectiveness of MYCAMINE have not been established for the treatment of candidemiameningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed.with• MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due toCandida.• The efficacy of MYCAMINE against infections caused by fungi other thanCandidahas not been established.
Dosage and Administration, Dosage for Pediatric Patients Younger
than 4 Months of Age (
The safety and effectiveness of MYCAMINE have
Warnings and Precautions, Infusion and Injection Site Reactions
(
Two dose levels of MYCAMINE were evaluated in a randomized, double-blind study to determine the efficacy and safety versus caspofungin in patients with invasive candidiasis and candidemia. Patients were randomized to receive once daily intravenous infusions (IV) of MYCAMINE, either 100 mg/day or 150 mg/day or caspofungin (70 mg loading dose followed by 50 mg maintenance dose). Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided they were non-neutropenic, had improvement or resolution of clinical signs and symptoms, had a
In this study, 111/578 (19.2%) of the patients had baseline APACHE II scores of greater than 20, and 50/578 (8.7%) were neutropenic at baseline (absolute neutrophil count less than 500 cells/mm3). Outcome, relapse and mortality data are shown for the recommended dose of MYCAMINE (100 mg/day) and caspofungin in Table 9.
MYCAMINE 100 mg/day n (%) % treatment difference (95% CI) | Caspofungin 70/50 mg/day 70 mg loading dose on day 1 followed by 50 mg/day thereafter (caspofungin).n (%) | |
Treatment Success at End of IV Therapy All patients who received at least one dose of study medication and had documented invasive candidiasis or candidemia. Patients withCandida endocarditis were excluded from the analyses. | 135/191 (70.7) 7.4 (-2.0, 16.3) | 119/188 (63.3) |
Success in Patients with Neutropenia at Baseline | 14/22 (63.6) | 5/11 (45.5) |
Success by Site of Infection | ||
Candidemia | 116/163 (71.2) | 103/161 (64) |
Abscess | 4/5 (80) | 5/9 (55.6) |
Acute Disseminated A patient may have had greater than 1 organ of dissemination. | 6/13 (46.2) | 5/9 (55.6) |
Endophthalmitis | 1/3 | 1/1 |
Chorioretinitis | 0/3 | 0 |
Skin | 1/1 | 0 |
Kidney | 2/2 | 1/1 |
Pancreas | 1/1 | 0 |
Peritoneum | 1/1 | 0 |
Lung/Skin | 0/1 | 0 |
Lung/Spleen | 0/1 | 0 |
Liver | 0 | 0/2 |
Intraabdominal abscess | 0 | 3/5 |
Chronic Disseminated | 0/1 | 0 |
Peritonitis | 4/6 (66.7) | 2/5 (40) |
Success by Organism A patient may have had greater than 1 baseline infection species. | ||
C. albicans | 57/81 (70.4) | 45/73 (61.6) |
C. glabrata | 16/23 (69.6) | 19/31 (61.3) |
C. tropicalis | 17/27 (63) | 22/29 (75.9) |
C. parapsilosis | 21/28 (75) | 22/39 (56.4) |
C. krusei | 5/8 (62.5) | 2/3 (66.7) |
C. guilliermondii | 1/2 | 0/1 |
C. lusitaniae | 2/3 (66.7) | 2/2 |
Relapse through 6 Weeks All patients who had a culture-confirmed relapse or required systemic antifungal therapy in the post-treatment period for a suspected or provenCandida infection. Also includes patients who died or were not assessed in follow-up. | ||
Overall | 49/135 (36.3) | 44/119 (37) |
Culture-confirmed relapse | 5 | 4 |
Required systemic antifungal therapy | 11 | 5 |
Died during follow-up | 17 | 16 |
Not assessed | 16 | 19 |
Overall study mortality | 58/200 (29) | 51/193 (26.4) |
Mortality during IV therapy | 28/200 (14) | 27/193 (14) |
In two cases of ophthalmic involvement assessed as failures in the above table due to missing evaluation at the end of IV treatment with MYCAMINE, therapeutic success was documented during protocol-defined oral fluconazole therapy.
The safety and effectiveness of MYCAMINE for the treatment of esophageal candidiasis, candidemia, acute disseminated candidiasis,
The safety and effectiveness of MYCAMINE for the treatment of candidemia, acute disseminated candidiasis,
The safety and effectiveness of MYCAMINE have
In a rabbit model of hematogenous
A randomized controlled trial evaluated a MYCAMINE dose regimen of 10 mg/kg once daily in pediatric patients younger than 4 months of age with suspected or proven
In six uncontrolled, open-label studies, and a neonatal intensive care unit (ICU) medical records database, pediatric patients younger than 4 months of age with suspected
Although the dosage for the treatment of candidemia with meningoencephalitis has not been established, antifungal activity in various CNS compartments in the rabbit HCME model and limited clinical trial data suggest that in patients younger than 4 months of age, dose regimens 10 mg/kg once daily or higher may be necessary for the treatment of candidemia with meningoencephalitis. Safety data from clinical studies for MYCAMINE at dose regimens of 10 to 15 mg/kg once daily in pediatric patients younger than 4 months of age did not reveal new safety signals.
The safety and effectiveness of MYCAMINE in pediatric patients younger than 4 months of age have
• Treatment of esophageal candidiasis• Prophylaxis ofCandidainfections in patients undergoing hematopoietic stem cell transplantation
The safety and effectiveness of MYCAMINE for the treatment of esophageal candidiasis, candidemia, acute disseminated candidiasis,
The safety and effectiveness of MYCAMINE for the treatment of candidemia, acute disseminated candidiasis,
The safety and effectiveness of MYCAMINE have
In a rabbit model of hematogenous
A randomized controlled trial evaluated a MYCAMINE dose regimen of 10 mg/kg once daily in pediatric patients younger than 4 months of age with suspected or proven
In six uncontrolled, open-label studies, and a neonatal intensive care unit (ICU) medical records database, pediatric patients younger than 4 months of age with suspected
Although the dosage for the treatment of candidemia with meningoencephalitis has not been established, antifungal activity in various CNS compartments in the rabbit HCME model and limited clinical trial data suggest that in patients younger than 4 months of age, dose regimens 10 mg/kg once daily or higher may be necessary for the treatment of candidemia with meningoencephalitis. Safety data from clinical studies for MYCAMINE at dose regimens of 10 to 15 mg/kg once daily in pediatric patients younger than 4 months of age did not reveal new safety signals.
The safety and effectiveness of MYCAMINE in pediatric patients younger than 4 months of age have
• Treatment of esophageal candidiasis• Prophylaxis ofCandidainfections in patients undergoing hematopoietic stem cell transplantation
In two controlled trials involving 763 patients with esophageal candidiasis, 445 adults with endoscopically-proven candidiasis received MYCAMINE, and 318 received fluconazole for a median duration of 14 days (range 1 to 33 days).
MYCAMINE was evaluated in a randomized, double-blind study which compared MYCAMINE 150 mg/day (n = 260) to intravenous fluconazole 200 mg/day (n = 258) in adults with endoscopically-proven esophageal candidiasis. Most patients in this study had HIV infection, with CD4 cell counts less than 100 cells/mm3. Outcome was assessed by endoscopy and by clinical response at the end of treatment. Endoscopic cure was defined as endoscopic grade 0, based on a scale of 0 to 3. Clinical cure was defined as complete resolution in clinical symptoms of esophageal candidiasis (dysphagia, odynophagia, and retrosternal pain). Overall therapeutic cure was defined as both clinical and endoscopic cure. Mycological eradication was determined by culture, and by histological or cytological evaluation of esophageal biopsy or brushings obtained endoscopically at the end of treatment. As shown in Table 10, endoscopic cure, clinical cure, overall therapeutic cure, and mycological eradication were comparable for patients in the MYCAMINE and fluconazole treatment groups.
Treatment Outcome Endoscopic and clinical outcome were measured in the modified intent-to-treat population, including all randomized patients who received 1 or more doses of study treatment. The mycological outcome was determined in the per protocol (evaluable) population, including patients with confirmed esophageal candidiasis who received at least 10 doses of study drug, and had no major protocol violations. | MYCAMINE 150 mg/day n = 260 | Fluconazole 200 mg/day n = 258 | % Difference Calculated as MYCAMINE – fluconazole.(95% CI) |
Endoscopic Cure | 228 (87.7%) | 227 (88.0%) | -0.3% (-5.9, +5.3) |
Clinical Cure | 239 (91.9%) | 237 (91.9%) | 0.06% (-4.6, +4.8) |
Overall Therapeutic Cure | 223 (85.8%) | 220 (85.3%) | 0.5% (-5.6, +6.6) |
Mycological Eradication | 141/189 (74.6%) | 149/192 (77.6%) | -3.0% (-11.6, +5.6) |
Most patients (96%) in this study had
Relapse was assessed at 2 and 4 weeks post-treatment in patients with overall therapeutic cure at end of treatment. Relapse was defined as a recurrence of clinical symptoms or endoscopic lesions (endoscopic grade greater than 0). There was no statistically significant difference in relapse rates at either 2 weeks or through 4 weeks post-treatment for patients in the MYCAMINE and fluconazole treatment groups, as shown in Table 11.
Relapse | MYCAMINE 150 mg/day n = 223 | Fluconazole 200 mg/day n = 220 | % Difference Calculated as MYCAMINE – fluconazole; N = number of patients with overall therapeutic cure (both clinical and endoscopic cure at end-of-treatment);(95% CI) |
RelapseRelapse included patients who died or were lost to follow-up, and those who received systemic anti-fungal therapy in the post-treatment period.at Week 2 | 40 (17.9%) | 30 (13.6%) | 4.3% (-2.5, 11.1) |
Relapse through Week 4 (cumulative) | 73 (32.7%) | 62 (28.2%) | 4.6% (-4.0, 13.1) |
In this study, 459 of 518 (88.6%) patients had oropharyngeal candidiasis in addition to esophageal candidiasis at baseline. At the end of treatment, 192/230 (83.5%) MYCAMINE-treated patients and 188/229 (82.1%) of fluconazole-treated patients experienced resolution of signs and symptoms of oropharyngeal candidiasis. Of these, 32.3% in the MYCAMINE group, and 18.1% in the fluconazole group (treatment difference = 14.2%; 95% confidence interval [5.6, 22.8]) had symptomatic relapse at 2 weeks post-treatment. Relapse included patients who died or were lost to follow-up, and those who received systemic antifungal therapy during the post-treatment period. Cumulative relapse at 4 weeks post-treatment was 52.1% in the MYCAMINE group and 39.4% in the fluconazole group (treatment difference 12.7%, 95% confidence interval [2.8, 22.7]).
In a randomized, double-blind study, MYCAMINE (50 mg IV once daily) was compared to fluconazole (400 mg IV once daily) in 882 [adult (791) and pediatric (91)] patients undergoing an autologous or syngeneic (46%) or allogeneic (54%) stem cell transplant. All pediatric patients, except 2 per group, received allogeneic transplants. The status of the patients’ underlying malignancy at the time of randomization was: 365 (41%) patients with active disease, 326 (37%) patients in remission, and 195 (22%) patients in relapse. The more common baseline underlying diseases in the 476 allogeneic transplant recipients were: chronic myelogenous leukemia (22%), acute myelogenous leukemia (21%), acute lymphocytic leukemia (13%), and non-Hodgkin’s lymphoma (13%). In the 404 autologous and syngeneic transplant recipients the more common baseline underlying diseases were: multiple myeloma (37.1%), non-Hodgkin’s lymphoma (36.4%), and Hodgkin's disease (15.6%). During the study, 198 of 882 (22.4%) transplant recipients had proven graft-versus-host disease; and 475 of 882 (53.9%) recipients received immunosuppressive medications for treatment or prophylaxis of graft-versus-host disease.
Study drug was continued until the patient had neutrophil recovery to an absolute neutrophil count (ANC) of 500 cells/mm3or greater or up to a maximum of 42 days after transplant. The average duration of drug administration was 18 days (range 1 to 51 days). Duration of therapy was slightly longer in the pediatric patients who received MYCAMINE (median duration 22 days) compared to the adult patients who received MYCAMINE (median duration 18 days).
Successful prophylaxis was defined as the absence of a proven, probable, or suspected systemic fungal infection through the end of therapy (usually 18 days), and the absence of a proven or probable systemic fungal infection through the end of the 4-week post-therapy period. A suspected systemic fungal infection was diagnosed in patients with neutropenia (ANC less than 500 cells/mm3); persistent or recurrent fever (while ANC less than 500 cells/mm3) of no known etiology; and failure to respond to at least 96 hours of broad spectrum antibacterial therapy. A persistent fever was defined as four consecutive days of fever greater than 38ºC. A recurrent fever was defined as having at least one day with temperatures 38.5ºC or higher after having at least one prior temperature higher than 38ºC; or having two days of temperatures higher than 38ºC after having at least one prior temperature higher than 38ºC. Transplant recipients who died or were lost to follow-up during the study were considered failures of prophylactic therapy.
Successful prophylaxis was documented in 80.7% of adult and pediatric MYCAMINE recipients, and in 73.7% of adult and pediatric patients who received fluconazole (7.0% difference [95% CI = 1.5, 12.5]), as shown in Table 12, along with other study endpoints. The use of systemic antifungal therapy post-treatment was 42% in both groups.
The number of proven breakthrough
The efficacy of MYCAMINE against infections caused by fungi other than
Outcome of Prophylaxis | MYCAMINE 50 mg/day (n = 425) | Fluconazole 400 mg/day (n = 457) |
SuccessDifference (MYCAMINE – fluconazole): +7.0% [95% CI=1.5, 12.5]. | 343 (80.7%) | 337 (73.7%) |
Failure: | 82 (19.3%) | 120 (26.3%) |
All DeathsThrough end-of-study (4 weeks post-therapy). Proven/probable fungal infection prior to death | 18 (4.2%) 1 (0.2%) | 26 (5.7%) 3 (0.7%) |
Proven/probable fungal infection (not resulting in death) | 6 (1.4%) | 8 (1.8%) |
Suspected fungal infectionThrough end-of-therapy. | 53 (12.5%) | 83 (18.2%) |
Lost to follow-up | 5 (1.2%) | 3 (0.7%) |
The safety and effectiveness of MYCAMINE for the treatment of esophageal candidiasis, candidemia, acute disseminated candidiasis,
The safety and effectiveness of MYCAMINE for the treatment of candidemia, acute disseminated candidiasis,
The safety and effectiveness of MYCAMINE have
In a rabbit model of hematogenous
A randomized controlled trial evaluated a MYCAMINE dose regimen of 10 mg/kg once daily in pediatric patients younger than 4 months of age with suspected or proven
In six uncontrolled, open-label studies, and a neonatal intensive care unit (ICU) medical records database, pediatric patients younger than 4 months of age with suspected
Although the dosage for the treatment of candidemia with meningoencephalitis has not been established, antifungal activity in various CNS compartments in the rabbit HCME model and limited clinical trial data suggest that in patients younger than 4 months of age, dose regimens 10 mg/kg once daily or higher may be necessary for the treatment of candidemia with meningoencephalitis. Safety data from clinical studies for MYCAMINE at dose regimens of 10 to 15 mg/kg once daily in pediatric patients younger than 4 months of age did not reveal new safety signals.
The safety and effectiveness of MYCAMINE in pediatric patients younger than 4 months of age have
• Treatment of esophageal candidiasis• Prophylaxis ofCandidainfections in patients undergoing hematopoietic stem cell transplantation
The recommended dosage for adult patients based on indications are shown in Table 1.
Indication | Recommended Reconstituted Dose Once Daily |
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and AbscessesIn patients treated successfully for candidemia and otherCandida infections, the mean duration of treatment was 15 days (range 10 to 47 days). | 100 mg |
Treatment of Esophageal CandidiasisIn patients treated successfully for esophageal candidiasis, the mean duration of treatment was 15 days (range 10 to 30 days). | 150 mg |
Prophylaxis of Candida Infections in HSCT RecipientsIn 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). | 50 mg |
The recommended dosage for pediatric patients 4 months of age and older based on indication and weight are shown in Table 2.
Indication | Dosage for Pediatric Patients 4 Months of Age and Older | |
30 kg or less | Greater than 30 kg | |
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses | 2 mg/kg once daily (maximum daily dose 100 mg) | |
Treatment of Esophageal Candidiasis | 3 mg/kg once daily | 2.5 mg/kg once daily |
Prophylaxis of Candida Infections in HSCT Recipients | 1 mg/kg once daily | |
The safety and effectiveness of MYCAMINE have
The safety and effectiveness of MYCAMINE for the treatment of esophageal candidiasis, candidemia, acute disseminated candidiasis,
The safety and effectiveness of MYCAMINE for the treatment of candidemia, acute disseminated candidiasis,
The safety and effectiveness of MYCAMINE have
In a rabbit model of hematogenous
A randomized controlled trial evaluated a MYCAMINE dose regimen of 10 mg/kg once daily in pediatric patients younger than 4 months of age with suspected or proven
In six uncontrolled, open-label studies, and a neonatal intensive care unit (ICU) medical records database, pediatric patients younger than 4 months of age with suspected
Although the dosage for the treatment of candidemia with meningoencephalitis has not been established, antifungal activity in various CNS compartments in the rabbit HCME model and limited clinical trial data suggest that in patients younger than 4 months of age, dose regimens 10 mg/kg once daily or higher may be necessary for the treatment of candidemia with meningoencephalitis. Safety data from clinical studies for MYCAMINE at dose regimens of 10 to 15 mg/kg once daily in pediatric patients younger than 4 months of age did not reveal new safety signals.
The safety and effectiveness of MYCAMINE in pediatric patients younger than 4 months of age have
• Treatment of esophageal candidiasis• Prophylaxis ofCandidainfections in patients undergoing hematopoietic stem cell transplantation
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 | See below | |
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without | |||
See above | See above | 4 mg/kg/day | |
Treatment of Esophageal Candidiasis | |||
150 mg daily | 3 mg/kg/day | 2.5 mg/kg/day | Not approved |
Prophylaxis of Candida Infections in HSCT Recipients | |||
50 mg daily | 1 mg/kg/day | Not approved | |
• Infuse over 1 hour. ()2.5 Infusion Volume and DurationAdminister MYCAMINE by intravenous infusion only. Infuse over one hour. More rapid infusions may result in more frequent histamine-mediated reactions
[see Warnings and Precautions ].Flush an existing intravenous line with 0.9% Sodium Chloride Injection, USP, prior to infusion of MYCAMINE.
Pediatric PatientsMYCAMINE should be infused over one hour. To decrease the risk of infusion reactions, concentrations above
1.5 mg/mL should be administered via central catheter[see Warnings and Precautions ].• See Full Prescribing Information for intravenous (IV) preparation and administration instructions. ()2 DOSAGE AND ADMINISTRATIONRecommended Dosage Administered by Indication, Weight and AgeAdultPediatric Patients4 Months and Older30 kg or lessPediatric Patients4 Months and Oldergreater than 30 kgPediatric Patients Younger than 4 Months of AgeTreatment of Candidemia, Acute Disseminated Candidiasis,CandidaPeritonitis and Abscesses100 mg daily
2 mg/kg/day
(maximum 100 mg daily)See below
Treatment of Candidemia, Acute Disseminated Candidiasis,CandidaPeritonitis and AbscessesMeningoencephalitis and/or Ocular DisseminationwithoutSee above
See above
4 mg/kg/day
Treatment of Esophageal Candidiasis150 mg daily
3 mg/kg/day
2.5 mg/kg/day
(maximum
150 mg daily)Not approved
Prophylaxis ofCandidaInfections in HSCT Recipients50 mg daily
1 mg/kg/day
(maximum 50 mg daily)Not approved
• Infuse over 1 hour.• See Full Prescribing Information for intravenous (IV) preparation and administration instructions.
2.1 Dosage for AdultsThe recommended dosage for adult patients based on indications are shown in Table 1.
Table 1. MYCAMINE Dosage in Adult Patients IndicationRecommended Reconstituted Dose Once DailyTreatment of Candidemia, Acute Disseminated Candidiasis,
CandidaPeritonitis and AbscessesIn patients treated successfully for candidemia and otherCandidainfections, the mean duration of treatment was 15 days (range 10 to 47 days).100 mgTreatment of Esophageal CandidiasisIn patients treated successfully for esophageal candidiasis, the mean duration of treatment was 15 days (range 10 to 30 days).
150 mgProphylaxis of
CandidaInfections in HSCT RecipientsIn 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).50 mg2.2 Dosage for Pediatric Patients 4 Months and OlderThe recommended dosage for pediatric patients 4 months of age and older based on indication and weight are shown in Table 2.
Table 2. MYCAMINE Dosage in Pediatric Patients (4 Months of Age and Older) IndicationDosage for Pediatric Patients4 Months of Age and Older30 kg or lessGreater than 30 kgTreatment of Candidemia, Acute Disseminated Candidiasis,
CandidaPeritonitis and Abscesses2 mg/kg once daily
(maximum daily dose 100 mg)
Treatment of Esophageal Candidiasis
3 mg/kg once daily
2.5 mg/kg once daily
(maximum daily dose 150 mg)Prophylaxis of
CandidaInfections in HSCT Recipients1 mg/kg once daily
(maximum daily dose 50 mg)2.3 Dosage for Pediatric Patients Younger than 4 Months of AgeTreatment of Candidemia, Acute Disseminated Candidiasis,CandidaPeritonitis and Abscessesmeningoencephalitis and/or ocular disseminationwithoutThe recommended dosage is 4 mg/kg once daily.
The safety and effectiveness of MYCAMINE havebeen established for the treatment of candidemianotmeningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be neededwith[see Use in Specific Populations , Clinical Pharmacology and Microbiology ].2.4 Directions for Reconstitution, Dilution, and PreparationDo not mix or co-infuse MYCAMINE with other medications. MYCAMINE has been shown to precipitate when mixed directly with a number of other commonly used medications. Please read this entire section carefully before beginning reconstitution.
ReconstitutionReconstitute MYCAMINE vials by aseptically adding 5 mL of one of the following compatible solutions:
• 0.9% Sodium Chloride Injection, USP (without a bacteriostatic agent)• 5% Dextrose Injection, USP
To minimize excessive foaming, gently dissolve the MYCAMINE powder by swirling the vial.
Do not vigorously shake the vial. Visually inspect the vial for particulate matter.MYCAMINE 50 mg vial: after reconstitution each mL contains 10 mg of micafungin.MYCAMINE 100 mg vial: after reconstitution each mL contains 20 mg of micafungin.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if there is any evidence of precipitation or foreign matter. Aseptic technique must be strictly observed in all handling since no preservative or bacteriostatic agent is present in MYCAMINE or in the materials specified for reconstitution and dilution.
The reconstituted product should be protected from light and may be stored in the original vial for up to 24 hours at room temperature, 25oC (77oF).
Dilution and PreparationThe diluted solution should be protected from light. It is not necessary to cover the infusion drip chamber or the tubing.
Adult Patients:1.000000000000000e+00 Add the appropriate volume of reconstituted MYCAMINE into 100 mL of 0.9% Sodium Chloride Injection, USP or 100 mL of 5% Dextrose Injection, USP.2.000000000000000e+00 Appropriately label the bag.
Pediatric Patients1.000000000000000e+00 Calculate the total MYCAMINE dose in milligrams (mg) by multiplying the recommended pediatric dose (mg/kg) for a given indication[see Table 2]and the weight of the patient in kilograms (kg).2.000000000000000e+00 To calculate the volume (mL) of drug needed, divide the calculated dose (mg) from step 1 by the final concentration of the selected reconstituted vial(s) (either 10 mg/mL for the 50 mg vialor20 mg/mL for the
100 mg vial), see example below:Using 50 mg vials:
Divide the calculated mg dose (from step 1) by 10 mg/mL to determine the volume (mL) needed.
ORUsing 100 mg vials:
Divide the calculated mg dose (from step 1) by 20 mg/mL to determine the volume (mL) needed.3.000000000000000e+00 Withdraw the calculated volume (mL) of drug needed from the selected concentration and size of reconstituted MYCAMINE vial(s) used in Step 2 (ensure the selected concentration and vial size used to calculate the dose is also used to prepare the infusion).4.000000000000000e+00 Add the withdrawn volume of drug (step 3) to a 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP intravenous infusion bag or syringe. Ensure that the final concentration of the solution is between 0.5 mg/mL to 4 mg/mL.
To decrease the risk of infusion reactions, concentrations above 1.5 mg/mL should be administered via central catheter[see Warnings and Precautions ].5.000000000000000e+00 Appropriately label the infusion bag or syringe. For concentrations above 1.5 mg/mL, if required, label to specifically warn to administer the solution via central catheter.
The diluted infusion bag should be protected from light and may be stored for up to 24 hours at room temperature, 25oC (77oF).
MYCAMINE is preservative-free. Discard partially used vials.
2.5 Infusion Volume and DurationAdminister MYCAMINE by intravenous infusion only. Infuse over one hour. More rapid infusions may result in more frequent histamine-mediated reactions
[see Warnings and Precautions ].Flush an existing intravenous line with 0.9% Sodium Chloride Injection, USP, prior to infusion of MYCAMINE.
Pediatric PatientsMYCAMINE should be infused over one hour. To decrease the risk of infusion reactions, concentrations above
1.5 mg/mL should be administered via central catheter[see Warnings and Precautions ].
MYCAMINE is a sterile, white lyophilized powder for reconstitution for intravenous infusion available as:
• 50 mg single-dose vial• 100 mg single-dose vial
Pregnancy – Based on animal data, MYCAMINE may cause fetal harm. Advise pregnant women of the risk to the fetus. (
Based on findings from animal studies, MYCAMINE may cause fetal harm when administered to a pregnant woman
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
In an embryo-fetal toxicity study in pregnant rabbits, intravenous administration of micafungin sodium during organogenesis (days 6 to 18 of gestation) resulted in fetal visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to four times the recommended human dose based on body surface area comparisons. Visceral abnormalities included abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, and dilatation of the ureter.
MYCAMINE is contraindicated in persons with known hypersensitivity to micafungin, any component of MYCAMINE, or other echinocandins.