Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous, as sodium [preservative free]:
Mycamine: 50 mg (1 ea)
Mycamine: 50 mg (1 ea) [contains lactose]
Mycamine: 100 mg (1 ea)
Mycamine: 100 mg (1 ea) [contains lactose]
Pharmacology
Mechanism of Action
Concentration-dependent inhibition of 1,3-beta-D-glucan synthase resulting in reduced formation of 1,3-beta-D-glucan, an essential polysaccharide comprising 30% to 60% of Candida cell walls (absent in mammalian cells); decreased glucan content leads to osmotic instability and cellular lysis
Pharmacokinetics/Pharmacodynamics
Absorption
Oral: Poor
Distribution
Distributes into lung, liver, and spleen; minimally to CNS and eyes (Caudle 2012)
Preterm infants (ELBW): Reported data highly variable; possibly dependent on GA/weight, and PNA: Vdss:
PNA 0 to 1 day: 0.76 L/kg (Kawada 2009)
PNA 4 days: 1.52 L/kg (Smith 2009)
PNA >3 weeks: 0.43 L/kg (range: 0.28 to 0.66 L/kg) (Heresi 2006)
Children 2 to 8 years: Vdss: 0.35 ± 0.18 L/kg (Seibel 2005)
Children and Adolescents 9 to 17 years: Vdss: 0.28 ± 0.09 L/kg (Seibel 2005)
Adults: Vd: 0.39 ± 0.11 L/kg
Metabolism
Hepatic to M-1, catechol form by arylsulfatase; further metabolized to M-2, methoxy form by catechol-O-methyltransferase; hydroxylation to M-5 by CYP3A
Excretion
Primarily feces (71%); urine (<1%, unchanged [Herbert 2005])
Clearance:
Preterm infants:
PNA 0 to 1 day: 1.48 mL/minute/kg (Kawada 2009)
PNA 4 days: 0.58 mL/minute (Smith 2009)
PNA >3 weeks: 0.64 mL/minute (Heresi 2006)
Children 4 months to 16 years: ≤30 kg: 0.328 mL/minute/kg; >30 kg: 0.241 mL/minute/kg
Adults: ~0.3 mL/minute/kg
Half-Life Elimination
Preterm infants: PNA <1 week: 6.7 hours (Kawada 2009); PNA >3 weeks: Mean 8.3 hours (range: 5.6 to 11 hours) (Heresi 2006)
Children 4 months to 16 years: ≤30 kg: 12.5 ± 4.6 hours; >30 kg: 13.6 ± 8.8 hours
Healthy Adults: 11 to 21 hours
Adults receiving bone marrow or peripheral stem-cell transplantation: 10.7 to 13.5 hours (Carver 2004)
Protein Binding
Neonates: 96.7% (Yanni 2011); Adults: >99% to albumin
Use in Specific Populations
Special Populations: Hepatic Function Impairment
Moderate impairment (Child-Pugh class B): AUC and Cmax reduced ~22% compared to normal hepatic function. Severe impairment (Child-Pugh class C): AUC and Cmax of parent drug reduced ~30% and M-5 metabolite increased ~2.3-fold compared to normal hepatic function; however, this exposure of parent/metabolite is comparable to patients with systemic Candida infections.
Use: Labeled Indications
Candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses: Treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses in adults and pediatric patients ≥4 months of age or in pediatric patients ≤4 months of age without meningoencephalitis and/or ocular dissemination.
Esophageal candidiasis: Treatment of esophageal candidiasis in adults and pediatric patients ≥4 months of age.
Prophylaxis of Candida infections: Prophylaxis of Candida infections in adults and pediatric patients ≥4 months of age undergoing hematopoietic stem cell transplantation.
Use: Off Label
Aspergillosis, invasive (salvage therapy)yes
Based on the Infectious Diseases Society of America (IDSA) Practice Guidelines for the Diagnosis and Management of Aspergillosis, micafungin is an effective and recommended therapeutic option for salvage therapy (either alone or in combination with another antifungal) for the treatment of invasive aspergillosis.
Candidiasis, intravascular infectionsyes
Based on the Infectious Diseases Society of America (IDSA) clinical practice guidelines for the management of candidiasis, micafungin is an effective and recommended treatment for patients with candida intravascular infections, including patients with endocarditis (native or prosthetic valve), infections of implantable cardiac devices (pacemaker, implantable cardiac defibrillator), and Candida suppurative thrombophlebitis.
Candidiasis, osteoarticular infectionsyes
Based on the Infectious Diseases Society of America (IDSA) clinical practice guidelines for the management of candidiasis, micafungin is an effective and recommended treatment for patients with Candida osteoarticular infections, including Candida osteomyelitis and Candida septic arthritis.
Candidiasis, chronic disseminated (hepatosplenic)yes
Based on the Infectious Diseases Society of America (IDSA) clinical practice guidelines for the management of candidiasis, micafungin is an effective and recommended treatment for patients with chronic disseminated (hepatosplenic) candidiasis.
Candidiasis empiric therapy (non-neutropenic ICU patients)yes
Based on the Infectious Diseases Society of America (IDSA) clinical practice guidelines for the management of candidiasis, micafungin is an effective and recommended agent for empiric therapy of suspected invasive candidiasis in non-neutropenic patients in the ICU.
Candidiasis, oropharyngeal (refractory disease)yes
Based on the Infectious Diseases Society of America (IDSA) clinical practice guidelines for the management of candidiasis, micafungin may be considered as an alternative for patients with oropharyngeal candidiasis refractory to other antifungals.
Candidiasis, prophylaxis against invasive candidiasis (high-risk ICU patients)yes
Based on the Infectious Diseases Society of America (IDSA) clinical practice guidelines for the management of candidiasis, micafungin may be considered as an alternative agent for prophylaxis against invasive candidiasis in high-risk patients in adult ICUs with a high rate of invasive candidiasis (>5%).
Empiric antifungal therapy (neutropenic fever)yes
Based on the Infectious Diseases Society of America (IDSA) Practice Guidelines for the Diagnosis and Management of Aspergillosis, micafungin is effective and recommended for empiric antifungal therapy in high-risk neutropenic patients who remain febrile despite broad-spectrum antibiotic therapy. According to the guidelines, empiric therapy is not recommended for patients with an anticipated duration of neutropenia <10 days, unless other findings indicate a suspected invasive fungal infection.
Contraindications
Hypersensitivity to micafungin, other echinocandins, or any component of the formulation
Dosage and Administration
Dosing: Adult
Aspergillosis, invasive (salvage therapy) (off-label use): IV: 100 to 150 mg once daily. Minimum duration of therapy is 6 to 12 weeks, although duration is highly dependent on degree/duration of immunosuppression, disease site, and evidence of disease improvement (IDSA [Patterson 2016])
Candidemia, acute disseminated candidiasis, and Candida peritonitis and abscesses: IV: 100 mg once daily; mean duration of therapy (from clinical trials) was 15 days (range: 10 to 47 days). Note: For treatment of candidemia, IDSA Candidiasis guidelines recommend a total duration of antifungal therapy of at least 2 weeks after the documented clearance of Candida from the bloodstream and resolution of candidemia-associated symptoms in patients without metastatic complications; may transition to fluconazole (eg, after 5 to 7 days in non-neutropenic patients) in clinically stable patients, with fluconazole-susceptible isolates and negative repeat cultures (IDSA [Pappas 2016]).
Candidiasis, chronic disseminated (hepatosplenic) (off-label use): IV: 100 mg daily for several weeks, followed by oral fluconazole therapy (IDSA [Pappas 2016])
Candidiasis, empiric therapy (suspected invasive candidiasis in non-neutropenic ICU patients) (off-label use): IV: 100 mg daily; treatment should continue for 14 days in patients showing clinical improvement. Consider discontinuing after 4 to 5 days in patients with no clinical response (IDSA [Pappas 2016]).
Candidiasis, intravascular infections (native or prosthetic valve endocarditis, infection of implantable cardiac devices, suppurative thrombophlebitis) (off-label use): IV: 150 mg daily. For native or prosthetic valve endocarditis, therapy should continue for at least 6 weeks after valve replacement surgery (longer durations in patients with abscesses or other complications); for patients with implantable cardiac devices, therapy should continue for 4 to 6 weeks after surgery (4 weeks for infections limited to generator pockets and at least 6 weeks for infections involving the wires); for suppurative thrombophlebitis, after catheter removal, continue for at least 2 weeks after candidemia has cleared. Note: Step-down to fluconazole therapy is recommended in clinically stable patients and fluconazole-susceptible isolates with negative repeat cultures (IDSA [Pappas 2016]).
Candidiasis, osteoarticular infections (osteomyelitis or septic arthritis) (alternative therapy) (off-label use): IV: 100 mg daily for at least 14 days, followed by fluconazole therapy (IDSA [Pappas 2016])
Candidiasis, oropharyngeal (refractory disease) (alternative therapy) (off-label use): IV: 100 mg once daily (IDSA [Pappas 2016])
Empiric antifungal therapy (neutropenic fever) (off-label use): IV: 100 mg once daily (IDSA [Patterson 2016])
Esophageal candidiasis: IV: 150 mg once daily; mean duration of therapy (from clinical trials) was 15 days (range: 10 to 30 days). Note: IDSA Candidiasis guidelines suggest considering a transition to oral fluconazole therapy once oral intake tolerable. In patients with fluconazole-refractory disease, continue micafungin for 14 to 21 days (IDSA [Pappas 2016]).
Prophylaxis of Candida infections: IV:
In hematopoietic stem cell transplantation: 50 mg once daily; mean duration of therapy (from clinical trials) was 19 days (range: 6 to 51 days)
In high-risk ICU patients in units with high incidence of invasive candidiasis (alternative therapy; off-label use): 100 mg daily (Pappas [IDSA 2016])
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Aspergillosis:
Treatment; invasive disease: Limited data available:
Infants ≥4 months and Children; independent of HIV status: IV: 1.5 to 3 mg/kg/day once daily; titration to a higher dose may be necessary for lack of clinical response or persistent positive cultures; reported usual maximum dose range: 4 to 8.6 mg/kg/day; in infants, initial doses at the higher end of the dosage range may be necessary due to pharmacokinetic differences (Denning 2006, Emiroglu 2011; Flynn 2006; Kobayashi 2007; Singer 2003)
Adolescents:
Non-HIV-exposed/-positive: IV: 1.5 mg/kg/day; increase if clinically indicated; maximum daily dose: 150 mg/day; dosing based on a noncomparative study of all ages, an abstract describing a study in pediatric patients 3 months to 16 years and single case report of a 13-year old who received 1.5 mg/kg/day for invasive aspergillosis (Denning 2006; Emiroglu 2011; Flynn 2006; Singer 2003).
HIV-exposed/-positive: IV: 100 to 150 mg once daily (DHHS [adult] 2013)
Prophylaxis in hematopoietic stem cell transplantation (HSCT): Limited data available: Infants ≥4 months, Children, and Adolescents: IV: 1 to 3 mg/kg daily; maximum dose: 50 mg (Kusuki 2009; Tomblyn 2009; van Burik 2004)
Candidiasis:
Acute disseminated infection, peritonitis, and abscesses; treatment:
Non-HIV-exposed/-positive:
Infants <4 months: Limited data available: IV: 2 mg/kg/day once daily; may increase higher doses (4 to 10 mg/kg/day) if no improvement in condition, or persistent positive cultures; reported range: 2 to 10 mg/kg/day (Benjamin 2010; Hope 2010; Myacin prescribing information [European Medicines Agency] 2013; Queiroz-Telles 2008)
Infants ≥4 months, Children, and Adolescents: IV: 2 mg/kg once daily; maximum dose: 100 mg/dose
HIV-exposed/-positive (DHHS [pediatric] 2013):
Infants <4 months (critically ill): IV: 5 to 7 mg/kg/day once daily; treatment duration variable, continue treatment for 2 weeks following last positive blood culture
Infants ≥4 months and weighing <15 kg: IV: 5 to 7 mg/kg once daily
Children 2 to 8 years and ≤40 kg: IV: 3 to 4 mg/kg once daily
Children ≥9 years and Adolescents:
≤40 kg: IV: 2 to 3 mg/kg once daily
>40 kg: IV: 100 mg once daily
Esophageal candidiasis, treatment:
Non-HIV-exposed/-positive: Infants ≥4 months, Children, and Adolescents:
≤30 kg: IV: 3 mg/kg once daily
>30 kg: IV: 2.5 mg/kg once daily; maximum dose: 150 mg/dose
HIV-exposed/-positive (DHHS [adult/pediatric] 2013):
Infants <4 months: IV: 5 to 7 mg/kg/day once daily; treatment duration: ≥3 weeks and for at least 2 weeks following symptom resolution
Infants ≥4 months and weighing <15 kg: IV: 5 to 7 mg/kg once daily
Children 2 to 8 years and ≤40 kg: IV: 3 to 4 mg/kg once daily
Children ≥9 years:
≤40 kg: IV: 2 to 3 mg/kg once daily
>40 kg: IV: 100 mg once daily
Adolescents:
<40 kg: IV: 2 to 3 mg/kg once daily
≥40 kg: IV: 150 mg once daily; treatment duration: 14 to 21 days
Prophylaxis in hematopoietic stem cell transplantation: Infants ≥4 months, Children, and Adolescents: IV: 1 mg/kg daily; maximum dose: 50 mg; doses as high as 3 mg/kg/day have been used in trials (Kusuki 2009; van Burik 2004)
Reconstitution
Aseptically add 5 mL of NS (preservative free) or D5W to each 50 or 100 mg vial. To minimize foaming, gently swirl to dissolve; do not shake. Further dilute 50 to 150 mg in 100 mL NS or D5W. Protect infusion solution from light (it is not necessary to protect the drip chamber or tubing from light).
Administration
IV: For IV use only; infuse over 1 hour; may reduce infusion rate for infusion reaction (eg, rash, pruritus, facial swelling, vasodilatation). Flush line with NS prior to administration.
Storage
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Reconstituted and diluted solutions in D5W or NS are stable for 24 hours at room temperature. Protect infusion solution from light (it is not necessary to protect the drip chamber or tubing from light).
Drug Interactions
Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic effect of Saccharomyces boulardii. Avoid combination
Sirolimus: Micafungin may increase the serum concentration of Sirolimus. Monitor therapy
Adverse Reactions
Candidiasis treatment:
>10%:
Cardiovascular: Phlebitis (19%)
Gastrointestinal: Vomiting (7% to 18%), diarrhea (7% to 13%)
Hematologic & oncologic: Anemia (pediatric: 18%)
Hepatic: Abnormal hepatic function tests (4%; pediatric: <15%), hyperbilirubinemia (pediatric: <15%)
Renal: Renal failure (<15%)
Miscellaneous: Fever (7% to 13%)
1% to 10%:
Cardiovascular: Atrial fibrillation (adults: 3% to 5%), tachycardia (pediatric: 4%)
Central nervous system: Headache (adults: 9%)
Dermatologic: Skin rash (2% to 5%)
Endocrine & metabolic: Hypoglycemia (adults: 6% to 7%), hypernatremia (adults: 4% to 6%), hyperkalemia (adults: 4% to 5%), abnormal aspartate transaminase (3%)
Gastrointestinal: Nausea (7% to 10%), abdominal pain (pediatric: 4%), abdominal distention (pediatric: 2%)
Hematologic & oncologic: Thrombocytopenia (pediatric: 9%), neutropenia (pediatric: 5%)
Hepatic: Increased serum alkaline phosphatase (3% to 8%)
Candidiasis prophylaxis in hematopoietic stem cell transplantation:
>10%:
Cardiovascular: Tachycardia (16% to 26%)
Central nervous system: Headache (adults: 44%), insomnia (adults: 37%), anxiety (22% to 23%)
Dermatologic: Pruritus (pediatric: 33%), skin rash (25% to 30%), urticaria (<5%; pediatric: 19%)
Endocrine & metabolic: Abnormal alanine aminotransferase (pediatric: 16%, increased)
Gastrointestinal: Diarrhea (77%; pediatric: 51%), nausea (70% to 71%), vomiting (65% to 66%), diarrhea (pediatric: 51%), abdominal pain (26% to 35%), abdominal distention (pediatric: 19%)
Genitourinary: Decreased urine output (pediatric: 23%), hematuria (pediatric: 23%)
Hematologic & oncologic: Neutropenia (75% to 77%), thrombocytopenia (72% to 75%), anemia (pediatric: 51%), febrile neutropenia (pediatric: 16%)
Hepatic: Abnormal hepatic function tests (pediatric: <15%), hyperbilirubinemia (pediatric: <15%)
Renal: Renal failure (pediatric: <15%)
Miscellaneous: Fever (pediatric: 61%), infusion-related reaction (pediatric: 16%)
1% to 10%:
Cardiovascular: Cardiac arrest (<5%), myocardial infarction (<5%), pericardial effusion (<5%)
Central nervous system: Brain disease (<5%), delirium (<5%), intracranial hemorrhage (<5%), seizure (<5%)
Hematologic & oncologic: Blood coagulation disorder (<5%), pancytopenia (<5%), thrombotic thrombocytopenic purpura (<5%)
Hepatic: Hepatic failure (<5%), hepatic injury (<5%), hepatomegaly (<5%), jaundice (<5%)
Hypersensitivity: Anaphylaxis (<5%), hypersensitivity reaction (<5%)
Local: Infusion site reaction (<5%), venous thrombosis at injection site (<5%)
Respiratory: Epistaxis (pediatric: 9%)
<1%, postmarketing and/or case reports (all indications): Disseminated intravascular coagulation, hepatic disease, renal insufficiency, shock, Stevens-Johnson syndrome, toxic epidermal necrolysis
Warnings/Precautions
Concerns related to adverse effects:
- Hemolytic anemia/hemoglobinuria: Hemolytic anemia and hemoglobinuria have been reported.
- Hepatic impairment: New-onset or worsening hepatic impairment, including hepatitis and hepatic failure, has been reported. Monitor closely and evaluate appropriateness of continued use in patients who develop abnormal liver function tests during treatment.
- Hypersensitivity reactions: Severe anaphylactic reactions, including shock, have been reported. Infusion reactions (eg, rash, pruritus, facial swelling, vasodilatation) have also been reported. Infusion should be discontinued for serious hypersensitivity reactions (eg, anaphylaxis). The infusion rate may be slowed for possible histamine-mediated infusion reactions.
- Injection-site reactions: Injection-site reactions (eg, phlebitis, thrombophlebitis) have been reported; more frequent with peripheral administration.
- Renal impairment: Increased BUN, serum creatinine, renal dysfunction, and/or acute renal failure has been reported; use with caution in patients that develop worsening renal function during treatment; monitor closely.
Monitoring Parameters
Periodic liver function tests, serum creatinine, BUN and CBC (increase monitoring in patients who develop abnormalities); infusion reactions (possible histamine-mediated symptoms) including rash, pruritus, facial swelling, and vasodilatation
Pregnancy
Pregnancy Considerations
Adverse events have been observed in animal reproduction studies.
Agents other than micafungin are preferred for the treatment of candidiasis in pregnancy (IDSA [Pappas 2016]).
Patient Education
What is this drug used for?
- It is used to treat fungal infections.
- It is used to prevent fungal infections.
Frequently reported side effects of this drug
- Nausea
- Vomiting
- Injection site irritation
- Diarrhea
- Headache
- Abdominal pain
- Trouble sleeping
- Anxiety
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain.
- Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.
- Low blood sugar like dizziness, headache, fatigue, feeling weak, shaking, fast heartbeat, confusion, increased hunger, or sweating.
- Electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting.
- Fast heartbeat
- Abnormal heartbeat
- Infection
- Bruising
- Bleeding
- Severe loss of strength and energy
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
