(mi ka FUN gin)
- Micafungin Sodium
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous, as sodium:
Mycamine: 50 mg (1 ea); 100 mg (1 ea)
Solution Reconstituted, Intravenous, as sodium [preservative free]:
Mycamine: 50 mg (1 ea); 100 mg (1 ea)
Brand Names: U.S.
- Antifungal Agent, Parenteral
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
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
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
Primarily feces (71%); urine (<1%, unchanged [Herbert 2005])
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
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)
Neonates: 96.7% (Yanni 2011); Adults: >99% to albumin
Special Populations: Hepatic Function Impairment
Moderate impairment (Child-Pugh class B): AUC and Cmaxreduced ~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
Esophageal candidiasis: Treatment of esophageal candidiasis
Prophylaxis of Candida infections: Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT)
Treatment of infections due to Aspergillus spp; prophylaxis of HIV-related esophageal candidiasis; primary antifungal prophylaxis in pediatric cancer patients
Hypersensitivity to micafungin, other echinocandins, or any component of the formulation
Aspergillosis (invasive) in HIV-infected patients (off-label use): IV: 100 to 150 mg once daily until infection resolution and CD4 count >200 cells/mm3 (HHS [OI adult 2015])
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])
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])
Refer to adult dosing.
Aspergillosis (invasive) in HIV-infected patients (off-label use): IV: Adolescents: Refer to adult dosing.
Candidemia, acute disseminated candidiasis, and Candida peritonitis and abscesses: Infants ≥4 months, Children, and Adolescents: IV: 2 mg/kg once daily; maximum: 100 mg once daily
Esophageal candidiasis: Infants ≥4 months, Children, and Adolescents: IV:
≤30 kg: 3 mg/kg once daily
>30 kg: 2.5 mg/kg once daily; maximum: 150 mg once daily
Prophylaxis of Candida infection in hematopoietic stem cell transplantation: Infants ≥4 months, Children, and Adolescents: IV: 1 mg/kg once daily; maximum: 50 mg once daily
Primary antifungal prophylaxis in allogeneic HSCT (when fluconazole is contraindicated; off-label dosing/population; guideline recommendation): Infants ≥1 month, Children, and Adolescents <19 years: IV: 1 mg/kg once daily; maximum: 50 mg once daily (Science, 2014)
Dosing: Renal Impairment
No dosage adjustment necessary.
Poorly dialyzed; no supplemental dose or dosage adjustment necessary, including patients on intermittent hemodialysis.
Dosing: Hepatic Impairment
No dosage adjustment necessary.
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 50-150 mg in 100 mL NS or D5W (when used in children the final concentration should be between 0.5-4 mg/mL; concentrations >1.5 mg/mL should be administered via central catheter). Protect infusion solution from light (it is not necessary to protect the drip chamber or tubing from light).
For intravenous use only; infuse over 1 hour. When used in children, administer infusions >1.5 mg/mL via central catheter to minimize risk of infusion reactions. Flush line with NS prior to administration.
Stable in D5W, NS.
Y-site administration: Incompatible with albumin, amiodarone, cisatracurium, diltiazem, dobutamine, epinephrine, insulin (regular), labetalol, meperidine, midazolam, morphine, mycophenolate, nesiritide, nicardipine, octreotide, ondansetron, phenytoin, rocuronium, telavancin, vecuronium.
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).
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
Frequency of adverse events generally higher following prophylaxis of Candida infections in hematopoietic stem cell transplant recipients.
Cardiovascular: Tachycardia (3% to 26%), localized phlebitis (with peripheral administration; 5% to 19%)
Central nervous system: Headache (2% to 44%), insomnia (4% to 37%), anxiety (≤23%), dizziness (13%)
Dermatologic: Pruritus (pediatric patients ages 3 days through 16 years: ≤33%; adults 6%), skin rash (2% to 30%), urticaria (pediatric patients ages 3 days through 16 years: ≤19%; adults <5%)
Endocrine & metabolic: Hypokalemia (14% to 18%), hypomagnesemia (6% to 13%)
Gastrointestinal: Diarrhea (7% to 77%), nausea (7% to 71%), vomiting (7% to 66%), abdominal pain (2% to 35%), abdominal distension (pediatric patients ages 3 days through 16 years: 2% to 19%), mucositis (14%), constipation (11%)
Genitourinary: Decreased urine output (pediatric patients ages 3 days through 16 years: ≤23%), hematuria (pediatric patients ages 3 days through 16 years: ≤23%)
Hematologic & oncologic: Neutropenia (5% to 75%), thrombocytopenia (4% to 75%), anemia (pediatric patients ages 3 days through 16 years: 13% to 51%; adults 3% to 10%), febrile neutropenia (≤16%)
Hepatic: Increased serum ALT (pediatric patients ages 3 days through 16 years: ≤16%; adults 5%), abnormal hepatic function tests (pediatric patients ages 3 days through 16 years: <15%; adults 4%), hyperbilirubinemia (pediatric patients ages 3 days through 16 years: <15%; adults <1%)
Renal: Renal failure (pediatric patients ages 3 days through 16 years: <15%)
Miscellaneous: Fever (pediatric patients ages 3 days through 16 years: 9% to 61%; adults 7% to 20%), infusion related reaction (pediatric patients ages 3 days through 16 years: ≤16%; adults <5%)
1% to 10%:
Cardiovascular: Hypotension (6% to 10%), peripheral edema (7%), edema (5%), atrial fibrillation (3% to 5%), bradycardia (3% to 5%), hypertension (3% to 5%), cardiac arrest (<5%), myocardial infarction (<5%), pericardial effusion (<5%)
Central nervous system: Rigors (9%), fatigue (6%), brain disease (<5%), convulsions (<5%), delirium (<5%), intracranial hemorrhage (<5%)
Endocrine & metabolic: Hypocalcemia (7%), hypoglycemia (6% to 7%), hyperglycemia (6%), hypernatremia (4% to 6%), hypervolemia (5%), hyperkalemia (4% to 5%)
Gastrointestinal: Anorexia (6%), dyspepsia (6%)
Hematologic & oncologic: Blood coagulation disorder (<5%), pancytopenia (<5%), thrombotic thrombocytopenic purpura (<5%)
Hepatic: Increased serum alkaline phosphatase (3% to 8%), increased serum AST (3% to 6%), hepatic failure (<5%), hepatic injury (<5%), hepatomegaly (<5%), jaundice (<5%)
Hypersensitivity: Anaphylaxis (<5%), hypersensivity reaction (<5%)
Infection: Bacteremia (5% to 9%), sepsis (5% to 6%)
Local: Venous thrombosis at injection site (<5%)
Neuromuscular & skeletal: Back pain (5%)
Respiratory: Epistaxis (≤9%), cough (8%), dyspnea (6%)
<1% (Limited to important or life-threatening) or frequency not defined: Acidosis, acute renal failure, anaphylactoid reaction, anuria, apnea, cardiac arrhythmia, cyanosis, decreased white blood cell count, deep vein thrombosis, disseminated intravascular coagulation, erythema multiforme, hemoglobinuria, hemolysis, hemolytic anemia, hepatic insufficiency, hepatitis, hiccups, hyponatremia, hypoxia, increased blood urea nitrogen, increased serum creatinine, infection, injection site reaction, oliguria, pneumonia, pulmonary embolism, renal insufficiency, renal tubular necrosis, seizure, shock, skin necrosis, Stevens-Johnson syndrome, thrombophlebitis, tissue necrosis at injection site, toxic epidermal necrolysis, vasodilatation
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.
• 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.
Liver function tests
Pregnancy Risk Factor
Adverse events have been observed in animal reproduction studies. There are no adequate and well-controlled studies in pregnant women. Use only if benefit outweighs risk.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience nausea, vomiting, diarrhea, headache, abdominal pain, insomnia, anxiety, dizziness, or constipation. Have patient report immediately to prescriber signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), signs of electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting), tachycardia, bruising, bleeding, or severe loss of strength and energy (HCAHPS).
• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about micafungin
- Other brands: Mycamine