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Micafungin: Drug information

Micafungin: Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Micafungin: Patient drug information" and "Micafungin: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Mycamine
Brand Names: Canada
  • Mycamine
Pharmacologic Category
  • Antifungal Agent, Parenteral;
  • Echinocandin
Dosing: Adult
Aspergillosis, invasive

Aspergillosis, invasive (including disseminated and extrapulmonary) (alternative agent) (off-label use):

Note: Reserve for salvage therapy, typically as part of an appropriate combination regimen. Monotherapy is further reserved for patients who are intolerant of or refractory to azoles and polyenes (Ref); for patients with severe or progressive infection, some experts use as initial therapy in combination with voriconazole (Ref).

IV: 100 to 150 mg once daily (Ref).

Duration: When given as monotherapy, the minimum duration is 6 to 12 weeks depending on degree/duration of immunosuppression, disease site, and response to therapy (Ref); immunosuppressed patients may require more prolonged treatment (Ref). When given as part of a combination regimen, the optimal duration is uncertain. Some experts have given an echinocandin for ~2 weeks in combination with voriconazole before step-down to voriconazole monotherapy (Ref).

Candidiasis

Candidiasis:

Candidemia (neutropenic and nonneutropenic patients), including disseminated candidiasis: IV: 100 mg once daily. Total duration (including oral step-down therapy) is ≥14 days after first negative blood culture and continues until signs/symptoms of candidemia and neutropenia, if present, have resolved; metastatic complications warrant a longer duration (Ref).

Cardiac device infection (including implantable cardiac defibrillator, pacemaker, ventricular assist device) (off-label use) : IV: 150 mg once daily; step down to azole therapy in clinically stable patients with susceptible isolates and negative repeat cultures; total antifungal duration is ≥4 weeks after device removal for isolated generator pocket infection and ≥6 weeks after device removal for wire infection (Ref).

Chronic disseminated (hepatosplenic) (off-label use): IV: 100 mg once daily for several weeks, followed by oral azole step-down therapy until lesion resolution and through periods of immunosuppression (Ref).

Empiric therapy, suspected invasive candidiasis (nonneutropenic ICU patients) (off-label use):

Note: Antifungal therapy is not routinely warranted for initial management of nonneutropenic patients with sepsis. Consider use for critically ill patients with unexplained fever or unexplained hypotension despite broad-spectrum antimicrobial therapy and risk factors for invasive candidiasis (eg, indwelling venous catheter, hemodialysis, trauma or burns, recent surgery, parenteral nutrition) (Ref).

IV: 100 mg once daily. For those who improve, continue empiric antifungal therapy for 2 weeks; consider discontinuing after 4 to 5 days in patients with no evidence of invasive candidiasis and no clinical response (Ref).

Endocarditis, native or prosthetic valve (off-label use): IV: 150 mg once daily; step down to azole therapy in clinically stable patients with susceptible isolates and negative repeat cultures; total antifungal duration is ≥6 weeks after valve replacement surgery, with longer duration for perivalvular abscesses, other complications, or a nonsurgical approach (Ref).

Esophageal, refractory disease (alternative agent):

Note: Reserve for fluconazole-refractory disease in patients who require IV therapy (eg, severe disease) (Ref).

IV: 150 mg once daily (Ref). Transition to an oral antifungal once patient tolerates oral intake if susceptibility allows; total antifungal duration is 14 to 28 days (Ref).

Intra-abdominal infection (eg, peritonitis, abdominal abscess): IV: 100 mg once daily. Total duration (including oral step-down therapy) is ≥14 days and continues until source control and clinical resolution (Ref).

Oropharyngeal, refractory disease (alternative agent) (off-label use):

Note: Reserve for fluconazole-refractory disease in patients who require IV therapy (eg, severe disease) (Ref).

IV: 100 mg once daily. Transition to an oral antifungal once patient tolerates oral intake if susceptibility allows; total antifungal duration is 14 to 28 days (Ref).

Osteoarticular infection (osteomyelitis or septic arthritis) (off-label use): IV: 100 mg once daily for ≥2 weeks; total duration of therapy (including oral step-down therapy) is 6 to 12 months for osteomyelitis and ≥6 weeks for septic arthritis (Ref).

Thrombophlebitis, suppurative (off-label use): IV: 150 mg once daily; continue antifungal therapy until catheter removed and thrombus resolved, and for ≥2 weeks after candidemia (if present) has cleared (Ref).

Neutropenic fever, empiric antifungal therapy

Neutropenic fever, empiric antifungal therapy (alternative agent) (off-label use):

Note: Recommended for patients with persistent or recurrent fever after ≥4 days of antimicrobial therapy when the duration of neutropenia is expected to exceed 7 days (Ref). Some experts reserve for patients without suspicion of mold infection (eg, pulmonary nodules) (Ref).

IV: 100 mg once daily (Ref).

Prophylaxis against invasive fungal infections

Prophylaxis against invasive fungal infections:

Hematologic malignancy or hematopoietic cell transplant (alternative agent):

Note: Some experts reserve for patients at low risk for mold infection (Ref).

IV: 50 to 100 mg once daily. Duration is at least until resolution of neutropenia and varies based on degree and duration of immunosuppression (Ref).

Solid organ transplant (alternative agent) (off-label use): IV: 100 mg once daily; duration varies based on patient risk factors and transplant center protocol (Ref).

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: No dosage adjustment necessary for any degree of kidney dysfunction (Ref).

Hemodialysis, intermittent (thrice weekly): Poorly dialyzed: No supplemental dose or dosage adjustment necessary (Ref).

Peritoneal dialysis: Unlikely to be significantly dialyzed (highly protein bound): No dosage adjustment necessary (Ref).

CRRT: Poorly dialyzed: No dosage adjustment necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Unlikely to be significantly dialyzed (highly protein bound): No dosage adjustment necessary (Ref).

Dosing: Hepatic Impairment: Adult

The liver dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Matt Harris, PharmD, MHS, BCPS, FAST, Jeong Park, PharmD, MS, BCTXP, FCCP, FAST, Arun Jesudian, MD, Sasan Sakiani, MD.

Liver impairment prior to treatment initiation:

Child-Turcotte-Pugh class A to C: No dosage adjustment necessary (Ref).

Dosing: Obesity: Adult

The recommendations for dosing in patients with obesity are based upon the best available evidence and clinical expertise. Senior Editorial Team: Jeffrey F. Barletta, PharmD, FCCM; Manjunath P. Pai, PharmD, FCP; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC.

Class 1, 2, or 3 obesity (BMI ≥30 kg/m2):

Candidiasis (C. albicans species), treatment:

Patients with BMI ≥30 kg/m2 and weight ≥ 120 kg: IV: 200 mg once daily. Note: Suboptimal pharmacodynamics may be achieved in this population when minimum inhibitory concentration (MIC) >0.032 mg/L; consider alternative regimens or therapies (Ref).

Patients with BMI ≥30 kg/m2 and weight <120 kg: IV: 150 mg once daily (Ref).

Candidiasis (non–albicans Candida species), treatment:

Patients with BMI ≥30 kg/m2: IV: 200 mg once daily. Note: Suboptimal pharmacodynamics may be achieved in this population when MIC >0.032 mg/L; consider alternative regimens or therapies (Ref).

Other indications, including prophylaxis: Evidence currently does not exist for other indications in patients with obesity; dosing recommendations provided are likely to result in consistent exposures in patients with indications other than candidiasis; however, because of limited data in other indications, specific dosing recommendations cannot be provided (Ref).

Rationale for recommendations:

Pharmacokinetic studies have demonstrated meaningful decreases in exposure with increasing body weight (Ref). The recommendations above are based on pharmacokinetic simulations using standard micafungin dose (eg, 100 mg once daily) that showed significantly lower exposure and decreased peak concentrations with increasing weight (Ref) and a pharmacokinetic/pharmacodynamic study using standard micafungin dose (eg, 100 to 150 mg once daily) in patients with obesity for the treatment of invasive candidiasis (Ref). When higher doses (ie, 150 to 200 mg once daily) were used during modeling, pharmacodynamic simulations showed improved probability of target attainment in patients with obesity (Ref). Higher than standard micafungin doses appear safe. In an observational study, high dose micafungin (ie, 300 to 400 mg once daily) for a median duration of 6 to 19 days was well tolerated (Ref).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Micafungin: Pediatric drug information")

Aspergillosis, invasive; treatment

Aspergillosis, invasive; treatment (salvage therapy): Infants, Children, and Adolescents: Limited data available:

Note: In infants, initial doses at the higher end of the dosage range may be necessary due to pharmacokinetic differences (Ref). Treatment duration should be individualized based on patient-specific factors including site of infection, immunosuppression, and response to therapy; minimum duration is 6 to 12 weeks (Ref).

≤40 kg: IV: 2 to 3 mg/kg/dose once daily (Ref); higher doses of 4 to 6 mg/kg/dose once daily have also been described (Ref).

>40 kg: IV: 100 mg/dose once daily; may increase to 150 mg/dose if clinically indicated; maximum daily dose: 150 mg/day (Ref).

Candidiasis, esophageal

Candidiasis, esophageal (alternative agent in patients who cannot tolerate oral therapy):

Non-HIV-exposed/-infected: Infants ≥4 months, Children, and Adolescents: Note: IDSA guidelines recommend 14 to 21 days of treatment for esophageal candidiasis (Ref).

≤30 kg: IV: 3 mg/kg/dose once daily.

>30 kg: IV: 2.5 mg/kg/dose once daily; maximum dose: 150 mg/dose.

HIV-exposed/-infected (HHS [OI adult 2019]; HHS [OI pediatric 2019]): Note: Treatment is recommended for 14 to 21 days for esophageal candidiasis (Ref):

Infants <15 kg: IV: 5 to 7 mg/kg/dose once daily.

Children 2 to 8 years and ≤40 kg: IV: 3 to 4 mg/kg/dose once daily.

Children ≥9 years:

≤40 kg: IV: 2 to 3 mg/kg/dose once daily.

>40 kg: IV: 100 mg/dose once daily.

Adolescents: IV: 150 mg/dose once daily.

Candidiasis, systemic

Candidiasis, systemic (including candidemia and invasive candidiasis):

Note: Duration of therapy should be individualized (based on deep-tissue foci, clinical response, etc); candidemia should be treated for a minimum of 14 days from the first negative blood culture and resolution of symptoms (Ref).

Infants <4 months: IV: 10 mg/kg/dose once daily (Ref); doses as high as 15 mg/kg/dose have been reported (Ref). Note: Manufacturer labeling recommends 4 mg/kg/dose once daily in patients without CNS or ocular involvement; however, a pharmacokinetic model in patients weighing 1 to 7 kg suggested that doses of 3 to 4 mg/kg/day in neonates and young infants would only result in 40.5% to 43.3% of patients achieving exposure similar to adults receiving 100 mg/day (Ref).

Infants ≥4 months, Children, and Adolescents: IV: Initial: 2 mg/kg/dose once daily; usual maximum dose: 100 mg/dose (Ref); may increase to 4 mg/kg/dose if clinical condition does not improve or mycologic persistence occurs at lower doses; maximum dose: 200 mg/dose (Ref). Manufacturer labeling recommends 2 mg/kg/dose once daily in patients without CNS or ocular involvement; however, a pharmacokinetic model indicates that doses of 3 to 4 mg/kg/day may be necessary to achieve AUC:MIC targets against Candida albicans in pediatric patients (Ref).

Empiric antifungal therapy

Empiric antifungal therapy (neutropenic fever): Infants ≥4 months, Children, and Adolescents: IV: 2 to 3 mg/kg/dose once daily; maximum dose: 200 mg/dose (Ref).

Fungal infection, prophylaxis in hematopoietic stem cell transplant recipients

Fungal infection, prophylaxis in hematopoietic stem cell transplant (HSCT) recipients:

Infants <4 months: Limited data available: IV: 2 mg/kg/dose once daily (Ref); dose based on pharmacokinetic exposure similar to adults receiving 50 mg.

Infants ≥4 months, Children, and Adolescents: IV: 1 mg/kg/dose once daily; maximum dose: 50 mg/dose; doses as high as 3 mg/kg/day have been used in trials (Ref).

Alternate day dosing: Very limited data available: Infants ≥7 months and Children ≤10 years: IV: 3 mg/kg/dose every 48 hours; dosing based on a small pharmacokinetic modeling study in which a total of 15 patients (age: 0.6 months to 10 years) undergoing HSCT received a single dose of 3 mg/kg of micafungin; modeled exposures with 3 mg/kg/dose every 48 hours were similar to those achieved in previous studies evaluating 1 mg/kg/dose once daily (Ref).

Dosing: Kidney Impairment: Pediatric

No dosage adjustment necessary; not dialyzable, supplemental dosing is not required following hemodialysis.

Dosing: Hepatic Impairment: Pediatric

No dosage adjustment necessary.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Candidiasis treatment:

>10%:

Cardiovascular: Phlebitis (19%)

Gastrointestinal: Diarrhea (7% to 11%), vomiting (7% to 18%)

Hematologic & oncologic: Anemia (infants, children, and adolescents: 18%)

Hepatic: Abnormal hepatic function tests (4%; infants, children, and adolescents: <15%), hyperbilirubinemia (infants, children, and adolescents: <15%)

Renal: Renal failure syndrome (infants, children, and adolescents: <15%)

Miscellaneous: Fever (9% to 13%)

1% to 10%:

Cardiovascular: Atrial fibrillation (adults: 3%), tachycardia (infants, children, and adolescents: 4%)

Dermatologic: Skin rash (2% to 5%)

Endocrine & metabolic: Abnormal aspartate transaminase (3%), hyperkalemia (adults: 5%), hypoglycemia (adults: 6%)

Gastrointestinal: Abdominal distention (infants, children, and adolescents: 2%), abdominal pain (infants, children, and adolescents: 4%), nausea (7% to 10%)

Hematologic & oncologic: Neutropenia (infants, children, and adolescents: 5%), thrombocytopenia (infants, children, and adolescents: 9%)

Hepatic: Increased serum alkaline phosphatase (3% to 6%)

Nervous system: Headache (adults: 9%)

Candidiasis prophylaxis in hematopoietic stem cell transplantation :

>10%:

Cardiovascular: Tachycardia (16% to 26%)

Dermatologic: Pruritus (infants, children, and adolescents: 33%), skin rash (25% to 30%), urticaria (<5%; infants, children, and adolescents: 19%)

Gastrointestinal: Abdominal distention (infants, children, and adolescents: 19%), abdominal pain (26% to 35%), diarrhea (77%; infants, children, and adolescents: 51%), nausea (70% to 71%), vomiting (65% to 66%)

Genitourinary: Decreased urine output (infants, children, and adolescents: 23%), hematuria (infants, children, and adolescents: 23%)

Hematologic & oncologic: Anemia (infants, children, and adolescents: 51%), febrile neutropenia (infants, children, and adolescents: 16%), neutropenia (75% to 77%), thrombocytopenia (72% to 75%)

Hepatic: Abnormal hepatic function tests (infants, children, and adolescents: <15%), hyperbilirubinemia (infants, children, and adolescents: <15%), increased serum alanine aminotransferase (16%)

Nervous system: Anxiety (22% to 23%), headache (adults: 44%), insomnia (adults: 37%)

Renal: Renal failure syndrome (infants, children, and adolescents: <15%)

Miscellaneous: Fever (infants, children, and adolescents: 61%), infusion-related reaction (infants, children, and adolescents: 16%)

1% to 10%:

Cardiovascular: Acute myocardial infarction (adults: <5%), pericardial effusion (adults: <5%)

Endocrine & metabolic: Hypernatremia (<5%), hypokalemia (<5%)

Hematologic & oncologic: Disorder of hemostatic components of blood (adults: <5%), pancytopenia (adults: <5%), thrombotic thrombocytopenic purpura (adults: <5%)

Hepatic: Hepatic failure (adults: <5%), hepatic injury (adults: <5%), hepatomegaly (adults: <5%), jaundice (adults: <5%)

Hypersensitivity: Anaphylaxis (adults: <5%), hypersensitivity reaction (adults: <5%)

Local: Infusion site reaction (adults: <5%), venous thrombosis at injection site (adults: <5%)

Nervous system: Encephalopathy (adults: <5%), delirium (adults: <5%), intracranial hemorrhage (adults: <5%), seizure (adults: <5%)

Respiratory: Epistaxis (infants, children, and adolescents: 9%)

Postmarketing (any indication):

Cardiovascular: Shock, vasodilation

Dermatologic: Facial swelling, Stevens-Johnson syndrome, toxic epidermal necrolysis

Hematologic & oncologic: Disseminated intravascular coagulation, hemolysis, hemolytic anemia

Hepatic: Hepatic disease

Hypersensitivity: Anaphylactic shock, anaphylaxis, nonimmune anaphylaxis, severe hypersensitivity reaction

Local: Injection site phlebitis, thrombophlebitis at injection site

Renal: Increased blood urea nitrogen, increased serum creatinine, renal insufficiency

Contraindications

Hypersensitivity to micafungin, other echinocandins, or any component of the formulation

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous, as sodium [preservative free]:

Generic: 100 mg (100 mL); 50 mg (50 mL)

Solution Reconstituted, Intravenous, as sodium:

Generic: 50 mg (1 ea); 100 mg (1 ea)

Solution Reconstituted, Intravenous, as sodium [preservative free]:

Mycamine: 50 mg (1 ea)

Mycamine: 50 mg (1 ea [DSC]) [contains lactose]

Mycamine: 100 mg (1 ea)

Mycamine: 100 mg (1 ea [DSC]) [contains lactose]

Generic: 50 mg (1 ea); 100 mg (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Micafungin Sodium-NaCl Intravenous)

50 mg/50 mL 0.9% (per mL): $1.11

100 mg/100 mL 0.9% (per mL): $0.87

Solution (reconstituted) (Micafungin Sodium Intravenous)

50 mg (per each): $28.80 - $112.20

100 mg (per each): $57.60 - $224.40

Solution (reconstituted) (Mycamine Intravenous)

50 mg (per each): $112.20

100 mg (per each): $224.40

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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) [contains lactose]

Generic: 50 mg (1 ea); 100 mg (1 ea)

Administration: Adult

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.

Administration: Pediatric

Parenteral: IV: In pediatric patients, final concentrations >1.5 mg/mL should be administered via a central line to minimize risk of infusion reactions. Prior to administration, flush line with NS. Infuse over 1 hour; more rapid infusions may result in a higher incidence of histamine-mediated reactions. Do not coinfuse with other medications since precipitation may occur.

Use: Labeled Indications

Candidemia and other Candida infections: Treatment of candidemia, acute disseminated candidiasis, and 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.

Candidiasis, esophageal: Treatment of esophageal candidiasis in adults and pediatric patients ≥4 months of age.

Prophylaxis against invasive fungal infections (hematopoietic cell transplant recipients): Prophylaxis of Candida infections in adults and pediatric patients ≥4 months of age undergoing hematopoietic cell transplantation.

Use: Off-Label: Adult

Aspergillosis, invasive (including disseminated and extrapulmonary); Candidiasis, cardiac device infection (including implantable cardiac defibrillator, pacemaker, ventricular assist device); Candidiasis, chronic disseminated (hepatosplenic); Candidiasis, empiric therapy, suspected invasive candidiasis (nonneutropenic ICU patients); Candidiasis, endocarditis, native or prosthetic valve; Candidiasis, oropharyngeal, refractory disease; Candidiasis, osteoarticular infections (osteomyelitis or septic arthritis); Candidiasis, thrombophlebitis, suppurative; Neutropenic fever, empiric antifungal therapy; Prophylaxis against invasive fungal infections (solid organ transplant recipients)

Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination

Sirolimus Products: Micafungin may increase the serum concentration of Sirolimus Products. Risk C: Monitor therapy

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]).

Breastfeeding Considerations

It is not known if micafungin is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

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

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 (Adult Data Unless Noted)

Absorption: Oral: Poor.

Distribution: Distributes into lung, liver, and spleen; minimally to CNS and eyes (Caudle 2012).

Preterm infants: Reported data highly variable; possibly dependent on GA/weight and PNA: Vdss:

PNA 0 to 1 day, weight <1,500 g: 0.76 ± 0.28 L/kg (Kawada 2009).

PNA >4 days, weight <2,500 g: 1.515 ± 0.516 L/kg (Smith 2009).

PNA >3 weeks, weight ≥1,000 g: 0.43 ± 0.11 L/kg (range: 0.28 to 0.66 L/kg) (Heresi 2006).

Neonates and infants <4 months: Median 0.35 L/kg (range: 0.225 to 0.482 L/kg) (Leroux 2018).

Infants ≥4 months and Children <2 years: 0.319 ± 0.0615 L/kg (range: 0.24 to 0.45 L/kg) (Albano 2015).

Children 2 to 8 years: Vdss: 0.35 ± 0.18 L/kg (Seibel 2005).

Children ≥9 years and Adolescents ≤17 years: Vdss: 0.28 ± 0.09 L/kg (Seibel 2005).

Adults: Vd: 0.39 ± 0.11 L/kg.

Protein binding: Neonates: 96.7% (Yanni 2011); Adults: >99% to albumin.

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.

Half-life elimination:

Preterm infants:

PNA <1 week: 6.7 ± 2.2 hours (Kawada 2009).

PNA >3 weeks: Mean 8.3 hours (range: 5.6 to 11 hours) (Heresi 2006).

Term and preterm infants <4 months: Mean range: 11 to 13.6 hours (Benjamin 2010; Leroux 2018).

Infants ≥4 months and Children <2 years: 11.5 ± 2.17 hours (range: 7.9 to 16 hours) (Albano 2015).

Children 2 to 5 years: 11.1 ± 1.32 hours (range: 8.9 to 13.8 hours) (Albano 2015).

Children 6 to 11 years: 14.7 ± 6.98 hours (range: 9.8 to 28.4 hours) (Albano 2015).

Children ≥12 years and Adolescents ≤16 years: 13.1 ± 1.68 hours (range: 10.5 to 16.2 hours) (Albano 2015).

Healthy Adults: 11 to 21 hours.

Adults receiving bone marrow or peripheral stem-cell transplantation: 10.7 to 13.5 hours (Carver 2004).

Time to peak, serum:

Infants ≥4 months, Children, and Adolescents ≤16 years: 0.9 to 2 hours (Albano 2015; Benjamin 2013).

Excretion: Primarily feces (71%); urine (<1%, unchanged [Hebert 2005]).

Clearance:

Preterm infants:

PNA 0 to 1 day, weight <1,500 g: 1.48 ± 0.78 mL/minute/kg (Kawada 2009).

PNA >4 days, weight <2,500 g: 0.575 ± 0.196 mL/minute/kg (Smith 2009).

PNA >3 weeks, weight ≥1,000 g: 0.648 ± 0.2 mL/minute (Heresi 2006).

Term and preterm infants <4 months: 0.5 ± 0.2 mL/minute/kg (range: 0.2 to 0.8 mL/minute/kg) (Benjamin 2010).

Infants ≥4 months and Children <2 years: 0.328 ± 0.046 mL/minute/kg (range: 0.243 to 0.402 mL/minute/kg) (Albano 2015).

Children 2 to 5 years: 0.34 ± 0.058 mL/minute/kg (range: 0.237 to 0.4 mL/minute/kg) (Albano 2015).

Children 6 to 11 years: 0.22 ± 0.039 mL/minute/kg (range: 0.155 to 0.267 mL/minute/kg) (Albano 2015).

Children ≥12 years and Adolescents ≤16 years: 0.217 ± 0.037 mL/minute/kg (range: 0.17 to 0.278 mL/minute/kg) (Albano 2015).

Adults: ~0.3 mL/minute/kg.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Liver function impairment: Moderate impairment (Child-Pugh class B): AUC and Cmax reduced ~22% compared to normal liver function. Severe impairment (Child-Pugh class C): AUC and Cmax of parent drug reduced ~30% compared to normal liver function (no dose adjustment required).

Obesity: Data suggest that micafungin clearance increases as a function of weight (Hall 2011).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Mycamine;
  • (AR) Argentina: Mycamine;
  • (AT) Austria: Micafungin hikma | Micafungin ratiopharm | Mycamine;
  • (AU) Australia: Mycamine;
  • (BD) Bangladesh: Micagin;
  • (BG) Bulgaria: Micafungin teva | Mycamine;
  • (BR) Brazil: Mycamine;
  • (CH) Switzerland: Mycamine;
  • (CN) China: Mycamine;
  • (CO) Colombia: Mycamine;
  • (CZ) Czech Republic: Micafungin olikla | Micafungin teva | Mycamine;
  • (DE) Germany: Micafungin inresa | Micafungin mylan | Micafungin Pharmore | Mycamine;
  • (EC) Ecuador: Mycamine;
  • (EE) Estonia: Mycamine;
  • (EG) Egypt: Mycamine;
  • (ES) Spain: Micafungina accord | Micafungina sala | Micafungina Sandoz | Micafungina Teva | Mycamine;
  • (FR) France: Micafungine hikma | Micafungine mylan | Micafungine ohre pharma | Mycamine;
  • (GB) United Kingdom: Micafungin | Micafungin teva | Mycamine;
  • (GR) Greece: Mycamine;
  • (HK) Hong Kong: Mycamine;
  • (HR) Croatia: Mycamine;
  • (HU) Hungary: Micafungin pharmacenter | Micafungin teva | Mycamine;
  • (ID) Indonesia: Mycamine;
  • (IE) Ireland: Mycamine;
  • (IN) India: B cagin | Ibimica | Ivfungin | Micafung | Micalan | Micanfa | Micedge | Mycamine | Mykes;
  • (IT) Italy: Micafungina hikma | Micafungina Teva | Mycamine;
  • (JO) Jordan: Mycamine;
  • (JP) Japan: Funguard;
  • (KE) Kenya: Mycamine;
  • (KR) Korea, Republic of: Mycamine;
  • (KW) Kuwait: Mycamine;
  • (LB) Lebanon: Mycamine;
  • (LT) Lithuania: Mycamine;
  • (LV) Latvia: Mycamine;
  • (MY) Malaysia: Mycamine;
  • (NL) Netherlands: Micafungine hikma | Micafungine mylan | Micafungine teva | Mycamine;
  • (NO) Norway: Mycamine;
  • (PH) Philippines: Mycamine;
  • (PL) Poland: Micafungin accord | Micafungin teva | Mycamine;
  • (PR) Puerto Rico: Micafungin | Mycamine;
  • (PT) Portugal: Micafungina accord | Micafungina hikma | Micafungina Teva | Mycamine;
  • (PY) Paraguay: Mycamine;
  • (RO) Romania: Micafungin rompharm | Mycamine;
  • (RU) Russian Federation: Micafungin-nativ | Micamin | Mycamine;
  • (SA) Saudi Arabia: Ezokamine | Mycamine;
  • (SE) Sweden: Micafungin bioglan | Micafungin mylan | Mikafungin teva | Mycamine;
  • (SG) Singapore: Mycamine;
  • (SI) Slovenia: Mikafungin teva | Mycamine;
  • (SK) Slovakia: Micafungin olikla | Mycamine;
  • (TH) Thailand: Mycamine;
  • (TR) Turkey: Mifundex | Mikafungus | Myacit | Mycamine;
  • (TW) Taiwan: Mycamine;
  • (UA) Ukraine: Micafungin accord | Micamin;
  • (ZA) South Africa: Mycamine
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