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Micafungin

Pronunciation

Pronunciation

(mi ka FUN gin)

Index Terms

  • Micafungin Sodium

Dosage Forms

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.

  • Mycamine

Pharmacologic Category

  • Antifungal Agent, Parenteral
  • Echinocandin

Pharmacology

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

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

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)

Use: Unlabeled

Treatment of infections due to Aspergillus spp; prophylaxis of HIV-related esophageal candidiasis; primary antifungal prophylaxis in pediatric cancer patients

Contraindications

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

Dosing: Adult

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)

Esophageal candidiasis: IV: 150 mg once daily; mean duration of therapy (from clinical trials) was 15 days (range: 10 to 30 days)

Prophylaxis of Candida infection in hematopoietic stem cell transplantation: IV: 50 mg once daily; mean duration of therapy (from clinical trials) was 19 days (range: 6 to 51 days)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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.

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 50-150 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).

Administration

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.

Compatibility

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.

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

Frequency of adverse events generally higher following prophylaxis of Candida infections in hematopoietic stem cell transplant recipients.

>10%:

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

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.

• 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

Liver function tests

Pregnancy Risk Factor

C

Pregnancy Considerations

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.

Patient Education

• 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, abdominal pain, insomnia, or constipation. Have patient report immediately to prescriber signs of kidney problems (urinary retention, blood in urine, change in amount of urine passed, or weight gain), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), angina, tachycardia, confusion, severe dizziness, passing out, bradycardia, injection site pain or irritation, seizures, severe headache, shortness of breath, swelling of arms or legs, 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 healthcare 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.

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