Dosing and uses of Mycamine (micafungin)
Adult dosage forms and strengths
powder for injection
- 50mg/vial
- 100mg/vial
Candidiasis
Treatment (esophageal): 150 mg/day IV infusion x10-30 days (mean 15 days)
Prophylaxis in hematopoietic stem cell transfer (HSCT) patients: 50 mg/day IV infusion x6-51 days (mean 19 days)
Candidemia, Disseminated Candidiasis, Candida Peritonitis & Abscesses
100 mg/day IV infusion x10-47 days (mean 15 days)
Administration
Infuse IV over 1 hr
Pediatric dosage forms and strengths
powder for injection
- 50mg/vial
- 100mg/vial
Candida Infections
Indicated for candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in hematopoietic stem cell transplants (HSCT) recipients
<4 months: Safety and efficacy not established
4 months or older: See specific Candida infection below
Treatment of Candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses
- 2 mg/kg IV qDay; not to exceed 100 mg/day
Treatment of esophageal candidiasis
- 30 kg or less: 3 mg/kg IV qDay
- >30 kg: 2.5 mg/kg IV qDay; not to exceed 150 mg/day
Prophylaxis of Candida infections in HSCT recipients
- 1 mg/kg IV qDay; not to exceed 50 mg/day
Administration
Infuse IV over 1 hr
Mycamine (micafungin) adverse (side) effects
1-10%
Abd pain
Anemia
Headache
Diarrhea
Increased LFTs
Leukopenia
Nausea
Neutropenia
Phlebitis
Pruritus
Pyrexia
Rash
Rigors
Thrombocytopenia
Vomiting
Facial swelling
Vasodilation
<1%
Delirium
Dizziness
Somnolence
Postmarketing Reports
Blood and lymphatic system disorders: white blood cell count decreased, hemolytic anemia, disseminated intravascular coagulation
Hepatobiliary disorders: hyperbilirubinemia, hepatic function abnormal, hepatic disorder, hepatocellular damage
Renal and urinary disorders: acute renal failure and renal impairment
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis
Vascular disorders: shock
Warnings
Contraindications
Hypersensitivity
Cautions
NOT for IV bolus
No data on effectiveness against fungi other than Candida
Anaphylaxis and anaphylactoid reactions (including shock) reported; discontinue therapy and administer appropriate treatment
Isolated cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria reported
Abnormalities in liver function tests; isolated cases of hepatic impairment, hepatitis, and hepatic failure reported
Elevations in BUN and creatinine; isolated cases of renal impairment or acute renal failure reported
Monitor closely patients who develop clinical or laboratory evidence of above reactions and evaluate risk/benefit of continuing therapy
Pregnancy and lactation
Pregnancy category: C
Lactation: use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Mycamine (micafungin)
Mechanism of action
Semisynthetic lipopeptide (echinocandin class), inhibits fungal cell wall synthesis
Pharmacokinetics
Protein Bound: >99%
Metabolism: Hepatic to catechol & methoxy forms
Half-life: 5.6-11hr (preterm infants); 12.5 +/- 4.6 hr (4 months to 16 years < 30 kg); 13.6 +/- 8.8 hr (4 months to 16 years > 30 kg); 11-21 hr (adults)
Excretion: Feces (71%), urine (<1%)
Dialyzable: No
Administration
IV Preparation
Aseptically add 5 mL NS to obtain 10 mg/mL (50 mg vial) or 20 mg/mL (100 mg vial)
Gently swirl to mix, do not shake vigorously or vortex
Protect from light
May be stored for up to 24 hr at room temp
IV Administration
Flush existing infusion line with NS prior to administration
Dilute into 100 mL NS or D5W
Protect from light
May be stored for up to 24 hr at room temp
Infuse over 1 hr
