Micafungin Sodium
Pronouncation: (mi-ka-FUN-gin SO-dee-uhm)Class: Antifungal agent
Trade Names:
Mycamine
- Powder for injection 50 mg
Pharmacology
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Inhibits synthesis of 1,3-B-D-glucan, an essential component of fungal cell walls, but not present in mammalian cells.
Pharmacokinetics
Distribution
More than 99% protein bound, primarily to albumin and to a lesser extent to α 1 -acid-glycoprotein.
Metabolism
Metabolized by arylsufatase, catechol-O-methyltransferase, and hydroxylation catalyzed by CYP-450 isoenzymes.
Elimination
The t ½ is 14 to 17 h. Fecal excretion is major route of elimination (71%).
Special Populations
Hepatic Function ImpairmentModerate (Child-Pugh score 7 to 9): AUC and C max were reduced about 22% compared with healthy hepatic function. No dosage adjustment needed.
Indications and Usage
Treatment of esophageal candidiasis; prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.
Contraindications
Standard considerations.
Dosage and Administration
Esophageal CandidiasisAdults
IV 150 mg once daily by slow infusion over 1 h.
Prophylaxis of Candida InfectionsAdults
IV 50 mg once daily by slow infusion over 1 h.
General Advice
- For IV infusion only. Not for oral, intradermal, subcutaneous, IM, IV bolus, or intraarterial administration.
- Reconstitute powder for injection by adding 5 mL sodium chloride 0.9% injection (without a bacteriostatic agent) or dextrose 5% injection to vial. To minimize excessive foaming, gently dissolve powder by swirling the vial until a clear solution is obtained. Do not vigorously shake vial. Final concentration is approximately micafungin 10 mg/mL.
- For treatment of esophageal candidiasis, add micafungin 150 mg from 3 of the 50 mg vials reconstituted with 15 mL of diluent to 100 mL of sodium chloride 0.9% injection or dextrose 5% injection.
- For prophylaxis of Candida infections, add micafungin 50 mg from 1 vial reconstituted with 5 mL of diluent to 100 mL sodium chloride 0.9% injection or dextrose 5% injection.
- Do not mix or co-infuse with other medications.
- Visually inspect reconstituted solution before use. Do not use if particulate matter, cloudiness, or discoloration noted.
- Flush existing IV line with sodium chloride 0.9% injection prior to infusing micafungin.
- Administer by IV infusion over 1 h. More rapid infusions may result in more frequent histamine-mediated reactions.
- Reconstituted solution contains no preservative. Discard any unused solution.
Storage/Stability
Store unopened vials at controlled room temperature (59° to 86°F). Reconstituted micafungin solution may be stored in the original vial at room temperature (77°F) for up to 24 h. Diluted infusion solution can be stored at room temperature (77°F) for 24 h. Protect diluted infusion solution from light.
Drug Interactions
NifedipinePlasma levels may be elevated by micafungin, increasing the pharmacologic effects and adverse reactions.
SirolimusSirolimus AUC increased but not C max .
Laboratory Test Interactions
None well documented.
Adverse Reactions
Cardiovascular
Hypotension (1%); shock (postmarketing).
CNS
Headache (3%); pyrexia (2%); delirium, dizziness, dysgeusia, somnolence (1%).
Dermatologic
Rash (3%); flushing, pruritus (1%).
GI
Nausea (3%); abdominal pain, diarrhea, vomiting (2%); dyspepsia (1%).
Genitourinary
Acute renal failure, renal function impairment (postmarketing).
Hematologic-Lymphatic
Leukopenia (3%); neutropenia, thrombocytopenia, anemia, lymphopenia, febrile neutropenia (1%); decreased WBC, hemolytic anemia (postmarketing).
Hepatic
Hyperbilirubinemia (3%); LFT abnormalities (2%); hepatic disorder, hepatocellular damage (postmarketing).
Lab Tests
Increased ALT and AST (3%); increased blood alkaline phosphatase (2%); increased blood creatinine, increased blood lactate dehydrogenase, increased transaminase, increased blood urea (1%).
Local
Infusion-site inflammation (2%) injection-site pain (1%).
Metabolic-Nutritional
Hypokalemia (2%); hypocalcemia, hypomagnesemia, hypophosphatemia, decreased appetite (1%).
Musculoskeletal
Rigors (2%).
Miscellaneous
Phlebitis (4%).
Precautions
MonitorEvaluate liver and renal function tests prior to and periodically thereafter during treatment. If abnormal LFTs noted, monitor liver and/or function more frequently. If worsening hepatic and/or renal function is noted, evaluate risk/benefit of continued therapy with micafungin. Monitor patient for clinical and laboratory evidence of hemolysis or hemolytic anemia during treatment. If evidence of hemolysis or hemolytic anemia develops, monitor more frequently. If worsening is suspected, evaluate risk/benefit of continued therapy with micafungin. |
Pregnancy
Category C .
Lactation
Undetermined
Children
Safety and efficacy not established.
Hypersensitivity
Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions have occurred. Monitor patient for signs of allergic reaction. Discontinue therapy and immediately notify health care provider if noted. Be prepared to treat appropriately.
Overdosage
Symptoms
None reported.
Patient Information
- Advise patient or caregiver that medication will be prepared and administered by health care professionals in a hospital setting.
- Advise patient to immediately report any discomfort at injection site or vein above the injection site.
- Instruct patient to report any of the following to health care provider: fever, chills, rash, itching, flushing, nausea, any unusual or unexplained symptoms.
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Esophageal Candidiasis, Candida Infections - Systemic, Fungal Infection Prophylaxis
