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All about: Micafungin Sodium

Big Image Pronouncation: (mi-ka-FUN-gin SO-dee-uhm)
Class: Antifungal agent

Trade Names:
Mycamine
- Powder for injection 50 mg

Mechanism of Action

Pharmacology

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 CYP450 isoenzymes.

Elimination

The t ½ is 14 to 17 hr. Fecal excretion is major route of elimination (71%).

Special Populations

Hepatic Function Impairment

Moderate (Child-Pugh score 7 to 9): AUC and C max were reduced about 22% compared with normal 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 Candidiasis
Adults

IV 150 mg once daily by slow infusion over 1 hr.

Prophylaxis of Candida Infections
Adults

IV 50 mg once daily by slow infusion over 1 hr.

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 injection 0.9% (without a bacteriostatic agent) or dextrose injection 5% 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 injection 0.9% or dextrose injection 5%.
  • For prophylaxis of Candida infections, add micafungin 50 mg from 1 vial reconstituted with 5 mL of diluent to 100 mL sodium chloride injection 0.9% or dextrose injection 5%.
  • 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 injection 0.9% prior to infusing micafungin.
  • Administer by IV infusion over 1 hr. 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 hr. Diluted infusion solution can be stored at room temperature (77°F) for 24 hr. Protect diluted infusion solution from light.

Drug Interactions

Nifedipine

Plasma levels may be elevated by micafungin, increasing the pharmacologic and adverse effects.

Sirolimus

Sirolimus 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 impairment (postmarketing).

Hematologic-Lymphatic

Leukopenia (3%); neutropenia, thrombocytopenia, anemia, lymphopenia, febrile neutropenia (1%); decreased WBC, hemolytic anemia (postmarketing).

Hepatic

Hyperbilirubinemia (3%); liver function test 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

Monitor

Evaluate liver and renal function tests prior to and periodically thereafter during treatment. If abnormal liver function tests 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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