micafungin

REMS

Treatment of esophageal candidiasis.
Treatment of candidemia/acute disseminated candidiasis/Candida peritonitis and abscesses (in adults and pediatric patients ≥4 mo).
Treatment of candidemia/acute disseminated candidiasis/Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination (in pediatric patients <4 mo).
Prophylaxis of Candida infections during hematopoetic stem cell transplantation.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

Severe hepatic impairment;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Children <4 mo with meningoencephalitis and/or ocular dissemination (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

GI: worsening hepatic function/hepatitis

GU: renal impairment

Hemat: hemolysis/hemolytic anemia

Local: injection site reactions

Misc: infusion reactions, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

↑levels and risk of toxicity with sirolimus and nifedipine (dose adjustments may be necessary).

Availability ⬆ ⬇

(Generic available)

Lyophilized powder for injection: 50 mg/vial; 100 mg/vial
Premixed infusion: 50 mg/50 mL 0.9% NaCl; 100 mg/100 mL 0.9% NaCl; 150 mg/150 mL 0.9% NaCl

Route/Dosage ⬆ ⬇

Treatment of Esophageal Candidiasis

IV (Adults ): 150 mg once daily for 15 days (range 10–30 days).
IV (Children ≥4 mo and >30 kg): 2.5 mg/kg once daily (max daily dose = 150 mg).
IV (Children ≥4 mo and ≤30 kg): 3 mg/kg once daily.

Treatment of Candidemia/Acute Disseminated Candidiasis/Candida Peritonitis and Abscesses

IV (Adults ): 100 mg once daily for 15 days (range 10–47 days).
IV (Children ≥4 mo and >30 kg): 2 mg/kg once daily (max daily dose = 100 mg).
IV (Children ≥4 mo and ≤30 kg): 2 mg/kg once daily.

Treatment of Candidemia/Acute Disseminated Candidiasis/Candida Peritonitis and Abscesses Without Meningoencephalitis and/or Ocular Dissemination

IV (Children <4 mo): 4 mg/kg once daily.

Prophylaxis of Candida Infections During Hematopoetic Stem Cell Transplantation

IV (Adults ): 50 mg once daily (duration range 6–51 days).
IV (Children ≥4 mo and >30 kg): 1 mg/kg once daily (max daily dose = 50 mg).
IV (Children ≥4 mo and ≤30 kg): 1 mg/kg once daily.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits synthesis of glucan required for the formation of fungal cell wall.

Therapeutic effects:

Death of susceptible fungi.

Spectrum:

Active against the following Candida spp.: C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis.

Classifications ⬆ ⬇

Therapeutic Classification: antifungals

Pharmacologic Classification: echinocandins

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Primarily distributed into lung, liver, and spleen; minimal distribution to CNS and eyes.

Protein Binding: >99%.

Metabolism/Excretion: Mostly metabolized in the liver; 71% fecal elimination.

Half-Life: 15 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	24 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
Advise patient to notify health care professional immediately if signs of anaphylaxis occur. Infusion should be discontinued if symptoms occur.
Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇