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.

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.

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

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).

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.

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

Assessment ⬆ ⬇

Assess symptoms of esophageal candidiasis (dysphagia, odynophagia, retrosternal pain) prior to and during therapy.
Monitor for signs of anaphylaxis (rash, pruritus, wheezing, laryngeal edema, abdominal pain). Discontinue micafungin and notify health care professional immediately if these occur.
Monitor for signs and symptoms of histamine-mediated reactions (rash, pruritus, facial swelling, vasodilation) during infusion. If symptoms occur, slow infusion rate.
Assess for injection site reactions (phlebitis, thrombophlebitis) during therapy. These occur more frequently in patients receiving micafungin via peripheral IV infusion.

Lab Test Considerations:

May cause ↑ serum alkaline phosphatase, bilirubin, ALT, AST, and LDH levels. If elevations occur, monitor for worsening liver function; may require discontinuation of therapy.
- May cause ↑ BUN and serum creatinine.
- May cause leukopenia, neutropenia, thrombocytopenia, and anemia. Monitor for worsening levels; may require discontinuation of therapy.
- May cause hypokalemia, hypocalcemia, and hypomagnesemia.

Implementation ⬆ ⬇

IV Administration:

Intermittent Infusion: Reconstitution: For Adults: Reconstitute each 50-mg vial with 5 mL of 0.9% NaCl or D5W to achieve concentration of 10 mg/mL. Reconstitute each 100-mg vial with 5 mL of 0.9% NaCl or D5W to achieve concentration of 20 mg/mL. Dissolve by gently swirling vial; do not shake vigorously.Diluent: Directions for further dilution based on indication for use. For prophylaxis of Candida infections, add 50 mg of micafungin to 100 mL of 0.9% NaCl or D5W. For treatment of esophageal candidiasis, add 150 mg of micafungin to 100 mL of 0.9% NaCl or D5W. Reconstituted vials and infusion are stable for 24 hr at room temperature. Protect diluted solution from light.Concentration: 0.5–1.5 mg/mL.
For Children:Diluent: Determine dose and divide by final concentration (10 or 20 mg/mL). Add withdrawn volume to 0.9% NaCl or D5W in IV bag or syringe.Concentration: 0.5–4 mg/mL. Concentrations >1.5 mg/mL should be administered via central venous catheter to minimize infusion reactions. Discard unused vials.
Rate: Flush line with 0.9% NaCl prior to administration. Infuse over 1 hr. More rapid infusions may result in more frequent histamine mediated reactions.

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.

Evaluation/Desired Outcomes ⬆ ⬇

Resolution of signs and symptoms of esophageal candidiasis, candidemia, acute disseminated candidiasis, candidal peritonitis, and abscesses.
Prevention of Candida infections during hematopoetic stem cell transplantation.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0469- Astellas Pharma US, Inc.
- 0469-3211- Mycamine
  - 0469-3211-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3211-10) > 10 mL in 1 VIAL, SINGLE-DOSE

0469- Astellas Pharma US, Inc.
- 0469-3211- Mycamine
  - 0469-3211-99- 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3211-99) > 10 mL in 1 VIAL, SINGLE-DOSE

0469- Astellas Pharma US, Inc.
- 0469-3250- Mycamine
  - 0469-3250-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-10) > 5 mL in 1 VIAL, SINGLE-DOSE

0469- Astellas Pharma US, Inc.
- 0469-3250- Mycamine
  - 0469-3250-50- 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-50) > 5 mL in 1 VIAL, SINGLE-DOSE

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇