anidulafungin

REMS

Candidemia and other serious candidal infections including intra-abdominal abscess, peritonitis.
Esophageal candidiasis.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Known or suspected hereditary fructose intolerance.

Use Cautiously in:

Underlying liver disease (may worsen);
OB: Safety not established in pregnancy; other antifungal agents preferred in pregnancy for infections caused by Candida;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children <1 mo (candidemia and intra-abdominal abscess and peritonitis caused by Candida or <18 yr (esophageal candidiasis); may lead to polysorbate toxicity in low-birth weight infants.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypotension

Derm: flushing, rash, urticaria

F and E: hypokalemia

GI: ↑liver enzymes, diarrhea

Resp: bronchospasm, dyspnea

Misc: ANAPHYLAXIS, infusion reactions

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Lyophilized powder for injection (contains fructose and polysorbate 80): 50 mg/vial; 100 mg/vial

Route/Dosage ⬆ ⬇

Candidemia and Intra-abdominal Abscess or Peritonitis Caused by Candida

IV (Adults ): 200 mg loading dose on Day 1, then 100 mg once daily. Continue therapy for ≥14 days after last positive culture.
IV (Children ≥1 mo): 3 mg/kg (max = 200 mg) loading dose on Day 1, then 1.5 mg/kg (max = 100 mg) once daily. Continue therapy for ≥14 days after last positive culture.

Esophageal Candidiasis

IV (Adults ): 100 mg loading dose on Day 1, then 50 mg once daily. Continue therapy for a minimum of 14 days and for ≥7 days following resolution of symptoms.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits the synthesis of fungal cell wall.

Therapeutic effects:

Death of susceptible fungi.

Spectrum:

Active against Candida albicans, C. glabrata, C. parapsilosis, and C. tropicalis.

Classifications ⬆ ⬇

Therapeutic Classification: antifungals

Pharmacologic Classification: echinocandins

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Undergoes chemical degradation without hepatic metabolism; <1% excreted in urine.

Half-Life: 40–50 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	24 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose of medication to patient.
Instruct patient to notify health care professional if signs and symptoms of anaphylaxis occur or if diarrhea becomes pronounced.
Inform patient that anidulafungin contains fructose. May be life-threatening when administered to patients with hereditary fructose intolerance.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0049- Roerig
- 0049-0114- ERAXIS
  - 0049-0114-28- 15 mL in 1 VIAL, SINGLE-USE (0049-0114-28)

0049- Roerig
- 0049-0116- ERAXIS
  - 0049-0116-28- 30 mL in 1 VIAL, SINGLE-USE (0049-0116-28)

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Indications ⬇