anidulafungin

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

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.

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.

Availability ⬆ ⬇

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

Assessment ⬆ ⬇

Assess infected area and monitor cultures before and periodically during therapy.
Obtain specimens for culture before starting therapy. Therapy may be started before results are obtained.
Monitor for signs and symptoms of anaphylaxis (rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, hypotension); usually related to histamine release. To decrease risk, do not exceed a rate of infusion of 1.1 mg/min.

Lab Test Considerations:

May cause ↑ ALT, AST, alkaline phosphatase, and hepatic enzymes.
- May cause hypokalemia.
- May cause neutropenia and leukopenia.

Implementation ⬆ ⬇

IV Administration:

Adults:: Intermittent Infusion: Reconstitution: Reconstitute each 50 mg vial with 15 mL or the 100 mg vial with 30 mL of sterile water for injection.Concentration: 3.33 mg/mL. Stable at room temperature for up to 24 hr. Adults: Diluent: Further dilute within 24 hr by transferring contents of reconstituted vial into IV bag of D5W or 0.9% NaCl. For the 50 mg dose, dilute with 50 mL for an infusion volume of 65 mL. For the 100 mg dose, dilute with 100 mL for an infusion volume of 130 mL. For the 200 mg dose, dilute with 200 mL for a total infusion volume of 260 mL.Concentration: Final concentration is 0.77 mg/mL. Do not administer solutions that are discolored or contain particulate matter. Solution is stable for up to 48 hr at room temperature.
Rate: Infuse over at least 45 min for the 50 mg dose, 90 min for the 100 mg dose, or 180 min for the 200 mg dose.
Pediatric Patients:: Intermittent Infusion: Reconstitution: Reconstitute each vial with sterile water for injection.Concentration: 3.33 mg/mL.Diluent: Dilute with 0.9% NaCl or D5W.Concentration: Final concentration is 0.77 mg/mL. Prepare in infusion syringe or IV infusion bag.
Rate: Administer at a rate not to exceed 1.1 mg/min (1.4 mL/min or 84 mL/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.

Evaluation/Desired Outcomes ⬆ ⬇

Resolution of clinical and laboratory indications of fungal infections. Duration of therapy should be based on the patients clinical response. Therapy should be continued for at least 14 days after the last positive culture. For esophageal candidiasis, treatment should continue for at least 7 days following resolution of symptoms.

US Brand Names ⬆ ⬇

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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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇