Usual Adult Dose for Candidemia

Initial dose: 200 mg IV as a single loading dose on Day 1
Maintenance dose: 100 mg IV once a day thereafter

Comments:

• Duration of therapy should be based on patient's clinical response.
• In general, antifungal therapy should continue for at least 14 days after the last positive culture.

Use: For the treatment of candidemia and the following Candida infections: intraabdominal abscess and peritonitis

Usual Adult Dose for Esophageal Candidiasis

Initial dose: 100 mg IV as a single loading dose on Day 1
Maintenance dose: 50 mg IV once a day thereafter
Duration of therapy: At least 14 days and at least 7 days after resolution of symptoms

Comments:

• Duration of therapy should be based on patient's clinical response.
• Due to risk of relapse in HIV-infected patients, suppressive antifungal therapy may be considered after a course of treatment.

Use: For the treatment of esophageal candidiasis

Usual Pediatric Dose for Candidemia

1 month or older:

• Initial dose: 3 mg/kg IV as a single loading dose on Day 1
• Maximum dose: 200 mg/dose
• Maintenance dose: 1.5 mg/kg IV once a day thereafter
• Maximum dose: 100 mg/dose

Comments:

• Overall, antifungal therapy should continue for at least 14 days after the last positive culture.

Use: For the treatment of candidemia and the following Candida infections: intraabdominal abscess and peritonitis

Renal Dose Adjustments

Any degree of renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Any degree of liver dysfunction: No adjustment recommended.

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to the active component, any of the ingredients, or other echinocandins
• Known/suspected hereditary fructose intolerance

Candidemia and other forms of Candida infections: Safety and efficacy have not been established in patients younger than 1 month.
Esophageal candidiasis: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: No adjustment recommended.

Comments:

• This drug is not dialyzable and may be administered without regard to the timing of hemodialysis.

Other Comments

Administration advice:

• Administer by IV infusion; use a programmable syringe or infusion pump for pediatric patients.
• Do not exceed a rate of infusion of 1.1 mg/minute.
• Do not co-infuse with other drugs or electrolytes.

Storage requirements:

• Unreconstituted vials: Store in refrigerator at 2C to 8C (36F to 46F); do not freeze. Excursions for 96 hours up to 25C (77F) permitted and vial can be returned to storage at 2C to 8C (36F to 46F).
• Reconstituted solution: Can store at up to 25C (77F) for up to 24 hours before dilution into infusion solution. Chemical and physical in-use stability shown for 24 hours at 25C (77F).
• Diluted infusion solution: Can store at up to 25C (77F) for up to 48 hours; do not freeze. Chemical and physical in-use stability shown for 48 hours at 25C (77F).

Reconstitution/preparation techniques:

• This drug must be reconstituted and then diluted before administration.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible (reconstitution): Sterile Water for Injection
• Compatible (dilution): 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP
• Compatibility of the reconstituted solution with other IV substances, additives, or medications has not been established; this drug must not be diluted with other solutions.

General:

• Limitations of Use:
• This drug has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida and has not been studied in enough neutropenic patients to establish efficacy in this group; the dosage to treat Candida dissemination into the CNS and the eye has not been established.
• This drug is associated with high relapse rates in esophageal candidiasis.
• Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be collected before therapy to isolate and identify causative organism(s); therapy may be started before results of cultures and other laboratory studies are known; antifungal therapy should be adjusted accordingly when results are available.
• This drug contains fructose and can be life-threatening when used in patients with hereditary fructose intolerance.

Monitoring:

• Hepatic: For evidence of worsening hepatic tests in patients who develop abnormal liver function tests (during therapy)

Patient advice:

• Notify healthcare provider if infusion-related symptoms (including rash, urticaria, flushing, pruritus, dyspnea, hypotension) occur.
• Patients of childbearing potential: Notify healthcare provider of known/suspected pregnancy.