Usual Adult Dose for Esophageal Candidiasis

150 mg IV once a day

Comments:

• In patients treated successfully, the mean duration of therapy was 15 days (range: 10 to 30 days).

Usual Adult Dose for Fungal Infection Prophylaxis

50 mg IV once a day

Comments:

• In hematopoietic stem cell transplant (HSCT) recipients who had successful prophylactic therapy, the mean duration of prophylaxis was 19 days (range: 6 to 51 days).

Usual Adult Dose for Candidemia

100 mg IV once a day

Comments:

• In patients treated successfully, the mean duration of therapy was 15 days (range: 10 to 47 days).

Usual Pediatric Dose for Esophageal Candidiasis

4 months or older:

• Weight 30 kg or less: 3 mg/kg IV once a day
• Weight greater than 30 kg: 2.5 mg/kg IV once a day
• Maximum dose: 150 mg/day

Usual Pediatric Dose for Fungal Infection Prophylaxis

4 months or older: 1 mg/kg IV once a day
Maximum dose: 50 mg/day

Use: For prophylaxis of Candida infections in patients undergoing HSCT

Usual Pediatric Dose for Candidemia

Younger than 4 months: 4 mg/kg IV once a day
4 months or older: 2 mg/kg IV once a day

• Maximum dose: 100 mg/day

• Safety and efficacy have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months as a higher dose may be needed.

• Pediatric patients younger than 4 months: For treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination
• Pediatric patients 4 months or older: For treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Mild, moderate, or severe liver dysfunction: No adjustment recommended.

Precautions

CONTRAINDICATIONS:
Known hypersensitivity to the active component, any of the ingredients, or other echinocandins

Safety and efficacy for the treatment of esophageal candidiasis, prophylaxis of Candida infection in patients undergoing HSCT, and treatment of candidemia with meningoencephalitis and/or ocular dissemination have not been established in patients younger than 4 months.

Consult WARNINGS section for additional precautions.

Dialysis

This drug is not dialyzable; supplementary dosing should not be required after hemodialysis.

Other Comments

Administration advice:

• Administer by IV infusion only.
• Infuse over 1 hour; more rapid infusions may result in more frequent histamine-mediated reactions.
• Flush existing IV line with 0.9% Sodium Chloride Injection, USP before infusion of this drug.
• Administer solutions with concentrations above 1.5 mg/mL via central catheter in pediatric patients (to reduce risk of infusion reactions).

• Unopened vials: Store at room temperature (25C [77F]); excursions permitted to 15C to 30C (59F to 86F).
• Reconstituted product: May store in original vial for up to 24 hours at room temperature (25C [77F]); protect from light.
• Diluted infusion bag: Protect from light; may store for up to 24 hours at room temperature (25C [77F])

• The manufacturer's product information should be consulted.

• Compatible IV solutions: 0.9% Sodium Chloride Injection, USP (without bacteriostatic agent); 5% Dextrose Injection, USP
• Do not mix or co-infuse this drug with other medications; this drug precipitates when mixed directly with many other commonly used medications.

• Limitations of use: Not adequately studied in patients with endocarditis, osteomyelitis, and meningoencephalitis due to Candida; efficacy against infections due to fungi other than Candida has not been established.

• Hematologic: For evidence of worsening hemolysis or hemolytic anemia in patients who develop clinical/laboratory evidence of such conditions (during therapy)
• Hepatic: For evidence of worsening hepatic function in patients who develop abnormal liver function tests (during therapy)
• Renal: For evidence of worsening renal function in patients who develop abnormal renal function tests (during therapy)