Usual Adult Dose for Fungal Infection - Disseminated

5 mg/kg IV once a day

Use: For the treatment of invasive fungal infections in patients refractory to/intolerant of conventional amphotericin B therapy

Usual Adult Dose for Aspergillosis - Aspergilloma

Infectious Diseases Society of America (IDSA) Recommendations: 5 mg/kg IV once a day

Comments:

• Recommended as alternative salvage therapy for invasive pulmonary aspergillosis, invasive sinus aspergillosis, aspergillosis of the CNS, Aspergillus infections of the heart (endocarditis, pericarditis, myocarditis), Aspergillus osteomyelitis and septic arthritis, cutaneous aspergillosis, Aspergillus peritonitis, aspergilloma, chronic cavitary pulmonary aspergillosis
• This drug should be considered when azoles are contraindicated or not tolerated.
• Duration of therapy not well defined; experts generally recommend therapy be continued for at least 6 to 12 weeks, depending on severity and continuation of immunosuppression plus extent of clinical disease resolution.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Aspergillosis - Invasive

Infectious Diseases Society of America (IDSA) Recommendations: 5 mg/kg IV once a day

Comments:

• Recommended as alternative salvage therapy for invasive pulmonary aspergillosis, invasive sinus aspergillosis, aspergillosis of the CNS, Aspergillus infections of the heart (endocarditis, pericarditis, myocarditis), Aspergillus osteomyelitis and septic arthritis, cutaneous aspergillosis, Aspergillus peritonitis, aspergilloma, chronic cavitary pulmonary aspergillosis
• This drug should be considered when azoles are contraindicated or not tolerated.
• Duration of therapy not well defined; experts generally recommend therapy be continued for at least 6 to 12 weeks, depending on severity and continuation of immunosuppression plus extent of clinical disease resolution.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Candidemia

IDSA Recommendations: 3 to 5 mg/kg IV once a day

Comments:

• Recommended (generally as an alternative) for candidemia in nonneutropenic patients, candidemia in neutropenic patients, chronic disseminated (hepatosplenic) candidiasis, empiric treatment for suspected invasive candidiasis in nonneutropenic patients in the intensive care unit, Candida endocarditis, Candida suppurative thrombophlebitis, Candida osteomyelitis, Candida septic arthritis
• Duration of therapy ranges from 5 to 7 days to at least 2 weeks; treatment may be continued after switching to a different antifungal agent.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Systemic Candidiasis

IDSA Recommendations: 3 to 5 mg/kg IV once a day

Comments:

• Recommended (generally as an alternative) for candidemia in nonneutropenic patients, candidemia in neutropenic patients, chronic disseminated (hepatosplenic) candidiasis, empiric treatment for suspected invasive candidiasis in nonneutropenic patients in the intensive care unit, Candida endocarditis, Candida suppurative thrombophlebitis, Candida osteomyelitis, Candida septic arthritis
• Duration of therapy ranges from 5 to 7 days to at least 2 weeks; treatment may be continued after switching to a different antifungal agent.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Leishmaniasis

IDSA Recommendations:

• Immunocompetent: 2 to 3 mg/kg IV once a day for 5 to 10 days
• Immunosuppressed: 3 to 5 mg/kg IV once a day for 10 days

• Recommended as an alternative for visceral leishmaniasis
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Fungal Infection - Disseminated

5 mg/kg IV once a day

Use: For the treatment of invasive fungal infections in patients refractory to/intolerant of conventional amphotericin B therapy

American Academy of Pediatrics Recommendations:
1 month or older: 3 to 5 mg/kg IV once a day

Comments:

• Dose should be infused over 2 hours.
• Limited/no data available regarding use in newborn infants.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Aspergillosis - Aspergilloma

IDSA Recommendations:
Children: 5 mg/kg IV once a day

Comments:

• Recommended as alternative salvage therapy for invasive pulmonary aspergillosis, invasive sinus aspergillosis, aspergillosis of the CNS, Aspergillus infections of the heart (endocarditis, pericarditis, myocarditis), Aspergillus osteomyelitis and septic arthritis, cutaneous aspergillosis, Aspergillus peritonitis, aspergilloma, chronic cavitary pulmonary aspergillosis
• This drug should be considered when azoles are contraindicated or not tolerated.
• Duration of therapy not well defined; experts generally recommend therapy be continued for at least 6 to 12 weeks, depending on severity and continuation of immunosuppression plus extent of clinical disease resolution.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Aspergillosis - Invasive

IDSA Recommendations:
Children: 5 mg/kg IV once a day

Comments:

• Recommended as alternative salvage therapy for invasive pulmonary aspergillosis, invasive sinus aspergillosis, aspergillosis of the CNS, Aspergillus infections of the heart (endocarditis, pericarditis, myocarditis), Aspergillus osteomyelitis and septic arthritis, cutaneous aspergillosis, Aspergillus peritonitis, aspergilloma, chronic cavitary pulmonary aspergillosis
• This drug should be considered when azoles are contraindicated or not tolerated.
• Duration of therapy not well defined; experts generally recommend therapy be continued for at least 6 to 12 weeks, depending on severity and continuation of immunosuppression plus extent of clinical disease resolution.
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Dose adjustment(s) may be required; however, no specific guidelines have been suggested.

Comments:

• Renal toxicity of this drug (as measured by serum creatinine levels) is dose-dependent.
• Decisions regarding dose adjustments should be made only after considering patient's overall clinical condition.

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:
Hypersensitivity to the active component or any of the ingredients

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer by IV infusion at a rate of 2.5 mg/kg/hour; if infusion time exceeds 2 hours, mix the contents by shaking the infusion bag every 2 hours.
• Flush an existing IV line with 5% Dextrose Injection before infusing this drug, or use a separate infusion line; do not use an in-line filter.

• Prior to admixture: Store at 2C to 8C (36F to 46F); protect from exposure to light; do not freeze; keep in carton until time of use.
• Admixed drug and 5% Dextrose Injection: May store for up to 48 hours at 2C to 8C (36F to 46F) and an additional 6 hours at room temperature; do not freeze.

• The manufacturer product information should be consulted.

• This drug should not be diluted with saline solutions or mixed with other drugs or electrolytes; compatibility not established.

• Hematologic: Complete blood counts (regularly)
• Hepatic: Liver function (regularly)
• Investigations: Serum electrolytes, especially potassium and magnesium (regularly)
• Renal: Serum creatinine (frequently during therapy)