Drug Detail:Ambisome (Amphotericin b liposomal [ am-foe-ter-i-sin-b-lye-poe-soe-mal ])
Drug Class: Polyenes
Usual Adult Dose for Aspergillosis - Invasive
3 to 5 mg/kg/day IV over 120 minutes
Comments:
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Uses: Treatment of Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or where renal impairment or toxicity precludes use of amphotericin B deoxycholate.
Usual Adult Dose for Candidemia
3 to 5 mg/kg/day IV over 120 minutes
Comments:
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Uses: Treatment of Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or where renal impairment or toxicity precludes use of amphotericin B deoxycholate.
Usual Adult Dose for Cryptococcosis
3 to 5 mg/kg/day IV over 120 minutes
Comments:
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Uses: Treatment of Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or where renal impairment or toxicity precludes use of amphotericin B deoxycholate.
Usual Adult Dose for Febrile Neutropenia
3 mg/kg/day IV over 120 minutes
Comments:
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Use: Empiric therapy for presumed fungal infection in febrile, neutropenic patients.
Usual Adult Dose for Cryptococcal Meningitis - Immunosuppressed Host
6 mg/kg/day IV over 120 minutes
Comments:
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Use: Treatment of Cryptococcal meningitis in HIV infected patients
Usual Adult Dose for Leishmaniasis
Immunocompetent patients: 3 mg/kg/day IV on days 1 through 5, and days 14 and 21
- Infuse over 120 minutes.
- If parasitic clearance is not achieved, a repeat course may be useful.
Immunocompromised patients: 4 mg/kg/day IV on days 1 through 5, and days 10, 17, 24, 31 and 38
- Infuse over 120 minutes.
- If parasitic clearance is not achieved or relapse occurs, seek expert advice regarding further treatment.
Comments:
- Relapse rates after initial clearance of parasites were high in immunocompromised patients treated with this drug.
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Use: Treatment of visceral leishmaniasis
Usual Adult Dose for Coccidioidomycosis
Severe, non-meningeal infection: 3 to 5 mg/kg/day IV
Duration of therapy: Until clinical improvement
- Follow with triazole
Use: Coccidioidomycosis
Usual Adult Dose for Blastomycosis
Moderate to severe pulmonary blastomycosis: 3 to 5 mg/kg/day IV
Duration of therapy: 1 to 2 weeks or until improvement is noted
- Follow with itraconazole
Moderate to severe extrapulmonary blastomycosis: 3 to 5 mg/kg/day IV
Duration of therapy: 1 to 2 weeks or until improvement is noted
- Follow with itraconazole
CNS blastomycosis: 5 mg/kg/day IV
Duration of therapy: 4 to 6 weeks
- Follow with an oral azole
Blastomycosis, immunosuppressed patient: 3 to 5 mg/kg/day IV
Duration of therapy: 1 to 2 weeks or until improvement is noted
- Follow with itraconazole
Blastomycosis during pregnancy: 3 to 5 mg/kg/day IV
Duration of therapy: 1 to 2 weeks or until improvement is noted
- Avoid azoles because of possible teratogenicity
Use: Blastomycosis
Usual Pediatric Dose for Aspergillosis - Invasive
1 month and older:
3 to 5 mg/kg/day IV over 120 minutes
Comments:
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Uses: Treatment of Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or where renal impairment or toxicity precludes use of amphotericin B deoxycholate.
Usual Pediatric Dose for Candidemia
1 month and older:
3 to 5 mg/kg/day IV over 120 minutes
Comments:
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Uses: Treatment of Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or where renal impairment or toxicity precludes use of amphotericin B deoxycholate.
Usual Pediatric Dose for Cryptococcosis
1 month and older:
3 to 5 mg/kg/day IV over 120 minutes
Comments:
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Uses: Treatment of Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or where renal impairment or toxicity precludes use of amphotericin B deoxycholate.
Usual Pediatric Dose for Febrile Neutropenia
1 month or older:
3 mg/kg/day IV over 120 minutes
Comments:
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Use: Empiric therapy for presumed fungal infection in febrile, neutropenic patients.
Usual Pediatric Dose for Cryptococcal Meningitis - Immunosuppressed Host
1 month or older:
6 mg/kg/day IV over 120 minutes
Comments:
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Use: Treatment of Cryptococcal meningitis in HIV infected patients
Usual Pediatric Dose for Leishmaniasis
1 month or older:
Immunocompetent patients: 3 mg/kg/day IV on days 1 through 5, and days 14 and 21
- Infuse over 120 minutes.
- If parasitic clearance is not achieved, a repeat course may be useful.
Immunocompromised patients: 4 mg/kg/day IV on days 1 through 5, and days 10, 17, 24, 31 and 38
- Infuse over 120 minutes.
- If parasitic clearance is not achieved or relapse occurs, seek expert advice regarding further treatment.
Comments:
- Relapse rates after initial clearance of parasites were high in immunocompromised patients treated with this drug.
- Individualize dosing and rate of infusion to ensure maximum efficacy and minimize toxicities or adverse events.
Use: Treatment of visceral leishmaniasis
Renal Dose Adjustments
Data not available
- This drug has been successfully administered to patients with pre-existing renal impairment.
Liver Dose Adjustments
Data not available
Precautions
Safety and efficacy have not been established in patients younger than 1 month.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
- Hemodialysis or peritoneal dialysis do not appear to significantly affect elimination of this drug.
Other Comments
Administration advice:
- Administer over approximately 120 minutes using a controlled infusion device.
- Administration time can be reduced to 60 minutes if treatment is well tolerated.
- Administration time can be increased if the patient experiences discomfort.
- An inline filter may be used if mean pore diameter is not less than 1 micron.
- Existing IV line must be flushed with 5% dextrose prior to administration; if line cannot be flushed with 5% dextrose, administer through a separate line.
Storage requirements:
- Store at temperatures up to 77F.
Reconstitution/preparation techniques:
- The manufacturer product information should be consulted.
IV compatibility:
- Dilute with 5% dextrose.
- Not compatible with saline.
- Do not mix with other drugs.
General:
- Carefully observe patients during the initial dosing period.