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🏅 FDA Orphan Designation

AmBisome

Liposomal amphotericin B

Manufacturer: Fujisawa USA, Inc.

Indicated for:
Diffuse leptomeningeal melanocytosisOrphanPneumococcal meningitisLegionella infectionListeriosisFetal parvovirus syndromeCryptosporidiosis

FDA-Approved Indications (6)

Treatment of visceral leishmaniasis.

Treatment of Cryptococcal Meningitis in HIV-infected patients

Population: HIV-infected patients

Treatment of patients with Aspergillus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B

Population: all ages

Treatment of patients with Candida species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deox

Population: all ages

Empirical therapy for presumed fungal infection in febrile, neutropenic patients

Population: febrile, neutropenic patients

Treatment of patients with Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B

Population: all ages

Indications & Usage

INDICATIONS AND USAGE Am B isome is indicated for the following: • Empirical therapy for presumed fungal infection in febrile, neutropenic patients. • Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES ). • Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate. • Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with Am B isome, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES ). See DOSAGE AND ADMINISTRATION for recommended doses by indication.

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AmBisome
Fujisawa USA, Inc.

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.