AMBISOME

Generic Name/API: amphotericin B

Manufacturer: Gilead Sciences, Inc.

Dosage Forms & Strength & Pack Size:
AmBisome for Injection is available as an individual carton.
Each carton contains one pre-packaged, disposable sterile 5 micron filter.

Storage:
Unopened vials of lyophilized material are to be stored at temperatures up to 25°C
(77°F).
Storage of Reconstituted Product Concentrate
The reconstituted product concentrate may be stored for up to 24 hours at
2°-8°C (36°-46°F) following reconstitution with Sterile Water for Injection, USP.
Do not freeze.
Storage of Diluted Product
Injection of AmBisome should commence within 6 hours of dilution with 5% Dextrose
Injection.
As with all parenteral drug products, the reconstituted AmBisome should be inspected
visually for particulate matter and discoloration prior to administration, whenever
solution and container permit. Do not use material if there is any evidence of
precipitation or foreign matter. Aseptic technique must be strictly observed in all
handling, since no preservative or bacteriostatic agent is present in AmBisome or in
the materials specified for reconstitution and dilution.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE
AmBisome is indicated for the following:

Empirical therapy for presumed fungal infection in febrile, neutropenic patients
Treatment of Cryptococcal Meningitis in HIV-infected patients
Treatment of patients with Aspergillus species, Candida species, and/or Cryptococcus species infections 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 AmBisome, relapse rates were high following initial clearance of parasites

IMPORTANT SAFETY INFORMATION
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CONTRAINDICATIONS
AmBisome is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product, unless benefit of therapy outweighs the risk.

WARNINGS AND PRECAUTIONS
Anaphylaxis has been reported with amphotericin B–containing drugs, including AmBisome. If a severe reaction occurs, the AmBisome infusion should be immediately discontinued and the patient should not receive further infusions of AmBisome.

General: During the initial dosing period, patients should be under close observation. AmBisome has been shown to be significantly less toxic than amphotericin B deoxycholate; however, adverse events may still occur.

Laboratory Tests: Patient management should include laboratory evaluation of renal, hepatic, and hematopoietic function, and serum electrolytes (magnesium and potassium).

Drug-Laboratory Interactions: Serum Phosphate false elevation. False elevations of serum phosphate may occur when samples from patients receiving AmBisome are analyzed using the PHOSm assay.

Drug Interactions: No formal drug-interaction studies have been conducted with AmBisome. However, the following drugs are known to interact with amphotericin B and may interact with AmBisome: antineoplastic agents, corticosteroids and corticotropin (ACTH), digitalis glycosides, flucytosine, azoles (e.g. ketoconazole, miconazole, clotrimazole, fluconazole), leukocyte transfusions, other nephrotoxic medications, and skeletal muscle relaxants. (Please see Package Insert, Drug Interactions)

ADVERSE REACTIONS
The commonly reported adverse reactions across all studies with an incidence of >20% with AmBisome include: rash, hyperglycemia, hypokalemia, hypomagnesemia, diarrhea, nausea, vomiting, anemia, increased alkaline phosphatase, increased blood urea nitrogen, chills, insomnia, increased creatinine, and dyspnea.

Infusion related reactions include chills/rigors, fever, nausea, vomiting, hypertension, tachycardia, dyspnea, and hypoxia. There were a few reports of flushing, back pain with or without chest tightness, and chest pain associated with AmBisome administration; on occasion this has been severe. Where these symptoms were noted, reaction developed within a few minutes after the start of infusion and disappeared rapidly when the infusion was stopped. These symptoms do not occur with every dose and usually do not recur on subsequent administrations when the infusion rate is slowed.

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