Ambisome
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Questions & Answers
Side Effects & Adverse Reactions
Anaphylaxis has been reported with amphotericin B deoxycholate and other amphotericin B-containing drugs, including AmBisome. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of AmBisome.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
AmBisome 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 AmBisome, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).
See DOSAGE AND ADMINISTRATION for recommended doses by indication.
History
There is currently no drug history available for this drug.
Other Information
AmBisome for Injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains 50 mg of amphotericin B, USP, intercalated into a liposomal membrane consisting of approximately 213 mg hydrogenated soy phosphatidylcholine; 52 mg cholesterol, NF; 84 mg distearoylphosphatidylglycerol; 0.64 mg alpha tocopherol, USP; together with 900 mg sucrose, NF; and 27 mg disodium succinate hexahydrate as buffer. Following reconstitution with Sterile Water for Injection, USP, the resulting pH of the suspension is between 5-6.
AmBisome is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. AmBisome consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the AmBisome liposomes. AmBisome contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below.
Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products.
Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as:
[1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*, 19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-β-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No. 1397-89-3).
Amphotericin B has a molecular formula of C47H73NO17 and a molecular weight of 924.09.
The structure of amphotericin B is shown below:
Sources
Ambisome Manufacturers
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Astellas Pharma Us, Inc.
![Ambisome (Amphotericin B) Injection, Powder, Lyophilized, For Solution [Astellas Pharma Us, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ambisome | Astellas Pharma Us, Inc.
AmBisome should be administered by intravenous infusion, using a controlled infusion device, over a period of approximately 120 minutes.
An in-line membrane filter may be used for the intravenous infusion of AmBisome; provided THE MEAN PORE DIAMETER OF THE FILTER IS NOT LESS THAN 1.0 MICRON.
NOTE: An existing intravenous line must be flushed with 5% Dextrose Injection prior to infusion of AmBisome. If this is not feasible, AmBisome must be administered through a separate line.
Infusion time may be reduced to approximately 60 minutes in patients in whom the treatment is well-tolerated. If the patient experiences discomfort during infusion, the duration of infusion may be increased.
The recommended initial dose of AmBisome for each indication for adult and pediatric patients is as follows:
Indication Dose (mg/kg/day) Empirical therapy 3Systemic fungal infections:
Aspergillus
Candida
Cryptococcus
3-5
Cryptococcal meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES) 6Dosing and rate of infusion should be individualized to the needs of the specific patient to ensure maximum efficacy while minimizing systemic toxicities or adverse events.
Doses recommended for visceral leishmaniasis are presented below:
Visceral Leishmaniasis Dose (mg/kg/day) Immunocompetent patients3 (days 1-5) and
3 on days 14, 21 Immunocompromised patients4 (days 1-5) and
4 on days 10, 17, 24, 31, 38For immunocompetent patients who do not achieve parasitic clearance with the recommended dose, a repeat course of therapy may be useful.
For immunocompromised patients who do not clear parasites or who experience relapses, expert advice regarding further treatment is recommended. For additional information see DESCRIPTION OF CLINICAL STUDIES.
Directions for Reconstitution, Filtration and DilutionRead This Entire Section Carefully Before Beginning Reconstitution
AmBisome must be reconstituted using Sterile Water for Injection, USP (without a bacteriostatic agent). Vials of AmBisome containing 50 mg of amphotericin B are prepared as follows:
Reconstitution
1. Aseptically add 12 mL of Sterile Water for Injection, USP to each AmBisome vial to yield a preparation containing 4 mg amphotericin B/mL.
CAUTION: DO NOT RECONSTITUTE WITH SALINE OR ADD SALINE TO THE RECONSTITUTED CONCENTRATION, OR MIX WITH OTHER DRUGS. The use of any solution other than those recommended, or the presence of a bacteriostatic agent in the solution, may cause precipitation of AmBisome.
2. Immediately after the addition of water, SHAKE THE VIAL VIGOROUSLY for 30 seconds to completely disperse the AmBisome. AmBisome forms a yellow, translucent suspension. Visually inspect the vial for particulate matter and continue shaking until completely dispersed.
Filtration and Dilution
3. Calculate the amount of reconstituted (4 mg/mL) AmBisome to be further diluted.
4. Withdraw this amount of reconstituted AmBisome into a sterile syringe.
5. Attach the 5-micron filter, provided, to the syringe. Inject the syringe contents through the filter, into the appropriate amount of 5% Dextrose Injection. (Use only one filter per vial of AmBisome.)
6. AmBisome must be diluted with 5% Dextrose Injection to a final concentration of 1 to 2 mg/mL prior to administration. Lower concentrations (0.2 to 0.5 mg/mL) may be appropriate for infants and small children to provide sufficient volume for infusion. DISCARD PARTIALLY USED VIALS.
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