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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.
DOSAGE AND ADMINISTRATION
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:
| Systemic fungal infections:
|Cryptococcal meningitis in HIV infected patients (see Description Of Clinical Studies)||6|
Dosing 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 patients||3 (days 1-5) and 3 on days 14, 21|
|Immunocompromised patients||4 (days 1-5) and 4 on days 10, 17,24,31,38|
For 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 Dilution Read 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:
- 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.
- 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.
Storage of AMBISOME
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.
AmBisome for Injection is available as single cartons (equivalent to 50mg amphotericin B) and in packs often individual vial cartons (NDC 0469-3051-30).
Each carton contains one pre-packaged, disposable sterile 5 micron filter.
1. Clinical and Laboratory Standards Institute (CLSI). Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard -3rd edition. CLSI document M27- A3. CLSI, 940 West Valley Rd. Suite 1400, Wayne, PA 19087-1898, 2008.
2. CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeast; 3rd Informational Supplement. CLSI document M27-S3, 2008.
3. CLSI. Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline- 2nd edition. CLSI document M44-A2, 2009.
4. CLSI Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard - 2nd edition. CLSI document M38-A2, 2008.
5. CLSI. Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline. CLSI document M51-A, 2010.
Marketed by: Astellas Pharma US, Inc. Deerfield, IL 60015-2548. Manufactured by: Gilead Sciences, Inc. San Dimas, CA91773. AmBisome is a registered trademark of Gilead Sciences, Inc. Abelcet® is a registered trademark of The Liposome Company, Inc.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/16/2012
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