5/28/2019

Amphotericin B Injection

Reason for the Shortage

- X-Gen had amphotericin B on shortage due to manufacturing delays. They are the sole suppliers of amphotericin B lyophilized powder for injection.[1]
- Lipid-based amphotericin is not affected by this shortage.

Available Products

- Amphotericin B lyophilized powder for injection, X-Gen, 50 mg, vial, 1 count, NDC 39822-1055-05

Estimated Resupply Dates

- X-Gen has amphotericin B 50 mg vials available.[1]

Alternative Agents & Management

- Hospitals should consider reserving supply of conventional amphotericin B for patients who require intrathecal or ophthalmic treatment due to the small amount of data available with liposomal amphotericin B.
- Intrathecal liposomal amphotericin B has been used to treat cryptococcal central nervous system infections. One study used AmBisome 5 mg/mL 2 mL mixed with 3 mL of 5% dextrose for treatment of cryptococcal meningitis in HIV-infected patients.[2]

References

1. X-Gen Pharmaceuticals (personal communication). January 24, February 4, March 11 and 25, April 12 and 22, and May 6 and 28, 2019.
2. Alvarez-Uria G, Midde M, Battula J, Pujari HNB. Safety and tolerability of intrathecal liposomal amphotericin B (AmBisome) for cryptococcal meningitis: a retrospective study in HIV-infected patients. Ther Adv Infect Dis. 2018 Jun 12;5(5):77-81. doi: 10.1177/2049936118782846. eCollection 2018 Sep. PubMed PMID: 30224950; PubMed Central PMCID: PMC6136115.
3. Bae JH, Lee SC. Intravitreal liposomal amphotericin B for treatment of endogenous candida endophthalmitis. Jpn J Ophthalmol. 2015 Sep;59(5):346-52. doi: 10.1007/s10384-015-0397-x. Epub 2015 Jul 28. PubMed PMID: 26215152.
4. Morand K, Bartoletti AC, Bochot A, Barratt G, Brandely ML, Chast F. Liposomal amphotericin B eye drops to treat fungal keratitis: physico-chemical and formulation stability. Int J Pharm. 2007 Nov 1;344(1-2):150-3. Epub 2007 May 6. PubMed PMID: 17669608.

Updated

Updated May 28, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 24, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

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