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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.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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