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Busulfan Injection Shortage

Last Updated: April 29, 2024
Status: Current

Products Affected - Description
    • Busulfan intravenous injection, Amneal, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 70121-1244-07 - discontinued
    • Busulfan intravenous injection, Armas Pharmaceuticals, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 72485-0210-08
    • Busulfan intravenous injection, Fresenius Kabi, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 65219-0160-10 - discontinued
Reason for the Shortage
    • Amneal discontinued busulfan injection.
    • Armas Pharmaceuticals has temporarily discontinued busulfan injection.
    • Athenex is not currently marketing busulfan injection.
    • Fresenius Kabi discontinued busulfan in early-2022.
    • Meitheal Pharmaceuticals has busulfan available.
    • Pfizer has busulfan injection available.
    • Sagent has busulfan injection available.
    • Viatris has busulfan injection available.
    • Otsuka has Busulfex available.
Available Products
    • Busulfex intravenous injection, Otsuka America Pharmaceuticals, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 59148-0070-91
    • Busulfan intravenous injection, Meitheal Pharmaceuticals, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 71288-0116-11
    • Busulfan intravenous injection, Mylan (Viatris), 6 mg/mL, 10 mL single dose vial, 8 count, NDC 67457-0893-08
    • Busulfan intravenous injection, Pfizer, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 00409-1112-01
    • Busulfan intravenous injection, Sagent, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 25021-0241-10

Estimated Resupply Dates

    • Most marketed presentations are available.

Alternative Agents & Management

    • Consider evaluating the health-care system's total supply of busulfan before beginning patients on combination chemotherapy regimens containing busulfan. If adequate supplies are not available, select an alternative regimen.
    • The choice of an alternative agent must be patient-specific and based on renal function, liver function, and the neoplasm type and location. No single agent can be substituted for busulfan.
    • Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
    • Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/managing-drug-product-shortages.pdf
    • Refer to national guidelines such as those from the National Comprehensive Cancer Network (www.nccn.org) or American Society of Clinical Oncology (http://www.asco.org/) for additional information regarding therapeutic use.

Updated

Updated April 29, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 4, 2019 by Stephen Andrews, PharmD, BCPS, CPPS, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.