Products Affected - Description

• • Busulfan intravenous injection, Amneal, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 70121-1244-07
  • 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 did not provide a reason for the shortage.
  • Armas Pharmaceuticals did not provide a reason for the shortage.
  • 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

• • Amneal has busulfan 6 mg/mL 10 mL vials on back order and the company cannot estimate a release date.
  • Armas has busulfan 6 mg/mL 10 mL vials on long-term back order and the company cannot estimate a release date.

• • 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.