Products Affected - Description

• • Fludarabine intravenous lyophilized powder for injection, Leucadia Pharmaceuticals, 50 mg, vial, 1 count, NDC 24201-0237-01
  • Fludarabine intravenous solution for injection, Sagent, 25 mg/mL, 2 mL vial, 1 count, NDC 25021-0242-02

Reason for the Shortage

• • Areva has fludarabine 25 mg/mL 2 mL vials available for direct orders only.
  • Fresenius Kabi has fludarabine injection available.
  • Leucadia did not provide a reason for the shortage.
  • Pfizer discontinued fludarabine in August 2020. Their estimated market share was less than 1%.
  • Sagent has fludarabine on shortage due to manufacturing delays.
  • Teva is not currently marketing 25 mg/mL 2 mL vials. The 50 mg lyophilized powder for injection vials are available.

Available Products

• • Fludarabine intravenous solution for injection, Areva, 25 mg/mL, 2 mL vial, 1 count, NDC 59923-0604-02
  • Fludarabine intravenous solution for injection, Fresenius Kabi, 25 mg/mL, 2 mL vial, 1 count, NDC 63323-0192-02
  • Fludarabine intravenous lyophilized powder for injection, Teva, 50 mg, vial, 1 count, NDC 45963-0609-55

• • Leucadia has fludarabine lyophilized powder 50 mg vials temporarily unavailable and the company cannot estimate a release date.
  • Sagent has fludarabine 25 mg/mL 2 mL vials on back order and the company estimates a release date of October 2023.

• • Consider evaluating the health-care system's total supply of fludarabine before beginning patients on combination chemotherapy regimens containing fludarabine. 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 fludarabine.
  • 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.