Products Affected - Description

• • Ellence injection, Pfizer, 2 mg/mL, 100 mL vial, 1 count, NDC 00009-5093-01
  • Ellence injection, Pfizer, 2 mg/mL, 25 mL vial, 1 count, NDC 00009-5091-01
  • Epirubicin hydrochloride injection, Areva, 2 mg/mL, 100 mL vial, 1 count, NDC 59923-0701-00
  • Epirubicin hydrochloride injection, Areva, 2 mg/mL, 25 mL vial, 1 count, NDC 59923-0701-25

Reason for the Shortage

• • Areva did not provide a reason for the shortage.
  • Pfizer has Ellence on shortage due to manufacturing delays related to flooding of a manufacturing plant in India.

Available Products

• • There is insufficient supply for usual ordering

• • Areva has epirubicin 2 mg/mL 25 mL and 100 mL vials on back order and the company cannot estimate a release date.
  • Pfizer has Ellence 2 mg/mL 25 mL and 100 mL vials available in limited supply with weekly releases.

• • Consider evaluating the health-care system's total supply of epirubicin before beginning patients on combination chemotherapy regimens containing epirubicin. 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 epirubicin.
  • Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
  • Refer to the ASHP Infographics on Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated. https://www.ashp.org/-/media/assets/drug-shortages/docs/ASHP-drug-shortages-infographic.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.