Products Affected - Description

• • Doxil injection, Baxter, 2 mg/mL, 25 mL (50 mg) vial, 1 count, NDC 00338-0067-01
  • Doxorubicin Liposomal injection, Dr. Reddy's, 2 mg/mL, 10 mL (20 mg) vial, 1 count, NDC 43598-0283-35
  • Doxorubicin Liposomal injection, Dr. Reddy's, 2 mg/mL, 25 mL (50 mg) vial, 1 count, NDC 43598-0541-25

Reason for the Shortage

• • Dr. Reddy's did not provide a reason for the shortage.
  • Sun Pharma has doxorubicin liposomal injection available.
  • Zydus has doxorubicin liposomal injection available.
  • Baxter states the shortage is due to increased demand.

Available Products

• • Doxil injection, Baxter, 2 mg/mL, 10 mL (20 mg) vial, 1 count, NDC 00338-0063-01
  • Doxorubicin Liposomal injection, Sun Pharma, 2 mg/mL, 10 mL (20 mg) vial, 1 count, NDC 47335-0049-40
  • Doxorubicin Liposomal injection, Sun Pharma, 2 mg/mL, 25 mL (50 mg) vial, 1 count, NDC 47335-0050-40
  • Doxorubicin Liposomal injection, Zydus, 2 mg/mL, 10 mL (20 mg) vial, 1 count, NDC 70710-1530-01
  • Doxorubicin Liposomal injection, Zydus, 2 mg/mL, 25 mL (50 mg) vial, 1 count, NDC 70710-1531-01

• • Dr. Reddy's has doxorubicin liposomal 2 mg/mL 10 mL and 25 mL vials on back order and the company estimates a release date in late-November 2024.
  • Baxter has Doxil 2 mg/mL 25 mL vials on back order and the company estimates a release date of mid-October 2024.

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