Products Affected - Description

• • Doxorubicin solution for injection, Hikma, 2 mg/mL, 10 mL vial, 1 count, NDC 00143-9085-01
  • Doxorubicin solution for injection, Hikma, 2 mg/mL, 100 mL vial, 1 count, NDC 00143-9087-01
  • Doxorubicin solution for injection, Hikma, 2 mg/mL, 25 mL vial, 1 count, NDC 00143-9086-01
  • Doxorubicin solution for injection, Hikma, 2 mg/mL, 5 mL vial, 1 count, NDC 00143-9084-01
  • Doxorubicin solution for injection, Pfizer, 2 mg/mL, 10 mL vial, 1 count, NDC 00069-0277-02

Reason for the Shortage

• • Athenex is not marketing doxorubicin at this time.[1]
  • Fresenius Kabi has doxorubicin available. Fresenius Kabi discontinued the 10 mL vial in October 2020.[2]
  • Hikma did not provide a reason for the shortage.[3]
  • Mylan Institutional discontinued doxorubicin 10 mg lyophilized powder for injection in 2019.[4]
  • Teva has doxorubicin available.[6-7]
  • Pfizer has doxorubicin available.[5]
  • Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials.[8]
  • Sagent discontinued doxorubicin in late-2020.[9]

Available Products

• • Doxorubicin solution for injection, Fresenius Kabi, 2 mg/mL, 100 mL vial, 1 count, NDC 63323-0101-61
  • Doxorubicin solution for injection, Fresenius Kabi, 2 mg/mL, 25 mL vial, 1 count, NDC 63323-0883-30
  • Doxorubicin solution for injection, Fresenius Kabi, 2 mg/mL, 5 mL vial, 1 count, NDC 63323-0883-05
  • Doxorubicin, Hikma, 10 mg, vial, 1 count, NDC 00143-9092-01
  • Doxorubicin, Hikma, 50 mg, vial, 1 count, NDC 00143-9093-01
  • Doxorubicin, Mylan Institutional (Viatris), 50 mg, vial, 1 count, NDC 67457-0436-50
  • Doxorubicin solution for injection, Pfizer, 2 mg/mL, 100 mL vial, 1 count, NDC 00069-1542-20
  • Doxorubicin solution for injection, Pfizer, 2 mg/mL, 25 mL vial, 1 count, NDC 00069-3032-20
  • Doxorubicin solution for injection, Pfizer, 2 mg/mL, 5 mL vial, 1 count, NDC 00069-3030-20
  • Doxorubicin injection, Teva, 2 mg/mL, 10 mL vial, 1 count, NDC 45963-0733-57
  • Doxorubicin injection, Teva, 2 mg/mL, 100 mL vial, 1 count, NDC 45963-0733-60
  • Doxorubicin injection, Teva, 2 mg/mL, 25 mL vial, 1 count, NDC 45963-0733-68
  • Doxorubicin injection, Teva, 2 mg/mL, 5 mL vial, 1 count, NDC 45963-0733-55

• • Hikma has doxorubicin 2 mg/mL 5 mL, 10 mL, 25 mL, and 100 mL vials on back order and the company cannot estimate a release date.[3]
  • Pfizer has doxorubicin 2 mg/mL 10 mL vials available in limited supply. The 100 mL vials are on back order and the company estimates a release date of September 2024.[5]

• • Doxorubicin is an anthracycline glycoside agent. It is labeled for use in patients with leukemias, lymphomas, and metastatic cancers including soft tissue and bone sarcomas, neuroblastoma, nephroblastoma, breast, gastric, ovarian, thyroid, bronchogenic, and transitional bladder cancers.[10-12]
  • Doxorubicin is used off-label in adults for treating refractory multiple myeloma, uterine sarcoma, and endometrial, liver, kidney, and head and neck cancers.[10-12]
  • 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

• • Chemotherapy agents, such as doxorubicin, pose additional safety risks both for patients and for healthcare workers handling these agents.[10-12]
  • Use additional caution when processing orders for chemotherapy drugs, especially when switching between chemotherapy agents or when processing orders for chemotherapy agents with which staff may be unfamiliar (eg, those not normally prescribed at a specific institution).[10-12]

• • 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. [10-12]
  • Consider evaluating the health-care system's total supply of doxorubicin before beginning patients on combination chemotherapy regimens containing doxorubicin. If adequate supplies are not available, select an alternative regimen.
  • 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. http://www.ashp.org/DocLibrary/Policy/DrugShortages/ASHP_shortage_guide09.pdf

• 1. Athenex (personal communications). March 5, April 18, June 11, July 3, October 24, 2018; February 7, May 1, September 5, December 4, 2019; January 22, August 13, November 11, 2020; February 1, and June 7, 2021.
  2. Fresenius Kabi, (personal communications). May 19, June 22, July 20, September 2, 13, and 29, October 14 and 25, November 12 and 29, December 17, 2010; January 7 and 19, February 1, March 9 and 25, April 11 and 20, May 18, June 8, August 16, September 20, October 25, November 28, 2011; January 4, March 15, April 13, May 9 and 21, June 19, July 9, August 27, October 1, November 26, 2012; January 11, February 4 and 11, March 17 and 29, April 29, June 18, July 8, September 17, October 3, November 5, December 6, 2013; February 11, March 12, April 24 and 30, May 12 and 21, June 10, July 31, August 27, September 22, October 16, November 12, 2014; January 5, February 18, March 11 and 18, April 29, May 13, June 25, July 29, September 29, November 4, 2015; February 5, March 7 and 31, June 8, August 3, October 27, December 8, 2016; March 5, April 3, June 20, August 15, October 27, December 15 and 22, 2017; January 26, February 24, March 30, April 13, June 7, July 5, August 17, October 20, November 25, December 14, 2018; January 18, March 1, 8, and 29, May 3 and 17, June 27, July 18, August 30, October 18, November 1 and 22, December 13, 2019; January 17, February 21, March 6 and 13, April 3 and 24, June 19, September 25, October 9, November 25, December 23, 2020; January 29, May 21 and 28, July 8 and 30, September 17, December 17, 2021; January 14, February 11, March 11, April 8, May 27, July 22, September 23, October 28, November 18, December 2 and 29, 2022; January 27, February 10, 17, and 24, March 3, 24, and 31, April 7 and 28, May 12 and 26, June 9 and 30, July 7, August 10, September 8, November 9 and 16, 2023; January 25, March 14 and 28, April 25, June 13, July 5 and 18, September 5, and October 31,2024.
  3. Hikma (personal communications). August 29 and October 16, 2014; April 5, June 20, August 15, October 27, December 14, 2017; January 5 and 18, February 22, April 18, June 6, July 3, August 15, October 24, November 21, December 12, 2018; January 23, March 6, 13, and 27, May 2 and 16, June 27, July 17, September 4 and 30, October 30, November 27, December 11, 2019; January 15, February 19, March 4 and 12, April 1 and 22, June 24, September 23, October 7, November 25, December 30, 2020; January 6 and 27, February 3, May 19, June 2, July 14 and 28, September 15, December 15, 2021; January 12, March 9, April 7, June 1, July 20, September 21, October 26, November 16, December 7, 2022; January 4, February 1, 8, and 22, March 8, 23, and 29, April 6 and 26, May 11 and 17, June 8 and 29, July 5, August 8, September 6, November 9, 15, and 29, 2023; January 24, March 20 and 27, April 24, June 12, July 3 and 24, September 4, and October 30, 2024.
  4. Mylan Institutional/Viatris (personal communications). December 11, 2013; February 10, March 10, April 21, May 12 and 27, July 31, September 23, October 20, November 5 and 14, 2014; January 7, February 18, March 11 and 18, April 6, May 13, June 30, August 3, September 21, November 2, 2015; January 21, February 22, April 4, December 16, 2016; February 27, April 3, October 26, December 20, 2017; February 28, April 18, June 11, August 15, October 24, and November 28, 2018; March 15, April 3, October 17, 2019; April 27, November 25, and December 28, 2020; April 12, June 14 and 22, September 20, November 10, 2021; March 14, May 25, July 22, September 27, December 8, 2022; March 13, May 16, June 1, July 5, August 4, 2023; January 29, April 23, and July 25, 2024.
  5. Pfizer (personal communications). June 20, July 15, August 15, September 20, October 27, November 23, 2011; January 4, March 13, April 11, May 7, June 15, July 12, August 28, November 27, 2012; January 11, February 6, 19, and 22, March 15 and 29, May 2, June 18, July 8 and 30, September 20, October 4, 24, and 28, November 8, December 6, 11, and 13, 2013; February 7, March 12, April 24, May 9 and 23, June 13, August 1, September 23, October 16, 2014; and January 5, February 13, March 11, and April 24, May 15, June 26, July 31, September 25, October 30, 2015; February 5, April 1, June 3, July 29, October 28, December 16, 2016; March 8 and 31, June 20, August 15, October 27, December 20 and 29, 2017; January 5 and 26, March 2, 5, and 30, April 13, May 4, July 6, August 17, October 19, November 26, December 18, 2018; January 22, March 6, 15, and 29, April 3 and 30, May 17, June 28, July 22, August 30, October 18, November 4, December 4 and 13, 2019; January 17, February 21, March 6 and 13, April 6 and 24, June 23, September 25, October 9, November 20, December 30, 2020; January 8 and 31, May 21, June 3, July 14 and 30, September 17, December 17, 2021; January 14, March 11, April 12, June 1, July 22, September 23, October 28, November 18, December 8, 2022; January 6, February 1, 12, and 26, March 10, 24, and 31, April 10, May 1, 12, 17, and 31, June 12, July 3 and 7, August 11, September 8, November 10 and 17, 2023; January 26, March 19 and 29, April 25, June 14, July 5 and 24, September 5, and November 4, 2024.
  6. Teva (personal communications). May 19, June 22, July 20, September 2, 13, and 30, October 14, November 11 and 29, December 16, 2010; January 19 , February 1 and 23, March 22 and 29, April 11, May 19, June 14, August 15, September 22, October 27, November 29, 2011; January 3 and 6, March 12, April 12, May 9 and 21, June 1 and 18, July 12, August 28, October 3, 2012; January 11, February 6, May 6, June 18, July 10, November 13, December 11, 2013; February 11, March 12, June 18, July 31, October 17, 2014; May 13, June 30, August 3, September 24, 2015; February 3, April 5, August 3, October 21, December 16, 2016; March 6, June 20, August 15, October 17, December 18, 2017; January 5 and 22, February 23, March 19, April 16, May 7, June 11, July 2, August 13, October 12, November 26, December 10, 2018; January 25, March 4 and 15, April 1 and 29, May 13, July 1, September 2, October 18, November 8, 2019; January 17, March 6, April 6 and 27, June 19, September 25, October 7, November 20, December 18, 2020; January 8 and 29, May 21, July 2 and 30, September 17, December 17, 2021; January 14, March 11, April 8, May 27, July 22, September 2 and 29, October 21, November 18, 2022; January 27, February 10 and 24, March 10 and 24, April 7 and 21, June 12, September 1, November 8, 2023; January 12, February 26, March 28, May 6, June 21, July 17, August 26, and October 1, 2024.
  7. Actavis (personal communications). November 11, 2015; February, April 4, December 13, 2016; March 6, June 20, and August 15, 2017.
  8. Caraco (personal communications). May 6, June 18, July 8, September 18, October 7, December 9, 2013; February 10, April 24, August 28, October 16, 2014; January 5, February 18, March 11, May 13, and June 30, 2015.
  9. Sagent (personal communications). November 12, December 5, 2013; February 3, March 12, April 21, May 7 and 22, June 13, August 1, September 19, October 16, November 13, December 23, 2014; February 12, March 11, 12, and 20, April 2 and 30, May 14, June 25, July 2 and 30, August 13, September 24, October 29, 2015; February 4 and 18, March 24 and 31, April 28, June 9, August 4, October 27, December 15, 2016; March 2 and 30, June 20, August 15, and November 2, 2017; January 8, May 2, October 24, November 21, December 13, 2018; January 24, March 7, 14, and 21, April 4, May 6 and 13, June 27, September 5, October 17 and 31, November 21, December 12, 2019; January 16, February 13, March 6, April 2 and 23, June 25, September 24, October 8, and November 19, 2020.
  10. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.
  11. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. (http://online.factsandcomparisons.com/index.aspx). March 2015.
  12. Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.