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Doxorubicin Injection

[15 May 2015]

Products Affected - Description

Doxorubicin solution for injection, Caraco
2 mg/mL, 25 mL vial, single count (NDC 62756-0826-40)
2 mg/mL, 100 mL vial, single count (NDC 62756-0827-40)
 
Doxorubicin solution for injection, Fresenius Kabi
2 mg/mL, 25 mL vial, single count (NDC 63323-0883-30)
 
Doxorubicin lyophilized powder, Mylan Institutional
10 mg vial, single count (NDC 67457-0478-10)
50 mg vial, single count (NDC 67457-0436-50)

Reason for the Shortage

  • West-Ward Pharmacetuicals’ parent company, Hikma Pharmaceuticals, acquired Adriamycin injection from Bedford in July 2014. West-Ward is not actively marketing Adriamycin injection at this time.1
  • Teva has doxorubicin solution for injection available.2
  • Fresenius Kabi has doxorubicin solution for injection available.3
  • Caraco has discontinued doxorubicin solution for injection 100 mL vials. The 25 mL vials are on shortage.4
  • Pfizer had doxorubicin solution for injection on shortage due to shipping delays.5
  • Sagent has doxorubicin solution for injection available.6
  • Mylan cannot provide a reason for the reason for the doxorubicin solution for injection available.7

Available Products

Doxorubicin solution for injection, Fresenius Kabi
2 mg/mL, 5 mL vial, single count (NDC 63323-0883-05)
2 mg/mL, 10 mL vial, single count (NDC 63323-0883-10)
2 mg/mL, 100 mL vial, single count (NDC 63323-0101-61)
Doxorubicin solution for injection, Pfizer
2 mg/mL, 5 mL vial, single count (NDC 00069-3030-20)
2 mg/mL, 10 mL vial, single count (NDC 00069-3031-20)
2 mg/mL, 25 mL vial, single count (NDC 00069-3032-20)
2 mg/mL, 75 mL vial, single count (NDC 00069-3033-20)
2 mg/mL, 100 mL vial, single count (NDC 00069-3034-20)

Doxorubicin solution for injection, Sagent
2 mg/mL, 5 mL vial, 5 count (NDC 25021-0207-05)
2 mg/mL, 25 mL vial, single count (NDC 25021-0207-25)
2 mg/mL, 100 mL vial, single count (NDC 25021-0207-51)
 
Doxorubicin solution for injection, Teva
2 mg/mL, 5 mL vial, 10 count (NDC 00703-5043-03)
2 mg/mL, 25 mL vial, single count (NDC 00703-5046-01)
2 mg/mL, 100 mL vial, single count (NDC 00703-5040-01)

Estimated Resupply Dates

  • Caraco has doxorubicin solution for injection 25 mL vials available in limited supply.4
  • Fresenius has doxorubicin solution for injection 25 mL vials on back order and the company estimates a release date of mid-May 2015.
  • Mylan Institutional has doxorubicin lyophilized powder 50 mg vials on back order and the company cannot estimate a release date. The 10 mg vials have been temporarily discontinued.7

Implications for Patient Care

  • 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. 8-10
  • Doxorubicin is used off-label in adults for treating refractory multiple myeloma, uterine sarcoma, and endometrial, liver, kidney, and head and neck cancers.8-10
  • Refer to national guidelines such as those from the National Comprehensive Cancer Network (www.nccn.org) or American Society of Clinical Oncology (www.asco.org) for additional information regarding therapeutic use.

Safety

  • Chemotherapy agents, such as doxorubicin, pose additional safety risks both for patients and for healthcare workers handling these agents.8-10
  • 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).8-10

Alternative Agents & Management

  • 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.8-10
  • 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. 

Related Shortages

References

  1. West-Ward (personal communications). August 29 and October 16, 2014.
  2. 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; and May 15, 2015.
  3. Fresenius Kabi, formerly APP (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, and 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; and January 5, February 18, March 11 and 18, April 29, and May 13, 2015.
  4. 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, and May 11, 2015.
  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, and 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; January 5, February 13, March 11, April 24, and May 15, 2015.
  6. Sagent (personal communications). November 12 and 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, and May 14, 2015.
  7. Mylan Institutional (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, and May 13, 2015. 
  8. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.
  9. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. March 2015.
  10. Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.

Updated

Updated May 15, 2015 by Michelle Wheeler, PharmD, Drug Information Specialist. Created September 21, 2010, by David M. Peterson, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT. 

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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