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Doxorubicin Injection

[19 June 2014]

Products Affected - Description

Adriamycin solution for injection, 2 mg/mL, Bedford1
5 mL vial (NDC 55390-0235-10)
10 mL vial (NDC 55390-0236-10)
25 mL vial (NDC 55390-0237-01)
100 mL vial (NDC 55390-0238-01)
 
Adriamycin lyophilized powder, Bedford1
(10 mg vials, NDC 55390-0231-10)
20 mg vials (NDC 55390-0232-10) 
50 mg vial (NDC 55390-0233-01)
 
Doxorubicin lyophilized powder, Mylan Institutional (formerly a Pfizer product)7
10 mg vial (NDC 00069-0170-01) - NDC discontinued
50 mg vial (NDC 67457-0436-50)
 
Doxorubicin solution for injection, 2 mg/mL, Teva2
100 mL vial (NDC 00703-5040-01)

Reason for the Shortage

  • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.1
  • Pfizer had doxorubicin solution for injection on shortage due to shipping delays.5  
  • Sagent introduced doxorubicin injection in November 2013.6
  • Mylan Institutional acquired doxorubicin lyophilized powder from Pfizer on December 6, 2013.7
  • Teva could not provide a reason for the shortage.2

Available Products

Doxorubicin solution for injection 2 mg/mL, Fresenius Kabi (formerly APP)3
5 mL vial (NDC 63323-0883-05)
10 mL vial (NDC 63323-0883-10)
25 mL vial (NDC 63323-0883-30)
100 mL vial (NDC 63323-0101-61)
 
Doxorubicin solution for injection, 2 mg/mL, Caraco4
25 mL vial (NDC 62756-0826-40)
100 mL vial (NDC 62756-0827-40)
 
Doxorubicin lyophilized powder, Mylan Institutional (formerly a Pfizer product)7
10 mg vial (NDC 67457-0478-10)

 
Doxorubicin solution for injection, 2 mg/mL, Pfizer5
5 mL vial (NDC 00069-3030-20)
10 mL vial (NDC 00069-3031-20)
25 mL vial (NDC 00069-3032-20)
75 mL vial (NDC 00069-3033-20)
100 mL vial (NDC 00069-3034-20)
 
Doxorubicin solution for injection, 2 mg/mL, Sagent6
5 mL vial (NDC 25021-0207-05)
25 mL vial (NDC 25021-0207-25)
100 mL vial (NDC 25021-0207-51)

 
Doxorubicin solution for injection, 2 mg/mL, Teva2
5 mL vial (NDC 00703-5043-03)
25 mL vial (NDC 00703-5046-01)

Estimated Resupply Dates

  • Bedford has all Adriamycin solution for injection and Adriamycin lyophilized powder presentations on long-term back order and the company cannot estimated a release date. Ben Venue manufactured Adriamycin solution for injection and Adriamycin lyophilized powder for Bedford.1
  • Mylan Institutional has doxorubicin lyophilized powder 50 mg vials on back order and the company cannot estimate a release date.7
  • Teva has doxorubicin 2 mg/mL solution 100 mL vials on back order with an estimated release date of late-July 2014.2
 
 

Implications for Patient Care

  • Doxorubicin is an anthracycline glycoside agent. It is labeled for use in adults with leukemias, lymphomas, soft tissue and bone sarcomas, and breast, gastric, ovarian, thyroid, small cell lung, and transitional bladder cancers.8-10
  • Doxorubicin is used off-label in adults for treating AIDS-related Kaposi sarcoma, refractory multiple myeloma, Ewing sarcoma, and adrenocortical, endometrial, islet cell, and liver cancers.8-10
  • Doxorubicin is labeled for leukemias, lymphomas, bone and soft tissue sarcomas, neuroblastoma, and Wilms tumor in children.8-10

Safety

  • Chemotherapy agents, such as doxorubicin, pose additional safety risks both for patients and for healthcare workers handling these agents.8,9
  • 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).8,9

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. Bedford (personal communications). May 18, June 22, July 20, August 2, September 2, 13, and 29, October 14 and 22, November 8, 17, and 29, December 17, 2010; January 11, 19, and 21, February 1 and 23, March 1, 22, and 29, April 11 and 18, May 17, June 15, July 20, August 16, September 23, October 24, November 30, 2011; January 3, March 1, April 13, May 9 and 21, June 20, July 11, August 29, September 27, November 26, 2012; January 11, February 6, 11, and 19, March 13 and 28, April 29, June 18 and 28, September 9, October 9 and 21, and December 2, 2013; February 11, March 12, April 24, May 27, and June 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, and December 11, 2013; February 11, March 12, and June 18, 2014.
  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, and June 10, 2014.
  4. Caraco (personal communications). May 6, June 18, July 8, September 18, October 7, and December 9, 2013; February 10 and April 24, 2014.
  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, and June 13, 2014.
  6. Sagent (personal communications). November 12 and December 5, 2013; February 3, March 12, April 21, May 7 and 22, and June 13, 2014.
  7. Mylan Institutional (personal communications). December 11, 2013; February 10, March 10, April 21, and May 12 and 27, 2014. 
  8. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
  9. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
  10. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc.September 2010.

Updated

Updated June 19, 2014 by David M. Peterson, PharmD, Drug Information Specialist. Created September 21, 2010, by David M. Peterson, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2014, 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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