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Etoposide Injection

[24 August 2012]

Products Affected - Description

Etoposide solution for injection, 20 mg/mL, Bedford 
5 mL vial (NDC 55390-0291-01)
25 mL vial (NDC 55390-0292-01)
50 mL vial (NDC 55390-0293-01)
5 mL Novaplus vial (NDC 55390-0491-01)
25 mL Novaplus vial (NDC 55390-0492-01) 
50 mL Novaplus vial (NDC 55390-0493-01)

Reason for the Shortage

  • Teva had etoposide on shortage due to manufacturing delays.1
  • APP had etoposide on shortage due to increased demand.2 
  • Ben Venue voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a temporary basis. Product will become available in stages as production resumes.
  • Bedford put all inventory on distribution hold in early-July, 2012 pending a new manufacturing-related investigation. Availability of products is updated on the Bedford Laboratories website.3
  • Accord could not provide a reason for the shortage.4

Available Products

Etoposide solution for injection, 20 mg/mL, Accord4
5 mL vial (NDC 16729-0114-31)
 
Etoposide solution for injection, 20 mg/mL, APP2
5 mL vial (NDC 63323-0104-05)
25 mL vial (NDC 63323-0104-25)
50 mL vial (NDC 63323-0104-50)
 
Toposar solution for injection, 20 mg/mL, Teva1
5 mL vial (NDC 00703-5653-01)
25 mL vial (NDC 00703-5656-01)
50 mL vial (NDC 00703-5657-01)

Etopophos powder for injection, BMS5
100 mg vial (NDC 00015-3404-20)

Estimated Resupply Dates

  • APP has etoposide presentations readily available and is able to supply the market.
  • Accord has etoposide presentations readily available and is able to supply the market.
  • Teva has etoposide presentations readily available and is able to supply the market.
  • BMS has etoposide presentations readily available and is able to supply the market.
  • Bedford has etoposide 20 mg/mL 5 mL vials on back order and the company cannot estimate a release date. All other presentations are pending production as capacity permits.3

Implications for Patient Care

  • Etoposide is a podophyllotoxin antineoplastic agent. Etoposide injection is labeled for the treatment of testicular cancer and small cell lung cancer.6-8
  • Etoposide injection is also used off-label for a variety of neoplastic diseases including bladder cancer, acute myelocytic leukemia in adults and children, lymphomas (Hodgkin, non-Hodgkin), sarcomas (Ewing, Kaposi, soft tissue, rhabdomyosarcoma), pediatric brain tumors, reproductive system cancers (uterine, cervical, prostate, testicular, germ cell), non-small cell lung cancer, gastric cancer, hepatoma, Wilms tumor, multiple myeloma, adenocarcinoma of unknown primary, and in patients undergoing hematopoietic stem cell transplantation.6-8
  • Etoposide injection is typically used in combination with other antineoplastic agents.6-8

Safety

  • Chemotherapy agents, such as etoposide, pose additional safety risks both for patients and for healthcare workers handling these agents.6,7
  • 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).6,7

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 etoposide.6-8
  • Consider evaluating the health-care system’s total supply of etoposide before beginning patients on combination chemotherapy regimens containing etoposide. 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. Teva (personal communications). December 16, 2008; January 6 and 22, February 27, April 13, May 18, July 1 and 30, August 31, October 14, November 17, 2009; January 14, March 19, June 8 and 18, July 1, August 3, 17, and 31, September 14, and October 7, 13, and 29, November 24, 2010; January 12, February 15 and 25, March 29, April 28, May 9 and 31, August 1 and 9, September 13, 16, and 27, and November 10, 22 and 30, 2011; January 3 and 24, February 15 and 27, March 20, May 4, June 26, July 12, and August 20, 2012.
  2. APP (personal communications). December 16, 2008; January 6 and 22, February 27, April 13, May 18, July 1 and 29, August 31, October 14, November 18, 2009; January 14, March 19, June 8 and 18, July 1, August 4, 13, and 31, October 7 and 8, November 3, 2010; January 14, February 16, April 28, May 11, June 1 and 22, July 29, August 8 and 23, September 16 and 27, November 10, 22 and 30, and December 14, 2011; January 4 and 23, February 14 and 29, March 7 and 20, May 4, June 25, July 9, and August 20, 2012.
  3. Bedford (personal communications). December 16, 2008; January 6 and 22, February 27, April 13, May 18, July 1 and 29, August 7, September 2, October 14, November 18, 2009; January 14, March 19, June 8 and 18, July 1, August 2, 4, 17, and 31, September 14, October 6, November 4 and 29, 2010; January 12, February 15 and 23, March 1 and 29, April 26, May 11 and 20, June 1, 15, 23 and 29, July 12, August 1, 10, and 24, September 15 and 27, November 10 and 22, and December 14, 2011; January 9, February 16, March 1 and 20, May 4, June 26, July 11, and August 20, 2012. 
  4. Accord (personal communications). June 14, July 5, August 10, September 13, and November 10 and 22, 2011; January 3 and 24, February 17 and 27, March 2, May 4, June 26, and August 24, 2012.
  5. BMS (personal communications). December 16, 2008; January 6 and 22, February 27, April 13, May 18, July 1 and 29, 2009; March 19, June 8 and 18, August 27 and 31, September 14, October 6 and 13, November 3 and 24, 2010; January 12, February 15, March 1, April 28, May 20, August 1, 10, and 24, September 13, and November 10 and 22, 2011; January 3 and 24, February 17, June 25, and August 20, 2012.
  6. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
  7. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
  8. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010. 

Updated

Updated August 24, 2012 by Elyse A. MacDonald, Pharm.D., Drug Information Specialist. Created September 3, 2010, by Michelle M. Wheeler, Pharm.D., and M. Christina Beckwith, Pharm.D., Drug Information Specialists. Copyright 2012, 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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