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Idarubicin Hydrochloride Injection

Last Updated: February 8, 2012
Status: Resolved

Products Affected - Description

Idarubicin injection, Bedford
1 mg/mL, 5 mL vial (NDC 55390-0215-01) – discontinued
1 mg/mL, 10 mL vial (NDC 55390-0216-01) – discontinued
1 mg/mL, 20 mL vial (NDC 55390-0217-01) – discontinued

Idarubicin injection, Teva

1 mg/mL, 5 mL vial, Novaplus (NDC 00703-4154-91) - discontinued 
1 mg/mL, 10 mL vial, Novaplus (NDC 00703-4155-91) - discontinued
1 mg/mL, 20 mL vial, Novaplus (NDC 00703-4156-91) - discontinued

Reason for the Shortage

  • APP had idarubicin on shortage due to increased demand.1
  • Bedford discontinued idarubicin in May, 2011 to concentrate on the manufacturing of other products.2
  • Teva had their idarubicin presentations on shortage due to manufacturing delays. Teva discontinued the Novaplus presentations as of September, 2011.3
  • Greenstone has discontinued their idarubicin presentations.4
  • Pfizer had their Idamycin on shortage due to increase in demand.4

Available Products

Idarubicin injection, APP1

1 mg/mL, 5 mL vial (NDC 63323-0194-05)
1 mg/mL 10 mL vial (NDC 63323-0194-10)
1 mg/mL, 20 mL vial (NDC 63323-0194-20)

Idarubicin injection, Teva3
1 mg/mL 5 mL vial (NDC 00703-4154-11)
1 mg/mL 10 mL vial (NDC 00703-4155-11)
1 mg/mL 20 mL vial (NDC 00703-4156-11)

Idamycin injection, Pfizer4
1 mg/mL 5 mL vial (NDC 00013-2576-91)
1 mg/mL 10 mL vial (NDC 00013-2586-91)
1 mg/mL 20 mL vial (NDC 00013-2596-91)

Estimated Resupply Dates

All presentations are now available.

Implications for Patient Care

  • Idarubicin is a semisynthetic anthracycline. It is labeled for use in combination with other antineoplastic agents for the treatment of adults with acute myelocytic leukemia.5-7
  • Idarubicin is used off-label for a variety of neoplastic diseases in adults including acute lymphocytic leukemia, chronic myelogenous leukemia, and breast cancer. Idarubicin has also been used for autologous hematopoietic stem cell transplantation.5-7
  • Idarubicin is used off-label for acute lymphocytic leukemia, acute nonlymphocytic leukemia, and solid tumors in children.5-7

Safety

  • Chemotherapy agents, such as idarubicin, pose additional safety risks both for patients and for healthcare workers handling these agents.5,6
  • 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).5,6

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 idarubicin.5-7
  • Consider evaluating the health-care system’s total supply of idarubicin before beginning patients on combination chemotherapy regimens containing idarubicin. 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. APP (personal communications). June 14, 17, and 30, August 4 and 18, September 13, October 28, December 17, 2010; February 16, May 18, June 8 and 23, August 3, September 16, October 12, November 15 and 28, and December 20, 2011, and January 4 and February 8, 2012.
  2. Bedford (personal communications). June 14 and 17, July 1, August 2 and 16, September 9, October 27, December 14, 2010; February 15, and May 3, 2011.
  3. Teva (personal communications). June 14, July 6, August 3 and 14, September 14, October 26, December 14, 2010; February 15, March 22, May 17, June 16, August 3, and September 13 and 30, October 10, November 16 and 28, and December 22, 2011; and January 5 and February 7, 2012.
  4. Pfizer (personal communications). June 14,18, and 30, August 2 and 17, October 26, and December 21, 2010 and February 16, March 23, May 17, June 13 and 21, July 8, September 16, October 11, November 15 and 29, and December 22, 2011; and February 8, 2012.
  5. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
  6. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
  7. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010.

Updated

Updated February 8, 2012, by Ginny Jones, RPh, Drug Information Specialist. Created September 10, 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.

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