[02 March 2012]
Products Affected - Description
Irinotecan 20 mg/mL solution for injection
Reason for the Shortage
- Sandoz states the shortage was due to manufacturing delays.2
- Bedford discontinued irinotecan in May, 2011 to concentrate on the manufacturing of other products.3
- Teva had irinotecan on shortage due to manufacturing delays.4
- Hospira had irinotecan on shortage due to other manufacturer shortages and marked withdrawals.5
- Pfizer discontinued Camptosar glass vials in early 2011.6
- Baxter, Greenstone, and Sagent discontinued irinotecan in 2010.6-8
Irinotecan 20 mg/mL solution for injection, APP1
2 mL vial (NDC 63323-0193-02)
5 mL vial (NDC 63323-0193-05)
Irinotecan 20 mg/mL solution for injection, Hospira
2 mL vial (NDC 61703-0349-16)
5 mL vial (NDC 61703-0349-09)
25 mL vial (NDC 61703-0349-36)
Campostar 20 mg/mL solution for injection, Pfizer6
2 mL polypropylene vial (NDC 00009-7529-04)
5 mL polypropylene vial (NDC 00009-7529-03)
15 mL polypropylene vial (NDC 00009-7529-05)
Novaplus Campostar 20 mg/mL solution for injection, Pfizer6
2 mL vial (NDC 00009-1111-01)
5 mL vial (NDC 00009-1111-02)
Irinotecan 20 mg/mL solution for injection, Sandoz
2 mL vial (NDC 66758-0048-01)
5 mL vial (NDC 66758-0048-02)
Irinotecan 20 mg/mL solution for injection, Teva
2 mL vial (NDC 00703-4432-11)
5 mL vial (NDC 00703-4434-11)
Estimated Resupply Dates
Irinotecan is currently available from all manufacturers.
Implications for Patient Care
- Irinotecan is a topoisomerase type I DNA inhibitor. It is labeled for in combination with other fluorouracil and leucovorin for the treatment of metastatic colon and rectal cancer or as monotherapy for recurrent or progressive colon or rectal cancer.4-6
- Irinotecan is used off-label for a variety of neoplastic diseases including cervical cancer, gastric cancer, lung cancer, and central nervous system tumors.4-6
- Irinotecan is typically used in combination with other antineoplastic agents.4-6
- Chemotherapy agents, such as irinotecan, pose additional safety risks both for patients and for healthcare workers handling these agents.4,5
- 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).4,5
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 irinotecan.4-6
- Consider evaluating the health-care system’s total supply of irinotecan before beginning patients on combination chemotherapy regimens containing irinotecan. 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.
- APP (personal communications). January 19, February 22, April 12, May 25, June 23, August 3 and 26, September 21, October 25, November 28, and December 20, 2011; and January 27, February 7 and 28, 2012.
- Sandoz (personal communications. January 19, April 12, May 25, June 29, August 3, October 25, December 1, 8, and 21, 2011; and January 30 and February 29, 2012.
- Bedford (personal communications. January 12, February 22, April 12, and May 27, 2011.
- Teva (personal communications). January 10, February 15, March 8 and 16, April 4 and 7, May 3 and 27, July 1, August 3 and 26, October 27, November 28, and December 19, 2011; and January 24, February 7 and 29, 2012.
- Hospira (personal communications). January 18, February 22, April 11, May 25, June 21, August 2 and 26, September 21, October 25 and 31, and December 1 and 21, 2011; and January 27, February 6 and 27, 2012.
- Pfizer (personal communications). February 23, April 13, June 23, August 2 and 26, October 25, November 29, and December 19, 2011.
- Baxter (personal communications). January 18, 2011.
- Sagent (personal communications). January 18, 2011.
- Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. April 2011.
Updated March 2, 2012 by Kristen Jefferies, Pharm.D., Drug Information Specialist. Created April 15, 2011, 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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