Products Affected - Description
Cyanocobalamin injection, American Regent
1000 mcg/mL, 1 mL vial (NDC 00517-0031-25)
1000 mcg/mL, 10 mL vial (NDC 00517-0032-25)
1000 mcg/mL, 30 mL vial (NDC 00517-0130-05)
Reason for the Shortage
- American Regent has cyanocobalamin injection on shortage due to manufacturing delays.1
- Fresenius Kabi had cyanocobalamin injection on shortage due to increased demand for the product.2
Cyanocobalamin injection, Fresenius Kabi
1000 mcg/mL, 1 mL vial (NDC 63323-0044-01)
Estimated Resupply Dates
American Regent has cyanocobalamin 1000 mcg/mL 10 mL and 30 mL vials available but with short expiration dating (September 2014). Cyanocobalamin 1000 mcg/mL 1 mL vials are on back order and the company cannot estimate a release date.1
Implications for Patient Care
Cyanocobalamin is used to treat vitamin B12 deficiency, including pernicious anemia.3
Cyanocobalamin nasal spray is not labeled for initial treatment or patients with vitamin B12 deficiency that includes nervous system involvement.4 When switching patients from cyanocobalamin injection to the nasal formulation, ensure patients understand differences in dosing as well as how to administer.
Alternative Agents & Management
- Consider reserving supplies of cyanocobalamin injection for patients who require initial treatment, or patients who have nervous system involvement.
- Cyanocobalamin nasal spray (Nascobal®) may be an appropriate alternative for patients who have successfully received treatment with cyanocobalamin injection and have no nervous system symptoms. The dose of cyanocobalamin nasal spray is one spray in one nostril once weekly. Ensure patients understand priming requirements.4
- American Regent (personal communications). March 31, April 13, June 21, July 22, August 10 and 23, October 10, November 10, and December 12, 2011. January 31, March 5, April 11, May 18, June 29, July 16, September 5, October 4 and 26, November 5, 12, and 28, and December 10, 2012. January 2 and 23, February 20, March 29, May 30, June 18, July 23 and 31, August 8 and 15, September 10, 17, and 25, October 28, November 5 and 26, and December 19, 2013. January 2, 14, and 20. February 10 and 28, March 12, April 22, May 27, June 19, July 28, and August 27, 2014
- Fresenius Kabi (personal communications). March 31, April 13, June 21, July 22, August 10 and 23, October 10, November 10, and December 12, 2011. January 30, March 5, April 11, May 18, June 28, July 16, September 5, October 4, 11, and 30, November 5, 12, and 28, and December 11 and 21, 2012. January 24, February 20, March 29, May 29, June 17, July 22 and 30, August 8 and 9, September 10, 18, and 25, November 1, 4, and 26, and December 20, 2013. January 2, 13, and 20. February 4 and 28, March 11, April 21, May 28, June 17, July 25, and August 22, 2014.
- Cyanocobalamin. In: McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS DI (Lexi-Comp Online). Bethesda, MD: American Society of Health-System Pharmacists; 2014.
- Par Pharmaceuticals. Nascobal (cyanocobalamin) nasal spray [product information]. Spring Valley, NY: Par Pharmaceuticals; 2011.
Updated August 27, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist, Drug Information Service. Created July 29, 2014, by Erin R. Fox, PharmD, Director, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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