Products Affected - Description
Fomepizole injection, Sandoz
1 gram/mL, 1.5 mL vial, 1 count (NDC 00781-3182-73)
1 gram/mL, 1.5 mL vial, 5 count (NDC 00781-3182-84)
Reason for the Shortage
- Sandoz could not provide a reason for the shortage.1 However, fomepizole injection is manufactured by Emcure for Sandoz.2 An Emcure manufacturing site was recently noted to have FDA observations related to GMP and aseptic practices.3
- X-Gen has fomepizole injection available.4
- Mylan Institutional has fomepizole injection available.5
Fomepizole injection, Mylan Institutional
1 gram/mL, 1.5 mL vial, 1 count (NDC 67457-0211-02)
Fomepizole injection, X-Gen
1 gram/mL, 1.5 mL vial, 1 count (NDC 39822-0710-01)
Estimated Resupply Dates
Sandoz has fomepizole 1.5 mL vials temporarily unavailable and the company cannot estimate a release date.1
Implications for Patient Care
Fomepizole is an antidote labeled to treat known or suspected ethylene glycol or methanol intoxication. Fomepizole may be used alone or in combination with hemodialysis.2, 6,7
Fomepizole therapy alone does not replace the need for supportive fluid and electrolyte therapy to address metabolic acidosis.6, 7
Alternative Agents & Management
- Consult a poison center (1-800-222-1222) or medical toxicologist for any patient with a suspected ethylene glycol or methanol intoxication.
- Ethanol is an alternative to fomepizole. Oral ethanol may be preferred to an extemporaneous intravenous preparation due to potential delays in preparation.7 Commercial intravenous ethanol in dextrose solutions are no longer marketed.7
- Consultation with a poison center or medical toxicologist is essential when using ethanol as an antidote. Ethanol must be dosed according to patient specific criteria such as past tolerance and requires significant laboratory monitoring.7
- Sandoz (personal communications). March 10 and 30, April 27, September 8, and October 28, 2015; February 22 and April 15, 2016.
- Fomepizole injection [product information]. Princeton, NJ: Sandoz; 2010.
- US Food and Drug Administration. MedWatch Alert. Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall – Potential Impact on Product Sterility. Accessed March 30, 2015.
- X-Gen (personal communications). March 11 and 30, April 27, May 18 and 29, June 29, September 8, October 28, November 9 and 19, 2015; January 12, February 22, March 1, and April 15, 2016.
- Mylan Institutional (personal communications). March 11 and 30, April 27, May 4 and 18, June 29, September 8, October 28, 2015; January 15, February 22, and April 15, 2016.
- 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; 2015.
- Antidotes in Depth – Ethanol. In: Hoffman RS, Howland MA, Lewin NA, Nelson, LS, and Goldfrank LR, eds. Goldfrank’s Toxicologic Emergencies, 10th ed. New York, NY: McGraw Hill Education; 2015:1369-1372.
Updated April 18, 2016 by Leslie Jensen, PharmD, Drug Information Specialist. Created May 29, 2015 by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.
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