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Fomepizole Injection

[09 June 2016]

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

Available Products

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

Safety

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

Related Shortages

References

  1. Sandoz (personal communications). March 10 and 30, April 27, September 8, and October 28, 2015; February 22 and April 15, 2016.
  2. Fomepizole injection [product information]. Princeton, NJ: Sandoz; 2010.
  3. US Food and Drug Administration. MedWatch Alert. Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall – Potential Impact on Product Sterility. Accessed March 30, 2015.
  4. 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, April 15, and June 9, 2016.
  5. 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, April 15, and June 9, 2016.
  6. 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.
  7. 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

Updated June 9, 2016 by Michelle Wheeler, 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.

Disclaimer

This information is provided through the support of Vizient 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. Vizient, 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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