Products Affected - Description

• • Fomepizole injection, Sandoz, 1 gram/mL, 1.5 mL vial, 1 count, NDC 00781-3182-73
  • Fomepizole injection, Sandoz, 1 gram/mL, 1.5 mL vial, 5 count, NDC 00781-3182-84

Reason for the Shortage

• • Sandoz discontinued fomepizole injection.[1]
  • X-Gen has fomepizole injection available.[3]
  • Mylan Institutional has fomepizole injection available.[4]

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

• • All marketed presentations are available.[3,4]

• • 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.[2,5,6]

• • Fomepizole therapy alone does not replace the need for supportive fluid and electrolyte therapy to address metabolic acidosis.[5,6]

• • 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.[6] Commercial intravenous ethanol in dextrose solutions are no longer marketed.[6]
  • 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.[6]

• 1. Sandoz (personal communications). March 10 and 30, April 27, September 8, and October 28, 2015; February 22, April 15, and September 7, 2016.
  2. Fomepizole injection [product information]. Princeton, NJ: Sandoz; 2010.
  3. 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, June 9, and September 8, 2016.
  4. 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, June 9, and September 8, 2016.
  5. 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.
  6. 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.