Products Affected - Description
Vasopressin 20 units/mL Injection, American Regent
0.5 mL multi-dose vial, 25 count (NDC 00517-0510-25) - discontinued
1 mL multi-dose vial, 25 count (NDC 00517-1020-25) - discontinued
10 mL multi-dose vial, 10 count (NDC 00517-0410-10) - discontinued
Vasopressin 20 units/mL Injection, Fresenius Kabi4
1 mL vial (NDC 63323-0302-01) - discontinued
Reason for the Shortage
- American Regent discontinued vasopressin injection in early 2015.1,2
- Par Sterile Products (formerly JHP) discontinued Pitressin injection in November 2014.3
- Par Sterile Products introduced Vasostrict injection in November 2014. This is the only FDA-approved vasopressin injection.3
- Fresenius Kabi will discontinue distributing vasopressin on March 15, 2015. A letter is available regarding this discontinuation.4
Vasostrict Injection, Par Sterile Products3
20 units/mL, 1 mL multi-dose vial, 25 count (NDC 42023-0164-25)
Estimated Resupply Dates
- American Regent discontinued vasopressin 20 units/mL 0.5 mL, 1 mL, and 10 mL vials.1,2
- Fresenius Kabi has released the last lot of vasopressin injection and distribution will be discontinued as of March 15, 2015. Product may be available through wholesalers until supply is depleted.4
Implications for Patient Care
- Vasopressin injection is a synthetic 8-arginine vasopressin, an antidiuretic hormone released from the posterior pituitary gland. Vasopressin injection (Vasostrict®) is FDA-labeled to increase blood pressure in adults with vasodilatory shock who have low blood pressure despite therapy with fluids and catecholamines.5
- Indications for unapproved vasopressin injection products include use in diabetes insipidus, for the prevention and treatment of postoperative abdominal distention, and to dispel gas that may interfere with interpretation of abdominal roentgenography.6,7,8
- Unlabeled uses of vasopressin include adjunctive treatment of gastrointestinal or esophageal variceal hemorrhage, pulseless cardiac arrest, and for donor management in brain-dead patients.7,8,9
- According to the product labeling, Vasostrict injection must be refrigerated (store between 2° and 8°C).5 A letter from Par Pharmaceuticals, Inc. states Vasostrict injection is stable for up to 90 days at room temperature (15° and 25°C) once the unopened vial is removed from refrigeration. Label the vial with the revised expiration date to prevent the medication from being used beyond the 90-day period. However, if the manufacturer’s original expiration date is shorter than the revised expiration date, use the shorter date. This information is based on extrapolated data.19
- To avoid dosing errors, be aware that vasopressin is dosed in units and desmopressin is dosed in micrograms.5,6,10
- Vasopressin and desmopressin have different indications and actions.5,8,10
Alternative Agents & Management
- Desmopressin acetate (DDAVP) is another antidiuretic peptide available in the US. Desmopressin is labeled for treatment of diabetes insipidus, primary nocturnal enuresis, Hemophilia A, and von Willebrand disease.10
- Desmopressin acetate has greater vasopressin receptor V2 selectivity compared with vasopressin and has greater anti-diuretic potency. However, desmopressin has less vasopressin receptor V1 activity, which results in lower vasopressor and smooth muscle contracting activity compared to vasopressin. Desmopressin increases Factor VIII activity to a greater degree than vasopressin in patients with hemophilia A or von Willebrand Disease.8
- Table 1 lists alternatives to vasopressin in specific situations.
- Vasopressin is used as hormone replacement therapy in brain-dead patients who are organ donors. Vasopressin is part of the United Network for Organ Sharing (UNOS) standardized donor management protocol.11 Institutions may want to consider conserving product for this indication.
- American Regent (personal communications). May 13, October 24, 2011; and March 17, 2015.
- American Regent. June 23, July 12 and 22, August 29, September 20, October 26, 2011; January 11, February 16, March 12, April 4 and 17, May 17, June 15, July 5 and 12, August 27, October 16, December 4, 2012; January 16, February 13, March 29, April 29, July 8, August 6, September 9, October 14, December 4, 2013; February 20, March 3 and 31, May 9, June 30, August 27, October 23, November 13, 2014; January 23, February 4 and 11, and March 4, 2015.
- Par Sterile Products (formerly JHP) (personal communications). May 16, June 7 and 20, July 22, August 30, September 21, October 24, 2011; January 11, February 16, March 12, April 4 and 17, May 16, June 15, July 5 and 11, August 27, October 16, December 4, 2012; January 16, February 13, March 29, July 11, August 6, September 9, October 14, December 12, 2013; February 20, March 6 and 31, May 14, June 30, August 27, October 31, November 11, 2014; January 22, and March 17, 2015.
- Fresenius Kabi (personal communications). May 16, June 7, July 12, August 30, September 16, October 24, 2011; January 11, February 15, March 9, April 4 and 17, May 14, June 12, July 3 and 9, August 27, October 16, December 4, 2012; January 16, February 13, March 29, April 23, May 7, July 8, August 6, September 9, October 8, December 6, 2013; February 20, March 5 and 31, May 12, June 27, August 27, October 29, November 11, 2014; January 26, February 2 and 11, and March 4 and 18, 2015.
- Par Sterile Products. Vasostrict (Vasopressin) Injection [product information]. Spring Valley, NY: Par Sterile Products; May 2014.
- JHP Pharmaceuticals. Pitressin (Vasopressin) Injection Synthetic [product information]. Rochester, MI: JHP Pharmaceuticals; January 2010.
- Baughman VL, Golembiewski J, Gonzales JP, Alvarez W, eds. Anesthesiology and Critical Care Drug Handbook. 9th ed. Hudson, OH: Lexi-Comp; 2010.
- 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; 2011.
- Wickersham RM, Novak KK, managing eds., eds. Drug Facts and Comparisons (eFacts). St. Louis, MO: Wolters Kluwer Health, Inc.; 2011.
- Sanofi-Aventis. DDAVP (Desmopressin) Injection [product information]. Bridgewater, NJ: Sanofi-Aventis; July 2007.
- United Network for Organ Sharing. Critical Pathway for Organ Donor. Accessed May 19, 2011.
- Anon. Drug Evaluation: Vasopressin. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2011. Updated periodically.
- Bauer SR, Lam SW. Arginine vasopressin for the treatment of septic shock in adults. Pharmacotherapy. Oct;30(10):1057-1071.
- Dictus C, Vienenkoetter B, Esmaeilzadeh M, Unterberg A, Ahmadi R. Critical care management of potential organ donors: our current standard. Clin Transplant. Dec 2009;23 Suppl 21:2-9.
- Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. Sep 2007;46(3):922-938.
- Maybauer MO, Walley KR. Best vasopressor for advanced vasodilatory shock: should vasopressin be part of the mix? Intensive Care Med. Sep;36(9):1484-1487.
- Shah VR. Aggressive management of multiorgan donor. Transplant Proc. May 2008;40(4):1087-1090.
- Fauci AS, Braunwald E, Kasper DL, et al., eds. Harrison's Principles of Internal Medicine. 17th ed. New York, NY: McGraw-Hill; 2008.
- Musaji, N. Personal communication: Vasostrict storage at room temperature. Par Sterile Products; Parsippany, NJ. November 11, 13, and 21, 2014.
Updated March 19, 2015 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 19, 2011 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.
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