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5/10/2023

Calcium Disodium Versenate Injection

Products Affected - Description

    • Calcium disodium versenate injection, Bausch Health, 200 mg/mL, 5 mL ampule, 5 count, NDC 99207-0240-05

Reason for the Shortage

    • Bausch Health did not provide a reason for the shortage. They are the sole suppliers of calcium disodium versenate injection.[1]

Available Products

    • FDA is allowing temporary importation of SERB's calcium edetate de sodium injection (NDC 50633-0320-10) 50 mg/mL 10 mL ampules. The main difference is the concentration 50 mg/ML of the SERB product and 200 mg/mL of the US approved product. More information can be found at: https://www.fda.gov/media/163578/download

Estimated Resupply Dates

    • Bausch Health has calcium disodium versenate 200 mg/mL 5 mL ampules on long-term back order and the company cannot estimate a release date.[1]

Implications for Patient Care

    • Calcium disodium versenate is a chelation therapy used in both pediatric and adult lead poisonings.[2-4]

Alternative Agents & Management

    • Information on assessing lead poisonings and initiating chelation therapy can be found at https://www.cdc.gov/nceh/lead/advisory/acclpp/actions-blls.htm
    • During this shortage, consider succimer (DSMA) 10 mg/kg (350 mg/m2) orally every 8 hours for the first 5 days, then every 12 hours for 2 weeks (treatment duration of 19 days and maximum daily dose of 500 mg). Use caution in patients with renal impairment.[5-7]
    • Dosing may vary for different heavy metal poisonings. Contact your local clinical toxicologist or poison control center for patient-specific recommendations.

References

    1. Bausch Health (personal communication): December 28, 2020; January 15, March 12, April 16, May 28, August 6, September 10, November 12, December 10, 2021; January 14, February 11, March 4 and 18, April 15 and 29, May 13, June 10, July 8 and 15, August 12, September 16 and 30, November 11, 2022; January 6, February 24, and May 5, 2023.
    2. Calcium Disodium versenate - edetate calcium disodium injection [package insert]. Scottsdale, AZ: Medicis; 2012.
    3. Edetate Calcium Disodium. Drugdex System. IBM Micromedex [database online]. http://www.micromedexsolutions.com. Updated March 8, 2021. Greenwood Village, CO, USA: Truven Health Analytics; Accessed April 6, 2021.
    4. Howland M. Edetate Calcium Disodium (CaNa2Edta). In: Nelson LS, Howland M, Lewin NA, Smith SW, Goldfrank LR, Hoffman RS. eds. Goldfrank's Toxicologic Emergencies. 11th ed. McGraw-Hill; Accessed April 6, 2021. https://accesspharmacy.mhmedical.com/content.aspx?bookid=2569§ionid=210263402
    5. Succimer. Drugdex System. IBM Micromedex [database online]. http://micromedexsolutions.com. Updated July 27, 2020. Greenwood Village, CO: Truven Health Analytics; Accessed April 6, 2021.
    6. Succimer. Lexicomp Online. Hudson, OH: Wolters Kluwer Clinical Drug Information, Inc; 2018. http://online.lexi.com/. Updated March 12, 2021. Accessed April 6, 2021.
    7. Howland M. Succimer (2,3-Dimercaptosuccinic Acid) and Dmps (2,3-Dimercapto-1-Propanesulfonic Acid). In: Nelson LS, Howland M, Lewin NA, Smith SW, Goldfrank LR, Hoffman RS. eds. Goldfrank's Toxicologic Emergencies, 11th ed. McGraw-Hill; Accessed April 06, 2021. https://accesspharmacy.mhmedical.com/content.aspx?bookid=2569§ionid=210263346

Updated

Updated May 10, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. Created December 28, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

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Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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