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.

Disclaimer

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