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8/14/2024

Conivaptan Hydrochloride Injection

Products Affected - Description

    • Vaprisol solution for injection, Cumberland Pharmaceuticals, 20 mg/100 mL, plastic container, NDC 66220-0160-10 - discontinued

Reason for the Shortage

    • Cumberland Pharmaceuticals has discontinued Vaprisol.[1]

Available Products

    • There are no presentations available

Estimated Resupply Dates

    • Cumberland Pharmaceuticals has discontinued Vaprisol.[1]

Implications for Patient Care

    • Conivaptan hydrochloride is a vasopressin receptor antagonist used to treat hyponatremia in euvolemic or hypervolemic patients.[2-4]

Safety

    • Alternative agents could correct serum sodium levels at different rates than conivaptan. Monitor sodium levels to avoid correcting sodium levels too quickly.[5]
    • Fluid restriction is recommended in most cases of euvolemic and hypervolemic patients. However, some sodium correcting therapies (eg. vaptans) should not be used in conjunction with fluid restriction due to the risk of too rapid serum sodium correction.[6]

Alternative Agents & Management

    • Hyponatremia management is described in: Diagnosis, evaluation, and treatment of hyponatremia: expert panel recommendations. American Journal of Medicine. 2013 Oct;126(10 Suppl 1):S1-42. doi: 10.1016/j.amjmed.2013.07.006.
    • During this shortage, if the enteral route is available consider oral tolvaptan.[7-8] Strategies to administer tolvaptan via nasogastric tube are available.[7]
    • If the enteral route is unavailable general alternatives for most cases of euvolemic and hypervolemic hyponatremia include fluid restriction and hypertonic saline.[8-10]
    • There is also evidence for the use of oral urea powder in the treatment of patients with syndrome of inappropriate antidiuretic hormone (SIADH) and nephrogenic syndrome of inappropriate antidiuresis (NSIAD).[8,11]

References

    1. Cumberland Pharmaceuticals (personal communication). July 6, October 9, 2023; March 18, April 30, and August 14, 2024.
    2. Vaprisol (Conivaptan) [Prescribing Information]. Nashville, TN: Cumberland Pharmaceuticals Inc; October 2016.
    3. Conivaptan. Drugdex System. IBM Micromedex [database online]. http://www.micromedexsolutions.com. Greenwood Village, CO, USA: Truven Health Analytics; Accessed July 5, 2023.
    4. Conivaptan. Lexicomp Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA. Accessed; Accessed July 5, 2023.
    5. Adrogu© HJ. Consequences of inadequate management of hyponatremia. Am J Nephrol. 2005;25(3):240-249. doi:10.1159/000086019
    6. Verbalis JG, Goldsmith SR, Greenberg A, et al. Diagnosis, Evaluation, and Treatment of Hyponatremia: Expert Panel Recommendations. The American Journal of Medicine. 2013;126(10, Supplement 1):S1-S42. doi:10.1016/j.amjmed.2013.07.006
    7. Tolvaptan. Lexicomp Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA. Accessed July 6, 2023.
    8. Verbalis JG, Goldsmith SR, Greenberg A, Korzelius C, Schrier RW, Sterns RH, Thompson CJ. Diagnosis, evaluation, and treatment of hyponatremia: expert panel recommendations. Am J Med. 2013 Oct;126(10 Suppl 1):S1-42. doi: 10.1016/j.amjmed.2013.07.006
    9. Adrogu© HJ, Tucker BM, Madias NE. Diagnosis and Management of Hyponatremia: A Review. JAMA. 2022;328(3):280. doi:10.1001/jama.2022.11176
    10. Baxter Healthcare Corporation: 3% and 5% Sodium Chloride Injection, USP [prescribing information]. FDA website. Revised March 2005. Accessed July 7, 2023. http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019022s021lbl.pdf
    11. Lockett J, Berkman KE, Dimeski G, Russell AW, Inder WJ. Urea treatment in fluid restriction-refractory hyponatraemia. Clin Endocrinol (Oxf). 2019;90(4):630-636. doi:10.1111/cen.13930[PubMed 30614552]

Updated

Updated August 14, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created February 23, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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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