Products Affected - Description

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

Reason for the Shortage

• • Cumberland Pharmaceuticals has Vaprisol on shortage due to an interruption in manufacturing.[1]

Available Products

• • There are no presentations available

• • Cumberland Pharmaceuticals has Vaprisol on back order and the company cannot estimate a release date.[1]

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

• • 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]

• • 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]

• 1. Cumberland Pharmaceuticals (personal communication). July 6, October 9, 2023; and March 18, 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]