WHA

Bonjesta, Diclegis (doxylamine/pyridoxine)

Indications for Prior Authorization

Bonjesta, Diclegis (doxylamine succinate and pyridoxine hydrochloride)
  • For diagnosis of Nausea and vomiting of pregnancy
    Indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

    Limitations of Use: Bonjesta and Diclegis have not been studied in women with hyperemesis gravidarum.

Criteria

Bonjesta, Brand Diclegis, Generic doxylamine/pyridoxine delayed-release

Prior Authorization

Length of Approval: 9 Months

  • Diagnosis of nausea and vomiting of pregnancy
    • AND
  • Trial and failure or intolerance to generic doxylamine and generic pyridoxine (Vitamin B6) taken together [5, 7]

  • Guideline ID
    GL-149713

  • Formulary
    EHB

  • Effective date
    Oct 1, 2024

  • P&T approval date
    Feb 25, 2016

P & T Revisions

2024-07-10, 2023-07-31, 2022-08-02, 2021-09-10, 2021-05-20, 2021-02-12, 2020-04-20, 2020-03-16, 2019-12-02, 2019-07-03, 2019-07-19

  1. Diclegis prescribing information. Duchesnay USA, Inc. Bryn Mawr, PA. June 2023.
  2. ACOG Practice Bulletin. Nausea and vomiting of pregnancy. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2018; 131(1): 190-193. (Practice Bulletin No. 189)
  3. Arsenault MY, Lane CA. The Management of Nausea and Vomiting in Pregnancy. J Obstet Gynaecol Can 2002; 24(10):817-23.
  4. Ebrahimi N, Maltepe C, Einarson A. Optimal management of nausea and vomiting of pregnancy. Int J Womens Health. 2010; 2: 241–248.
  5. Matthews A, Haas DM, O'Mathúna DP, et al. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2015 Sep 8; 9:CD007575.
  6. Bonjesta prescribing information. Duchesnay USA, Inc. Bryn Mawr, PA. October 2022.
  7. Campbell K, Rowe H, Azzam H, Lane C. The Management of Nausea and Vomiting of Pregnancy. Journal of Obstetrics and Gynaecology Canada. 2016;38(12):1127-1137. doi:10.1016/j.jogc.2016.08.009
  1. Bonjesta and Diclegis (doxylamine succinate/pyridoxine hydrochloride) are contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines. [1, 6]
  • 2024-07-10: 2024 UM Annual Review. No criteria changes
  • 2023-07-31: 2023 UM Annual Review. No criteria changes. Updated references
  • 2022-08-02: 2022 Annual Review, no criteria changes.
  • 2021-09-10: Updated references section.
  • 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-02-12: Under Product Name section, updated listed product from "generic doxylamine/pyridoxine extended-release" to "Generic doxylamine/pyridoxine delayed-release"; No other changes to guideline made.
  • 2020-04-20: Updated for June annual reviews- no changes
  • 2020-03-16: Revised criteria to require a trial of combination doxylamine and pyridoxine.
  • 2019-12-02: Fixed UMCS search function, no changes to guideline.
  • 2019-07-03: Verified generic populates in product field
  • 2019-07-19: July P&T: add generic Diclegis to the program, for 9/1/19 effective date. Removal of criteria due to PA team feedback (use with MAOI and T/F conservative management).