Doxylamine-Pyridoxine Fixed Dose Combinations

Preferred Drug - Diclegis (doxylamine succinate and pyridoxine tablet) [Duchesnay USA, Inc.]

Nonpreferred Drug - Bonjesta (doxylamine succinate and pyridoxine tablet) [Duchesnay USA, Inc.]

September 2019

Therapeutic area - Antiemetic/Antivertigo Agents

Approval criteria

Patient is at least 18 years or older AND
Patient has diagnosis of pregnancy-induced nausea or vomiting AND
Patient does NOT have a diagnosis of hyperemesis gravidarum AND
Patient has failed documented non-pharmacologic measures (e.g., dietary changes [eat smaller, more frequent meals and to avoid smells and food textures that cause nausea], trigger avoidance) AND
Patient does not have known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the formulation AND
Patient is not using a monoamine oxidase (MAO) inhibitor AND
Patient has documented failures to TWO of the following:
- pyridoxine (vitamin B6)
- doxylamine
- diphenhydramine
- meclizine
- metoclopramide
- promethazine
- prochlorperazine
- ondansetron
Documented maximum tolerated daily dosages and treatment duration (start and end dates) of TWO pharmacologic treatment failures above must be provided at time of request
If the request is for Bonjesta, patient has clinically valid reason as to why Diclegis cannot be used. A pill burden rationale will not be accepted
Approval is for 9 months

MHCP Provider Call Center 651-431-2700 or 800-366-5411