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
Quantity limits
- Diclegis: 4 tablets per day
- Bonjesta: 2 tablets per day
- Subsequent request may be approved for a future pregnancy
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411