Frequently
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Individuals depicted throughout are not actual patients.

    Common questions about Bonjesta®

    What is Bonjesta®?

    Bonjesta®, a new formulation of DICLEGIS® (a combination of doxylamine succinate and pyridoxine hydrochloride), is indicated for the treatment of NVP in women who do not respond to conservative management.

    Bonjesta®’s unique multilayer formulation is designed to provide fast-acting, long-lasting symptom relief:

    • An immediate-release outer coating for fast absorption and rapid onset of action
    • An enteric-coated core for long-lasting therapeutic effects

    Bonjesta®’s extended-release tablets deliver a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride.

    What is Bonjesta® indicated for?

    Bonjesta® is indicated to treat NVP in women who do not respond to conservative management.

    It is important to note that Bonjesta® has not been studied for the treatment of hyperemesis gravidarum, the most severe form of NVP, and that it is not indicated for any other condition.

    The safety and effectiveness of Bonjesta® has not been studied in patients under 18 years of age.

    Is Bonjesta® FDA-approved?

    Yes. Bonjesta® was approved by the FDA in November 2016.

    Is Bonjesta® safe?

    Two meta-analyses (16 cohort and 11 case-controlled studies and 12 cohort and 5 case-controlled studies) have shown:

    • No statistically significant relationship was found between fetal abnormalities and first trimester use of the combination of doxylamine succinate and pyridoxine hydrochloride ± dicyclomine hydrochloride
    • No differences were found in separate analyses for cardiac defects, limb defects, oral clefts or genital tract malformations

    The combination of ingredients in Bonjesta® has been prescribed for over 60 years and has been used by over 35 million worldwide for the safe and effective treatment of NVP when conservative management fails.

    What is the most common side effect of Bonjesta®?

    The most common side effect of Bonjesta® is somnolence. Therefore, patients should not drive, operate heavy machinery, or perform other activities that require their full attention without your prior approval.

    Is Bonjesta® suitable for women with dietary restrictions?

    Yes. Bonjesta® is suitable for women with both medical and religious dietary restrictions as it is lactose free, gluten free and tartrazine free and certified kosher, kosher for Passover and halal.

    How should you prescribe Bonjesta®?

    • Prescribe one Bonjesta® tablet by mouth at bedtime.
    • If symptoms are adequately controlled the next day, patient is to continue taking only one tablet daily at bedtime.
    • If symptoms are not adequately controlled the next day, prescribe a second daily tablet in the morning so that your patient is taking two tablets daily: one tablet in the morning and one tablet at bedtime.
    • Bonjesta® is a daily prescription, not PRN
    • Dosage should not exceed two tablets per day
    • Bonjesta® should be taken orally, with a glass of water, on an empty stomach
    • Bonjesta® tablets must be taken whole (they must not be crushed, chewed or broken before swallowing)

    How should Bonjesta® be stored?

    • Store Bonjesta® between 68°F to 77°F (20°C to 25°C) 
    • Keep Bonjesta® tablets dry, in a tightly closed container
    • Safely dispose of any medicine that is out of date or no longer needed
    • Bonjesta®, like all medications, should be kept out of the reach of children

    Indication and important safety information

    INDICATION

    BONJESTA® is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

    LIMITATIONS OF USE

    BONJESTA® has not been studied in women with hyperemesis gravidarum.

    IMPORTANT SAFETY INFORMATION

    Contraindications:

    BONJESTA® is contraindicated in women with any of the following conditions:

    • Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation;
    • Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of BONJESTA®.

    Warnings and Precautions:

    • Somnolence: BONJESTA® may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using BONJESTA® until cleared to do so by their healthcare provider.
    • Central nervous system (CNS) depressants: Use of BONJESTA® is not recommended if a woman is concurrently using CNS depressants, such as alcohol or sedating medications, including other antihistamines (present in some cough and cold medications), opiates, and sleep aids. The combination of BONJESTA® and CNS depressants could result in severe drowsiness leading to falls or other accidents.
    • Concomitant Medical Conditions: BONJESTA® has anticholinergic properties and, therefore, should be used with caution in women with increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder-neck obstruction.
    • Interference with Urine Screen for Methadone, Opiates and Phencyclidine Phosphate (PCP): There have been reports of false positive urine screening tests for methadone, opiates, and PCP with doxylamine succinate/pyridoxine hydrochloride use. Women should be informed that use of BONJESTA® may result in false positive urine drug screening for methadone, opiates and PCP.

    Adverse Reactions: The most common adverse reaction (≥5 percent and exceeding the rate in placebo) is somnolence.

    Drug-Food Interactions: BONJESTA® should be taken on an empty stomach with a glass of water.

    Drug Interactions: Severe drowsiness can occur when used in combination with alcohol or other sedating medications.

    Use in Specific Populations:

    • Pregnancy: BONJESTA® is intended for use in pregnant women.
    • Lactation: Women should not breastfeed while using BONJESTA® because the antihistamine component (doxylamine succinate) in BONJESTA® can pass into breast milk. Excitement, irritability, and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of BONJESTA® resulting in worsening of their apnea or respiratory conditions.
    • Pediatric Use: The safety and effectiveness of BONJESTA® in children under 18 years of age have not been established. Fatalities have been reported from doxylamine overdose in children. Children appear to be at a high risk for cardiorespiratory arrest.

    Overdosage: BONJESTA® is an extended-release formulation; therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion, and tachycardia. At toxic doses, doxylamine exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death. If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment. If you suspect an overdose or seek additional information about overdose treatment, call a poison control center at 1-800-222-1222.

    To report suspected adverse reactions, contact Duchesnay Inc. at 1-855-722-7734 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Indication and important safety information

    INDICATION

    BONJESTA® is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

    LIMITATIONS OF USE

    BONJESTA® has not been studied in women with hyperemesis gravidarum.

    IMPORTANT SAFETY INFORMATION

    Contraindications: BONJESTA® is contraindicated in women with any of the following conditions:

    • Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation;
    • Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of BONJESTA®.

    Indication and important safety information

    INDICATION

    BONJESTA® is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

    LIMITATIONS OF USE

    BONJESTA® has not been studied in women with hyperemesis gravidarum.