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safety
and
efficacy

The combination of doxylamine succinate and pyridoxine hydrochloride, the ingredients in Bonjesta®, is one of the most studied drug combinations in pregnancy, including in the first trimester:3, 7

Two meta-analyses

  • 16 cohort and 11 case-controlled studies5
  • 12 cohort and 5 case-controlled studies6

Findings

  • No statistically significant relationship was found between fetal abnormalities and first trimester use of the combination of doxylamine succinate and pyridoxine hydrochloride ± dicyclomine hydrochloride5, 7
  • No differences were found in separate analyses for cardiac defects, limb defects, oral clefts or genital tract malformations5, 7

Efficacy

Bonjesta® is a multilayer, extended-release tablet designed to provide both fast-acting and long-lasting symptom relief:7

Pill schema

Note

Bonjesta® may cause somnolence. 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. Bonjesta® has not been studied in women with hyperemesis gravidarum. The safety and effectiveness of Bonjesta® has not been studied in children 18 and under.

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.

Potential Advantages of Bonjesta®3, 4, 7, 8

Faster onset of action

Bonjesta® has a faster onset of action (Tmax) than Diclegis®, thanks to its immediate-release outer coating.2, 7

Reduced pill burden7

The maximum daily recommended dose is decreased from 4 tablets with Diclegis® to 2 tablets per day with Bonjesta®.1,8

Improved patient compliance

A randomized double-blind trial conducted with the combination of ingredients found in Bonjesta® demonstrated that as the number of pills increased, adherence to study medication decreased.1

Less variation in effective concentrations

Bonjesta® should be taken as a daily prescription, not PRN, to optimally control NVP. The schedule of administration of Bonjesta® and the reduced pill burden may improve patient compliance. This, in turn, may reduce variations in the effective concentrations of doxylamine and PLP in plasma.2, 7

Potential concerns regarding over-the-counter products

Because doxylamine is present in certain over-the-counter (OTC) products, such as one of five different formulations of a popular sleep aid, some of your patients may be under the impression that these products can effectively treat NVP. However, four of the other five versions of this OTC brand use different ingredients such as diphenhydramine, acetaminophen and melatonin.3

Furthermore, these products:

  • Do not have the critical immediate action combined with delayed-release properties
  • Are not labeled for use during pregnancy and are not indicated for the treatment of NVP when conservative management fails
  • Are not available at the correct dosage and require the tablets to be manipulated (split) by the patient5

Remember, no single FDA-approved OTC product has ever been tested for safety or effectiveness in treating NVP.

Other anti-emetics that have been used off-label in recent years to manage NVP are not specifically indicated for use in pregnancy, primarily because they lack adequate and well-controlled studies in pregnant women and some of them even include boxed warning products.4

Bonjesta® is an approved, safe and effective treatment option for NVP when conservative management fails.7

References

  1. Costantine MM et al. Ther Drug Monit. 2012;34:569-73.
  2. Duchesnay Inc. Data on file
  3. Madjunkova, S., Maltepe, C., & Koren, G. The Delayed Release Combination of Doxylamine and Pyridoxine (Diclegis®/Diclectin®) for the Treatment of Nausea and Vomiting of Pregnancy. Pediatr Drugs 2014; 16(3): 199-211.
  4. Food and Drug Administration. FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs . FDA News Release (2009). Available at: http://wayback.archive-it.org/7993/20161022205301/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149533.htm. Accessed August 24, 2017; Food and Drug Administration. FDA Requires Boxed Warning for Promethazine Hydrochloride Injection. FDA News Release (2009). Available at: https://wayback.archive-it.org/7993/20170112033324/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm182498.htm. (2009). Accessed August 24, 2017.]
  5. McKeigue PM, et al. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology 1994;50:27–37.
  6. Einarson TR, et al. A method for meta-analysis of epidemiological studies. Drug Intell Clin Pharm 1988;22(10):813–24.
  7. Bonjesta® Prescribing Information, Bryn Mawr, PA: Duchesnay USA Inc., 2017
  8. Diclegis® Prescribing Information, Bryn Mawr, PA: Duchesnay USA Inc., 2013

Indication and important safety information

INDICATION

Bonjesta® is a fixed-dose combination drug product of 20 mg doxylamine succinate, an antihistamine, and 20 mg pyridoxine hydrochloride, a vitamin B6 analog, 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: Use Bonjesta® with caution in women with (1) asthma, (2) increased intraocular pressure, (3) narrow angle glaucoma, (4) a stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) 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) with combination 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets is somnolence.

Drug-Food Interactions: A food-effect trial demonstrated that the delay in the onset of action of Bonjesta® may be further delayed, and a reduction in absorption may occur when tablets are taken with food. Therefore, Bonjesta® should be taken on an empty stomach with a glass of water.

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 medicalinfo@duchesnayusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

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