Start Helping Your Patients with Diclegis®Today

For some patients with nausea and vomiting of pregnancy (NVP), symptoms can be controlled with diet and lifestyle changes alone. However, when conservative management fails, consider FDA-approved Diclegis®.

Make Diclegis® Your Standard of Care When Conservative Management Fails

Diclegis® is a fixed dose combination of doxylamine succinate, an antihistamine, and 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. It is FDA-approved for use throughout pregnancy, including the first trimester.

patients nausea graph

NVP Facts
  • Up to 85% of pregnant women experience NVP.
  • 95% of those women may experience symptoms that last beyond the morning.
  • Symptoms generally appear at 4-6 weeks and peak around week 10.
  • For approximately 10% of women, symptoms persist throughout pregnancy.

Safety and Efficacy

Safety

The combination of doxylamine succinate and pyridoxine hydrochloride in Diclegis® has been the subject of many epidemiological studies designed to detect possible teratogenicity and has consistently been shown to be safe for both mother and baby.

A meta-analysis of 16 cohort and 11 case-control studies reported no increased risk for malformations after first trimester exposure to doxylamine succinate and pyridoxine hydrochloride, with or without dicyclomine hydrochloride.

A second meta-analysis of 12 cohort and 5 case-control studies corroborated these findings: no statistically significant relationships between fetal abnormalities and first trimester exposure to the combination of doxylamine succinate and pyridoxine hydrochloride, with or without dicyclomine hydrochloride were observed.

The drug combination in Diclegis®:

  • Showed no increased risk for malformations after first trimester exposure in 26 cohort and case-controlled studies
  • Is recommended as first-line pharmacotherapy for managing NVP when conservative management fails according to the American College of Obstetricians and Gynecologists (ACOG) and the Association of Professors of Gynecology and Obstetrics (APGO)
  • Has 60 years of clinical experience
  • Has been used by over 35 million women worldwide to treat NVP

Efficacy

Diclegis® is proven to help control the nausea, retching and vomiting associated with NVP. Its delayed-release coating allows medication to achieve peak effectiveness 5-7 hours after dosing, thus daily dosing of up to 4 tablets ensures effective all-day symptom management.

Diclegis® Clinical Trial

A double-blind, randomized, multi-center, placebo-controlled study found a greater reduction in NVP symptoms in women treated with Diclegis® as compared to placebo.

Women 18 years of age or older and 7 to 14 weeks gestation (median 9 weeks of gestation) with nausea and vomiting of pregnancy were randomized to receive Diclegis® or placebo for 14 days.

Two tablets of Diclegis® were administered at bedtime on Day 1. If symptoms of nausea and vomiting persisted into the afternoon hours on Day 2, the woman was directed to take her usual dose of two tablets at bedtime that night and, beginning on Day 3, to take one tablet in the morning and two tablets at bedtime. Based upon assessment of symptoms at her clinic visit on Day 4 (± 1 day), the woman may have been directed to take an additional tablet mid-afternoon. A maximum of four tablets (one in the morning, one in the mid-afternoon and two at bedtime) were taken daily.

The primary efficacy endpoint was the change from baseline at Day 15 in the Pregnancy-Unique Quantification of Emesis (PUQE) score. The PUQE score incorporates the number of daily vomiting episodes, number of daily heaves, and length of daily nausea in hours, for an overall score of symptoms rated from 3 (no symptoms) to 15 (most severe).

At baseline, the mean PUQE score was 9.0 (standard deviation of 2.1) in the Diclegis® arm and 8.8 (standard deviation of 2.1) in the placebo arm. There was a mean decrease of 0.7 (95% confidence interval: 0.2-1.2, p=0.006) from baseline in PUQE score at Day 15 with Diclegis® compared to placebo, indicating improvement in nausea and vomiting symptoms.

Delayed Release Action

Unlike a PRN treatment, Diclegis® provides continuous daily NVP symptom management. Its delayed-release coating is designed to allow doxylamine and pyridoxine to reach peak concentrations 5-7 hours after administration. The terminal elimination half-life of doxylamine and pyridoxine are 12.5 hours and 0.5 hours, respectively. Thus, the pharmacokinetics of Diclegis® allow for sustained levels of doxylamine and pyridoxine in order to control NVP symptoms.

A food-effect study demonstrated that the delay in the onset of action of Diclegis® may be further delayed, and a reduction in absorption may occur when tablets are taken with food.

Therefore, Diclegis® should be taken on an empty stomach with a glass of water.

Diclegis® has not been studied in women with hyperemesis gravidarum or in children under 18 years of age.

The most common adverse reaction observed with Diclegis® was somnolence.

Prescribing Diclegis

Diclegis® is taken as a daily prescription, not PRN.

Start your patients on 2 tablets daily at bedtime. If symptoms are not adequately controlled, dose may be increased to a maximum recommended dose of 4 tablets daily:

Diclegis® must be taken daily, as indicated in the product information leaflet.

2 tablets at bedtime
1 in the morning
1 mid-afternoon

Day 1: Start patients on 2 tablets daily at bedtime.

Day 3: If symptoms are not adequately controlled, add 1 tablet daily in the morning, starting day 3.

Day 4: If symptoms are not adequately controlled, add 1 tablet daily in the mid-afternoon, starting day 4.

Do not prescribe more than 4 tablets daily (2 at bedtime, 1 in the morning, 1 mid-afternoon). Dosing should be tailored to a woman's NVP symptoms to ensure appropriate treatment.

Patients should take Diclegis® on an empty stomach with a glass of water. Patients should be instructed that Diclegis® tablets should be swallowed whole and not crushed, chewed or broken before swallowing.

Inform women to avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Diclegis® until cleared to do so.

Inform women of the importance of not taking Diclegis® with alcohol or sedating medications, including other antihistamines (present in some cough and cold medications), opiates and sleep aids because somnolence could worsen leading to falls or other accidents.

Contraindications

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

Warnings and Precautions

Diclegis® 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 Diclegis® until cleared to do so by their healthcare provider.

Diclegis® use is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol. The combination may result in severe drowsiness leading to falls or accidents.

Concomitant Medical Conditions

Diclegis® has anticholinergic properties and, therefore, should be used with caution in women with: asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction.

Adverse Reactions

The following adverse reactions are discussed elsewhere in the labeling:

  • Somnolence
  • Falls or other accidents resulting from the effect of the combined use of Diclegis® with CNS depressants including alcohol

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

Interference with urine screenings

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 Diclegis® may result in false positive urine drug screening for methadone, opiates and PCP.

Diclegis® Prescribing Information

Diclegis® Patient Information

Indication and Important Safety Information

INDICATION

Diclegis® is a fixed-dose combination drug product of 10 mg doxylamine succinate, an antihistamine, and 10 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

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

IMPORTANT SAFETY INFORMATION

Contraindications:

Diclegis® 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 Diclegis®.

Warnings and Precautions:

  • Somnolence: Diclegis® 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 Diclegis® until cleared to do so by their healthcare provider.
  • Central nervous system (CNS) depressants: Use of Diclegis® 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 Diclegis® and CNS depressants could result in severe drowsiness leading to falls or other accidents.
  • Concomitant Medical Conditions: Use Diclegis® 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 Diclegis® 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 Diclegis® may be further delayed, and a reduction in absorption may occur when tablets are taken with food. Therefore, Diclegis® should be taken on an empty stomach with a glass of water.

Use in Specific Populations:

  • Pregnancy: Diclegis® is intended for use in pregnant women.
  • Lactation: Women should not breastfeed while using Diclegis® because the antihistamine component (doxylamine succinate) in Diclegis® 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 Diclegis® resulting in worsening of their apnea or respiratory conditions.
  • Pediatric Use: The safety and effectiveness of Diclegis® 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: Diclegis® is a delayed-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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