Nausea and vomiting of pregnancy (NVP)

Why Not Prescribe the Only Pregnancy Category A Medication for Morning Sickness?

…Now You Can.

Diclegis® is the only Pregnancy Category A and FDA-approved prescription treatment for morning sickness.7*

Pregnancy Category A means that the results of controlled studies have not shown increased risk to an unborn baby during pregnancy.13

*Morning sickness is a common term for a medical condition called Nausea and Vomiting of Pregnancy.1


Why Diclegis®?

Diclegis can help control your patient's nausea and vomiting of pregnancy (NVP), commonly called morning sickness1

Diclegis is a delayed-release formulation that is a fixed-dose combination of doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg).

  • Only Pregnancy Category A prescription treatment for NVP
  • Only FDA-approved prescription treatment for NVP
  • Only delayed-release formulation to help control NVP symptoms throughout the day when taken as prescribed

Treating NVP/morning sickness

NVP is commonly called morning sickness1

  • NVP can affect 70% to 85% of pregnant women2-5
  • 95% of women with NVP experience symptoms beyond morning hours2
Prevalence of NVP throughout the day

When can NVP start?

  • NVP typically develops between the 4th and 6th week of pregnancy2
  • Approximately 10% of cases last beyond the 16th week2
  • Some women experience NVP throughout the entire pregnancy6
Typical duration of NVP

Diclegis® Dosage

Diclegis is the only FDA-approved delayed-release formulation to help control NVP symptoms throughout the day when taken as prescribed.

Write Diclegis as a Daily Prescription, not PRN7,10

Diclegis is a fixed-dose combination of doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg).

Learn How to Dose and Prescribe Diclegis:

Diclegis is Taken as a Daily Prescription to Help Control Symptoms Throughout the Day10

How to dose Diclegis
  • Take on an empty stomach with a glass of water. Swallow tablets whole. Do not crush, chew, or split Diclegis tablets
  • Reassess the woman for continued need for Diclegis as her pregnancy progresses
  • Diclegis® does not contain lactose, gluten or tartrazine.
  • The product has also received Kosher-Passover and Halal certifications.

Write Diclegis® as a Daily Prescription, not PRN7,10

Diclegis Daily Prescription

PUQE score

Assessing NVP treatment efficacy

The Pregnancy-Unique Quantification of Emesis (PUQE) scoring system is a validated tool that was accepted by the FDA for use as a primary endpoint in the Diclegis clinical trial.7

  • Provides HCPs and patients with an externally validated tool to treat and track NVP symptoms
  • Standardizes and enables consistent symptom assessment throughout treatment

In 2002, the PUQE score was the first scale of its kind to focus on the nausea and vomiting specific to pregnancy.8

  • It was adapted from the Rhodes scale8
  • The PUQE score is based on the quantification of the 3 physical symptoms of NVP (nausea, vomiting, and retching)7
  • Validated in 2009, the PUQE-24 was introduced to simplify and specifically account for nausea and vomiting over the entire course of the day, not just for 12 hours9
  • Overall score of symptoms is rated from 3 (no symptoms) to 15 (most severe)7,9

In the last 24 hours, for how long have you felt nauseated or sick to your stomach?9,10

  1. 1 Not at all
  2. 2 1 hour or less
  3. 3 2 to 3 hours
  4. 4 4 to 6 hours
  5. 5 More than 6 hours

In the last 24 hours, have you vomited or thrown up?9,10

  1. 5 7 or more times
  2. 4 5 to 6 times
  3. 3 3 to 4 times
  4. 2 1 to 2 times
  5. 1 I did not throw up

In the last 24 hours, how many times have you had retching or dry heaves without bringing anything up?9,10

  1. 1 No time
  2. 2 1 to 2 times
  3. 3 3 to 4 times
  4. 4 5 to 6 times
  5. 5 7 or more times

Add up your results to check the potential severity of your symptoms.

PUQE-24 Score: Mild = 3-6 (No symptoms = 3); Moderate = 7-12;
Severe = 13-159,10


Efficacy

Diclegis® demonstrated a statistically significant improvement in symptoms of nausea and vomiting

See the Diclegis Clinical Design and Results

Diclegis clinical study design

  • A double-blind, randomized, placebo-controlled, multicenter study (N = 256) to assess the safety and efficacy of Diclegis in the treatment of NVP7,11
    • Subjects were older than 18 years, with a gestational age of 7-14 weeks, with a PUQE* score of ≥6, and without response to conservative management of NVP consisting of dietary/lifestyle advice10
    • Women were given Diclegis or placebo for 14 days. A maximum of 4 tablets (1 in the morning, 1 in the mid-afternoon, and 2 at bedtime) were taken10
    • Primary endpoint was improvement in symptoms of NVP assessed as change from baseline in PUQE score at day 15 with Diclegis compared to placebo10

*The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) score incorporated 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). Baseline was defined as the PUQE score completed at the enrollment visit.7

Diclegis efficacy

Daily dosing of Diclegis to help control NVP symptoms

  • The majority of patients (60%) treated with Diclegis received 4 tablets daily7
  • To help control NVP symptoms throughout the day, 81% of Diclegis-treated patients received more than the bedtime dose7
  • If a dose of 2 or 3 tablets did not eradicate symptoms (ie, PUQE score was still above 3) a tablet was added, up to a maximum of 4 tablets a day7
Patients receiving 4 tablets

Safety/Adverse Reactions

Safety

Diclegis® is the only Pregnancy Category A prescription treatment for NVP

Pregnancy Category A means that the results of controlled studies have not shown increased risk to an unborn baby during pregnancy13

FDA regulations require that each product that is absorbed systemically be classified under 1 of 5 pregnancy categories (A, B, C, D, or X) on the basis of risk of reproductive and developmental adverse effects or, for certain categories, on the basis of such risk weighted against potential benefit.13

FDA Pregnancy Categories

Adverse reactions

The most common adverse reaction with Diclegis is somnolence.

  • Diclegis may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine7
  • 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 provider7
  • In the Diclegis clinical trial, there were no additional adverse reactions occurring at an incidence ≥5% and at a higher incidence with Diclegis than placebo7
Patients experiencing somnolence

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Duchesnay USA Patient Assistance Program

We at Duchesnay USA believe that every pregnant woman has the right to access safe and effective therapies. And we understand that at times the affordability of prescription medications can be a challenge. This is exactly why we have created our Patient Assistance Program.

If you have been prescribed a Duchesnay USA medication and cannot currently afford it, Duchesnay USA may be able to help.

Please click here to access an enrollment application.

 

Questions or Concerns?

Please contact Q-Pharma, the administrator of the Diclegis Patient Assistance Program at:
Phone: 855-720-4147
Fax: 855-720-1400
DuchesnayUSA@qpharmacorp.com


Indication

Diclegis® is a fixed-dose combination drug product 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.

Limitations of Use

Diclegis has not been studied in women with hyperemesis gravidarum.

Important Safety Information

Diclegis is contraindicated in women with known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the formulation. Diclegis is also contraindicated in combination with monoamine oxidase inhibitors (MAOIs) as MAOIs intensify and prolong the adverse CNS effects of Diclegis. Use of MAOIs may also prolong and intensify the anticholinergic (drying) effects of antihistamines.

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.

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.

Diclegis has anticholinergic properties and should be used with caution in women who have: (1) asthma, (2) increased intraocular pressure, (3) an eye problem called narrow angle glaucoma, (4) a stomach problem called stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) a bladder problem called bladder-neck obstruction.

Fatalities have been reported from doxylamine overdose in children. Children appear to be at a high risk for cardiorespiratory arrest. However, the safety and effectiveness of Diclegis in children under 18 years of age have not been established.

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. If you suspect an overdose or seek additional overdose information, you can contact a poison control center at 1-800-222-1222.

The FDA granted Diclegis Pregnancy Category A status, which means that the results of controlled studies have not shown increased risk to an unborn baby during pregnancy.

Women should not breast-feed 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.

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.

Please click here for full Prescribing Information and Patient Information.

Tablet(s) shown are not actual size.

References

  1. ACOG Committee on Practice Bulletins – Obstetrics. ACOG practice bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 52, April 2004. Nausea and vomiting of pregnancy. Obstet Gynecol. 2004;103(4)803-815.
  2. Gadsby R, Barnie-Adshead AM, Jagger C. A prospective study of nausea and vomiting during pregnancy. Br J Gen Pract. 1993;43(371):245-248.
  3. Jewell D, Young G. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2002;(1):CD000145.
  4. Medalie JH. Relationship between nausea and/or vomiting in early pregnancy and abortion. Lancet.1957;273(6986)117-119.
  5. Whitehead SA, Andrews PLR, Chamberlain GVP. Characterisation of nausea and vomiting in early pregnancy: a survey of 1000 women. J Obstet Gynaecol. 1992;12:364-369.
  6. Jarnfelt-Samsioe A, Samsioe G, Velinder GM. Nausea and vomiting of pregnancy – a contribution to its epidemiology. Gynecol Obstet Invest. 1983;16(4):221-229.
  7. Diclegis [package insert]. Bryn Mawr, PA: Duchesnay USA, Inc; 2013.
  8. Koren G, Boskovic R, Hard M, Maltepe C, Navioz Y, Einarson A. Motherisk – PUQE (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy. Am J Obstet Gynecol. 2002;186(5 suppl Understanding):S228-S231. doi:10.1067/mob.2002.123054.
  9. Ebrahimi N, Maltepe C, Bournissen FG, Koren G. Nausea and vomiting of pregnancy: using the 24-hour Pregnancy-Unique Quantification of Emesis (PUQE-24) scale. J Obstet Gynaecol Can. 2009;31(9):803-807.
  10. Data on file. Duchesnay USA, Inc.
  11. Koren G, Clark S, Hankins GDV, et al. Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Am J Obstet Gynecol. 2010;203(6):571.e1-7. doi:10.1016/j.ajog.2010.07.030.
  12. Department of Health and Human Services, Food and Drug Administration. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Fed Regist. 2008;73(104): 30831-30868
  13. US Department of Health and Human Services. Food and Drug Administration. Labeling. 21 CFR 201.57. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.57. Revised April 1, 2013. Accessed August 22, 2013.
  14. US Department of Health and Human Services. Food and Drug Administration website. Table 1. FDA Pregnancy Category Definitions. http://www.fda.gov/Drugs/DrugSafety/ucm245470.htm#table. Updated March 7, 2011. Accessed August 22, 2013.