Nausea and vomiting of pregnancy (NVP)

Is Your Morning Sickness Medicine Pregnancy Category A?

FDA-approved Diclegis® is the only Pregnancy Category A medicine for morning sickness*12

Pregnancy Category A means that a medicine has been tested in pregnant women and their babies did not have any problems related to using the medicine.†11

Developed with the safety of mother and child in mind, Diclegis can provide you with symptom relief throughout the day when taken as prescribed.12

*Morning sickness is a common term for a medical condition called Nausea and Vomiting of Pregnancy.1
†Although no harm has ever been observed, you should still speak with your doctor about any potential risks.


Diclegis® can help control nausea and vomiting of pregnancy (NVP) throughout the day when taken as prescribed

Discover Diclegis

Diclegis is FDA-approved for use during pregnancy

Diclegis is an FDA-approved Pregnancy Category A prescription medicine to help with relief from NVP, commonly referred to as morning sickness.1 Below are a few more reasons you may want to consider for taking Diclegis.

  • Diclegis is the only FDA-approved medicine to treat the medical condition known as nausea and vomiting of pregnancy (NVP), which is commonly called morning sickness1
  • Diclegis has a delayed-release formulation and a dosing schedule that helps you control symptoms throughout the day. Diclegis should be taken as a daily prescription and not on an as-needed basis
  • FDA-approved Diclegis is a fixed-dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a vitamin B6 analog
  • The combination of ingredients in Diclegis (doxylamine succinate, 10 mg, and pyridoxine hydrochloride, 10 mg) has been commercially available as the active ingredients in Diclectin® for more than 30 years in Canada2

Understanding NVP and morning sickness

Important facts about NVP and morning sickness

NVP is a medical condition commonly called morning sickness and can affect up to 85% of pregnant women.1,3-6 NVP stands for nausea and vomiting of pregnancy. Despite the name morning sickness, 95% of women with NVP experience symptoms beyond the morning hours.3

When can NVP, also known as morning sickness,1 start?

  • NVP typically starts between the 4th and 6th weeks of pregnancy3
  • Approximately 10% of the cases last beyond the 16th week3
  • Some women experience NVP throughout the entire pregnancy7

Morning isn’t the only time NVP occurs.3

NVP can occur beyond the morning

What are common symptoms of NVP?

  • Nausea is the most frequently experienced symptom8,9
  • Vomiting and/or dry heaving8,9

You may want to talk to your healthcare provider about your symptoms to learn if Diclegis® might be right for you.


PUQE score

Check the potential severity of your NVP, commonly referred to as morning sickness1

You could be one of the up to 85% of women who may suffer from nausea and vomiting of pregnancy (NVP).3-6 If you have NVP, a standardized questionnaire called the Pregnancy-Unique Quantification of Emesis (PUQE) may be used by healthcare providers to help track your symptoms.10 The PUQE score is not a diagnosis of NVP. It is for informational purposes only. You should consult with your healthcare provider about your symptoms and score.

The PUQE score below can help you learn the potential severity of your NVP. Check the answer that best describes how you’ve been feeling during the last 24 hours. Remember that this score is not a diagnosis of NVP. Talk to your healthcare provider about your answers at your next office visit.

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


Taking Diclegis®

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

How to take Diclegis

Helping control your symptoms of NVP, commonly referred to as morning sickness1

When taken as prescribed, Diclegis can help if NVP, commonly referred to as morning sickness,1 affects you all day.

How should I take Diclegis?

Talk to your healthcare provider about how much Diclegis to take and when to take it. Take Diclegis every day as prescribed by your healthcare provider. Do not stop taking Diclegis without talking to your healthcare provider first.

See the following schedule for the usual way you should start taking Diclegis*:

  • Day 1: Take 2 tablets, by mouth at bedtime.
  • Day 2: Take 2 tablets at bedtime. If your nausea and vomiting is better or controlled on Day 2, continue to take 2 tablets every night at bedtime. This will be your usual dose unless your healthcare provider tells you otherwise.
  • Day 3: If you still had nausea and vomiting on Day 2, take 3 tablets on Day 3 (1 tablet in the morning and 2 tablets at bedtime).
  • Day 4: If your nausea and vomiting was better or controlled on Day 3, continue to take 3 tablets each day (1 tablet in the morning and 2 tablets at bedtime). If you still had nausea and vomiting on Day 3, start taking 4 tablets each day (1 tablet in the morning, 1 tablet in the afternoon, and 2 tablets at bedtime).
  • Do not take more than 4 tablets (1 in the morning, 1 in the mid-afternoon, and 2 at bedtime) in 1 day.
  • Take Diclegis on an empty stomach with a glass of water.
  • Take Diclegis tablets whole. Do not crush, chew, or break Diclegis tablets before swallowing. If you cannot swallow Diclegis tablets whole, tell your healthcare provider.
  • *Talk to your healthcare provider about how much Diclegis to take and when to take it.

Diclegis® does not contain lactose, gluten or tartrazine.

The product has also received Kosher-Passover and Halal certifications.


Safety and side effects

Safety

Diclegis® is the only FDA-approved Pregnancy Category A treatment for nausea and vomiting of pregnancy. Pregnancy Category A means that a medicine has been tested in pregnant women and their babies did not have any problems related to using the medicine11

Understanding FDA Pregnancy Categories11

The FDA created pregnancy letter categories to help explain what is known about using medicine during pregnancy. The FDA chooses a medicine’s letter category based on what is known about the medicine when used in pregnant women and animals. The letter category is listed in the label of a prescription medicine. The label states whether studies were done in pregnant women or pregnant animals and if so, what happened.

Pregnancy Categories Definition

Side effects

The most common Diclegis side effect is drowsiness.

Do not drive, operate heavy machinery, or engage in other activities that need your full attention unless your healthcare provider says that you may do so.

Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis.

Severe drowsiness can happen or become worse causing falls or accidents.


Diclegis® Savings Offer

Pay no more than $30* for Diclegis

Most patients with commercial insurance coverage should expect to pay no more than $30* for up to a 30-day supply of Diclegis.

*Please see below for Restrictions and Conditions of Use.

Diclegis savings offer

To get your Diclegis savings offer, please fill out the information below and click Submit.

Patients with questions regarding the CoPay Offer please call: 1-800-250-5195





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*Restrictions and Conditions of Use:

  1. Patients must be 18 years of age or older.
  2. This offer is not available to individuals enrolled in Medicare, Medicaid, TRICARE, or any other federal or state healthcare plan.
  3. Federal law prohibits the selling, purchasing, trading, or counterfeiting of this offer. Such activities may result in imprisonment of 10 years, fines of $250,000, or both.
  4. May not be accepted at all pharmacies.
  5. This offer is only good in the United States. Duchesnay USA reserves the right to rescind, revoke, or amend this offer without notice at any time.
  6. No photocopies accepted.
  7. Patients and pharmacies are responsible for disclosing to insurance carriers the redemption and value of the co-pay and complying with any other conditions imposed by insurance carriers or third-party payers.
  8. The value of this offer is not contingent on any prior or future purchases. The offer is solely intended to provide up to $100 off any purchase of Diclegis. Use of this offer for any one purchase does not obligate the patient to make future purchases of Diclegis or any other product.
  9. Void where prohibited by law.

Duchesnay USA Patient Assistance Program

We at Duchesnay USA believe that every pregnant woman and her Healthcare Professional have the right to access safe and effective therapies. This is why we are broadening the availability of Diclegis through our Patient Assistance Program while Managed Care Organizations and State Medicaid Agencies perform their clinical reviews to decide Diclegis' formulary status.

If a woman cannot currently obtain or afford Duchesnay USA medication due to these temporary gaps in coverage, she may be eligible to participate in our Patient Assistance Program. 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


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Duchesnay USA Values Your Privacy

I agree that the information I am providing may be used by Duchesnay USA, Inc., its affiliates, or vendors to keep me informed over time about products, services, special offers, or other opportunities that may be of interest to me. THESE COMMUNICATIONS MAY CONTAIN MARKETING MATERIALS, GOODS, OR SERVICES. DUCHESNAY USA MAY BE REQUIRED BY LAW TO REPORT TO THE STATE AND/OR FEDERAL GOVERNMENT THE VALUE ASSOCIATED WITH SUCH MARKETING MATERIALS, GOODS, OR SERVICES PROVIDED. Under no circumstances will Duchesnay USA sell my personal information to third parties. However, in rare instances, Duchesnay USA may be required by law to disclose my personal information. Duchesnay USA will take appropriate measures to protect my information, and I can opt out from receiving future communications from Duchesnay USA by contacting Duchesnay USA by mail, or by clicking on the "unsubscribe" link which will be available in future e-mail communications. By providing my information to Duchesnay USA and checking this box, I certify that I am at least eighteen (18) years of age.

Indication

Diclegis® is 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

Do not take Diclegis if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse CNS effects of Diclegis. Use of MAOIs may also prolong and intensify the anticholinergic (drying) effects of antihistamines.

The most common side effect of Diclegis is drowsiness. You 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 your healthcare provider.

Do not take Diclegis with alcohol or sedating medicines, including other antihistamines (present in some cough and cold medications), opiates, or sleep aids, because severe drowsiness can happen or become worse, causing falls or accidents.

Diclegis should be used with caution in women who have: (1) asthma, (2) increased pressure in the eye, (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 younger than 18 years 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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. Ornstein M, Einarson A, Koren G. Bendectin/Diclectin for morning sickness: a Canadian follow-up of an American tragedy. Reprod Toxicol. 1995;9(1):1-6.
  3. 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.
  4. Jewell D, Young G. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2002;(1):CD000145.
  5. Medalie JH. Relationship between nausea and/or vomiting in early pregnancy and abortion. Lancet.1957;273(6986)117-119.
  6. 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.
  7. 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.
  8. Smith C, Crowther C, Beilby J, Dandeaux J. The impact of nausea and vomiting on women: a burden of early pregnancy. Aust N Z J Obstet Gynaecol. 2000;40(4):397-401.
  9. Data on File. Duschesnay USA, Inc.
  10. 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.
  11. US Department of Health and Human Services, Office on Women’s Health; Pregnancy and Medicines Frequently Asked Questions. http://www.womenshealth.gov.
  12. Diclegis [package insert]. Bryn Mawr, PA: Duchesnay USA, Inc; 2013.