Coverage for the only FDA-approved and only Pregnancy Category A prescription treatment for Nausea and Vomiting of Pregnancy when conservative management fails1 expands to Wyoming through the state-administered Medicaid Drug Rebate Program.
Rosemont, PA. – January 30, 2017 – Duchesnay USA today announced that Diclegis® (doxylamine succinate and pyridoxine hydrochloride) delayed release tablets, for the treatment of Nausea and Vomiting of Pregnancy (NVP) in women who do not respond to conservative management,1 are on the preferred drug list under the Wyoming state-administered Medicaid program.
NVP (commonly called morning sickness) is a very common medical condition that is experienced by 70% to 85% of pregnant women. NVP can be quite debilitating throughout a woman’s pregnancy; however, treatment with Diclegis® can help manage NVP symptoms.
The addition of the Wyoming Medicaid program further expands availability to the already numerous commercially insured consumers that can currently access Diclegis®. Wyoming joins a growing list of influential State Medicaid programs, including California, Connecticut, Nebraska, Tennessee, Texas, Wisconsin, Indiana, Colorado and Nevada, which cover Diclegis® without special authorization requirements. Now, even more women across the country will be able to receive Diclegis® under state-administered Medicaid programs.
Diclegis® is the only FDA-approved medicine for NVP when conservative management fails and is safe and effective.1 The FDA granted Diclegis® Pregnancy Category A status,1 the highest rating available.2
Diclegis® has not been studied in women with hyperemesis gravidarum.
For more information about Diclegis®, visit www.Diclegis.com
About Nausea and Vomiting of Pregnancy (NVP)
Nausea and vomiting of pregnancy (NVP), or morning sickness, affects 70 to 85 percent of pregnant women.3,4,5,6 NVP can present differently for each woman, the symptoms include: nausea, gagging, retching, dry heaving, vomiting and odor and/or food aversion.7 For most pregnant women, symptoms generally subside at approximately 16 to 20 weeks gestation.6 However, some women can experience symptoms throughout their pregnancy.8
Diclegis (doxylamine succinate 10 mg, pyridoxine hydrochloride 10 mg) delayed-release tablets are the only FDA-approved prescription treatment for nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.1 Diclegis has proven to be a safe and effective treatment option for NVP and received Pregnancy Category A status, which means the results of controlled studies have not shown an increased risk to an unborn baby.1,2
Indication and Important Safety Information
Diclegis is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments.
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 central nervous system (CNS) effects of Diclegis.
The most common side effect of Diclegis is drowsiness. Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so.
Do not drink alcohol, or take other CNS 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 should be used with caution in women who have certain medical conditions, such as asthma (1), or eye (2, 3), stomach (4, 5, 6) or bladder problems. Tell your healthcare provider about all of your medical conditions so he/she can assess if Diclegis is right for you.
It is not known if Diclegis is safe and effective in children under 18 years of age. Keep Diclegis and all medicines out of the reach of children.
Diclegis is a delayed-release formulation, so signs of overdose may not appear right away. If you take too much Diclegis (overdose), you may have the following symptoms: restlessness, dry mouth, the pupils of your eyes become larger (dilated), sleepiness, dizziness, confusion, fast heart rate, seizures, muscle pain or weakness, and sudden and severe kidney problems. If you have these symptoms and they are severe, they may lead to death. Stop taking Diclegis, call your healthcare provider or go to the nearest hospital emergency room right away. For more information about overdose treatment, call your poison control center at 1-800-222-1222.
Diclegis is intended for use in pregnant women.
Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed. Diclegis can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call1-800-FDA-1088.
For additional important safety information, please see full Prescribing and Patient Information at www.diclegis.com. This information is not intended to replace discussions with your healthcare provider.
About Duchesnay USA
Duchesnay USA is a specialty pharmaceutical company with a long-standing commitment to women’s health. Until now, we have focused on filling the void in terms of scientific research and education and on developing pharmacological solutions that are safe for use during pregnancy and breastfeeding. Today, Duchesnay is equally committed to ensuring women’s health and to improving their quality of life at every stage.
Thus, Duchesnay is broadening its portfolio of products to offer safe and effective therapeutic options that meet the health and quality of life needs of women and their family members at different stages of their lives.
For more information about Duchesnay USA, please visit www.DuchesnayUSA.com.