WAKIX Pregnancy Registry

Pregnant and have narcolepsy?

Sign up for a study to help others like you.

The WAKIX Pregnancy Registry is a study that collects information from women who take medicines like WAKIX while pregnant as well as from those who don’t. It tracks the health of their babies up to age one. There are no additional visits or tests. You just give the researchers permission to collect health information from your doctors about you and your baby, up to age one.

Would you like to participate? Contact the registry today.

Enroll in the registry

Why is it important?

Your participation could help other pregnant women and healthcare professionals learn more about the safety of WAKIX when used during pregnancy.

Who is eligible to enroll?

The WAKIX Pregnancy Registry is open to pregnant women of any age who provide consent to participate and meet certain enrollment criteria. You may be eligible to participate even if you are not taking WAKIX.

Please note, this registry is for US patients only.

How do I enroll?

If you are interested in enrolling, please complete the Contact Request Form, email us at wakixpregnancyregistry@ppd.com or call 1-877-302-2813. A registry team member will contact you and provide more information.

Compensation for participation?

You will receive $50.00 for your participation in the registry.

Talk to your healthcare provider

We encourage you to talk to your doctor if you are pregnant, nursing, or plan to become pregnant while taking WAKIX.

Contact WAKIX Pregnancy Registry
To learn more about the WAKIX Pregnancy Registry or if you have any questions, complete the Contact Request Form, email us at wakixpregnancyregistry@ppd.com or call 1-877-302-2813.

Contact Request Form

Complete this form and a registry team member will contact you with more information about participating in the registry.

I authorize the WAKIX Pregnancy Registry to contact me and/or leave a message for me at these numbers; or to contact me via email at the address listed below:

I agree to the Registry referencing the “WAKIX Pregnancy Registry” in messages or emails addressed to me.

Privacy Statement:

Pharmaceutical Product Development, LLC (PPD) respects that privacy is important to you. The information you provide on this form will be used to contact you for the purposes of assessing your eligibility to participate in the WAKIX Pregnancy Registry. This information will be held by PPD and not shared with the study sponsor (Harmony Biosciences, LLC) or any other third party without your written permission. In the event you choose not to enroll, Registry staff will request permission to share your contact information with Harmony Biosciences, LLC in order for them to contact you for safety follow up about your pregnancy. If you do not provide permission, and do not enroll in the Registry your contact details will be deleted.

Indications and Usage

WAKIX is a prescription medicine used to treat excessive daytime sleepiness (EDS) or sudden onset of weak or paralyzed muscles (cataplexy) in adults with narcolepsy.

Important Safety information

Do not take WAKIX if you are allergic to pitolisant or any ingredient in WAKIX, or if you have severe liver disease.

Tell your healthcare provider about all your medical conditions, including if you have heart rhythm irregularities, were born with a heart condition, or the levels of electrolytes in your blood are too high or too low. WAKIX has an effect on the electrical activity of the heart known as QT/QTc prolongation. Medicines with this effect can lead to disturbances in heart rhythm, which are more likely in patients with risk factors such as certain heart conditions, or when taken in combination with other medicines that affect QT. Tell your healthcare provider about all the other medicines you take.

The risk of QT prolongation may be greater in patients with liver or kidney disease. WAKIX is not recommended in patients with end-stage kidney disease.

The most common side effects seen with WAKIX were insomnia, nausea, and anxiety. Other side effects included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, and decreased appetite. These are not all the possible side effects of WAKIX. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines. Some medicines can increase the amount of WAKIX that gets into your blood and some medicines can decrease the amount of WAKIX that gets into your blood. The dosage of WAKIX may need to be adjusted if you are taking these medicines.

WAKIX can also decrease the effectiveness of some medicines, including hormonal birth control methods. You should use an alternative non-hormonal birth control method during treatment with WAKIX and for at least 21 days after discontinuation of treatment.

Tell your healthcare provider if you are pregnant or planning to become pregnant. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. You are encouraged to enroll in the WAKIX pregnancy registry if you become pregnant while taking WAKIX. To enroll or obtain information from the registry, call 1-877-302-2813.

The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age.

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. You can also report negative side effects to Harmony Biosciences at 1-800-833-7460.

Please see Full Prescribing Information.