WAKIX Pregnancy Registry
What is the WAKIX Pregnancy Registry?
The WAKIX Pregnancy Registry is a voluntary study which collects information about the health of women and their babies during pregnancy. The information is being collected to better understand if WAKIX has any effect on a woman’s pregnancy, delivery, or baby. However, you do not have to be currently taking WAKIX to participate.
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 call 1-877-302-2813. A Registry Coordinating Center representative will provide you with more information about the registry and allow you the opportunity to initiate enrollment.
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.
I authorize the WAKIX Pregnancy Registry (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:
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.
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.