Terms of Use | WAKIX® (pitolisant) tablets

Terms of Use

Last updated: October, 2019

Harmony Biosciences, LLC (“Harmony“) has provided this website and its content for general informational purposes only, for US residents. Harmony will undertake reasonable efforts to ensure that all information added to this site is accurate at the time such content is made available. Please note, however, that Harmony makes no warranties or representations that the information is accurate and accepts no liability for any errors or omissions in the content of the site or any losses or damage that may arise from relying on this information. The information may be changed by Harmony at any time.

We encourage you to read these Terms of Use in their entirety before using the site. By accessing and using the site or its services, you agree to these Terms of Use and to the collection and use of information in accordance with our Privacy Policy, without limitation or qualification.

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Changes to Terms of UseHarmony may modify these Terms of Use at any time without notice. Harmony may terminate these Terms of Use, terminate user access to all or any part of this site or any content or any service, or suspend any individual user’s access to all or any part of this site or any content or any service, at any time, without notice, if we believe in our sole judgment that the user has breached or may breach any term or condition of this agreement, or for our convenience. The user may terminate these Terms of Use at any time by destroying all materials received from this site (including content) and ceasing to use this site and its content and services. Harmony reserves the right to remove any content or services from the site at any time.

Agreement to Terms of UseBy accessing and using the site or its services, you agree to these Terms of Use and to the collection and use of information in accordance with our Privacy Policy, without limitation or qualification. Except as expressly provided in a particular “legal notice” on this site, these Terms of Use constitute the entire agreement between the user and Harmony with respect to the use of this site and its content and services.

All materials and information appearing on this site are intended for US residents only. These Terms of Use were last updated: October 2019.

Indications and usage & Important Safety Information

Important Safety Information

Do not use WAKIX 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 1-800-833-7460.

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, LLC at 1-800-833-7460.

Please see Full Prescribing Information.

Indications and Usage

WAKIX is a prescription medicine for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

Indications and usage & Important Safety Information

Important Safety Information

Do not use WAKIX 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 1-800-833-7460.

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, LLC at 1-800-833-7460.

Please see Full Prescribing Information.

Indications and Usage

WAKIX is a prescription medicine for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

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