Possible Side Effects | WAKIX® (pitolisant) tablets

Possible Side Effects

What side effects might I experience?

WAKIX® (pitolisant) may cause side effects. The most common side effects in clinical trials in narcolepsy with WAKIX compared with placebo (sugar pill) were:

  • insomnia, nausea, and anxiety
Side Effects Reported in Clinical Trials With WAKIX

Side effects that occurred in greater than or equal to 2% of patients treated with WAKIX and more frequently than placebo

WAKIX (n=152)Placebo (n=114)
Headache*18%15%
Insomnia*6%2%
Nausea6%3%
Upper respiratory tract infection*5%3%
Musculoskeletal pain*5%3%
Anxiety*5%1%
Heart rate increased*3%0%
Hallucinations*3%0%
Irritability3%2%
Abdominal pain*3%1%
Sleep disturbance*3%2%
Decreased appetite3%0%
Cataplexy2%1%
Dry mouth2%1%
Rash*2%1%

n indicates the number of people who were treated with WAKIX or received placebo.

*Indicates side effects for similar terms that were combined.

These are not all the possible side effects of WAKIX. Tell your healthcare provider about any side effect that bothers you or does not go away.

In these clinical trials, 3.9% of people treated with WAKIX stopped treatment due to side effects, which was similar to people who received placebo (3.5%).

Talk with your healthcare provider about any side effects you may experience while taking WAKIX.

What else should I know about WAKIX?

  • In a study where WAKIX was taken with sodium oxybate or modafinil, there were no significant interactions between medications.

    • Tell your healthcare provider about all the medicines you take or plan to take.

  • WAKIX may reduce the effect of hormonal contraceptives (birth control).

    • Women who can become pregnant should use an alternative non-hormonal type of birth control while taking WAKIX and for at least 21 days after discontinuation of treatment.

  • WAKIX is the only FDA-approved treatment for EDS in narcolepsy that is not a controlled substance.

    • A controlled substance is a drug or chemical that is regulated by the government based on its potential for abuse and dependence.

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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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