Buy Wakix (pitolisant)

What is Wakix (pitolisant) for?

Wakix (pitolisant) is a histamine-3 (H3) receptor antagonist/inverse agonist used to treat excessive daytime sleepiness or cataplexy (sudden loss of muscle strength) in adults with narcolepsy.^[1]

It is available as an oral tablet, containing 4.45 mg and 17.8 mg pitolisant.^[1]

How does Wakix (pitolisant) work?

How Wakix works exactly is not yet understood, but it is thought to affect histamine. It increases histamine levels in the brain. Histamine is found naturally in the brain and helps the body to stay awake and the muscles to have a stable tone throughout the day.^[2]

The active ingredient in Wakix, pitolisant, can bind to receptors in the brain called ‘histamine H3’. By doing so, Wakix can increase the activity of brain cells and help keep the body awake.^[2]

Where has Wakix (pitolisant) been approved?

Wakix (pitolisant) was approved by:

• The European Medicines Agency (EMA) on March 31, 2016 to treat EDS and cataplexy in narcolepsy.^[3]
• The Food and Drug Administration (FDA), USA:
  • On August 15, 2019 to treat EDS in narcolepsy.^[4]
  • On October 13, 2020 to treat cataplexy in narcolepsy.^[5]
• Health Canada on June 9, 2021 to treat EDS and cataplexy in narcolepsy.^[6]

Wakix (pitolisant) was granted Orphan Drug Designation by the EMA.^[3]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Wakix (pitolisant) taken?

The standard dosage is:^[1]

• 17.8 mg to 35.6 mg taken orally once per day, as soon as you wake up.

Your treating doctor will determine the right dosage for you via a process called titration: you will start at a lower dose and increase the dose gradually to find the right dose.^[1]

Take the capsules at the same time every day. If you miss a dose, skip the dose and take it the following day as soon as you wake up.^[1]

It is important to know that it may take some time for Wakix (pitolisant) to start to have effect, for some patients it may take up to 8 weeks.^[1]

If you have moderately reduced liver function or kidney problems, your maximum dose should be 18 mg per day. You should not use Wakix (pitolisant) if you have severe liver disease.^[1]

Complete information about Wakix (pitolisant) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Wakix (pitolisant)?

Common adverse reactions

The most common side effects (≥5% of patients) listed in the prescribing information include:^[1]

• Insomnia
• Nausea
• Anxiety

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Heart rhythm disturbances called heart rate-corrected QT (QTc) prolongation

Use in a specific population

Tell your treating doctor if you are pregnant or planning to become pregnant.^[1]

Wakix (pitolisant) can decrease the effectiveness of some medicines, including hormonal birth control methods. Patients should use an alternative non-hormonal birth control method during treatment and for at least 21 days after stopping treatment.^[1]

Tell your treating doctor about all the medicines you take and of 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.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [EMA]: Wakix (pitolisant) [PDF]
EMA, Mar 2016

2. How does Wakix work?
Wakix.com, cited Sep 2021

3. Wakix
EMA, cited Sep 2021

4. Harmony Biosciences Announces FDA Approval Of WAKIX® (Pitolisant), A First-In-Class Medication For The Treatment Of Excessive Daytime Sleepiness In Adult Patients With Narcolepsy
BioSpace.com, Aug 2019

5. FDA approves expanded use of Wakix for narcolepsy
AASM.org, Oct 2020

6. Paladin Labs Says Wakix Approved In Canada For Cataplexy In Adult Patients With Narcolepsy
Nasdaq.com, Jun 2021