Wakix (pitolisant)
Wakix (pitolisant) is a medication used to treat excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.
- Disease Indications : Narcolepsy
- Manufacturer : Harmony Biosciences
- Usage : Oral
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Health Canada
Details
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.
It is available as an oral tablet, containing 4.45 mg and 17.8 mg pitolisant.
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.
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.
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.
- The Food and Drug Administration (FDA), USA:
- On August 15, 2019 to treat EDS in narcolepsy.
- On October 13, 2020 to treat cataplexy in narcolepsy.
- Health Canada on June 9, 2021 to treat EDS and cataplexy in narcolepsy.
Wakix (pitolisant) was granted Orphan Drug Designation by the EMA.
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:
- 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.
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.
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.
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.
Complete information about Wakix (pitolisant) dosage and administration can be found in the official prescribing information listed in our references section.
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:
- Insomnia
- Nausea
- Anxiety
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- 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.
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.
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.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
- Full prescribing information [EMA]: Wakix (pitolisant) [PDF] EMA, Mar 2016
- How does Wakix work? Wakix.com, cited Sep 2021
- Wakix EMA, cited Sep 2021
- 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
- FDA approves expanded use of Wakix for narcolepsy AASM.org, Oct 2020
- Paladin Labs Says Wakix Approved In Canada For Cataplexy In Adult Patients With Narcolepsy Nasdaq.com, Jun 2021
Clinical trials
Excessive daytime sleepiness
The European Medicines Agency (EMA) approval of Wakix (pitolisant) for treatment excessive daytime sleepiness (EDS) in adults with narcolepsy was based on two studies Study 1 (NCT01067222) and Study 2 (NCT01638403).
These trials were two multicenter, randomized, double-blind, placebo-controlled studies that included a total of 261 patients. Patients were randomized to receive Wakix or placebo once daily for 8 weeks.
Results
The main endpoint of the studies was the measure of how sleepy patients felt during daytime, assessed using the Epworth Sleepiness Scale or ESS.
Wakix was effective in reducing EDS in patients with narcolepsy. At the end of the study:
- The ESS score with Wakix was 12.4 versus 15.5 with placebo in Study 1
- The ESS score with Wakix was 13.3 versus 15.5 with placebo in Study 2
Wakix showed greater improvement in ESS score compared with placebo. At the end of the study:
- Wakix had reduced the ESS score by 6 points, compared to the 2.9 points reduction seen with placebo in Study 1.
- Wakix had reduced the ESS score by 5 points, compared to the 2.8 points reduction seen with placebo in Study 2.
Cataplexy
The European Medicines Agency (EMA) approval of Wakix (pitolisant) for treatment of cataplexy in adults with narcolepsy was based on two studies: Study 1 (see EDS) and Study 3 (NCT01800045).
Study 3 was a 7-week, multicenter, randomized, double-blind, placebo-controlled study that involved a total of 154 patients. In both trials, patients were treated with either Wakix or placebo once daily.
Results
The main endpoint of the studies was the number of weekly cataplexy attacks, which are defined as sudden muscle weakness often triggered by emotions. One trial measured the number of weekly cataplexy attacks and the other trial measured the number of daily cataplexy attacks
Wakix nearly halved the number of cataplexy attacks per week compared with placebo:
- The number of weekly attacks was reduced by 6.8 with Wakix versus 2.8 with placebo in Study 3
On average, patients taking Wakix had approximately 8 weekly cataplexy attacks.
Wakix significantly lowered the number of daily cataplexy attacks compared to placebo.
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Wakix (pitolisant) for the approved indication.
References
- Efficacy in EDS Wakixhcp.com, cited Sep 2021
- Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1) Study 1, cited Sep 2021
- Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy. Study 2, cited Sep 2021
- Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP) Study 3, cited Sep 2021
- Full prescribing information [EMA]: Wakix (pitolisant) [PDF] EMA, Mar 2016
Price & Costs
Wakix (pitolisant) price in other currencies*
| Package | Euro | Australian dollars | Canadian dollar | New Zealand dollar | Nigerian naira | Singapore dollar | Pound sterling | United States dollar |
|---|---|---|---|---|---|---|---|---|
| 30 tablets of 4.5 mg | 532 EUR | 878 AUD | 794 CAD | 966 NZD | 884014 NGN | 751 SGD | 438 GBP | 560 USD |
| 30 tablets of 18 mg | 532 EUR | 878 AUD | 794 CAD | 966 NZD | 884014 NGN | 751 SGD | 438 GBP | 560 USD |
*The prices listed above are based on the cheapest package size and strength everyone.org has access to. Please make an enquiry for more specific pricing. The prices listed above are a guide only, we operate in Euros.
Wakix (pitolisant) treatment costs
The cost for a monthly or yearly treatment of Wakix (pitolisant) depends on your prescription requirements which includes the dosage in mg and medicine type (Tablets).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Wakix (pitolisant) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.
Wakix (pitolisant) price and additional costs
- The price of Wakix (pitolisant)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Wakix (pitolisant)
The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.
everyone.org provides access to Wakix (pitolisant) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.
The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.
When you buy Wakix (pitolisant), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Wakix (pitolisant) reimbursement
It might be possible for you to claim the cost of Wakix (pitolisant) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Medical insurance
Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.
Crowdfunding
Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.
Shipping
Room temperature shipping
For this medication, standard shipping applies. This means that a consistent room temperature of 15 to 25°C is maintained during transit.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
Our Process
Four steps to access the medicines you need
How and where to access and buy Wakix: You can access Wakix from everyone.org if the drug has not been approved or is not available in your country.
- Step 1: You send a request for your medicine online
- Step 2: We verify your prescription and medical details
- Step 3: We source your medicine
- Step 4: We deliver your medicine
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
Contact Patient Support
If you have any questions or need any help, contact our Patient Support Team. We will get in touch with you within 24 hours from Monday to Friday between 9:00 and 10:00 CET.
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