Wakix

Wakix (pitolisant) is a prescription medicine used to treat excessive daytime sleepiness (EDS) or cataplexy (sudden loss of muscle strength) in patients 6 years and older who have narcolepsy.

Wakix tablets are taken once in the morning upon waking.

Wakix works by increasing the amount of histamine in the area of the brain that controls sleep and wakefulness. Wakix is a histamine-3 (H3) receptor antagonist/inverse agonist.

Wakix is not a controlled substance or stimulant medicine.

What is Narcolepsy and Cataplexy?

Narcolepsy is a disorder that affects how well the brain controls sleep-wake cycles. Often, people with narcolepsy have interrupted sleep and may feel very sleepy during the day, which interferes with their lives. Everyone who has narcolepsy has excessive daytime sleepiness, which is when they have an overwhelming sense of sleepiness that comes on quickly.

Cataplexy is the sudden loss of muscle tone while awake, resulting in muscle weakness and loss of muscle control. Cataplexy can be mild and only last a short time, or it can be severe with a full-body collapse.

Take Wakix exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Wakix tablet is usually taken once daily when you wake up, it can be taken with or without food.

Your doctor will probably start you on a low dose and gradually increase your dose, not more than once every 7 days.

It may take up to 8 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

You should not use Wakix if you have severe liver disease or known hypersensitivity to the active ingredient pitolisant or any component of the formulation. Anaphylaxis has been reported in patients treated with this medicine.

Before taking this medicine

You should not use this medicine if you are allergic to pitolisant or any of the inactive ingredients. The full list of ingredients is below.

You should not use Wakix if you have:

• severe liver disease.

Tell your doctor if you have ever had:

• liver disease;
• kidney disease;
• a heart rhythm disorder; or
• long QT syndrome (in you or a family member).

Pregnancy

Ask a doctor before using this medicine if you are pregnant or planning a pregnancy.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this medicine on the baby.

Wakix can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using this medicine, use a barrier form of birth control: a condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 21 days after your last dose of this medicine.

Breastfeeding

Ask a doctor before using this medicine if you are breastfeeding or planning to breastfeed

Common side effects of Wakix may include nausea, anxiety, or sleep problems (insomnia).

Wakix may cause serious side effects.

Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fast or pounding heartbeats;, fluttering in your chest;
• shortness of breath; or
• sudden dizziness (like you might pass out).

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Wakix dose for adults

The adult recommended dosage range for Wakix is 17.8 mg to 35.6 mg taken once daily in the morning, upon waking.

The dosage should be increased gradually as follows:

• Week 1: Start with a dosage of 8.9 mg (two 4.45 mg tablets) once daily
• Week 2: Increase dosage to 17.8 mg (one 17.8 mg tablet) once daily
• Week 3: Dose may increase to the maximum recommended dosage of 35.6 mg (two 17.8 mg tablets) once daily

Wakix dose for pediatric patients (6 years and older)

• Week 1: Start with a dosage of 45 mg (one 4.45 mg tablet) once daily
• Week 2: Increase dosage to 8.9 mg (two 4.45 mg tablets) once daily
• Week 3: Increase dosage to 17.8 mg (one 17.8 mg tablet) once daily, the maximum recommended dosage for patients weighing <40 kg
• Week 4: For patients weighing ≥40 kg, may increase to the maximum recommended dosage of 35.6 mg (two 17.8 mg tablets) once daily

Dosing Comments

• The dose may be adjusted based on tolerability.
• It may take up to 8 weeks for some patients to achieve a clinical response.
• The dose should be modified or may not be recommended in renal impairment, hepatic impairment, or poor CYP2D6 metabolizers. More information is available in the Detailed Wakix dosage information
• Wakix is supplied as an oral tablet containing 4.45 mg or 17.8 mg of pitolisant.

Skip the missed dose and use your next dose the following morning at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

When you start or stop taking this medicine, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Wakix can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

This medicine may reduce the effectiveness of hormonal contraceptives, including birth control pills, injections, implants, skin patches, and vaginal rings. Use an alternative non-hormonal contraceptive method during treatment with this medicine and for at least 21 days after discontinuation of treatment.

Drug interactions can occur with strong CYP2D6 Inhibitors, strong CYP3A4 Inducers, and sensitive CYP3A4 Substrates (including hormonal contraceptives).

Medicines that are centrally acting H1 receptor antagonists can prevent histamine from working to promote wakefulness and may reduce the effectiveness of Wakix. Examples of these medicines include pheniramine maleate, diphenhydramine (example: Benadryl), promethazine (antihistamines), imipramine, clomipramine, and mirtazapine (tri- or tetracyclic antidepressants).

Other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products, may affect Wakix. Tell your doctor about all your current medicines and any medicine you start or stop using.

This list is not complete, and many other drugs may interact with Wakix. Click the link below to check for interactions with this medicine.

Store at 20° C to 25° C (68° F to 77°F); excursions permitted between 15° C to 30° C (59° F to 86° F)

Active ingredient: pitolisant hydrochloride

Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Distributed by: Harmony Biosciences, LLC, Plymouth Meeting, PA 19462 USA Wakix is a registered trademark of Bioprojet Pharma.