Wakix: Uses, Side Effects and Dosage

What is WAKIX used for?

WAKIX is used in adults and children (6 to 17 years of age and weighing at least 30 kg) with narcolepsy (a type of sleep disorder) to reduce:

• Excessive sleepiness during the day
• Cataplexy (sudden weak or paralyzed muscles)

WAKIX is also used in adults with obstructive sleep apnea (OSA) to reduce excessive sleepiness during the day. OSA is a disorder where the muscles in the throat temporarily relax causing breathing problems during sleep. WAKIX is used along with other medical treatments for this sleep problem. WAKIX does not treat the breathing problems. WAKIX is not a replacement for other treatments that have been prescribed for OSA. It is important that you continue to use these treatments as prescribed by your healthcare professional.

How does WAKIX work?

WAKIX contains pitolisant, which attaches to receptors in the brain that are involved in making you feel more alert. This helps to combat daytime sleepiness and cataplexy and promote wakefulness.

What are the ingredients in WAKIX?

Medicinal ingredient: pitolisant hydrochloride

Non-medicinal ingredients: colloidal anhydrous silica, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, purified water, talc, and titanium dioxide

WAKIX comes in the following dosage forms:

Tablets; 5 mg and 20 mg

Do not use WAKIX if you/your child:

• are allergic to pitolisant hydrochloride or to any of the other ingredients in this medication or to any part of the container.
• have severe liver problems.
• are breastfeeding or plan to breastfeed.

To help avoid side effects and ensure proper use, talk to your or your child’s healthcare professional before WAKIX is taken. Talk about any health conditions or problems, including if you or your child:

• have or have had heart problems, or problems with the way the heart beats.
• have a severe kidney disease or are on dialysis.
• have or have had anxiety, depression, or depressive symptoms.
• have a history of seizures; WAKIX may make seizures worse.

Other warnings you should know about:

Heart rhythm disorder: WAKIX may cause a heart rhythm disorder. This disorder is called Long QT Syndrome. You may have no symptoms or you may:

• feel dizzy
• have chest pain or discomfort
• have a rapid and/or irregular heart beat
• faint
• have seizures

Tell your healthcare professional immediately if you have these symptoms. If you continue to have these symptoms, you could develop a more serious heart rhythm problem that could lead to death.

Driving and Using Machines: Before you do tasks which may require special attention, wait until you know how you respond to WAKIX.

Pregnancy: If you are pregnant, think you may be pregnant or are planning to have a baby, do not use this medicine unless your doctor tells you to. It is not known if WAKIX will harm your unborn baby. If you are taking a hormonal birth control, you should use an additional reliable non-hormonal method to avoid getting pregnant during treatment and for at least 21 days after you stop taking WAKIX.

Dependence and Tolerance: Because WAKIX works on the brain, there is a small risk of drug abuse, misuse or dependence. If you find you are craving more WAKIX than you are supposed to take, talk to your healthcare professional right away. When WAKIX is stopped, children may experience symptoms of withdrawal such as feeling uneasy or frustrated, having trouble sleeping, or an increased appetite. If you notice worrying changes in your child’s health or behaviour when WAKIX is stopped, tell their healthcare professional right away.

Tell your healthcare professional about all the medicines you or your child take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with WAKIX:

• medicines used for depression, such as paroxetine, fluoxetine, venlafaxine and bupropion
• medicines used to control seizures/epilepsy, such as phenytoin and carbamazepine
• medicines used to control allergic reactions, such as pheniramine maleate, diphenhydramine and promethazine (H1 receptor antagonist)
• tri- and tetra-cyclic antidepressants, such as imipramine, clomipramine and mirtazapine
• medicines used for irregular heart rhythm, such as procainamide, disopyramide, amiodarone and sotalol
• medicines used to manage psychosis, such as ziprasidone and chlorpromazine
• medicines used to treat fungal infections, such as terbinafine and amphotericin B
• medicines used to increase your production of urine (diuretics or “water pills”)
• medicines known as “inhibitors of uridine glucuronyl transferases”, such as probenecid. If you are unsure, ask your healthcare professional.
• rifampin, used for tuberculosis
• moxifloxacin, used to control infections
• metformin, used to improve your blood sugar
• midazolam, used for sedation
• cyclosporine, used to suppress the immune system (e.g., in transplant rejection)
• cinacalcet, used for increased parathyroid hormone
• quinine, used for malaria
• strong corticosteroids (used to lower inflammation)
• laxatives and enemas
• types of plants called goldenseal and St. John’s Wort
• hormonal birth control

How to take WAKIX:

• Take WAKIX once a day when you wake up.

• Take WAKIX with food.

• Swallow tablets whole, do not chew, divide or crush the tablets before swallowing.
• Only take WAKIX in the morning. If you take it in the afternoon you may have difficulty sleeping at night.
• It might take a few days before you feel the benefit of the medicine and the maximum benefits are usually felt after a few weeks.

Usual dose:

Take WAKIX every day as prescribed by your healthcare professional. Do not decrease, stop or change your dose on your own.

Narcolepsy

Adults (18 years of age and older): The usual starting dose is 10 mg (two 5 mg tablets) once daily. Your healthcare professional will slowly increase your dose if necessary. The total daily dose should not exceed 40 mg per day.

Children (6 to 17 years of age and weighing at least 30 kg): The usual starting dose is 5 mg (one 5 mg tablet) once daily. The dose may be slowly increased by the healthcare professional as necessary.

The maximum dose of WAKIX is:

• 20 mg per day for children weighing under 50 kg.
• 40 mg per day for children weighing 50 kg or more.

Obstructive sleep apnea

Adults (18 years of age and older): The usual starting dose is 5 mg (one 5 mg tablet) once daily. Your healthcare professional will slowly increase your dose if necessary. The total daily dose should not exceed 20 mg per day.

Overdose:

If you think you, or a person you are caring for, have taken too much WAKIX, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

If you miss a dose, take the next dose when you wake up the next morning. Do not take an extra dose to make up for a missed dose.

What are possible side effects from using WAKIX?

These are not all the possible side effects you may have when taking WAKIX. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with WAKIX may include:

• Acid reflux
• Anxiety
• Back pain
• Diarrhea
• Dizziness
• Decreased appetite

• Dry mouth

  • Fatigue
  • Headache
  • Insomnia (trouble sleeping)
  • Irritability
  • Joint pain
  • Muscle spasms
  • Nausea
  • Stomach pain

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store between 15 and 30°C.
• Keep out of reach and sight of children.

If you want more information about WAKIX:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://knighttx.com), by emailing medinfo@knighttx.com, or by calling 1-844-483-5636.