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WAKIX - Pitolisant Tablets
WAKIX comes in tablet forms with dosages such as 4.45 mg and 17.8 mg, and the dose is typically started low and gradually increased based on patient tolerability. For adults, the dosing usually starts at 8.9 mg once daily, with adjustments up to 17.8 mg if needed. In children, the initial dose is 4.45 mg once daily, with possible gradual increases. The medication is taken once daily in the morning upon waking. It may take up to 8 weeks to see the full clinical effect. Important considerations include avoiding use in patients with known QT interval prolongation or cardiac arrhythmias, as WAKIX can prolong the QT interval. Dose adjustments are required when used with certain drugs that inhibit CYP2D6 enzymes, which affect pitolisant metabolism. Women of childbearing potential should use effective contraception during treatment and for 21 days after stopping, as pitolisant may reduce hormonal contraceptive effectiveness.
- In a clinical study in adults, WAKIX did not show potential for abuse, similar to placebo (sugar pill).
- excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
- excessive daytime sleepiness (EDS) in children 6 years of age and older with narcolepsy.
Do not take WAKIX if you are allergic to pitolisant or any ingredient in WAKIX, or if you have severe liver disease.
WAKIX can cause a change in the electrical activity of the heart known as QT prolongation. This is a heart rhythm problem that can lead to an abnormal heartbeat. You have a higher chance of getting QT prolongation if you have certain heart or other medical conditions, or if you take WAKIX with certain medicines. Tell your healthcare provider right away if you have a change in your heartbeat or if you feel dizzy or faint while taking WAKIX.
Tell your healthcare provider about all your medical conditions, including if you have any heart, liver, or kidney problems, or problems with blood levels of your electrolytes, such as potassium or magnesium.
Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking WAKIX with certain medicines may cause side effects or affect the way each other works.
Hormonal birth control methods may not work while taking WAKIX. Use an alternative non-hormonal birth control method during treatment with WAKIX and for at least 21 days after stopping WAKIX.
Tell your healthcare provider if you are pregnant or planning to become pregnant. You are encouraged to enroll in the WAKIX pregnancy registry if you become pregnant while taking WAKIX. The registry collects information about the health of you and your baby. To enroll or obtain information from the registry, call 1-800-833-7460.
The most common side effects of WAKIX in adults include insomnia, nausea, and anxiety.
The most common side effects of WAKIX in children include headache and insomnia.
These are not all the possible side effects of WAKIX. Call your healthcare provider for medical advice about side effects.
It is not known if WAKIX is safe and effective to treat excessive daytime sleepiness in children under 6 years of age with narcolepsy or to treat cataplexy in people under 18 years of age with narcolepsy.
WAKIX is a first-of-its-kind medication that is thought to work differently
While the way WAKIX works is not fully understood, it is thought that WAKIX reduces excessive daytime sleepiness (EDS) in people 6 years of age and older with narcolepsy or cataplexy in adults with narcolepsy by increasing histamine levels in the brain.
What does histamine do in the brain?
Histamine is a natural chemical in the brain that works in two ways to help us stay awake during the day.
WAKIX only needs to be taken once each day in the morning. Avoid taking WAKIX later in the day.
- If a dose is missed, the next dose should be taken the following morning, as soon as you wake up.
- WAKIX tablets should not be crushed or chewed.
TAKE WAKIX
- In the morning, as soon as you wake up
- Once a day, every day
- With or without food
DO NOT TAKE WAKIX
- Later in the day
- More than once a day
- Only on certain days
If you have any questions about when WAKIX should be taken, talk with your healthcare provider.
WAKIX comes in two tablet strengths (4.45 mg and 17.8 mg)
Depending on the WAKIX dose, more than one tablet may have to be taken.
Your healthcare provider will start at a lower dose and increase the dose each week to find the dose that is right for you. This process is called titration.
- Titration can take time, but it`s important for you and your healthcare provider to find the dose that`s right for you.
Talk to your healthcare provider about how you are feeling after starting WAKIX.
- Tell them about any improvements you notice as well as any potential side effects.