Pitolisant (pi-TOE-li-sant)

Treats sudden onset of weak or paralyzed muscles, or excessive daytime sleepiness in patients with narcolepsy.

Brand Name(s):

Wakix

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Take the tablet when you wake up in the morning.
• Missed dose: If you missed a dose, take the next dose the following day when you first wake up in the morning.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how pitolisant works. Tell your doctor if you are using any of the following:
  • Carbamazepine, cyclosporine, midazolam, moxifloxacin, phenytoin, rifampin
  • Birth control pills
  • Medicine to treat allergy (including diphenhydramine, pheniramine maleate, promethazine)
  • Medicine to treat depression (including bupropion, clomipramine, fluoxetine, imipramine, mirtazapine, paroxetine)
  • Medicine to treat heart rhythm problems (including amiodarone, disopyramide, procainamide, quinidine, sotalol)
  • Medicine to treat mental illness (including chlorpromazine, thioridazine, ziprasidone)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or have had heart rhythm problems (including arrhythmia, slow heartbeat).
• Birth control pills may not work while you are using pitolisant. To keep from getting pregnant, use another form of birth control during treatment and for at least 21 days after your last dose. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.
• This medicine may cause heart rhythm problems, including QT prolongation.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fast, pounding, or uneven heartbeat
• Lightheadedness, dizziness, or fainting

If you notice these less serious side effects, talk with your doctor:

• Headache
• Nausea
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088