Description and Brand Names

US Brand Name

• Wakix

Descriptions

Pitolisant is used to treat cataplexy (weak or paralyzed muscles) or excessive daytime sleepiness (EDS) in patients with narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of pitolisant in children with narcolepsy younger than 6 years of age to treat excessive daytime sleepiness and in children with narcolepsy to treat cataplexy. Safety and efficacy have not been established.

Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pitolisant in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Cisapride
Dronedarone
Fluconazole
Ketoconazole
Levoketoconazole
Mavorixafor
Mesoridazine
Pimozide
Piperaquine
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir
Abiraterone Acetate
Acrivastine
Adagrasib
Alcaftadine
Alfuzosin
Amiodarone
Amisulpride
Amitriptyline
Anagrelide
Antazoline
Apalutamide
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Avacopan
Azatadine
Azelastine
Azithromycin
Bedaquiline
Bepotastine
Bromodiphenhydramine
Brompheniramine
Buclizine
Buprenorphine
Bupropion
Buserelin
Carbamazepine
Carbinoxamine
Celecoxib
Ceritinib
Cetirizine
Chloroquine
Chlorpheniramine
Chlorpromazine
Cinnarizine
Ciprofloxacin
Citalopram
Clarithromycin
Clemastine
Clofazimine
Clomipramine
Clothiapine
Clozapine
Crizotinib
Cyclizine
Cyclobenzaprine
Cyproheptadine
Dabrafenib
Dasatinib
Degarelix
Delamanid
Desipramine
Desloratadine
Deslorelin
Desogestrel
Desvenlafaxine
Deutetrabenazine
Dexchlorpheniramine
Dexmedetomidine
Dienogest
Dimenhydrinate
Diphenhydramine
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Doxylamine
Droperidol
Drospirenone
Duloxetine
Ebastine
Efavirenz
Emedastine
Encorafenib
Entrectinib
Eribulin
Erythromycin
Escitalopram
Estradiol
Ethinyl Estradiol
Ethynodiol
Etonogestrel
Etrasimod
Famotidine
Fedratinib
Felbamate
Fexinidazole
Fexofenadine
Fingolimod
Flecainide
Flunarizine
Fluoxetine
Formoterol
Foscarnet
Fosphenytoin
Fostemsavir
Galantamine
Gatifloxacin
Gemifloxacin
Gepirone
Gestodene
Givinostat
Glasdegib
Gonadorelin
Goserelin
Granisetron
Haloperidol
Histrelin
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibutilide
Iloperidone
Imipramine
Inotuzumab Ozogamicin
Itraconazole
Ivabradine
Ivosidenib
Ketotifen
Lapatinib
Lefamulin
Lenvatinib
Leuprolide
Levocabastine
Levocetirizine
Levofloxacin
Levonorgestrel
Lofexidine
Lonafarnib
Loratadine
Lumacaftor
Lumefantrine
Macimorelin
Mavacamten
Meclizine
Medroxyprogesterone
Mefloquine
Mestranol
Methadone
Methdilazine
Methotrimeprazine
Metronidazole
Mifepristone
Mirtazapine
Mitotane
Mizolastine
Mobocertinib
Moricizine
Moxifloxacin
Nafarelin
Nelfinavir
Nilotinib
Nomegestrol
Norelgestromin
Norethindrone
Norfloxacin
Norgestimate
Norgestrel
Octreotide
Ofloxacin
Olanzapine
Olopatadine
Omaveloxolone
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Ozanimod
Pacritinib
Paliperidone
Panobinostat
Papaverine
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Perphenazine
Pheniramine
Phenobarbital
Phenytoin
Pimavanserin
Pipamperone
Ponesimod
Posaconazole
Primidone
Probucol
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Pyrilamine
Quetiapine
Quinidine
Quinine
Quizartinib
Ranolazine
Relugolix
Ribociclib
Rifampin
Rilpivirine
Risperidone
Ritonavir
Segesterone
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Siponimod
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
St John’s Wort
Sulpiride
Sultopride
Sunitinib
Tacrolimus
Tamoxifen
Telaprevir
Telavancin
Telithromycin
Terbinafine
Tetrabenazine
Tolterodine
Toremifene
Trazodone
Triclabendazole
Trimeprazine
Trimipramine
Tripelennamine
Triprolidine
Triptorelin
Ulipristal
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vilanterol
Vinflunine
Voclosporin
Voriconazole
Vorinostat
Zotepine
Zuclopenthixol
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Heart rhythm problems (eg, arrhythmia, slow heartbeat), or history of or
Hypokalemia (low potassium in the blood) or
Hypomagnesemia (low magnesium in the blood)—May increase risk for more serious side effects.
Kidney disease, end stage—Use is not recommended in patients with this condition.
Kidney disease, moderate to severe or
Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Liver disease, severe—Should not be used in patients with this condition.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you think this medicine is not working properly after you have taken it for several weeks, check with your doctor.

Take the tablet when you wake up in the morning.

Swallow the tablet whole. Do not crush, break, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For cataplexy caused by narcolepsy:
    • Adults—At first, 8.9 milligrams (mg) (two tablets of 4.45 mg) once a day on Week 1. Your doctor may increase your dose to 17.8 mg (one tablet of 17.8 mg) once a day on Week 2. Then, your doctor may increase your dose to 35.6 mg (two tablets of 17.8 mg) once a day on Week 3. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 35.6 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For excessive daytime sleepiness caused by narcolepsy:
    • Adults—At first, 8.9 milligrams (mg) (two tablets of 4.45 mg) once a day on Week 1. Your doctor may increase your dose to 17.8 mg (one tablet of 17.8 mg) once a day on Week 2. Then, your doctor may increase your dose to 35.6 mg (two tablets of 17.8 mg) once a day on Week 3. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 35.6 mg per day.
    • Children 6 years of age and older weighing 40 kilograms (kg) or more—At first, 4.45 mg (one tablet of 4.45 mg) once a day on Week 1. Your doctor may increase your dose to 8.9 mg (two tablets of 4.45 mg) once a day on Week 2. Then, your doctor may increase your dose to 17.8 mg (one tablet of 17.8 mg) once a day on Week 3. Your doctor may increase your dose to 35.6 mg (two tablets of 17.8 mg) once a day on Week 4. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 35.6 mg per day.
    • Children 6 years of age and older weighing less than 40 kg—At first, 4.45 mg (one tablet of 4.45 mg) once a day on Week 1. Your doctor may increase your dose to 8.9 mg (two tablets of 4.45 mg) once a day on Week 2. Then, your doctor may increase your dose to 17.8 mg (one tablet of 17.8 mg) once a day on Week 3. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 17.8 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed a dose, take the next dose on the following day when you first wake up in the morning.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine does not take the place of getting enough sleep. It should not be used for occasional sleepiness that has not been diagnosed as narcolepsy. Ask your doctor for advice about good sleep habits.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

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.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy exposure registry for patients taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Changes in behavior
• chest tightness
• cough
• difficulty swallowing
• discouragement
• feeling sad or empty
• dizziness
• fast or irregular heartbeat
• fainting
• hives, itching, skin rash
• irritability
• lack of appetite
• loss of interest or pleasure
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• thoughts of killing oneself
• trouble breathing
• trouble concentrating
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache
• nausea
• trouble sleeping

Less common

• Anxiety
• body aches or pain
• burning, numbness, pain, or tingling in all fingers except smallest finger
• chills
• decreased appetite
• difficulty in moving
• dry mouth
• ear congestion
• fever
• headache
• loss of voice
• muscle or joint pain
• runny or stuffy nose
• seeing, hearing, or feeling things that are not there
• sneezing
• sore throat
• stomach pain or discomfort

Incidence not known

• Weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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