Pitolisant

Pitolisant is used to treat excessive daytime sleepiness or cataplexy (sudden loss of muscle strength) in adults with narcolepsy.

Pitolisant is also used to treat excessive daytime sleepiness caused by narcolepsy in children who are at least 6 years old.

Pitolisant may also be used for other purposes not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

Pitolisant is typically taken once daily when you wake up.

Doses for children and teenagers are based on weight. Your child's dose may change if they gain or lose weight.

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

Store at room temperature, away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use pitolisant if you are allergic to it, or if you have:

• severe liver disease.

Tell your doctor if you have or have ever had:

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

It is not known if pitolisant will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

Pitolisant can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 21 days after your last dose. Tell your doctor right away if a pregnancy occurs.

Ask a doctor if it is safe to breastfeed while using pitolisant.

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

Pitolisant may cause serious side effects. Call your doctor right away if you experience:

• pounding heartbeats or fluttering in your chest;
• dizziness, fainting;
• loss of consciousness; or
• hallucinations.

Common side effects of pitolisant may include:

• headache;
• nausea;
• anxiety; or
• sleep problems (insomnia).

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

Usual Adult Dose for Narcolepsy:

Initial Up Titration: 8.9 mg orally once a day for 1 week, then 17.8 mg orally once a day for 1 week, then may increase to 36 mg orally once a day-Adjust dose based on patient response and tolerabilityMaintenance dose: 17.8 to 35.6 mg/day Maximum dose: 35.6 mg/day Comments: -Total dose should be administered as a single dose in the morning during breakfast. -It may take up to 8 weeks for some patients to achieve a clinical response. Use: For the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients with narcolepsy.

Usual Pediatric Dose for Narcolepsy:

Initial Up Titration:-Week 1: 4.45 mg orally once a day for 1 week-Week 2: 8.9 mg orally once a day for 1 week-Week 3: 17.8 mg orally once a day; may continue to titrate after 1 week in patients 40 kg and over.-Week 4 (patients 40 kg and over): 35.6 mg orally once a day---Adjust dose based on patient response and tolerabilityMaintenance dose: 17.8 to 35.6 mg/dayMaximum dose: 17.8 mg (less than 40 kg); 35.6 mg/day (40 kg and over) Comments:-Total dose should be administered as a single dose in the morning during breakfast.-It may take up to 8 weeks for some patients to achieve a clinical response.Use: For the treatment of EDS or cataplexy in patients with narcolepsy.

Skip the missed dose and take your next dose the following morning at the usual time. Do not take two doses at once.

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.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Pitolisant 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.

Tell your doctor about all your other medicines, especially:

• medication used to treat or prevent allergies.

This list is not complete, and many other drugs may affect pitolisant. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.