(pi tol' i sant)

Brand Name(s): Wakix^®

WHY is this medicine prescribed?

Pitolisant is used to treat excessive daytime sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness) and to treat cataplexy (episodes of muscle weakness that begin suddenly and last for a short time) in adults with narcolepsy. Pitolisant is in a class of medications called H₃ blockers. It works by changing the amounts of certain natural substances in the area of the brain that controls sleep and wakefulness.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Pitolisant comes as a tablet to take by mouth. It is usually taken once a day with or without food as soon as you wake up in the morning. Take pitolisant at the same time every day. Do not change the time of day that you take pitolisant without talking to your doctor. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pitolisant exactly as directed.

Your doctor will probably start you on a low dose of pitolisant and gradually increase your dose, not more than once every 7 days.

Pitolisant may decrease your sleepiness, but it will not cure your sleep disorder. It may take 8 weeks or longer before you feel the full benefit of pitolisant. Continue to take pitolisant even if you feel well-rested. Do not stop taking pitolisant without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking pitolisant,

• tell your doctor and pharmacist if you are allergic to pitolisant, any other medications, or any of the ingredients in pitolisant tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking pitolisant. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have liver disease. Your doctor may tell you not to take pitolisant.

• tell your doctor if you have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or a fast, slow, or irregular heartbeat; and if you have low levels of magnesium or potassium in your blood; and if you have kidney disease.

• you should know that pitolisant may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, injections, and intrauterine devices). Use another form of birth control while taking pitolisant and for 21 days after you stop taking it. Talk to your doctor about types of birth control that will work for you during and after your treatment with pitolisant.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pitolisant, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Pitolisant may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• difficulty falling asleep or staying asleep
• nausea
• stomach pain
• loss of appetite
• upper respiratory infection
• muscle or joint pain
• sleep talking, sleep terrors, or difficulty moving when sleeping or upon waking
• muscle weakness that begins suddenly and lasts for a short time
• rash
• dry mouth
• anxiety
• irritability

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• fast, pounding, or irregular heartbeat
• difficulty breathing or swallowing
• fainting
• hallucinating (seeing things or hearing voices that do not exist)

Pitolisant may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2023.