Cenobamate

WHY is this medicine prescribed?

Cenobamate is used alone or with other medications to treat certain types of partial onset seizures (seizures that involve only one part of the brain) in adults. Cenobamate is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

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?

Cenobamate comes as a tablet to take by mouth. It is usually taken once daily with or without food. Take cenobamate at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cenobamate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are unable to swallow the tablet whole, you may crush the tablet and mix with water to take either by mouth or give through a nasogastric tube. Place the crushed tablet in 25 mL water in a cup and then swirl the cup to combine the mixture. Then either drink the suspension or pull the mixture up into a syringe and place in the nasogastric tube. If giving by mouth, add 25 mL more water to the cup used to create the mixture then swirl around and drink again to make sure all of the crushed tablet is given. If more tablet pieces are left, repeat the last step. If giving through the nasogastric tube, add 10 mL more water to the syringe used to place in the nasogastric tube and place in the nasogastric tube again. Once the crushed tablet is mixed with water, it should be administered right away. Do not store for later use.

Your doctor will probably start you on a low dose of cenobamate and gradually increase your dose, not more than once every 2 weeks.

Cenobamate may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Cenobamate may help control your condition, but it does not cure it. Do not stop taking cenobamate without talking to your doctor. If you suddenly stop taking cenobamate, your seizures may become worse. Your doctor will probably decrease your dose gradually.

What SPECIAL PRECAUTIONS should I follow?

Before taking cenobamate,

• tell your doctor and pharmacist if you are allergic to cenobamate, any other medications, or any of the ingredients in cenobamate tablets. Ask your pharmacist or check the Medication Guide 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 cenobamate. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• you should know that cenobamate may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, or implants). Talk to your doctor about methods of birth control that will work for you while taking cenobamate.

• tell your doctor if you have familial short QT syndrome (an inherited condition that causes irregular heartbeat, dizziness, fainting, or sudden death). Your doctor will probably tell you not to take cenobamate.

• tell your doctor if you have or have ever had liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking cenobamate, call your doctor.

• you should know that cenobamate may cause dizziness, drowsiness, and problems with coordination and balance. Do not drive a car, operate machinery, or participate in activities requiring alertness or coordination until you know how this medication affects you.

• ask your doctor about the safe use of alcoholic beverages while you are taking cenobamate. Alcohol can make the side effects from cenobamate worse.

• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking cenobamate. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants like cenobamate to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as 1 week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as cenobamate, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling asleep or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

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?

Take the missed dose as soon as you remember it. However, if it is almost time for the next 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?

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

• headache
• tiredness
• nausea
• constipation
• diarrhea
• vomiting
• dry mouth
• heartburn
• stomach pain
• loss of appetite
• weight loss
• back pain
• taste changes
• difficulty reading, writing, or speaking
• confusion
• hallucinations
• paranoia
• hostility
• aggression

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• double vision or blurred vision
• rash; hives; swelling of your face or legs; difficulty swallowing or breathing
• fever, sore throat, or swollen glands
• sores in mouth or around eyes
• unusual bruising or bleeding
• fatigue or weakness; muscle pain; yellowing of skin or eyes; or dark urine
• shortness of breath
• irregular heartbeat or fainting

Cenobamate 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.

Do not let anyone else take your medication. Cenobamate is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

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.