Xcopri (Cenobamate)
Cenobamate is used to treat partial-onset seizures in adults.
Cenobamate may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Xcopri (Cenobamate)?
You should not use cenobamate if you are allergic to it or any of its ingredients, or if you have:
- a genetic heart rhythm disorder called short QT syndrome (in you or a family member).
Tell your doctor if you have or have ever had:
- depression, or a mood disorder;
- suicidal thoughts or actions;
- trouble swallowing;
- an allergic reaction to a medicine that caused a rash, affected your internal organs or blood cells;
- blood problems; or
- liver or kidney disease.
Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.
It is not known if cenobamate will harm an unborn baby. Tell your doctor right away if you are pregnant or plan to become pregnant. Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby.
Cenobamate can make hormonal birth control less effective. Ask your doctor about using non-hormonal (barrier) birth control to prevent pregnancy such as condom, diaphragm, cervical cap, or contraceptive sponge.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cenobamate on the baby.
Ask a doctor if it is safe to breastfeed while using this medicine.
Cenobamate is not approved for use by anyone younger than 18 years old.
Side Effects
What are the side effects of Xcopri (Cenobamate)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, painful sores in your mouth or around your eyes, unusual bruising, infection or illness that does not get better, or yellowing of your skin or eyes.
Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.
Call your doctor right away if you have:
- nervous system problems--dizziness, trouble walking, loss of coordination, feeling weak or tired, drowsiness, problems with thinking or memory, trouble concentrating, vision problems; or
- heart problems--fainting, feeling like you may pass out, fast or uneven heart rate that lasts a long time.
Common side effects may include:
- feeling tired;
- dizziness, drowsiness;
- double vision; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Xcopri (Cenobamate) if I’m pregnant or breastfeeding?
It is not known if cenobamate will harm an unborn baby. Tell your doctor right away if you are pregnant or plan to become pregnant. Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby.
Cenobamate can make hormonal birth control less effective. Ask your doctor about using non-hormonal (barrier) birth control to prevent pregnancy such as condom, diaphragm, cervical cap, or contraceptive sponge.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cenobamate on the baby.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Xcopri (Cenobamate)?
Avoid driving or hazardous activity until you know how this medicine will affect you. This medicine may cause dizziness, blurred vision, balance or memory problems and this may impair your reactions, cause falls, accidents, or severe injuries.
Do not drink alcohol. Dangerous side effects could occur.
Dosage Guidelines & Tips
How to take Xcopri (Cenobamate)?
Use Xcopri (Cenobamate) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Cenobamate is usually taken once per day. You may take it with or without food.
Your doctor will determine how much cenobamate you should take. You may need to take more than one tablet to receive your full dose.
Read and carefully follow any instructions provided with this medicine on how to prepare a mixture with water if you cannot swallow tablets whole. Cenobamate can also be given through a feeding tube. Do not store the mixture for later use. Ask your doctor or pharmacist if you don't understand these instructions.
Your doctor will need to check your progress on a regular basis.
Do not stop using cenobamate suddenly, you could have withdrawal symptoms or seizures may increase. Follow your doctor's instructions about tapering your dose.
Cenobamate may be habit-forming. Misuse can cause addiction. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.
Store at room temperature away from moisture and heat.
Call your doctor for instructions if you miss a dose.
Overdose Signs
What happens if I overdose on Xcopri (Cenobamate)?
Images
SK, 25
Color: brown
Shape: round
Form: film coated
Imprint: SK, 25
SK, 50
Color: yellow
Shape: round
Form: film coated
Imprint: SK, 50
SK, 100
Color: brown
Shape: round
Imprint: SK, 100