The U.S. Food and Drug Administration approved XCOPRI (cenobamate tablets) to treat partial-onset seizures in adults. A seizure is a usually short episode of abnormal electrical activity in the brain. Seizures can cause uncontrolled movements, abnormal thinking or behavior, and abnormal sensations. Movements can be violent, and changes in consciousness can occur. Seizures occur when clusters of nerve cells (neurons) in the brain undergo uncontrolled activation. A partial-onset seizure begins in a limited area of the brain.
hile the precise mechanism by which XCOPRI exerts its therapeutic effect is unknown, XCOPRI is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ‑aminobutyric acid (GABAA) ion channel.
XCOPRI should be initiated at 12.5 mg once-daily and titrated every two weeks; it will be available in six tablet strengths for once-daily dosing: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. XCOPRI can be combined with other AEDs or used alone.
Long-term safety of XCOPRI has been evaluated in the ongoing open-label extensions of the randomized studies and the open-label safety study. Additional clinical trials are investigating XCOPRI in other seizure types.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI®(cenobamate tablets) CX
XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older.
It is not known if XCOPRI is safe and effective in children under 18 years of age.
DO NOT TAKE XCOPRI IF YOU:
Are allergic to cenobamate or any of the other ingredients in XCOPRI.
Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart.
XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells.You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away.Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider.
QT shortening: XCOPRImay causeproblems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting.
Suicidal behavior and ideation:Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.
Nervous system problems:XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems.Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you.
Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider.
DISCONTINUATION: Do not stop taking XCOPRI without first talking to your healthcare provider.Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works.Do not start or stop other medicines without talking to your healthcare provider.Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
PREGNANCY AND LACTATION:
XCOPRI may cause your birth control medicine to be less effective.Talk to your healthcare provider about the best birth control method to use.
Talk to your healthcare provider if you are pregnant or plan to become pregnant.It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.
Talk to your healthcare provider if you are breastfeeding or plan to breastfeed.It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI.
COMMON SIDE EFFECTS:
The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired.
These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects.
Scheduling of XCOPRI is pending review by the U.S. Drug Enforcement Administration (DEA).