Xcopri: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is XCOPRI used for?

XCOPRI is used in adults with epilepsy to control partial-onset seizures. It is used in combination with other antiepileptic medicines.

How does XCOPRI work?

XCOPRI belongs to a group of medicines called antiepileptic agents. It is thought to work by keeping the brain’s “overexcitable” nerve cells under control. This helps reduce the number of seizures you may have.

What are the ingredients in XCOPRI?

Medicinal ingredient: cenobamate

Non-medicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, purified water, and sodium starch glycolate

In addition, the tablets also contain:

• 25 mg and 100 mg tablets: FD&C blue indigo carmine aluminum lake, iron oxide red, iron oxide yellow, macrogol/PEG, polyvinyl alcohol-part. hydrolyzed, talc, and titanium dioxide
• 50 mg tablets: iron oxide yellow, macrogol/ PEG, polyvinyl alcohol-part. hydrolyzed, talc, and titanium dioxide
• 150 mg and 200 mg tablets: iron oxide red, iron oxide yellow, macrogol/ PEG, polyvinyl alcohol-part. hydrolyzed, talc, and titanium dioxide

XCOPRI comes in the following dosage forms:

Tablets: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg

Do not use XCOPRI if:

• you are allergic to cenobamate or any of the other ingredients in XCOPRI.
• you have or have a family history of a genetic condition called Familial Short QT Syndrome that affects the electrical system of the heart.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take XCOPRI. Talk about any health conditions or problems you may have, including if you:

• have ever shown any unusual sensitivity (rash or other signs of allergy) to other medicines.
• are taking medicines that are known to shorten a part of the heartbeat called the “QT interval” such as some other antiepileptic medicines and some medicines used to treat heart problems.
• have heart problems.
• have liver problems.
• have kidney problems.
• have or have had depression, mood problems or suicidal thoughts or behaviours.
• have a history of alcohol or drug abuse.
• use hormonal birth control (such as “the pill”).
• are pregnant, think you might be pregnant or planning to become pregnant.
• are breastfeeding or plan to breastfeed.

Other warnings you should know about:

Stopping your treatment: Do NOT suddenly stop taking XCOPRI without first talking to your healthcare professional. If you do this, it may increase the number of seizures you have and their severity. Stopping your treatment must be a gradual process that you discuss with your healthcare professional.

Dependence: Even when XCOPRI has been taken as directed, there have been some cases of physical and psychological dependence, and withdrawal symptoms (e.g., trouble sleeping, low appetite, depressed mood, shaking and memory loss). Your healthcare professional should monitor you while you are taking XCOPRI for signs of misuse or abuse. If you find you are craving more XCOPRI than you are supposed to take, tell your healthcare professional right away.

Changes in behaviour: You should pay attention to any mental changes while taking XCOPRI, especially sudden changes in your mood, behaviours, thoughts, or feelings. Tell your healthcare professional anytime you notice any changes in behaviour that are new, worse, or worry you. These changes may include:

• feeling depressed, nervous, or anxious
• feeling irritable, angry, agitated or hostile
• psychotic symptoms such as hallucinations (seeing or hearing things that are not really there), delusions (false or strange thoughts or beliefs), paranoia (intense feeling of distrust, fear of persecution) and unusual behaviour

There have been reports that antiepileptic medications like XCOPRI may cause you to have thoughts of harming or killing yourself. If you have these thoughts at any time, contact a healthcare professional or go to a hospital right away. Do not stop taking XCOPRI on your own.

Nervous system problems: XCOPRI may cause problems that affect your nervous system, especially at high doses. Some of them can increase your risk of injury or falls. Tell your healthcare professional if you experience:

• dizziness
• trouble walking or with coordination

• feeling sleepy and tired

  • trouble concentrating, remembering, and thinking clearly
  • vision problems

Driving and using machines: XCOPRI may cause drowsiness, fatigue or sleepiness. Do not drive, use machinery, or do activities that require you to be alert until you know how XCOPRI affects you. Drinking alcohol or taking medicines that cause sleepiness while taking XCOPRI may further increase your risk of experiencing these side effects.

Pregnancy:

• It is not known if XCOPRI can harm your unborn baby. Only take XCOPRI during pregnancy if you and your healthcare professional have discussed the risks and have decided that you should.
• If you become pregnant while taking XCOPRI, talk to your healthcare professional about registering with the North American Antiepileptic Drug Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy. You can enroll in this registry by calling 1-888-233-2334. Information on the registry can also be found at the following website: http://www.aedpregnancyregistry.org/.

Birth control: XCOPRI may cause your hormonal birth control, such as “the pill”, to be less effective. You must use an additional non-hormonal birth control method while you are taking XCOPRI and for at least 21 days after stopping your treatment. Talk to your healthcare professional about the best birth control for you.

Breastfeeding: It is not known if XCOPRI passes into breast milk and if it can harm your baby. You and your healthcare professional should decide whether you should take XCOPRI or breastfeed, but you should not do both.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with XCOPRI:

• other medicines used to control epilepsy such as carbamazepine, phenytoin, phenobarbital, rufinamide, and clobazam
• digoxin (used to treat various heart conditions)
• mexiletine (used to treat an abnormal heart rhythm)
• bupropion (used to treat depression or help quit smoking)
• omeprazole (used to prevent and treat excess stomach acid)
• isavuconazole (used to treat fungal infections)
• magnesium sulfate and primidone (used to control convulsions)
• birth control pills or other hormonal contraceptives

• central nervous system (CNS) depressants used to slow down the nervous system. They include:

  • medicines used to treat anxiety, seizures and/or insomnia such as benzodiazepines (e.g., midazolam), hypnotics (e.g., sleeping pills), and barbiturates (e.g., pentobarbital)
  • opioid medicines (used to relieve pain)
  • alcohol

Do not drink alcohol or take other CNS depressants during your treatment with XCOPRI without first talking to your healthcare professional.

How to take XCOPRI:

• Always take XCOPRI exactly as your healthcare professional tells you to. Check with them if you are not sure.
• It is important that you take your dose every day.
• Swallow the tablets whole with liquid. Do not split, crush or chew the tablets.

• XCOPRI tablets can be taken with or without food.

• Continue taking XCOPRI every day for as long as your healthcare professional tells you to. Do not change your dose without talking to your healthcare professional first.

Usual dose:

• When you start treatment with XCOPRI, your healthcare professional will slowly increase your dose every 2 weeks, usually over a period of 12 weeks (see table below). The starting dose is 12.5 mg.

Usual dosing schedule:

• The usual maintenance dose is 200 mg once a day. Your healthcare professional may prescribe you a higher maintenance dose depending on how you respond to XCOPRI. They may instruct you to take tablets from different strengths to make up your daily dose. Carefully follow your healthcare professional’s instructions.
• The maximum daily dose is 400 mg.

Overdose:

Missed Dose:

If you missed a dose, take it as soon as you remember. However, if your next dose is due in the next 12 hours, skip the missed dose and take the next dose at your regular time.

What are possible side effects from using XCOPRI?

These are not all the possible side effects you may have when taking XCOPRI. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with XCOPRI may include:

• feeling sleepy or weak, trouble falling or staying asleep
• dizziness, feeling like you or the room is spinning (vertigo), trouble with walking or coordination
• headache, trouble concentrating, remembering or thinking clearly, difficulty speaking or slurred speech, tremors (shaking)
• blurred or double vision, involuntary, rapid and repetitive movement of the eyes (nystagmus)
• abdominal pain, constipation, diarrhea, low appetite • dry mouth, toothache
• sore throat, runny or stuffy nose, sinus problems
• feeling nauseous or vomiting
• back pain
• shortness of breath

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store XCOPRI tablets between 15°C to 30°C.
• Keep out of reach and sight of children.

If you want more information about XCOPRI:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://knighttx.com), by emailing medinfo@knighttx.com, or by calling 1-844-483-5636.