Xcopri

Xcopri (cenobamate) is an oral, once-daily, tablet that may be used to treat partial-onset seizures in adults. The tablets can be swallowed or crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube.

Xcopri works as an anticonvulsant and can be used on its own to treat partial-onset seizures or can be used with other anti-seizure medications. Exactly how Xcopri works to reduce the frequency of partial-onset seizures is unknown but may be because it inhibits voltage-gated sodium channels and positively affects the γ-aminobutyric acid (GABAA) ion channel. Some people may have their seizures reduced to zero.

Xcopri was FDA-approved on 21 November 2019.

Partial-onset seizures (sometimes called focal onset seizures) are caused by irregular electrical signals that start in one area of the brain and stay in that one area. The way that Xcopri works to reduce partial-onset seizures is not fully understood, but thought to be related to regulating the irregular electrical brain signals.

Yes, Xcopri contains the active ingredient cenobamate which is a Schedule V controlled substance. This means it does have some potential for abuse and if abused may cause limited physical dependence or psychological dependence.

Take Xcopri exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Xcopri tablets can be swallowed whole or crushed.

• If you crush the tablet, it can be mixed with water and taken by mouth as an oral suspension or given via a nasogastric (NG) feeding tube. Talk with your healthcare provider about how to take crushed tablets.

Xcopri may be taken with or without food, at any time of the day.

Do not stop using Xcopri suddenly, even if you feel fine. Stopping this medicine suddenly may cause increased seizures or unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Xcopri can cause serious or life-threatening allergic reactions that can affect your liver, blood cells, or other parts of the body. Call your doctor or get emergency medical help if you have symptoms such as: severe weakness or muscle pain, a fever, swollen glands, unusual bruising or bleeding, swelling in your face or throat, trouble breathing, hives or a rash, yellowing of your skin or eyes, or any illness that does not get better.

Some people have thoughts about suicide while taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Xcopri can cause problems 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.

Clinically significant liver injury has occurred with this medicine. Before you start this Xcopri you should have blood tests to measure ALT, AST and total bilirubin to establish baseline liver function, if you have not had these tests done in the last 3 months. For patients with baseline hepatic impairment, dosage modifications are recommended.

Do not stop using Xcopri suddenly. Follow your doctor's instructions about tapering your dose.

You should not use Xcopri if you are allergic to the active ingredient cenobamate or any of the inactive ingredients, or if you have:

• a genetic heart rhythm disorder called short QT syndrome.

Tell your doctor if you have ever had:

• depression, or a mood disorder;
• suicidal thoughts or actions;
• liver or kidney disease;
• a blood cell disorder; or
• an allergic reaction to a medicine that caused a rash or affected your internal organs or blood cells.

Some people have thoughts about suicide while taking Xcopri. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

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. Tell your doctor right away if you become pregnant.

Xcopri can make birth control pills less effective. Ask your doctor about using a non-oral birth control to prevent pregnancy. This includes injections, implants, skin patches, vaginal rings, 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 Xcopri on the baby.

It may not be safe to breastfeed while using Xcopri. Ask your doctor about any risk.

Cenobamate is not approved for use by anyone younger than 18 years old.

Common Xcopri side effects may include:

• feeling tired;
• dizziness, drowsiness;
• double vision; or
• headache.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction to Xcopri: hives; difficulty 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, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Xcopri can cause serious or life-threatening allergic reactions that can affect your liver, blood cells, or other parts of the body. Call your doctor or get emergency medical help if you have symptoms such as:

• problems with the electrical system of the heart - fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out);
• feeling very weak or tired;
• severe muscle pain;
• fever, swollen glands, sore throat; unusual bruising or bleeding;
• painful sores in your mouth or around your eyes;
• swelling in your face, mouth, or throat;
• trouble breathing or swallowing;
• hives or a rash;
• yellowing of your skin or eyes;
• any infection or illness that does not get better; or
• nervous system problems-dizziness, trouble walking, loss of coordination, vision problems, drowsiness, tiredness, problems with thinking or memory.

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.

Usual Adult Dose for Partial-onset Seizures:

Initial dose:

Weeks 1 and 2: Take 12.5 mg orally once a day.

Titration:

Weeks 3 and 4: Take 25 mg orally once a day.

Weeks 5 and 6: Take 50 mg orally once a day.

Weeks 7 and 8: Take 100 mg orally once a day.

Weeks 9 and 10: Take 150 mg orally once a day.

Maintenance Dose (starting at week 11):

Week 11 onwards. Take 200 mg orally once a day

Maximum Dose: 400 mg orally once a day

Dose Modification for hepatic (liver) impairment:

Use with caution in mild to moderate (Child-Pugh Class A to B) hepatic impairment: maximum recommended dosage is 200 mg once daily, and additional dosage reduction may be considered.

Xcopri is not recommended for use in patients with severe (Child-Pugh Class C) hepatic impairment.

Dose Modification for renal (kidney) impairment:

Xcopri should be used with caution, and dosage reduction may be considered in patients with mild to moderate (CLcr 30 to less than 90 mL/min) and severe (CLcr less than 30 mL/min) renal impairment. Use in patients with end-stage renal disease undergoing dialysis is not recommended

Comments:

Xcopri may be used on its own (monotherapy) to treat seizures or taken with another anti-seizure medication (adjunctive therapy).

Dosage and titration should not be exceeded because of the potential for serious adverse reactions.

Titration to the maximum dose should be accomplished in increments of 50 mg/day every 2 weeks; the decision to increase the dose above the maintenance dose should be based on clinical response and tolerability.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Xcopri may cause blurred vision and may impair your reactions. You should avoid driving or participating in hazardous activities until you know how this medicine will affect 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.

Other drugs may affect Xcopri, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor, pharmacist or other healthcare professionals about all your current medicines and any medicine you start or stop using.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Using Xcopri with other drugs that make you dizzy or drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety.

Xcopri may cause your birth control medicine to be less effective. Women should use additional or alternative non-hormonal birth control

Examples of medications that have important drug interactions with Xcopri include phenytoin, phenobarbital, clobazam, lamotrigine, carbamazepine, CYP2B6 Substrates, CYP3A Substrates, CYP2C19 Substrates.

Not all possible interactions are listed here, use the link below to check for other Xcopri drug interactions.

• Store Xcopri at room temperature between 68°F to 77°F (20°C to 25°C).
• Safely throw away medicine that is out of date or no longer needed.
• Keep all medicines out of the reach of children and pets.

Active ingredient: cenobamate

Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

25 mg and 100 mg tablets: FD&C Blue #2/indigo carmine aluminum lake, iron oxide red, iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

50 mg tablets: iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

150 mg and 200 mg tablets: iron oxide red, iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

SK Life Science, Inc.