Cenobamate

What is Cenobamate?

Cenobamate (XCOPRI) is a prescription medicine used to treat partial-onset seizures in adults.

What are the uses of this medicine?

• This medicine is used for the treatment of partial-onset seizures in adult patients.

How does this medicine work?

• The precise mechanism by which cenobamate exerts its therapeutic effects in patients with partial-onset seizures is unknown.
• Cenobamate has been demonstrated 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to cenobamate, any of the other ingredients in XCOPRI. See the end of this Medication Guide for a complete list of ingredients in XCOPRI.
• have a genetic problem (called familial short QT syndrome) that affects the electrical system of the heart.

What drug interactions can this medicine cause?

Avoid coadministration of XCOPRI with:

• Phenytoin
• Phenobarbital and Clobazam
• Lamotrigine, Carbamazepine
• CYP2B6 and CYP3A Substrates
• CYP2C19 Substrates
• Oral Contraceptives

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage

• The recommended initial dosage of XCOPRI is 12.5 mg once daily, titrated to the recommended maintenance dosage of 200 mg once daily.
• The recommended titration schedule should not be exceeded. The maximum dosage is 400 mg once daily.

Dosage Modifications in Patients with Hepatic Impairment

• For patients with mild to moderate (5-9 points on Child-Pugh assessment) hepatic impairment, the maximum recommended dosage is 200 mg once daily.
• XCOPRI is not recommended for use in patients with severe hepatic impairment.

Administration

• 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.
• Do not stop taking XCOPRI without talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems, including seizures that will not stop (status epilepticus).
• Your healthcare provider may change your dose, if needed.
• Your healthcare provider will tell you how much XCOPRI to take.
• XCOPRI can be taken at any time of day, with or without food.
• Swallow tablets whole with liquid. Do not crush or chew.
• Talk with your healthcare provider about what you should do if you miss a dose.
• If you take too much XCOPRI, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.

This medicine is available in fallowing brand namesː

• XCOPRI

What side effects can this medication cause?

The most common side effects of this medicine include:

• feeling sleepy and tired
• dizziness
• double vision
• headache

XCOPRI may cause serious side effects, including:

• problems with the electrical system of the heart (QT shortening)

nervous system problems which may include:

• dizziness
• trouble walking or with coordination
• feeling sleepy and tired
• trouble concentrating, remembering, and thinking clearly
• vision problems

What special precautions should I follow?

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking XCOPRI. Discontinue if no alternate etiology.
• This mediicne may cause QT Shortening. Use caution when administering XCOPRI with other drugs that shorten the QT interval.
• Antiepileptic drugs (AEDs), including XCOPRI, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients for suicidal behavior and ideation.
• XCOPRI causes dose-dependent increases in somnolence and fatigue-related adverse reactions (somnolence, fatigue, asthenia, malaise, hypersomnia, sedation, and lethargy). Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on XCOPRI. Concomitant use with other CNS depressants or alcohol may have additive effects.
• XCOPRI should be gradually withdrawn to minimize the potential of increased seizure frequency.
• Do not drive, operate machinery, or do other dangerous activities until you know how XCOPRI affects you. XCOPRI may slow your thinking and motor skills and may affect your vision.
• 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.

What to do in case of emergency/overdose?

Management for overdosage:

• There is no specific antidote for overdose with XCOPRI.
• In the event of overdose, standard medical practice for the management of any overdose should be used.
• An adequate airway, oxygenation and ventilation should be ensured; monitoring of cardiac rate and rhythm and vital signs is recommended.
• A certified poison control center should be contacted for updated information on the management of overdose with XCOPRI.
• There are no data on the removal of XCOPRI using dialysis.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of XCOPRI in pregnant women.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as XCOPRI, during pregnancy. Encourage women who are taking XCOPRI during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334 .

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

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.

Who manufactures and distributes this medicine?

• Manufactured for SK Life Science, Inc., Paramus, NJ 07652
• © 2019 SK Life Science, Inc.

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Cenobamate
• FDA Cenobamate

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