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Xcopri

Last reviewed on RxList: 9/16/2020
Xcopri Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Xcopri?

Xcopri (cenobamate tablets) is an antiepileptic drug (AED) used to treat partial-onset seizures in adult patients.

What Are Side Effects of Xcopri?

Common side effects of Xcopri include:

Dosage for Xcopri

The recommended initial dosage of Xcopri is 12.5 mg once daily, adjusted to the recommended maintenance dosage of 200 mg once daily.

Xcopri In Children

Safety and effectiveness of Xcopri in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Xcopri?

Xcopri may interact with other medicines such as:

  • antiepileptic drugs (AEDs),
  • CYP2B6 and CYP3A substrates,
  • CYP2C19 substrates,
  • oral contraceptives,
  • other drugs that shorten the QT interval,
  • alcohol, and
  • other CNS depressants

Tell your doctor all medications and supplements you use and all vaccines you recently received.

Xcopri During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Xcopri; it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Xcopri, during pregnancy. Women of reproductive potential concomitantly using oral contraceptives should use additional or alternative non-hormonal birth control. It is unknown if Xcopri passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Xcopri (cenobamate tablets), for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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.

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Xcopri Consumer Information

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, 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.

Cenobamate 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:

  • 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.

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.

Read the entire detailed patient monograph for Xcopri (Cenobamate Tablets)

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Xcopri Professional Information

SIDE EFFECTS

The following serious adverse reactions are described in more detail in the Warnings and Precautions section of the labeling:

  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • QT Shortening [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Neurological Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Withdrawal of Antiepileptic Drugs [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions and for varying durations, adverse reaction frequencies observed in the clinical trials of a drug cannot be directly compared with frequencies in the clinical trials of another drug and may not reflect the frequencies observed in practice.

In all controlled and uncontrolled trials performed in adult partial-onset seizure patients, XCOPRI was administered as adjunctive therapy to 1944 patients. Of these patients, 1575 were treated for at least 6 months, 710 for at least 12 months, 349 for at least 24 months, and 320 for at least 36 months. A total of 658 patients (442 patients treated with XCOPRI and 216 patients treated with placebo) constituted the safety population in the pooled analysis of placebo-controlled studies in patients with partial-onset seizures (Studies 1 and 2) [see Clinical Studies]. The adverse reactions presented in Table 4 are based on this safety population; the median length of treatment in these studies was 18 weeks. Of the patients in those studies, approximately 49% were male, 76% were Caucasian, and the mean age was 39 years.

In Study 1 and Study 2, adverse events occurred in 77% of patients treated with XCOPRI and 68% treated with placebo. Table 4 gives the incidence of adverse reactions that occurred in subjects with partial-onset seizures in any XCOPRI treatment group and for which the incidence was greater than placebo during the controlled clinical trials. The most common adverse reactions that occurred in XCOPRI-treated patients (incidence at least 10% and greater than placebo) were somnolence, dizziness, fatigue, diplopia, and headache.

The discontinuation rates because of adverse events were 11%, 9%, and 21% for patients randomized to receive XCOPRI at doses of 100 mg/day, 200 mg/day, and 400 mg/day, respectively, compared to 4% in patients randomized to receive placebo. The adverse reactions most commonly (1% or greater in any XCOPRI treatment group, and greater than placebo) leading to discontinuation, in descending order of frequency, were ataxia, dizziness, somnolence, diplopia, nystagmus, and vertigo.

Table 4: Adverse Reactions in Pooled Placebo-Controlled Adjunctive Therapy Studies in Patients with Partial-Onset Seizures with XCOPRI Frequency in Any Treatment Arm Greater Than 1% Over Placebo

Adverse ReactionXCOPRIPlacebo
100mg200mg400mg
n = 108
%
n= 223
%
n=111
%
n=216
%
Cardiac Disorders
Palpitations0020
Ear and Labyrinth Disorders
Vertigo1161
Eye Disorders
Diplopia67152
Vision Blurred2240
Gastrointestinal Disorders
Nausea6693
Constipation2480
Diarrhea1350
Vomiting2450
Dry Mouth1130
Abdominal Pain2210
Dyspepsia2200
Infections and Infestations
Nasopharyngitis2453
Pharyngitis1200
Urinary Tract Infection2502
Injury, Poisoning and Procedural Complications
Head Injury1020
Investigations
Alanine Aminotransferase Increased*1140
Aspartate Aminotransferase Increased1130
Weight Decreased2010
Metabolism and Nutrition Disorders
Decreased Appetite3151
Musculoskeletal and Connective Tissue Disorders
Back Pain4253
Musculoskeletal Chest Pain2100
Nervous System Disorders
Somnolence19223711
Dizziness18223315
Fatigue1214247
Headache1012109
Balance Disorder3591
Gait Disturbance1381
Dysarthria2170
Nystagmus3760
Ataxia2362
Aphasia2140
Asthenia0131
Dysgeusia2020
Memory Impairment2120
Migraine0020
Sedation1120
Tremor0311
Psychiatric Disorders
Confusional State2230
Euphoric Mood0020
Irritability1020
Suicidal Ideation2100
Renal and Urinary Disorders
Pollakiuria0100
Reproductive System and Breast Disorders
Dysmenorrhea1210
Respiratory, Thoracic and Mediastinal Disorders
Hiccups0110
Dyspnea0300
Skin and Subcutaneous Tissue Disorders
Pruritus2100
Rash Papular2000
* Reported as an adverse reaction; see Laboratory Abnormalities for ALT changes from collected laboratory Values

Laboratory Abnormalities

Hepatic Transaminases

In Study 2, there was a post-baseline elevation of alanine aminotransferase (ALT) to greater than 3 times the upper limit of normal (ULN) in 1 (0.9%) patient treated with 100 mg XCOPRI, 2 (1.8%) patients treated with 200 mg, and 3 (2.7%) patients treated with 400 mg, compared to no patients who took placebo. The maximum ALT elevation was 7.6 times ULN in patients treated with 400 mg XCOPRI.

Potassium

In clinical studies, there was a post-baseline elevation of potassium values greater than 5 meq/L (upper reference range) in patients treated with XCOPRI. In Study 1, there were 17 (17%) patients treated with XCOPRI 200 mg compared to 8 (7%) patients who took placebo with normal baseline potassium values who had at least one post-baseline maximum value greater than 5 meq/L. In Study 2, there was a dose-related distribution where at least one post-baseline potassium value was greater than 5 meq/L, occurring in 8.3%, 9.1%, and 10.8% of the patients treated with XCOPRI 100 mg, 200 mg, and 400 mg, respectively, compared to 5.6% of patients who took placebo. Two patients had a maximum potassium value of 5.9 meq/L.

Other Adverse Reactions

Gastrointestinal disorders: There was an incidence of appendicitis in the overall clinical trial safety population of 2.9 cases of appendicitis/1000 patient-years of exposure that is in excess of the expected background rate in the general population.

Adverse Reactions Based On Gender

No significant gender differences were noted in the incidence of adverse reactions.

Read the entire FDA prescribing information for Xcopri (Cenobamate Tablets)

SLIDESHOW

Epilepsy: Symptoms, Causes and Treatment See Slideshow
Related Resources for Xcopri

© Xcopri Patient Information is supplied by Cerner Multum, Inc. and Xcopri Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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