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Brand Name :
Xcopri
Synonyms :
cenobamate
Class :
Anticonvulsants
Brand Name :
Xcopri
Synonyms :
cenobamate
Class :
Anticonvulsants
Dosage Forms & StrengthsÂ
Tablet Â
12.5mgÂ
25mgÂ
50mgÂ
100mgÂ
150mgÂ
200mgÂ
Dose and titration schedule
1, 2 Weeks:
12.5
mg
Orally 
every day
Titration dose
3, 4 Weeks: 25 mg orally daily
5, 6 Weeks: 50 mg orally daily
7, 8 Weeks: 100 mg orally daily
9, 10 Weeks: 150 mg orally daily
Maintenance dose:
11 Week and following: 200 mg orally daily
Maximum dose:
The dose may be raised above 200 mg by additions of 50 mg/day every two weeks, up to 400 mg PO every day, as needed, depending on the clinical response and tolerability
Note:
Used either alone or in conjunction with other therapies to treat partial-onset seizures
Safety and efficacy not establishedÂ
Refer adult dosingÂ
It may diminish the effect when combined with lumateperone by affecting CYP3A4 metabolism
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may increase the risk of adverse effects of antipsychotic agents
may increase the risk of adverse effects of antipsychotic agents
may increase the risk of adverse effects of antipsychotic agents
may increase the risk of adverse effects of antipsychotic agents
may increase the risk of adverse effects of antipsychotic agents
may enhance the risk of adverse/toxic effect of antipsychotic agents
may enhance the risk of adverse/toxic effect of antipsychotic agents
may enhance the adverse effect of antipsychotic agents
may enhance the adverse effect of antipsychotic agents
may enhance the adverse effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may increase the risk of adverse effect
may increase the risk of adverse effect
may increase the risk of adverse effect
may increase the risk of adverse effect
may increase the risk of adverse effect
may increase the risk of adverse effect
may increase the risk of adverse effect
may increase the risk of adverse effect
may increase the risk of adverse effect
may increase the risk of adverse effect
It may diminish the levels when combined with tamsulosin by affecting CYP3A4 metabolism
When alprazolam and cenobamate is used together, this leads to reduction in the alprazolam’s metabolism
When indisulam is used together with cenobamate, this leads to a reduction in cenobamate metabolism
Cenobamate: it may increase the excretion rate of oxtriphylline
cenobamate: it may increase the metabolism of CNS depressants
cenobamate: it may increase the metabolism of CNS depressants
cenobamate: it may increase the metabolism of CNS depressants
cenobamate: it may increase the metabolism of CNS depressants
cenobamate: it may increase the metabolism of CNS depressants
Decreased therapeutic efficacy of cenobamate.
cyclophosphamide effect of action decreased by affecting enzyme CYP3A4 metabolism
when both drugs are combined, there may be a decreased level of serum concentration of etoposide   
when both drugs are combined, there may be a decreased level of serum concentration of paclitaxel  
cenobamate on interacting with brentuximab has its effect decreased by changing the intestinal or hepatic CYP3A4 enzyme metabolism.
when both drugs are combined, there may be an increased effect of abemaciclib by affecting hepatic or intestinal enzyme CYP3A4 metabolism  
when both drugs are combined, there may be a decreased level of serum concentration of erlotinib  
the effect of cenobamate is decreased by lorlatinib, by altering intestinal or hepatic CYP3A4 enzyme metabolism
cenobamate decreases the effect of ixazomib by altering intestinal/hepatic CYP3A4 enzyme metabolism
May decrease the serum level of docetaxel by affecting the enzyme CYP3A4
when both drugs are combined, there may be a decreased effect of ivosidenib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
cenobamate decreases the effect of lapatinib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
May decrease the serum level of erdafitinib by affecting the enzyme CYP3A4
cenobamate decreases the effect or level of pexidartinib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
it decreases the concentration of antiseizure agents in the serum
may decrease the level by affecting hepatic enzyme CYP3A4 metabolism
they increase the toxicity of iobitridol
seizure lowering agents increase the toxic or adverse effects of iohexol
Actions and Spectrum:Â
Action: cenobamate is a selective, high-affinity antagonist of the α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor, which is involved in the transmission of excitatory signals in the brain. By blocking the AMPA receptor, cenobamate reduces the hyperactivity of neurons in the brain that contribute to seizures.Â
Efficacy: cenobamate has been shown to be effective in reducing the frequency of seizures in clinical trials. In a randomized, double-blind, placebo-controlled trial, cenobamate reduced the median seizure frequency by 55.6% compared to 21.3% in the placebo group.Â
Spectrum: cenobamate is effective against partial-onset seizures, which are seizures that originate from a specific area of the brain. It is also effective against secondary generalized tonic-clonic seizures, which occur when a seizure that starts in one part of the brain spreads to involve the entire brain.Â
Â
Frequency defined Â
>10%Â
Dizziness (18-33%)Â
Somnolence (19-37%)Â
Fatigue (12-24%)Â
Headache (10-12%)Â
Diplopia (6-15%)Â
1-10%Â
Constipation (2-8%)Â
Balance disorder (3-9%)Â
Gait disturbance (1-8%)Â
Dysarthria (1-7%)Â
Nausea (6-9%)Â
Nystagmus (3-7%)Â
Black Box Warning:Â
The black box warning for cenobamate is related to the risk of serious allergic reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multi-organ Hypersensitivity, which can be life-threatening or fatal.Â
Contraindication/Caution:Â
Contraindications:Â
Precautions:Â
Pregnancy warnings:    Â
Pregnancy category: N/AÂ
Lactation: Excreted into human milk is unknownÂ
Pregnancy Categories:        Â
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.Â
Category B: There were lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.  Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   Â
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.  Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.   Â
Category N: There is no data available for the drug under this category
Pharmacology: Â
cenobamate is a medication used for the treatment of partial-onset seizures in adults. It was approved by the US Food and Drug Administration (FDA) in 2019.Â
Pharmacodynamics:Â
The exact mechanism of action of cenobamate is not fully understood, but it is believed to work by enhancing the activity of inhibitory neurotransmitters such as gamma-aminobutyric acid (GABA) and reducing the activity of excitatory neurotransmitters such as glutamate.Â
Pharmacokinetics:Â
Absorption
cenobamate is rapidly absorbed after oral administration, with peak plasma concentrations achieved within 3 to 4 hours. Food can delay the time to reach peak concentration by about 2 hours, but it does not affect the extent of absorption. The bio-availability of cenobamate is approximately 100%.Â
Distribution
cenobamate is highly protein-bound (>95%), primarily to albumin, and has a volume of distribution of about 0.6 L/kg. It crosses the blood-brain barrier and is distributed throughout the central nervous system.Â
Metabolism
cenobamate is primarily metabolized in the liver by CYP3A4 and to a lesser extent by CYP2C19. The main metabolite is N-desmethylcenobamate, which is pharmacologically active and has similar potency to cenobamate. Other minor metabolites include hydroxycenobamate and glucuronide conjugates.Â
Elimination and excretion
cenobamate and its metabolites are eliminated primarily by renal excretion, with approximately 70% of the dose excreted unchanged in the urine and the remaining 30% eliminated as metabolites. The elimination half-life of cenobamate is about 55 hours, and it takes about 10 days to reach steady-state concentrations.Â
Administration:
It is usually administered orally, and the dose can vary depending on the patient’s age, weight, and medical history.
The recommended starting dose of cenobamate is 12.5 mg orally once daily at bedtime, which is gradually increased over several weeks to the target maintenance dose of 200 mg orally once daily at bedtime. However, your healthcare provider may adjust your dose depending on your response to treatment.
Patient information leafletÂ
Generic Name: cenobamateÂ
Why do we use cenobamate?Â
cenobamate is an antiepileptic drug used to treat partial-onset seizures in adults. It works by enhancing the activity of the neurotransmitter gamma-aminobutyric acid (GABA) in the brain, which helps to reduce the abnormal electrical activity that can lead to seizures.Â
Partial-onset seizures are a type of epilepsy in which the seizure activity is localized to one area of the brain. These seizures can be simple partial seizures, which affect only one part of the body or complex partial seizures, which affect consciousness and can cause abnormal movements, behaviors, or sensations.Â
cenobamate has been shown to be effective in reducing the frequency of partial-onset seizures in clinical trials. It may be used alone or in combination with other antiepileptic drugs to achieve better seizure control.Â
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