Before taking Xcopri(Cenobamat)

1. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity:

Some patients taking Xcopri (cenobamate) have experienced adverse reactions of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity. It typically presents with fever, rash, lymphadenopathy and/or facial swelling, as well as diseases of other organ systems, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis that sometimes resembles an acute viral infection. Generally, DRESS occurs when the drug dose is increased too rapidly, but this does not mean that a slower increment can prevent DRESS. It should DRESS. It should be taken according to the recommended dosage, starting at 12.5 mg per day and increasing the dose every two weeks. In addition, it should be noted that allergic reactions, such as fever or lymphadenopathy, may occur even if the rash is not obvious. If such symptoms appear, medical attention should be sought immediately. If it is indeed caused by Xcopri (cenobamate), the use of cenobamate Xcopri (cenobamate) should be stopped immediately.

2. QT Interval Shortening:

Studies have found that taking Xcopri (cenobamate) can shorten the QT interval. If there is an inherent familial short QT syndrome, it will increase the risk of sudden death and ventricular arrhythmias, especially ventricular fibrillation. Therefore, patients with familial short QT syndrome must not use Xcopri (cenobamate). Caution should be exercised when Xcopri (cenobamate) is used together with other drugs that shorten the QT interval, as it may increase the risk of QT interval shortening.

3. Suicidal Behavior and Tendencies:

Antiepileptic drugs (AEDs), including Xcopri (cenobamate), may increase the risk of suicide. Therefore, patients should be monitored for suicidal thoughts or behaviors and/or any abnormal changes in mood or behavior.

4. Nervous System Adverse Reactions:

Xcopri (cenobamate) can cause drowsiness and fatigue-related adverse reactions (drowsiness, fatigue, lassitude, weakness, insomnia, sedation, and somnolence), and these reactions may worsen as the dose increases. Xcopri (cenobamate) can cause adverse reactions related to dizziness, gait, and coordination disorders (dizziness, vertigo, balance disorder, ataxia, nystagmus, gait disturbance, and abnormal coordination). It can also cause adverse reactions related to cognitive dysfunction events (e.g., memory impairment, attention disorder, amnesia, confusional state, aphasia, speech disorder, slowness of thought, disorientation, and psychomotor retardation). In addition, Xcopri (cenobamate) may lead to adverse reactions related to vision changes, including diplopia, blurred vision, and visual impairment. Doctors should advise patients not to engage in dangerous activities that require mental concentration, such as driving a car or operating dangerous machinery. When Xcopri (cenobamate) is used together with other drugs with sedative effects, patients should be carefully observed for signs of central nervous system (CNS) depression, such as drowsiness and sedation, due to potential additive effects.

5. Discontinuation of Antiepileptic Drugs:

Like most antiepileptic drugs, Xcopri (cenobamate) should generally be discontinued gradually due to the risk of increased seizure frequency and status epilepticus. However, if discontinuation is necessary due to severe adverse events, rapid discontinuation may be considered.

6. Pregnancy:

There are currently insufficient data to indicate the developmental risks associated with the use of Xcopri (cenobamate) in pregnant women. However, in animal studies, administration of Xcopri (cenobamate) during pregnancy or throughout pregnancy and lactation had adverse effects on development (increased embryo-fetal mortality, decreased fetal and offspring weight, impaired neurobehavioral and reproductive functions in offspring).

7. Lactation:

There is currently no evidence of Xcopri (cenobamate) in breast milk. The decision to use Xcopri (cenobamate) should be made by considering the mother's need for the drug and the potential adverse effects of the drug on the infant.

8.Geriatric Use:

Clinical studies of Xcopri (cenobamate) did not include a sufficient number of patients aged 65 years and older to determine the safety and efficacy of Xcopri (cenobamate) in the elderly population. In general, dose selection for elderly patients should be cautious, usually starting from the lower end of the dosing range.

9.Renal Impairment:

Xcopri (cenobamate) should be used with caution. Dose reduction should be considered for patients with mild to moderate renal impairment (CLcr less than 30 mL/min) and severe renal impairment (CLcr less than 30 mL/min). It is not recommended for patients undergoing dialysis.

10. Hepatic Impairment:

Xcopri (cenobamate) should be used with caution in patients with mild to moderate hepatic impairment (liver function assessment score of 5-9 points; Class A or B). In these patients, the maximum recommended dose is 200 mg once daily, and reduction of other doses may be considered. It is not recommended for patients with severe hepatic impairment.