苯巴那酯(cenobamate)中文说明书

The first approval by the US FDA in November 2019 has brought new treatment options to the majority of epilepsy patients. It has brought new hope for survival to patients who have poor response to traditional anti-epileptic drugs. For most patients, their epilepsy symptoms can be better controlled or their quality of life has been improved.

‌Indications of cenobamate‌

Adult partial-onset epilepsy (focalonsetseizures).

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Usage and dosage of cenobamate

1. Dosage regimen (adult partial-onset epilepsy)

(1) Initial dose

Take 12.5 mg orally once a day in weeks 1-2.

(2) Titration dose

Take 25 mg orally once a day in weeks 3-4; take 50 mg orally once a day in weeks 5-6; take 100 mg orally once a day in weeks 7-8; take 150 mg orally once a day in weeks 9-10.

(3) Maintenance dose

Take 200 mg orally once a day starting from the 11th week; the maximum dose is 400 mg once a day.

Even if you feel well, stopping the drug suddenly may cause an increase in epileptic seizures or withdrawal symptoms, so you need to gradually reduce the dose according to your doctor's advice.

2. Administration method

Swallow the tablet whole, or take it directly with water.

‌It can be crushed and mixed with water to make an oral suspension, or it can be administered through a nasogastric tube. Please consult a medical professional for specific crushing methods. ‌Can be taken before or after meals.

3. Medication precautions

It can be used as a single drug (monotherapy) or in combination with other anti-epileptic drugs (adjuvant therapy).

Be sure to follow the correct dosage of the drug. Exceeding the recommended dosage may cause some serious adverse reactions.

Increase the dose by 50mg/day every 2 weeks and gradually adjust it to the maximum tolerated dose.

Based on the patient’s clinical response and tolerance to the drug, we can determine the required maintenance dose accordingly.

4. Treatment of missed doses

If you miss a dose, please contact your doctor immediately to obtain corresponding treatment instructions.

5. Overdose treatment

In the event of drug overdose, seek medical help immediately and send the patient to the hospital's emergency room or other medical assistance institution in a timely manner.

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Mechanism of action of cenobamate (cenobamate)

As an anti-epileptic drug, it works by regulating abnormal brain electrical signals. Its mechanism of action includes:

Inhibition of voltage-gated sodium channels and positive regulation of γ-aminobutyric acid (GABAA) ion channels.

It can be used as a single drug or in combination with other anti-epileptic drugs. Some patients can achieve zero seizures.

Principle of action

Partial-onset epilepsy is caused by abnormal local electrical signals in the brain. Cenobamate works by regulating these abnormal electrical signals. The specific mechanism has not been fully elucidated.

Side effects of cenobamate

1. Common side effects

Fatigue, dizziness, drowsiness, double vision, and headache.

2. Serious side effects (immediate medical attention required)

If typical systemic allergic reactions such as urticaria, obvious difficulty in breathing, sudden swelling of the face/lips/tongue/throat occur, the patient should be sent to the hospital's emergency room immediately for emergency rescue treatment.

Rash, fever, swollen lymph nodes, muscle pain, severe weakness, unusual bruising, or yellowing of the skin/eyes.

Mood/behavior changes, anxiety, insomnia, impulsivity, irritability, aggression, suicidal thoughts.

May affect the liver, blood system or other organs, manifesting as: heart problems (palpitations, chest pain, sudden dizziness), extreme weakness, severe muscle pain, painful ulcers in the mouth/around the eyes, swelling of the face/throat, yellowing of the skin/eyes, neurological problems (difficulty walking, coordination problems, vision problems, thinking and memory problems).

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Precautions for cenobamate (cenobamate)

1. Drug reactions and hypersensitivity reactions

May cause serious or life-threatening allergic reactions, affecting the liver, blood cells or other organs. Seek medical attention immediately if you develop any of the following symptoms: severe weakness or muscle pain with fever, swollen lymph nodes, unusual bruising or bleeding, swelling of the face/throat, difficulty breathing, hives or rash, yellowing of the skin or eyes, or persistent illness.

2. Suicidal behavior and thoughts

Many patients will have suicidal thoughts and even commit suicide while taking this drug. You need to be alert to changes in mood or symptoms, and promptly report new or worsening symptoms to your doctor.

3. Shortening of the QT interval

(Heart rhythm problems) Be cautious when combined with other drugs that shorten the QT interval.

4. Nervous system adverse reactions

Symptoms of drowsiness and fatigue need to be monitored.

To avoid unnecessary safety risks, patients should understand the effects of the drug before driving or operating machinery.

Combined use with other central nervous system depressants or alcohol may produce superimposed adverse effects, so it should not be used in combination or with caution.

5. Drug discontinuation warning

Follow the doctor's instructions, it is best not to stop the drug suddenly, but to gradually stop it according to the principle of gradual reduction.

Contraindications of cenobamate

Allergy, hereditary short QT syndrome (a heart rhythm disorder).

Cenobamate (cenobamate) medication for special groups

1. Information before use

The following medical history must be explained to the doctor: depression or other mood disorders, suicidal thoughts or behaviors, liver/kidney disease, blood system diseases, rashes caused by drugs or allergic reactions affecting internal organs/blood cells.

2. Pregnancy and contraception

Do not adjust the dosage of anti-epileptic drugs during pregnancy.

It may reduce the effectiveness of oral contraceptives. It is recommended to consult non-oral contraceptive methods (such as injections, implants, condoms, etc.).

Pregnant patients may be included in a pregnancy registry to monitor the effects of medications on the fetus.

3. Breastfeeding

The safety of breastfeeding is still unclear. You should go to the obstetrics clinic of the hospital for medical treatment. The doctor will make a preliminary assessment of the potential risks of breastfeeding and the potential impact on the fetus.

4. Young patients

It is prohibited for patients under 18 years old.

Drug interactions with cenobamate

Including prescription drugs, over-the-counter drugs, vitamins and herbal products, all current and newly started drugs must be explained to the doctor/pharmacist.

‌1. Special risks‌:

Long-term or high-dose use of central-depressant drugs may also cause drowsiness/dizziness in some people.

May reduce the effectiveness of birth control pills, so women are advised to use additional non-hormonal contraceptive measures.

2. Known interacting drugs:

Lamotrigine (Lamictal), phenytoin, phenobarbital, clobazam, carbamazepine, CYP2B6/3A/2C19 substrate drugs.

Storage conditions of cenobamate

Save the drug at room temperature of 20℃-25℃, and promptly dispose of expired or no longer needed drugs, keeping them away from the sight and reach of children and pets.