Is Cenobamate approved by the FDA?

Yes, cenobamate, marketed under the brand name Xcopri, is FDA approved. The U.S. Food and Drug Administration (FDA) approved cenobamate on November 21, 2019, for the treatment of partial-onset seizures in adults.

What is Cenobamate?

Cenobamate is a medication used to treat partial-onset seizures in adults. Partial-onset seizures begin in one specific part of the brain and can affect both adults and children. Cenobamate works as an anticonvulsant, helping to reduce the frequency and severity of these seizures.

Dosage and Administration

Cenobamate is available in oral tablet form and is usually taken once daily. The dosage is titrated up gradually over several weeks to minimize side effects and allow the body to adjust to the medication:

• Initial Dose: 12.5 mg once daily for the first 2 weeks.
• Titration Schedule:
  • 25 mg once daily for weeks 3 and 4.
  • 50 mg once daily for weeks 5 and 6.
  • 100 mg once daily for weeks 7 and 8.
  • 150 mg once daily for weeks 9 and 10.
• Maintenance Dose: 200 mg once daily starting from week 11.
• Maximum Dose: 400 mg once daily, depending on clinical response and tolerability.

It is important to follow the dosing instructions carefully and not to exceed the recommended titration schedule to avoid serious adverse reactions.

Side Effects

Common Side Effects

• Feeling tired
• Dizziness
• Drowsiness
• Double vision
• Headache

Serious Side Effects

Cenobamate can cause serious or life-threatening allergic reactions that may affect the liver, blood cells, or other parts of the body. Symptoms to watch for include:

• Fast or pounding heartbeats, dizziness
• Severe weakness or muscle pain
• Fever, swollen glands, sore throat
• Unusual bruising or bleeding
• Painful sores in the mouth or around the eyes
• Swelling in the face, mouth, or throat
• Trouble breathing or swallowing
• Yellowing of the skin or eyes
• Nervous system problems like trouble walking, loss of coordination, vision problems, drowsiness, or tiredness

Warnings and Precautions

• Allergic Reactions: Monitor for signs of allergic reactions and seek immediate medical attention if symptoms occur.
• Mood Changes: Some people may experience mood or behavior changes, including thoughts about suicide. Report any new or worsening symptoms to a healthcare provider.
• Pregnancy: Do not start or stop taking seizure medication during pregnancy without medical advice. Cenobamate can make birth control pills less effective, so alternative non-oral contraceptives are recommended.
• Breastfeeding: Consult a healthcare provider regarding the safety of breastfeeding while using cenobamate.
• Driving and Operating Machinery: Cenobamate may cause blurred vision and impair reactions. Avoid driving or hazardous activities until you know how the medication affects you.
• Alcohol: Avoid drinking alcohol while taking this medication as it can increase side effects.

Drug Interactions

Cenobamate can interact with other medications, including other seizure drugs, opioids, sleeping pills, muscle relaxers, and medications for anxiety. It is crucial to inform your healthcare provider about all the medications you are taking to avoid potential interactions and side effects.

Conclusion

Cenobamate (Xcopri) is an FDA-approved medication for the treatment of partial-onset seizures in adults. Approved on November 21, 2019, it represents a significant advancement in seizure management. Patients should follow their healthcare provider’s instructions closely and report any side effects or mood changes promptly to ensure the safe and effective use of this medication.

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