APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
• Most common adverse reactions in adult patients receiving APTIOM (≥4% and ≥2% greater than placebo): dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor.
• Adverse reactions in pediatric patients are similar to those seen in adult patients.
• Carbamazepine: May need dose adjustment for APTIOM or carbamazepine.
• Phenytoin: Higher dosage of APTIOM may be necessary and dose adjustment may be needed for phenytoin.
• Phenobarbital or Primidone: Higher dosage of APTIOM may be necessary.
• Hormonal Contraceptives: APTIOM may decrease the effectiveness of hormonal contraceptives.
• Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior.
• Serious Dermatologic Reactions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Anaphylactic Reactions and Angioedema: Monitor and discontinue if another cause cannot be established.
• Hyponatremia: Monitor sodium levels in patients at risk or patients experiencing hyponatremia symptoms.
• Neurological Adverse Reactions: Monitor for dizziness, disturbance in gait and coordination, somnolence, fatigue, cognitive dysfunction, and visual changes. Use caution when driving or operating machinery.
• Withdrawal of APTIOM: Withdraw APTIOM gradually to minimize the risk of increased seizure frequency and status epilepticus.
• Drug Induced Liver Injury: Discontinue APTIOM in patients with jaundice or evidence of significant liver injury.
• Hematologic Adverse Reactions: Consider discontinuing.