Aptiom (eslicarbazepine acetate) – Treatment for Partial-Onset Seizures in Patients 4 Years and Older

Aptiom is an oral medication approved for the treatment of partial-onset seizures in patients aged 4 years and older. It is available in tablet form with strengths of 200 mg, 400 mg, 600 mg, and 800 mg.

Aptiom is used for managing partial-onset seizures in patients aged 4 years and above. It can be prescribed as either monotherapy or adjunctive therapy depending on the patient's seizure control needs.

eslicarbazepine acetate

Aptiom contains eslicarbazepine acetate, which works by stabilizing electrical activity in the brain to help reduce the frequency of seizures. This anticonvulsant effect is achieved through modulation of voltage-gated sodium channels, although the precise mechanism is not fully described in the label.

Adults

The initial advised dose is 400 mg once daily, increasing weekly by increments of 400-600 mg based on response and tolerability. Maintenance dose ranges from 800 mg to 1600 mg once daily. Some patients may start at 800 mg daily if seizure control is a priority despite a higher risk of side effects.

For monotherapy, 800 mg daily is typical if 1200 mg daily is not tolerated; for adjunctive therapy, doses up to 1600 mg daily may be used if lower doses are not effective.

Pediatric Patients (4 to 17 years)

Dosing depends on body weight, administered once daily with weekly titration no more frequent than once a week using these schedules:

Special Populations

• Renal impairment: Dosages should be reduced by 50% in patients with moderate to severe renal impairment (creatinine clearance <50 mL/min).
• Hepatic impairment: No dose adjustment required for mild to moderate impairment. Use in severe hepatic impairment is not recommended.

Administration

Tablets may be taken whole or crushed, with or without food.

Discontinuation

Gradually reduce dose to avoid increased seizure risk; abrupt discontinuation is not recommended unless necessary due to serious adverse effects.

• Known hypersensitivity to eslicarbazepine acetate or oxcarbazepine.
• History of serious dermatologic reactions or anaphylaxis with Aptiom, oxcarbazepine, or carbamazepine.

Serious Risks and Monitoring

• Suicidal behavior and ideation: Increased risk observed with Aptiom and other antiepileptic drugs. Monitor patients closely for signs of depression, suicidal thoughts, or behavioral changes.
• Serious dermatologic reactions: Cases of Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), DRESS (drug reaction with eosinophilia and systemic symptoms), anaphylaxis, and angioedema have been reported. Discontinue Aptiom if these occur.
• Hyponatremia: Significant decreases in serum sodium (less than 125 mEq/L) can occur and may be severe. Monitor sodium levels in at-risk patients or those with symptoms such as nausea, confusion, lethargy, muscle weakness, or increased seizures.
• Neurological adverse reactions: Dizziness, ataxia, vertigo, coordination problems, somnolence, fatigue, cognitive impairment, and visual disturbances are dose-dependent and may be more frequent during dose titration or in elderly patients.
• Withdrawal: Taper gradually to lower risk of seizure worsening or status epilepticus.
• Liver injury: Discontinue if jaundice or significant liver damage occurs.
• Hematologic effects: Rare reports of pancytopenia, agranulocytosis, and leukopenia; consider discontinuation if these develop.

Patients should be advised not to engage in hazardous activities requiring alertness until effects are known.

Common Adverse Reactions

• Dizziness and disturbances in gait or coordination (reported by up to 38% at higher doses)
• Somnolence and fatigue (up to 28% at higher doses)
• Cognitive dysfunction (e.g., memory impairment, attention disturbance)
• Visual changes including diplopia and blurred vision

Serious Adverse Reactions

• Serious dizziness and coordination problems leading to study withdrawal (about 9% at higher doses)
• Severe hyponatremia causing seizures and requiring hospitalization
• Rare severe skin reactions (SJS, TEN)
• Rare blood cell abnormalities (pancytopenia, agranulocytosis)

• Concomitant use with carbamazepine may increase adverse reactions like dizziness and diplopia; dose adjustments of either medication may be needed.
• Carbamazepine reduces plasma concentrations of eslicarbazepine, possibly necessitating higher doses of Aptiom or carbamazepine adjustments.
• Other enzyme-inducing antiepileptic drugs (phenobarbital, phenytoin, primidone) may require higher doses of Aptiom.
• Aptiom should not be used as adjunctive therapy with oxcarbazepine due to chemical similarity and overlapping side effects.