INDICATIONS AND USAGE

Aptiom® (eslicarbazepine acetate) is indicated for the treatment of partial-onset seizures as monotherapy or adjunctive therapy.

Important Safety Information & Indications

Contraindications: APTIOM is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine.

Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including APTIOM, increase the risk of suicidal thoughts or behavior. Anyone considering prescribing APTIOM or any other AED must balance this risk with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Patients and caregivers should also be advised to be alert to these behavioral changes and to immediately report them to the health care provider.

Serious Dermatologic Reactions, including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with APTIOM use. Serious and sometimes fatal dermatologic reactions, including TEN and SJS, have also been reported in patients using oxcarbazepine or carbamazepine, which are chemically related to APTIOM. Should a patient develop a dermatologic reaction while using APTIOM, discontinue APTIOM use unless it is clearly not drug related.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan Hypersensitivity, has been reported in patients taking APTIOM. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement. If this reaction is suspected, treatment with APTIOM should be discontinued.

Anaphylactic Reactions and Angioedema: Rare cases of anaphylaxis and angioedema have been reported in patients taking APTIOM. Anaphylaxis and angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions, the drug should be discontinued. Patients with a prior anaphylactic-type reaction after treatment with either oxcarbazepine or APTIOM should not be treated with APTIOM.

Hyponatremia: Clinically significant hyponatremia (sodium <125 mEq/L) can develop in patients taking APTIOM. In the controlled adjunctive epilepsy trials, 1.0% (800 mg) and 1.5% (1200 mg) of patients treated with APTIOM had at least one serum sodium level value less than 125 mEq/L, compared to none on placebo. These effects were dose related and generally appeared within the first 8 weeks of treatment (as early as after 3 days). Measurement of serum sodium and chloride levels should be considered during maintenance treatment with APTIOM, particularly if the patient is receiving other medications known to decrease serum sodium levels. Hyponatremia was also observed in monotherapy trials.

Neurological Adverse Reactions: APTIOM causes dose-dependent increases in the following reactions (dizziness, disturbance in gait and coordination, somnolence, fatigue, cognitive dysfunction, and visual changes) compared to placebo. These events were more often serious in APTIOM-treated patients than placebo. There was an increased risk of dizziness, disturbance in gait and coordination, and visual changes during the titration period (compared to the maintenance period), and there may be an increased risk of these adverse reactions in patients 60 years of age and older compared to younger adults. The incidences of dizziness and diplopia were greater with concomitant use of APTIOM and carbamazepine compared to the use of APTIOM without carbamazepine. Prescribers should advise patients against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of APTIOM is known. Dizziness, disturbance in gait and coordination, somnolence, fatigue, cognitive dysfunction, and visual changes were also observed in monotherapy trials.

Withdrawal of AEDs: As with all AEDs, APTIOM should be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

Drug Induced Liver Injury: Hepatic effects, ranging from mild to moderate elevations in transaminases (>3 times the upper limit of normal) to rare cases with concomitant elevations of total bilirubin (>2 times the upper limit of normal) have been reported with APTIOM use. Baseline evaluations of liver laboratory tests are recommended. APTIOM should be discontinued in patients with jaundice or other evidence of significant liver injury.

Abnormal Thyroid Function Tests: Dose-dependent decreases in serum T3 and T4 (free and total) values have been observed in patients taking APTIOM. These changes were not associated with other abnormal thyroid function tests suggesting hypothyroidism. Abnormal thyroid function tests should be clinically evaluated.

Adverse Reactions: The most frequently reported adverse reactions in patients receiving APTIOM as adjunctive therapy at doses of 800 mg or 1200 mg (≥4% and ≥2% greater than placebo) were dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. Adverse reactions in monotherapy studies were generally similar to those observed and attributed to APTIOM in adjunctive therapy studies.

Safety and Efficacy in Patients <18 Years of Age: Safety and effectiveness in patients below 18 years of age have not been established.

Dosing Considerations
Some adverse reactions occur more frequently when patients take APTIOM adjunctively with carbamazepine. When APTIOM and carbamazepine are taken concomitantly, the dose of APTIOM or carbamazepine may need to be adjusted based on efficacy and tolerability. APTIOM should not be taken as an adjunctive therapy with oxcarbazepine. For patients taking other enzyme-inducing AEDs (i.e., phenobarbital, phenytoin, and primidone), higher doses of APTIOM may be needed.

A dose reduction is recommended in patients with moderate and severe renal impairment (i.e., creatinine clearance <50 mL/min).

Dose adjustments are not required in patients with mild to moderate hepatic impairment. Use of APTIOM in patients with severe hepatic impairment has not been studied, and use in these patients is not recommended.

Concomitant use of APTIOM and oral contraceptives containing ethinylestradiol and levonorgestrel is associated with lower plasma levels of these hormones. Patients should use additional or alternative non-hormonal birth control during APTIOM treatment and after discontinuation of APTIOM for one menstrual cycle, or until otherwise instructed.

Indications and Usage
Aptiom® (eslicarbazepine acetate) is indicated for the treatment of partial-onset seizures as monotherapy or adjunctive therapy.

Before prescribing APTIOM, please read the Full Prescribing Information.