Adult patients reach a therapeutic dose in as early as 1 week
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APTIOM is taken ONCE A DAY, WHOLE OR CRUSHED, WITH OR WITHOUT FOOD 1
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APTIOM once-daily dosing recommendations for adults
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INITIAL DOSE 400 mg/day
TITRATION weekly increments* 400 to 600 mg/day
MAINTENANCE DOSE 800 to 1600 mg/day
*Based on clinical response and tolerability.
APTIOM tablet strengths
200 mg
400 mg
600 mg
800 mg
Tablets shown are not actual size.
200 mg, 600 mg, and 800 mg tablets have a functional score and can be split
Choose APTIOM because it:
Does not induce its own metabolism
Does not require eslicarbazepine therapeutic drug monitoring
Is not a controlled substance
Showed no clinically significant drug-drug interactions with valproate, lamotrigine, topiramate, levetiracetam, or gabapentin
Treatment may be initiated at 800 mg QD if the need for seizure reduction outweighs an increased risk of adverse reactions during initiation
For patients on APTIOM monotherapy, the 800 mg QD maintenance dose should generally be considered in patients who are unable to tolerate a 1200 mg daily dose
For patients on APTIOM adjunctive therapy, the 1600 mg daily dose should generally be considered in patients who did not achieve a satisfactory response with a 1200 mg daily dose
Dosage modifications with other antiepileptic drugs
Some adverse reactions occur more frequently when patients take APTIOM adjunctively with carbamazepine. However, carbamazepine reduces the plasma concentration of eslicarbazepine. When APTIOM and carbamazepine are taken concomitantly, the dose of APTIOM or carbamazepine may need to be adjusted based on efficacy and tolerability. For patients taking other enzyme-inducing ASMs (ie, phenobarbital, phenytoin, and primidone), higher doses of APTIOM may be needed. APTIOM should not be taken as an adjunctive therapy with oxcarbazepine.
Dosage modifications in patients with renal impairment
In patients with moderate and severe renal impairment (ie, creatinine clearance <50 mL/min), the initial, titration, and maintenance dosages should generally be reduced by 50%. Titration and maintenance dosages may be adjusted according to clinical response.
Patients with hepatic impairment
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.
Discontinuation of APTIOM
When discontinuing APTIOM, reduce the dosage gradually and avoid abrupt discontinuation in order to minimize the risk of increased seizure frequency and status epilepticus.
Other antiepileptic drugs
Several ASMs (eg, carbamazepine, phenobarbital, phenytoin, and primidone) can induce enzymes that metabolize APTIOM and can cause decreased plasma concentrations of eslicarbazepine. Higher doses of APTIOM may be needed.
CYP2C19 substrates
APTIOM can inhibit CYP2C19, which can cause increased plasma concentrations of drugs that are metabolized by this isoenzyme (eg, phenytoin, clobazam, and omeprazole). Dose adjustment may be needed.
CYP3A4 substrates
In vivo studies suggest that APTIOM can induce CYP3A4, decreasing plasma concentrations of drugs that are metabolized by this isoenzyme (eg, simvastatin, lovastatin). Dose adjustment of simvastatin and lovastatin may be needed if a clinically significant change in lipids is noted.
Oral contraceptives
Because concomitant use of APTIOM and ethinylestradiol and levonorgestrel is associated with lower plasma levels of these hormones, females of reproductive potential should use additional or alternative nonhormonal birth control.
Important Safety Information and Indication for APTIOM
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) and syndrome of inappropriate antidiuretic hormone secretion (SIADH) can develop in patients taking APTIOM. 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. Depending on the severity of hyponatremia, the dose of APTIOM may need to be reduced or discontinued.
Neurological Adverse Reactions: APTIOM causes dose‐dependent increases in the following reactions (dizziness, disturbance in gait and coordination, somnolence, fatigue, and visual changes). There was an increased risk of dizziness, disturbance in gait and coordination, and visual changes during the titration period (compared to maintenance treatment), and there may be an increased risk of these adverse reactions in patients 60 years of age and older compared to younger adults. APTIOM causes dose-dependent increases in cognitive dysfunction-related events in adults (memory impairment, disturbance in attention, amnesia, confusional state, aphasia, speech disorder, slowness of thought, disorientation, and psychomotor retardation). 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.
Withdrawal of AEDs: As with all AEDs, APTIOM should be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus, but if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered.
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.
Hematologic Adverse Reactions: Rare cases of pancytopenia, agranulocytosis, and leukopenia have been reported during postmarketing use in patients treated with APTIOM. Discontinuation of APTIOM should be considered in patients who develop pancytopenia, agranulocytosis, or leukopenia.
Most Common Adverse Reactions: The most common adverse reactions in adult patients receiving APTIOM (≥4% and ≥2% greater than placebo) were 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.
Safety and Efficacy in Patients <4 Years of Age: Safety and effectiveness in patients below 4 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.
Indication and Usage Aptiom® (eslicarbazepine acetate) is indicated for the treatment of partial‐onset seizures in patients 4 years of age and older.
