Adult Adverse Reactions | APTIOM® (eslicarbazepine acetate)

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Adult Adverse Reactions

Incidence of Adverse Reactions

APTIOM adjunctive therapy was studied in 3 separate randomized, double-blind, placebo-controlled, multicenter studies.1

  • Patients were adults with partial-onset seizures with or without secondary generalization inadequately controlled on 1-3 concomitant AEDs
  • Patients were randomly assigned to placebo or APTIOM 400 mg, 800 mg, or 1200 mg once daily (APTIOM 400 mg was evaluated only in Studies 3 & 4 and did not show a significant treatment effect). Following a 2-week titration phase, patients remained on a stable dose of APTIOM or placebo for a 12-week maintenance phase1

Most common adverse reactions in adult adjunctive therapy studies

  • In adjunctive clinical studies, the incidence of most common adverse reactions was generally lower when initiating APTIOM at 400 mg without concomitant carbamazepine2

Most Common APTIOM Treatment-Emergent Adverse Reactions in Adult Adjunctive Therapy Studies

*Occurring in ≥4% of APTIOM-treated patients and ≥2% greater than placebo.
Includes all APTIOM dose initiation groups and concomitant AEDs in placebo-controlled adjunctive epilepsy studies.

  • Some adverse reactions occur more frequently when patients take APTIOM adjunctively with carbamazepine1
  • Dosage modifications of both APTIOM and carbamazepine should be considered if these drugs are used concomitantly1
  • Adverse reactions observed in the adult monotherapy historical-control studies were generally similar to those observed and attributed to the drug in the adjunctive placebo-controlled studies1

Most Common Aggression-Related and Psychiatric Adverse Reactions in Adult Adjunctive Studies

Defined as events occurring in the Standardised MedDRA Queries of hostility/aggression.
§Defined as events occurring in the System Organization Class of psychiatric disorders.
Includes APTIOM 400 mg, 800 mg, and 1200 mg.

Cognitive Dysfunction–Related Adverse Reactions in Adult Adjunctive Studies

  • Dose-dependent cognitive dysfunction–related adverse reactions were reported in 1% of placebo patients, 4% of patients on APTIOM 800 mg, and 7% of patients on APTIOM 1200 mg in controlled adult adjunctive epilepsy studies1
  • Cognitive dysfunction-related adverse reactions were also observed in adult monotherapy studies1

% incidence of hyponatremia (sodium <125 mEq/L) in adult adjunctive therapy epilepsy studies1

Incidence of Hyponatremia in Adult Adjunctive Therapy Studies

  • Hyponatremia was also observed in monotherapy studies1
  • 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 adults1

Incidence of Dizziness in Adult Adjunctive Therapy Studies

  • Treatment in adults may be initiated at 800 mg QD if the need for seizure reduction outweighs an increased risk of adverse reactions during initiation1

Incidence of Falls With APTIOM vs Placebo in Adjunctive Therapy Studies

Discontinuation Rates in Adult Adjunctive Therapy Studies

Includes all APTIOM dose initiation groups and concomitatnt AEDs in placebo controlled adjunctive epilepsy studies.

  • The adverse reactions that most commonly led to discontinuation (incidence ≥1% in any APTIOM treatment group and greater than placebo) in descending order of frequency were dizziness, nausea, vomiting, ataxia, diplopia, somnolence, headache, blurred vision, vertigo, asthenia, fatigue, rash, dysarthria, and tremor1

Adverse reactions were reported throughout the 18-week dose-blinded treatment period: 2-week APTIOM titration, 6-week AED withdrawal, and 10-week monotherapy phases2

Adult Monotherapy Study Design

Most common# adverse reactions in adult monotherapy studies

Most Common APTIOM Treatment-Emergent Adverse Reactions in Adult Monotherapy Studies

#Adverse reactions occurring in the 18-week dose-blinded treatment period (≥5% of patients in either dose group) and the 10-week monotherapy phase.
Defined as 2 weeks' APTIOM titration + 6 weeks' baseline AED withdrawal + 10 weeks' APTIOM monotherapy.2

The monotherapy studies did not include a placebo-controlled group; therefore, causality could not be established.2

  • 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.2 Adverse reactions related to dizziness and disturbance in gait and coordination were also observed in adult monotherapy trials and pediatric trials1

Incidence of Falls With APTIOM in Adult Monotherapy Studies

No significant effect on cardiac conduction

  • No significant effect on QTc interval was detected in a dedicated QTc study; routine ECG monitoring is not required1,2

Effect on weight vs placebo in adjunctive epilepsy studies

  • Mean changes in weight in controlled adjunctive epilepsy studies were 0.3 kg, 0.3 kg, and 0.3 kg for placebo, APTIOM 800 mg, and APTIOM 1200 mg, respectively.2 However, given variability in patients who either lost or gained weight, no definitive conclusions regarding weight changes and APTIOM use can be made

 APTIOM® [prescribing information]. Sunovion Pharmaceuticals Inc., Marlborough, MA, March 2019.  
2. Data on file, Sunovion Pharmaceuticals Inc.

Important Safety Information & Indication

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.

Before prescribing APTIOM, please read the Full Prescribing Information.