APTIOM Tablet (2020)

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Sunovion Pharmaceuticals Inc.

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1. Indications and Usage

APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

2. Dosage and Administration

2.1 Important Administration Instructions Instruct patients to administer APTIOM either as whole or as crushed tablets. Instruct patients to take APTIOM either with or without food. The APTIOM dosing regimen ...

3. Dosage Forms and Strengths

APTIOM tablets are available in the following shapes and color (Table 2) with respective one-sided engraving: Table 2. APTIOM Tablet Presentations: Tablet Strength Tablet Color/Shape Tablet Markings ...

4. Contraindications

APTIOM is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see Warnings and Precautions (5.2, 5.3, and 5.4)].

5. Warnings and Precautions

5.1 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including APTIOM, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with ...

6. Adverse Reactions

The following adverse reactions are described in more detail in the Warnings and Precautions section of the label: Suicidal Behavior and Ideation [see Warnings and Precautions (5.1)] ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of APTIOM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to ...

7. Drug Interactions

7.1 Other Antiepileptic Drugs Several AEDs (e.g., carbamazepine, phenobarbital, phenytoin, and primidone) can induce enzymes that metabolize APTIOM and can cause decreased plasma concentrations of eslicarbazepine ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as APTIOM, during pregnancy. Encourage women who are taking APTIOM during ...

8.2. Lactation

Eslicarbazepine is present in human milk. The effects of APTIOM on the breastfed infant or on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along ...

8.3. Females and Males of Reproductive Potential

Contraception Use of APTIOM with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with lower plasma levels of these hormones. Advise women of reproductive potential taking ...

8.4. Pediatric Use

Safety and effectiveness of APTIOM have been established in the age groups 4 to 17 years. Use of APTIOM in these age groups is supported by evidence from adequate and well-controlled studies of APTIOM ...

8.5. Geriatric Use

There were insufficient numbers of patients ≥65 years old enrolled in the controlled adjunctive epilepsy trials (N=15) to determine the efficacy of APTIOM in this patient population. The pharmacokinetics ...

8.6. Renal Impairment

Clearance of eslicarbazepine is decreased in patients with impaired renal function and is correlated with creatinine clearance. Dosage adjustment is necessary in patients with CrCl<50 mL/min (Figure 1) ...

8.7. Hepatic Impairment

Dose adjustments are not required in patients with mild to moderate hepatic impairment (Figure 1). Use of APTIOM in patients with severe hepatic impairment has not been evaluated, and use in these patients ...

9.1. Controlled Substance

APTIOM is not a controlled substance.

9.2. Abuse

Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. Drug addiction, which develops after repeated drug abuse, ...

9.3. Dependence

Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. There was some evidence of physical dependence or a withdrawal syndrome ...

10. Overdosage

10.1 Signs, Symptoms, and Laboratory Findings of Acute Overdose in Humans Symptoms of overdose are consistent with the known adverse reactions of APTIOM and include hyponatremia (sometimes severe), dizziness, ...

11. Description

The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula ...

12.1. Mechanism of Action

APTIOM is extensively converted to eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity ...

12.2. Pharmacodynamics

The effect of APTIOM on cardiac repolarization was evaluated in a randomized, double-blind, placebo- and active-controlled 4-period crossover trial in healthy adult men and women. Subjects received APTIOM ...

12.3. Pharmacokinetics

The pharmacokinetics of eslicarbazepine is linear and dose-proportional in the dose range of 400 mg to 1600 mg once daily, both in healthy adult subjects and patients. The apparent half-life of eslicarbazepine ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In a two-year carcinogenicity study in mice, eslicarbazepine acetate was administered orally at doses of 100, 250, and 600 mg/kg/day. An increase in the incidence of hepatocellular adenomas ...

14. Clinical Studies

14.1 Monotherapy for Partial-Onset Seizures The effectiveness of APTIOM as monotherapy for partial-onset seizures was established in two identical, dose-blinded historical control trials in a total of ...

15. References

French JA, Wang S, Warnock B, Temkin N. Historical control monotherapy design in the treatment of epilepsy. Epilepsia 2010;51(10):1936-43.

16.1. How Supplied

APTIOM tablets are white, oblong and with functional scoring on one side (200 mg, 600 mg, and 800 mg) or white, circular bi-convex and plain on one side (400 mg) and identified with strength-specific one-sided ...

16.2. Storage and Handling

Store APTIOM tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

See FDA-approved patient labeling (Medication Guide). Inform patients and caregivers of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking APTIOM. Instruct ...