Patient Considerations | APTIOM® (eslicarbazepine acetate)

Dr. Smith's Dashboard

Sunovion Services

Request free samples of APTIOM® (eslicarbazepine acetate) tablets for your patients

ORDER YOUR SAMPLES NOW

Need support? Ask Sunovion Answers for information about APTIOM® (eslicarbazepine acetate)

 

A dedicated team is available between 8 AM and 8 PM ET, Monday through Friday, to answer patient's calls at 1-844-427-8466

LEARN MORE

Most Viewed

APTIOM Patient Considerations

TUNING IN TO PATIENTS’ NEEDS


Click a photo below to learn more about a representative patient coping with focal seizures.

Pediatrics  - Patient Considerations
patient-profile-alex

Madison, age 12

"I don't like swallowing whole pills."

Actor portrayal

Treatment Considerations

  • Patient requires flexible administration options

APTIOM tablets can be taken whole or crushed

The safety and effectiveness of APTIOM in patients below 4 years of age have not been established.

APTIOM may not be appropriate for all patients with partial-onset seizures. For additional information regarding APTIOM, please see Full Prescribing Information.

Reference:
1. APTIOM® [prescribing information]. Sunovion Pharmaceuticals Inc., Marlborough, MA, March 2019.

Pediatrics  - Patient Considerations
APTIOM Patient Profile

Alejandro, age 16

“I only want to take my medication once a day.”

Actor portrayal

Treatment Considerations

  • Patient prefers once-daily treatment

APTIOM is taken once a day

The safety and effectiveness of APTIOM in patients below 4 years of age have not been established.

APTIOM may not be appropriate for all patients with partial-onset seizures. For additional information regarding APTIOM, please see Full Prescribing Information.

Reference:
1. APTIOM® [prescribing information]. Sunovion Pharmaceuticals Inc., Marlborough, MA, March 2019.

Pediatrics  - Patient Considerations
APTIOM Patient Profile

Harrison, age 6

“The only way I can take my medication is if it's in food.”

Actor portrayal

Treatment Considerations

  • Patient requires treatment that can be taken during meals

APTIOM can be taken with or without food

The safety and effectiveness of APTIOM in patients below 4 years of age have not been established.

APTIOM may not be appropriate for all patients with partial-onset seizures. For additional information regarding APTIOM, please see Full Prescribing Information.

Reference:
1. APTIOM® [prescribing information]. Sunovion Pharmaceuticals Inc., Marlborough, MA, March 2019.

Adults  - Patient Considerations
APTIOM Patient Profile

Kylee, age 23

“I want something I can take with my breakfast.”

Actor portrayal

Treatment Considerations

  • Patient requires a treatment that fits into their schedule

APTIOM is taken once a day, with or without food

APTIOM may not be appropriate for all patients with partial-onset seizures. For additional information regarding APTIOM, please see Full Prescribing Information.

Reference:
1. APTIOM® [prescribing information]. Sunovion Pharmaceuticals Inc., Marlborough, MA, March 2019.

Adults  - Patient Considerations
patient-profile-steven

Steven, age 58

"I want to know if this is covered by my insurance."

Actor portrayal

Treatment Considerations

  • Patient has questions about insurance coverage and financial assistance options

Sunovion Answers is a support team ready to help, and can help answer questions patients may have about insurance coverage

APTIOM may not be appropriate for all patients with partial-onset seizures. For additional information regarding APTIOM, please see Full Prescribing Information.

Adults  - Patient Considerations
APTIOM Patient Profile

David, age 38

“I’m concerned about side effects.”

Actor portrayal

Treatment Considerations

  • Patient wants to learn more about the potential side effects of APTIOM

APTIOM has an established safety and tolerability profile

APTIOM may not be appropriate for all patients with partial-onset seizures. For additional information regarding APTIOM, please see Full Prescribing Information.

Reference:
1. APTIOM® [prescribing information]. Sunovion Pharmaceuticals Inc., Marlborough, MA, March 2019.

LTC  - Patient Considerations
Aptiom_Patient_Profiles_Doc1

Dr. Silva

“We need an option that's convenient for our staff to administer.”

Actor portrayal

Treatment Considerations

  • Patient requires flexible administration

APTIOM is a once-daily treatment that can be taken whole or crushed, with or without food, and does not require eslicarbazepine therapeutic drug monitoring

APTIOM may not be appropriate for all patients with partial-onset seizures. For additional information regarding APTIOM, please see Full Prescribing Information.

Reference:
1. APTIOM® [prescribing information]. Sunovion Pharmaceuticals Inc., Marlborough, MA, March 2019.

LTC  - Patient Considerations
Aptiom_Patient_Profiles_Doc2

Dr. Reid

“We need something our patients can take with their current AED.”

Actor portrayal

Treatment Considerations

  • Patient needs a therapy that can be taken adjunctively with their current AED

APTIOM has established safety and efficacy as adjunctive therapy for focal seizures

APTIOM may not be appropriate for all patients with partial-onset seizures. For additional information regarding APTIOM, please see Full Prescribing Information.

AED=antiepileptic drug.

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.

Please see Important Safety Information below and Full Prescribing Information.

 

Reference:
1. APTIOM® [prescribing information]. Sunovion Pharmaceuticals Inc., Marlborough, MA, March 2019.

LTC  - Patient Considerations
APTIOM Patient Profile

Jenny, RN

“Giving her medication isn't always easy. The fewer doses, the better.”

Actor portrayal

Treatment Considerations

  • Caregiver of IDD patient looking for a focal seizure treatment that is taken once a day

APTIOM is a once-daily treatment that can be taken whole or crushed, with or without food

APTIOM may not be appropriate for all patients with partial-onset seizures. For additional information regarding APTIOM, please see Full Prescribing Information.

Reference:
1. APTIOM® [prescribing information]. Sunovion Pharmaceuticals Inc., Marlborough, MA, March 2019.

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.