Aptiom | (eslicarbazepine acetate) 

Medication Class: anticonvulsant, antiepileptic  
Similar Drugs: Trileptal (oxcarbazepine), Tegretol (carbamazepine)
Manufacturer: Sunovion
Approval date: November 8, 2013

What is Aptiom and its mechanism of action?

Aptiom (eslicarbazepine acetate) is a prodrug (inactive form) which is converted into eslicarbazepine (active form). It is used along with other medications to treat seizures. Aptiom's exact mechanism of action is unknown. It may block voltage-gated sodium channels which regulate the movement of sodium ions into and out of neurons. Sodium ion are important for nerves to send signals to other neurons and organs. During a seizure the brain abnormally and excessively sends signals across neurons. By reducing the ability of neurons to send signals Aptiom prevents repetitive neuron activity in the brain and reduces seizure activity. 

What is Aptiom used for treating?

Aptiom is used for treating partial-onset seizures in combination with other drugs. 

How effective is Aptiom?

Aptiom 400 mg, 800 mg, and 1200 mg were compared to a placebo in patients that experienced 4 or more seizures within a 28-day period. Patients were started on either Aptiom 400 mg or 800 mg, and dosage was increased by 400 mg increments after about one or two weeks. Aptiom 400 mg did not show any significant reductions in seizures compared to placebo. Within a 28-day period here was a reduction in seizure frequency by 36% for Aptiom 800 mg, 39% for Aptiom 1200 mg, and 15% for placebo. In an another study there was a reduction in seizure frequency by 33% for Aptiom 800 mg, 28% for Aptiom 1200 mg, and 6% for placebo within a 28-day period,. 

Interesting Facts about Aptiom

• Aptiom is used as an add-on medication to help in the treatment of seizures
• Aptiom is a prodrug which means that it must be broken down into its active form in order for it to be effective. 
• Anyone with an allergic reaction to Aptiom may have an allergic reaction with oxcarbazepine and vice versa.

What are side effects of Aptiom?

Common: nausea, vomiting, dizziness, somnolence (drowsiness), headache, diplopia (double vision), fatigue, vertigo, ataxia (uncoordinated muscle movement), blurred vision, and tremor.

Serious: drug induced eosinophilia, angioedema, suicidal thoughts, serious skin reactions (e.g., Stevens Johnson Syndrome , liver injury, and serious allergic reactions (anaphylaxis), and hyponatremia (low sodium)

What is the dosage of Aptiom?

Aptiom is available in 200 mg, 400 mg, 600 mg, and 800 mg tablets. The initial starting dose is 400 mg once daily. The dosage should be increased to 800 mg (maintenance dose) after about 1 week. May increase to the maximum dosage of 1200 mg daily after 1 week at 800 mg daily. 

What are Aptiom drug interactions?

Some possible drug-drug interactions that can affect the benefits of Aptiom include:

• Carbamazepine: May decrease the blood concentration of Aptiom, dose adjustment may be needed for Aptiom or carbamazepine for effectiveness.
• Phenytoin, Primidone: May increase the breakdown of Aptiom requiring higher dosage of Aptiom for effectiveness.
• Phenobarbital: May increase the breakdown of Aptiom requiring higher dosage of Aptiom for effectiveness.
• Hormonal Contraceptives: Aptiom may decrease effectiveness of birth control pills and similar contraceptives  Females treated with Aptiom should use alternative non-hormonal birth control methods.

Aptiom may increase blood levels of omeprazole, phenytoin, and clobazam by reducing their breakdown in the liver. Aptiom may reduce blood levels of simvastatin and other drugs broken down by CYP3A4 liver enzymes.

What are warnings and precautions for Aptiom?

Some warnings and precautions for Aptiom include:

• Suicidal behavior or thoughts
• Neurological side effects such as dizziness and drowsiness occur so driving or operating machinery should be avoided.
• Slow withdrawal of Aptiom if discontinuing because abrupt discontinuation of may cause seizures.
• May cause significant liver injury.

Pregnancy: Aptiom is pregnancy category C which means it has not been adequately evaluated in pregnant women. 

Pregnant patients taking Aptiom should enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334 (toll-free) or visit the pregnancy registry.

Nursing Mothers: Aptiom is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants mothers should discontinue nursing or discontinue Aptiom. 

What is the cost of Aptiom?

The average wholesale price of a bottle of 30 tablets for Aptiom 800 mg is about $720. One tablet cost about $24. 

How to obtain prescription assistance for Aptiom?

Below is a resource that can be used to help with the cost of Aptiom:

Aptiom Co-pay Card

References

Aptiom Prescribing Information (Package Insert)