EFGSI Logo

Aptiom (AntiEpileptic Drug)

The Epilepsy Foundation of Greater Southern Illinois does not endorse any product, but want to make the information available for individuals to make informed decisions in their epilepsy care.

Sunovion Pharmaceuticals Inc., announced that Aptiom® (eslicarbazepine acetate), a once-daily antiepileptic drug (AED) indicated for use as adjunctive treatment of partial-onset seizures, is now available by prescription in pharmacies across the United States. On November 8, 2013, the Food and Drug Administration (FDA) approved APTIOM.

As you know, approximately one-third of people with epilepsy in the United States are unable to adequately control their seizures. APTIOM offers physicians and patients living with partial-onset seizures a new once-daily adjunctive treatment option that may improve seizure control for some patients. 

Since your organization is a leading resource for patients in the area, I want to make sure you receive the press release announcing the launch of APTIOM and request that you consider including APTIOM in the treatment section of your website so patients and caregivers have the latest information on available therapies. 

The press release can be accessed here.

 

Indication

APTIOM (eslicarbazepine acetate) is a prescription medicine used with other medicines to treat partial-onset seizures.

Important Safety Information

Do not take APTIOM if you are allergic to eslicarbazepine acetate, any of the other ingredients in APTIOM, or oxcarbazepine.

Suicidal behavior and ideation: APTIOM may cause suicidal thoughts or actions, depression, or mood problems. Call your doctor right away if you experience these or any other effects or reactions: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.

Allergic reactions: APTIOM may cause serious skin rash or other serious allergic reactions that may affect organs or other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your doctor right away if you experience any of the following symptoms: swelling of the face, eyes, lips, or tongue; trouble swallowing or breathing; hives; fever, swollen glands, or sore throat that do not go away or come and go; painful sores in the mouth or around your eyes; yellowing of the skin or eyes; unusual bruising or bleeding; severe fatigue or weakness; severe muscle pain; or frequent infections or infections that do not go away.

Low salt (sodium) levels in the blood: APTIOM may cause the level of sodium in your blood to be low. Symptoms may include nausea, tiredness, lack of energy, irritability, confusion, muscle weakness or muscle spasms, or more frequent or more severe seizures.

Nervous system problems: APTIOM may cause problems that can affect your nervous system, including dizziness, sleepiness, vision problems, trouble concentrating, and difficulties with coordination and balance. APTIOM may slow your thinking or motor skills. Do not drive or operate heavy machinery until you know how APTIOM affects you.

Liver problems: APTIOM may cause problems that can affect your liver. Symptoms of liver problems include yellowing of your skin or the whites of your eyes, nausea or vomiting, loss of appetite, stomach pain, or dark urine.

Most common adverse reactions: The most common side effects in patients taking APTIOM include dizziness, sleepiness, nausea, headache, double vision, vomiting, feeling tired, problems with coordination, blurred vision, and shakiness.

Drug interactions: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking APTIOM with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you take oxcarbazepine, carbamazepine, phenobarbital, phenytoin, primidone, clobazam, omeprazole, simvastatin, rosuvastatin, or birth control medicine.

Discontinuation: Do not stop taking APTIOM without first talking to your healthcare provider. Stopping APTIOM suddenly can cause serious problems.

Pregnancy and lactation: APTIOM may cause your birth control medicine to be less effective. Talk to your healthcare provider about the best birth control method to use. APTIOM may harm your unborn baby. APTIOM passes into breast milk. Tell your healthcare provider if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. You and your healthcare provider will decide if you should take APTIOM. If you become pregnant while taking APTIOM, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

Get medical help right away if you have any of the symptoms listed above.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information please see the APTIOM Medication Guide and full Prescribing Information at Aptiom.com

APTIOM is under license from BIAL. Bial_logo_4c