If you’re living with epilepsy, seizure freedom is your goal. APTIOM may make it a reality.
Talk to your doctor about whether APTIOM could be right for you.
~9 out of 10
insured people have coverage for APTIOM nationwide2*
*Among the insured population, 85% of lives covered across Commercial (86%), Medicare (100%), and Medicaid (75%). Coverage=drug covered on formulary on any
tier, with or without restriction. Individual costs and benefits may vary according to plan—this is not a guarantee of coverage. Please check directly with health plans
to confirm coverage for individual patients as formularies do change and individual plan designs may vary.2
Most people who start APTIOM, stay on it
About 70% of people were able to stay on APTIOM*
The effectiveness and safety of APTIOM as an add-on were studied over the course of 12 weeks in 3 clinical trials of about 1400 people with
hard-to-treat focal seizures. These people were taking 1 to 3 antiseizure medicines before the study but still having
focal seizures when they enrolled. About 1000 of them added APTIOM to their current antiseizure medicine(s), and the rest added a placebo
(sugar pill).
*At the highest dose of APTIOM studied in clinical trials when added to other antiseizure medicine(s).
Effectiveness
Proven effective in clinical trials
4 out of 10 adults had their seizures cut by at least half when APTIOM was added*
*During the 12-week period, up to 41% of people who took the highest dose of APTIOM saw their number of seizures each month reduced by at least half,
compared to 21% of adults who took the placebo. At the same dose of APTIOM, 35% of people had their number of monthly seizures reduced by less than half (compared
to 46% of people taking placebo) and 24% of people had more seizures each month (compared to 33% of people taking placebo). Individual results may vary.
It is not known if APTIOM is safe and effective in children under 4 years of age. Do not take APTIOM if you are allergic to eslicarbazepine acetate, any of the
other ingredients in APTIOM, or oxcarbazepine.
Side Effects
Established safety in people ages 4 and up
The most common side effects from taking APTIOM by itself or with other seizure medicines include dizziness, sleepiness, nausea, headache, double vision, vomiting,
feeling tired, problems with coordination, blurred vision, and shakiness. It is not known if APTIOM is safe and effective in children under 4 years of age.
Aggression-related and psychiatric side effects with APTIOM were comparable to placebo (sugar pill).
Less than 2% of adults taking APTIOM experienced memory loss or lack of attention.* Other side effects related to thinking were even more
uncommon.
*Compared to less than 1% of adults taking placebo who experienced memory loss and lack of attention.
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. Some medicines can also cause low sodium in your blood. Be sure to tell your health care provider about all
the other medicines that you are taking.
Antiepileptic drugs, including APTIOM, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your doctor right away if you
have any of the following symptoms, especially if they are new, worse, or worry you: 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.
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.
These are not all the possible side effects of APTIOM. Please review additional
Important Safety Information for APTIOM.
Dosing
Dosing options to fit your needs
People starting APTIOM may reach an effective dose in as early as 1 week
APTIOM is taken:
Once-daily
Whole or crushed
With or without food
As with all medicines, it’s important to take APTIOM according to your doctor’s instructions. APTIOM is available in 200 mg, 400 mg, 600 mg, and
800 mg dosage strengths. Your doctor will decide which dosage strength may be right for you.
*
Restrictions and eligibility requirements apply. Not all patients will qualify to receive a 14-day Trial Voucher, Savings Card, or High-deductible Discount Card.
Formulary data provided by DR/Decision Resources, LLC and is current as of May 2023.
Important Safety Information and
Indication for APTIOM
It is not known if APTIOM is safe and effective in children under 4 years of age.
Important Safety Information and
Indication for APTIOM
It is not known if APTIOM is safe and effective in children under 4 years of age.
Do not take APTIOM if you are allergic to eslicarbazepine acetate, any of the other ingredients in APTIOM, or oxcarbazepine.
Suicidal behavior and ideation: Antiepileptic drugs, including APTIOM, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call your doctor right away if you have any of the following symptoms, especially if they are new, worse, or worry you: 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. Some medicines can also cause low sodium in your blood. Be sure to
tell your health care provider about all the other medicines that you are taking.
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 health care 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 health care provider.
Especially tell your health care 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 health care 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 health care provider about the best birth control method
to use. APTIOM may harm your unborn baby. APTIOM passes into breast milk. Tell your health care provider if you are pregnant or plan to become pregnant, or are
breastfeeding or plan to breastfeed. You and your health care provider will decide if you should take APTIOM. If you become pregnant while taking APTIOM, talk to your
health care 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.
INDICATION:
Aptiom® (eslicarbazepine acetate) is a prescription medicine to treat partial-onset seizures in patients 4 years of age and older.
