BRIVIACT® (brivaracetam) CV is a prescription medicine that can be used to treat partial-onset (focal) seizures in people 4 years of age and older. It is not known if BRIVIACT injection is safe for use in children. Children 4 years of age and older should only take BRIVIACT by mouth. BRIVIACT injection is only for use in people 16 years of age and older and may be given in the vein (intravenously) when BRIVIACT is not able to be taken by mouth. It is not known if BRIVIACT is safe and effective in children younger than 4 years of age.
BRIVIACT® (brivaracetam) CV oral formulations are prescription medicines that can be used to treat partial-onset (focal) seizures in people 4 years of age and older.

About Epilepsy

I've been diagnosed with epilepsy; what does this mean?

Your brain is made up of billions of cells called neurons that communicate using electrical and chemical signals to control how your body works. Seizures can happen when these electrical and chemical signals are not working the way they normally do. Not all seizures, however, are a result of epilepsy. A seizure is a single episode, while epilepsy is a disease involving unprovoked seizures over time. Unprovoked seizures are not linked to a recent or current incident affecting the brain such as brain injury, alcohol or drug withdrawal, stroke, brain infection, or another identifiable acute cause.

You may be diagnosed with epilepsy if you experience any of the following:

  • At least two unprovoked seizures more than 24 hours apart
  • One unprovoked seizure and a probability of more seizures similar to the general recurrence risk after two unprovoked seizures (at least 60% over the next 10 years)
  • A diagnosis of an epilepsy syndrome

You are not alone. Approximately 50 million people around the world have epilepsy.

UCB, the maker of BRIVIACT, also makes several of the most commonly prescribed epilepsy medicines. To learn more about all our antiepileptic medicines, and free support resources for patients and families living with epilepsy, visit the UCB website.

What are partial-onset seizures?

The type of seizures you experience depends on where the abnormal electrical activity in your brain begins. When abnormal electrical activity begins in only one part of the brain, it is called a partial-onset seizure.

Partial-onset seizures include:

Simple partial seizures, where a person remains fully aware (does not lose consciousness). He/she may:

  • Experience muscle jerking or stiffening
  • Smell, taste, see, hear, or feel things that are not there
  • Experience a sudden sense of fear, depression or happiness
  • Have changes in heart rate or breathing, sweating, or goose bumps

Complex partial seizures, where a person loses awareness (either partially or fully). He/she may:

  • Stare blankly or may seem to be daydreaming
  • Pick at the air or their clothing
  • Repeat words or phrases
Illustrative example of staring blankly during complex partial seizures
Complex partial seizures

Stare blankly or may seem to be daydreaming

Illustrative example of picking at the air or their clothing from complex partial seizures
Complex partial seizures

Pick at the air or their clothing

PARTIAL SEIZURES & REGIONS OF THE BRAIN

Impact of partial seizures depending on starting brain region
  • Seizures that start in the frontal lobe may cause behaviors such as running, screaming, fear, anger and aggression.
  • Seizures in the olfactory bulb may cause changes in sense of smell.
  • Seizures in the temporal lobe may disrupt speech and cause automatic, repetitive moments like chewing.
  • Seizures in the sensory cortex may cause illusions of sound, such as ringing or music.
  • Seizures in the occipital lobe may cause visual hallucinations.
  • Seizures in the temporal lobe may alter consciousness and mood. The person may stare blankly, appear afraid, or be unresponsive.

How are partial-onset seizures treated?

Controlling seizures with medicine

Many people are able to control their seizures on one antiepileptic medicine, but when seizures cannot be managed on one medicine alone, another medicine may need to be added.

Turning to an add-on therapy

Some people with epilepsy will continue to have seizures even though they are taking antiepileptic drugs. When one medicine is not enough to control partial-onset seizures, your doctor may recommend an “add-on” therapy, also called “adjunctive” therapy. An adjunctive antiepileptic medicine is added to your current treatment of 1 or more antiepileptic medicines and may be able to provide additional partial-onset seizure control. Studies suggest about 50% of patients will need an additional antiepileptic drug after their first medication.

Taking your time back from seizures may mean working with your doctor to find the combination of antiepileptic medicines that work for you. If you are still experiencing partial-onset seizures on your current medicine, ask your doctor about your treatment options.

How can I find the right doctor for me?

Your family doctor is an important part of your healthcare team, but to get treatment that is better tailored to epilepsy and your personal needs, you should visit a neurologist or an epileptologist. A neurologist is a medical doctor who is specially trained to diagnose and treat brain and nervous system disorders. An epileptologist is a neurologist who has gone through specialized training in epilepsy and its treatment.

Partnering with your healthcare provider

Some people find talking to a healthcare provider intimidating, but remember that he or she is there to help. You both share the same goal of seizure control, and the first step to getting there is to have an open and honest conversation.

The following tools can help you make the most of your visits with your healthcare provider:

IMPORTANT SAFETY INFORMATION

What is BRIVIACT?

BRIVIACT® (brivaracetam) CV is a prescription medicine used to treat partial-onset seizures in people 4 years of age and older.

  • It is not known if BRIVIACT injection is safe for use in children.
  • Children 4 years of age and older should only take BRIVIACT by mouth.
  • BRIVIACT injection is only for use in people 16 years of age and older and may be given in the vein (intravenously) when BRIVIACT is not able to be taken by mouth.

It is not known if BRIVIACT is safe and effective in children younger than 4 years of age.

What is the most important information I should know about BRIVIACT?

BRIVIACT is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep BRIVIACT in a safe place to prevent misuse and abuse. Selling or giving away BRIVIACT may harm others and is against the law.

Like other antiepileptic drugs, BRIVIACT may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, feeling angry, or being violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

Do not stop BRIVIACT without first talking to a healthcare provider.

  • Stopping BRIVIACT suddenly can cause serious problems.
  • Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).

Who should not take BRIVIACT?

Do not take BRIVIACT if you are allergic to brivaracetam or any of the inactive ingredients in BRIVIACT.

What should I tell my healthcare provider before starting BRIVIACT?

Before taking BRIVIACT, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have liver problems
  • have abused or been dependent on prescription medicines, street drugs, or alcohol
  • have any other medical problems
  • are pregnant or plan to become pregnant. It is not known if BRIVIACT will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if BRIVIACT passes into your breast milk.

What should I avoid while taking BRIVIACT?

Do not drive or operate heavy machinery until you know how BRIVIACT affects you. BRIVIACT may cause drowsiness, tiredness, dizziness, and problems with your balance and coordination.

What are the possible side effects of BRIVIACT?

BRIVIACT may cause serious side effects, including:

  • See “What is the most important information I should know about BRIVIACT?”
  • Nervous system problems. Drowsiness, tiredness, and dizziness are common with BRIVIACT, but can be severe. See “What should I avoid while taking BRIVIACT?” BRIVIACT can also cause problems with balance and coordination.
  • Mental (psychiatric) symptoms. BRIVIACT can cause mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. Irritability and anxiety are common with BRIVIACT, and can be severe. People who take BRIVIACT can also get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs), and unusual behavior.

The most common side effects of BRIVIACT include:

  • sleepiness
  • dizziness
  • feeling tired
  • nausea and vomiting

Side effects of BRIVIACT in children 4 to less than 16 years of age are similar to those seen in adults.

These are not all the possible side effects of BRIVIACT. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to UCB, Inc. at UCBCares® (1-844-599-CARE [2273]).

Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment. For more information, go to www.BRIVIACT.com or call 1-844-599-2273.