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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.

Understanding Partial-Onset Seizures

Get the facts about partial-onset seizures

Education can be empowering. If you care for someone living with partial-onset seizures, you want to know all that you can about the condition, what to expect, and what someone with partial-onset seizures may experience. Getting the facts means that you'll be better equipped to help.

What are partial-onset seizures?

Partial seizures occur when abnormal electrical activity begins in only one part of the brain.

Partial-onset seizures include:

  • Simple partial seizures, where a person remains fully aware and does not lose consciousness. He/she may experience muscle jerking or stiffening, or sense things that are not actually present.
  • Complex partial seizures, where a person loses awareness, stares blankly, or may seem to be daydreaming. He/she may pick at their clothing or repeat words or phrases.

Share the facts about partial-onset seizures

One of the challenges facing those with epilepsy is the public's lack of knowledge about the condition. Misconceptions based on historical perceptions, lack of public awareness, and inaccurate television and movie portrayals lead to incorrect assumptions about epilepsy. Sometimes these create the misguided perception that those with epilepsy are mentally disabled or are more likely to be violent. Sometimes the forms seizures take can be mistaken to be deliberate acts, but they are not.

As a group, people with epilepsy have the same range of intelligence as the general public. As in any segment of the population, people with epilepsy have varying intellectual abilities.

Through public awareness and education, attitudes towards the condition are slowly changing. While it may not be necessary to discuss a person's epilepsy with everyone, thought should be given as to who should be told. The decision may depend partially on:

  • The type and frequency of the seizures
  • How close the relationship is
  • Whether or not the person with epilepsy is likely to have a seizure in the person's company.

Caregivers can also help build a support system for the individual within his or her community that involves family, friends, neighbors, and professionals.

By learning about epilepsy and by sharing that information with others, caregivers can both help people to better understand the condition and increase awareness on how to assist a person who is having a seizure.

It has become accepted knowledge that many brilliant historical figures had epilepsy, including Vincent van Gogh, Fyodor Dostoyevsky, and Isaac Newton.

A CAREGIVER'S GUIDE

This guide can help you collect useful information to share with your loved one's neurologist or epileptologist.

As a caregiver, you're in the unique position of being able to observe what your loved one is experiencing. The information below can help you identify what you should be looking for, and the patterns you should be noting and communicating to your loved one's healthcare team. Consider writing down what you observe in a journal that you can share with your loved one's healthcare team.

  • Is there a pattern to your loved one's recent seizures? (Think of any changes in the number of seizures, how long they last, or what the seizures look like. Bring a video if possible).
  • What event or activity was your loved one involved in before the seizure? (Triggers can include lack of sleep, stress, nutrition, flashing lights or use of alcohol).
  • Did your loved one take their medication as prescribed before the seizure?
  • Are the current antiepileptic medicines your loved one is taking helping to control the partial-onset seizures? Tell the doctor the number and types of seizures your loved one is still having.
  • Is your loved one having possible side effects from their current antiepileptic medicine(s)? Tell the doctor which side effects interfere with daily activities, or which are the most difficult to cope with.
  • Do you want to learn more about other antiepileptic medicines?
  • Do you have any questions since your last visit?

The content above was adapted from Epilepsy: A Guide for Professionals and Caregivers, © Edmonton Epilepsy Association, 2011. Edmonton, Alberta, Canada.

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.