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.

Your Role as a Caregiver

The do's and don'ts for helping during a seizure

When a friend or family member has a seizure, knowing what to do and what not to do, can make a difference.

How BRIVIACT® (brivaracetam) CV may help

If the doctor has prescribed BRIVIACT for your loved one, it's important to know that BRIVIACT can be taken alone or as an add-on therapy that is taken in addition to current antiepileptic medicine(s). BRIVIACT is a prescription medicine that can be used to treat partial-onset seizures in people 4 years of age and older with epilepsy, and may provide additional seizure control.

In clinical studies, patients who added BRIVIACT to their current antiepileptic treatment had fewer partial-onset seizures, compared to patients who took a placebo with their current medicine(s).

If your loved one is still experiencing partial-onset seizures on their current treatment, ask your doctor about BRIVIACT.

BRIVIACT may cause serious side effects including suicidal thoughts or actions; drowsiness; tiredness; dizziness; balance and coordination problems; mood and behavior changes including irritability, anxiety, and psychotic symptoms; and allergic reactions to ingredients in BRIVIACT.

The most common side effects of BRIVIACT include sleepiness, dizziness, feeling tired, and nausea and vomiting.

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

Partnering with your doctor in treatment decisions

As a caregiver, you play an important role in the treatment decision process. The information you share can be useful in helping the doctor make informed decisions about your loved one's treatment. Work together to understand the benefits and possible side effects of epilepsy medicines or other treatments. Think about what works best for your loved one.

Promoting well-being when caring for a loved one

A person who has been diagnosed with epilepsy may experience a range of emotions such as anger, frustration, and depression. Concern for the future and negative responses from friends and family can leave a person feeling vulnerable and alone. Depression is more common in individuals with epilepsy than it is in the general population. This could be due to psychosocial factors, the seizures themselves, and/or to seizure medication.

As a caregiver, it’s important to realize that mood changes can be a side effect of seizure medication. It can also be that a person with epilepsy is feeling distressed, isolated, frustrated, or angry and may act out negatively as a result. Being patient, encouraging the person to talk about his or her feelings with someone, and recording behavior changes to share with the doctor, are all helpful ways to promote well-being. If a person with epilepsy seems uncharacteristically depressed, encourage a visit to the doctor to discuss these feelings. The doctor may adjust the seizure medication in order to determine whether these issues are due to medication side effects.

Being patient, encouraging the person to talk about his or her feelings with someone, and recording behavior changes to share with the doctor are all helpful ways to promote well-being.

Encouraging Participation

People with epilepsy can participate in most recreational activities and sports. These activities can enhance well-being and maintain health. Some activities are considered too dangerous and others pose some risk due to the possibility of head injury. Participation in recreational activities and sports should be discussed with the doctor.

Activities to
enjoy include:

  • tennis
  • volleyball
  • track and field
  • jogging
  • cross-country skiing
  • basketball
  • hiking
  • baseball
  • golfing

Sports that pose
some risk:

  • hockey
  • soccer
  • karate
  • football
  • boxing

Activities that are
considered dangerous:

  • SCUBA diving
  • rock climbing
  • parachuting

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

Working with your loved one

If you have concerns about your loved one, talk to them about it. Encourage your loved one to talk with the neurologist or epileptologist.

The following tools can help you and your loved one make the most of your visits with the 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.