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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.

What is BRIVIACT

What does “take your time back from seizures” mean to you?

Seizures may be a part of your life, but your life is so much more than your condition. If you are missing out on what matters because your seizures are not under control, you have the right to expect more from your treatment. Everyone's treatment goals are different, and taking your time back from seizures means finding a treatment plan that helps you achieve your personal best in seizure control. When considering another option to treat your partial-onset seizures, you and your doctor may look for a treatment that offers such things as:

  • A medicine that helps reduce the frequency of partial-onset seizures
  • A treatment that can be taken alone without other antiepileptic medicines
  • Additional seizure control without having to give up the benefits of your current treatment
  • A treatment that doesn't require increased doses over several weeks.

What is BRIVIACT and could it be right for me?

Controlling your partial-onset seizures may mean taking one or more antiepileptic medicines. BRIVIACT is a prescription medicine that can be used to treat partial-onset seizures in people 4 years of age and older with epilepsy.

BRIVIACT may:

  • Reduce the number of partial-onset seizures in people 4 years of age and older with epilepsy
  • Provide additional seizure control:
    • without having to give up the benefits of your current antiepileptic medicine(s)
    • even if you have tried or are taking multiple antiepileptic medicines

In clinical trials:

  • BRIVIACT was added to 1 to 2 common antiepileptic medicines, including DEPAKENE® (valproic acid), Dilantin® (phenytoin), KEPPRA® (levetiracetam), LAMICTAL® (lamotrigine), Lyrica® (pregabalin), phenobarbital, Tegretol® (carbamazepine), Topamax® (topiramate), Trileptal® (oxcarbazepine), VIMPAT® (lacosamide), and Zonegran® (zonisamide).
  • Some patients were also being treated with vagal nerve stimulation (VNS)
  • The most common side effects of BRIVIACT include sleepiness, dizziness, feeling tired, and nausea and vomiting. Most of these side effects were reported to be mild to moderate.

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

Starting Day One with BRIVIACT:

  • Your doctor will tell you how much BRIVIACT to take and when to take it. You start with the full recommended dose from day one. BRIVIACT does not require titration – which means that you do not need to increase your dose over several weeks. See Taking BRIVIACT for complete information on taking BRIVIACT.

How does BRIVIACT work?

The exact way that BRIVIACT works is not yet fully understood, but it is thought that BRIVIACT reduces the frequency of partial-onset seizures by binding to synaptic vesicle protein 2A (SV2A) in the brain.

KEPPRA® and KEPPRA XR® are registered trademarks of the UCB Group of Companies. VIMPAT® is a registered trademark used under license from Harris FRC Corporation. All other trademarks are property of their respective owners.

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.