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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.

About Add-on Therapy

Why take more than one antiepileptic medicine?

If you are experiencing partial-onset seizures on your current antiepileptic medicine, your doctor may recommend switching your medicine or adding another antiepileptic medicine to your treatment to help with seizure control. This additional medicine is called an “add-on therapy” or “adjunctive therapy”.

BRIVIACT® (brivaracetam) CV is a prescription medicine that can be used to treat partial-onset seizures in people 4 years of age and older with epilepsy. In clinical studies, patients who added BRIVIACT to their current antiepileptic treatment had fewer partial-onset seizures compared to patients who were taking a placebo and their current medicine(s). This means that BRIVIACT may provide you with additional seizure control without the need to switch from your current treatment.

Can I afford to take more than one medicine?

Taking more than one medicine does come at an extra cost, but don't let that stop you from achieving your personal best in seizure control. To help make your treatment more affordable, BRIVIACT has savings offers for eligible patients. Checking to see if you're eligible only takes a minute, and you may pay as little as $20 per 30-day supply of BRIVIACT.*

*Eligibility Criteria & Terms: This savings card is not valid for use by patients who are covered by any federal or state funded healthcare program (including, but not limited to, Medicare [Part D and Medigap], Medicaid, any state pharmaceutical assistance program, TRICARE, VA, or DoD). This is not an insurance card.

I'm concerned about additional side effects

It's important to be aware of the benefit and risks of any medicine that your are taking. 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
  • allergic reactions to the ingredients in BRIVIACT

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.

Most of these side effects were reported to be mild to moderate.

Work with your doctor to decide if BRIVIACT may be right for you. Report side effects you may experience with BRIVIACT to the FDA at 1-800-FDA-1088. You may also report side effects to UCB, Inc. at UCBCares (1-844-599-CARE [2273]).

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.