What is BRIVIACT?
BRIVIACTÂ® (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 aboutÂ 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 theÂ law.
Like other antiepileptic drugs, BRIVIACT may cause suicidal thoughts or actions in a very small number of people, about 1Â in 500Â people takingÂ it.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, orÂ worryÂ you:
- thoughts about suicide orÂ dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated orÂ restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, feeling angry, or beingÂ violent
- acting on dangerous impulses
- an extreme increase in activity and talkingÂ (mania)
- other unusual changes in behavior orÂ mood
Do not stop BRIVIACT without first talking to a healthcareÂ provider.
- Stopping BRIVIACT suddenly can cause seriousÂ problems.
- Stopping a seizure medicine suddenly can cause seizures that will not stop (statusÂ epilepticus).
Who should not take BRIVIACT?
Do not take BRIVIACT if you are allergic to brivaracetam or any of the inactive ingredients inÂ BRIVIACT.
What should I tell my healthcare provider before startingÂ 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 orÂ behavior
- have liver problems
- have abused or been dependent on prescription medicines, street drugs, orÂ alcohol
- have any other medical problems
- are pregnant or plan to become pregnant. It is not known if BRIVIACT will harm your unbornÂ baby.
- are breastfeeding or plan to breastfeed. It is not known if BRIVIACT passes into your breastÂ milk.
What should I avoid while takingÂ 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 ofÂ BRIVIACT?
BRIVIACT may cause serious side effects, including:
- See âWhat is the most important information I should know about BRIVIACT?â
- Nervous system problems. Drowsiness, tiredness, and dizziness are common with BRIVIACT, but can be severe. See âWhat should I avoid while taking BRIVIACT?â BRIVIACT can also cause problems with balance andÂ 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 unusualÂ behavior.
The most common side effects of BRIVIACT include:
- 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 UCBCaresÂ® (1-844-599-CARE ).
Please see additional patient information in the 5059853532. This information does not take the place of talking with your healthcare provider about your condition or your treatment. For more information, go to (585) 590-5191 or call 1-844-599-2273.