BRIVIACT- brivaracetam tablet, film coated
BRIVIACT- brivaracetam solution
BRIVIACT- brivaracetam injection, suspension
BRIVIACT® (briv ee akt) CV
tablets, oral solution, and injection for intravenous use
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:
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
How can I watch for early symptoms of suicidal thoughts and actions?
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop BRIVIACT without first talking to a healthcare provider.
What is BRIVIACT?
BRIVIACT is a prescription medicine used to treat partial-onset seizures in people 1 month of age and older.
It is not known if BRIVIACT is safe and effective in children younger than 1 month of age.
Who should not take BRIVIACT?
Do not take BRIVIACT if you are allergic to brivaracetam or any of the ingredients in BRIVIACT. See the end of this Medication Guide for a complete list of 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:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRIVIACT may affect the way other medicines work, and other medicines may affect how BRIVIACT works. Do not start a new medicine without first talking with your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
How should I take BRIVIACT?
Do not drive or operate machinery until you know how BRIVIACT affects you. BRIVIACT may cause drowsiness, tiredness, dizziness, and problems with your balance and coordination.
BRIVIACT may cause serious side effects, including:
The most common side effects of BRIVIACT in adults include:
Side effects of BRIVIACT in children 1 month 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.
How should I store BRIVIACT?
Keep BRIVIACT and all medicines out of the reach of children.
General information about the safe and effective use of BRIVIACT.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRIVIACT for a condition for which it was not prescribed. Do not give BRIVIACT to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about BRIVIACT. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about BRIVIACT that is written for health professionals.
What are the ingredients in BRIVIACT?
Active ingredient: brivaracetam
Tablet inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, and magnesium stearate. The tablet film coating contains the inactive ingredients listed below:
Oral solution inactive ingredients: sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water.
Injection inactive ingredients: sodium acetate, trihydrate (1.64 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9.00 mg/mL), and water for injection.
Manufactured for UCB, Inc., Smyrna, GA 30080.
BRIVIACT® is a registered trademark of the UCB Group of Companies. ©2021, UCB, Inc., Smyrna, GA 30080. All rights reserved.
For more information, go to www.BRIVIACT.com or call 1-844-599-2273.
This Medication Guide has been approved by the U.S. Food and Drug Administration