These highlights do not include all the information needed to use BRIVARACETAM INJECTION safely and effectively. See full prescribing information for BRIVARACETAM INJECTION BRIVARACETAM injection, for intravenous use, CV Initial U.S. Approval: 2016

MEDICATION GUIDE Brivaracetam (bri'' a ra' se tam) injection, for intravenous use, CV
This Medication Guide has been approved by the U.S. Food and Drug Administration			Revised: 10/2025
What is the most important information I should know about brivaracetam? Brivaracetam is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep Brivaracetam in a safe place to prevent misuse and abuse. Selling or giving away brivaracetam may harm others and is against the law. Like other antiepileptic drugs, brivaracetam 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 new or worse depression feeling agitated or restless trouble sleeping (insomnia) acting aggressive, feeling angry, or being violent an extreme increase in activity and talking (mania)		attempts to commit suicide new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood
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? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop brivaracetam without first talking to a healthcare provider. Stopping brivaracetam suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).
What is brivaracetam? Brivaracetam is a prescription medicine used to treat partial-onset seizures in people 1 month of age and older. It is not known if brivaracetam is safe and effective in children younger than 1 month of age.
Who should not take brivaracetam? Do not take brivaracetam if you are allergic to brivaracetam or any of the ingredients in brivaracetam injection. See the end of this Medication Guide for a complete list of ingredients in brivaracetam injection.
What should I tell my healthcare provider before starting brivaracetam? Before taking brivaracetam, tell your healthcare provider about all of your medical conditions, including if you : have or had depression, mood problems, or suicidal thoughts or behavior. have liver problems. have abused or been dependent on prescription medicines, street drugs, or alcohol. are pregnant or plan to become pregnant. It is not known if brivaracetam will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking brivaracetam. You and your healthcare provider will have to decide if you should take brivaracetam while you are pregnant. If you become pregnant while taking brivaracetam, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of brivaracetam and other antiepileptic medicines during pregnancy. are breastfeeding or plan to breastfeed. brivaracetam passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take brivaracetam.
Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Brivaracetam may affect the way other medicines work, and other medicines may affect how brivaracetam 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 brivaracetam? Brivaracetam injection can be given to you by intravenous (IV) infusion into your vein, as prescribed by your healthcare provider. If you take too much brivaracetam, call your Poison Control Center or go to the nearest emergency room right away.
What should I avoid while taking brivaracetam? Do not drive or operate machinery until you know how brivaracetam affects you. Brivaracetam may cause drowsiness, tiredness, dizziness, and problems with your balance and coordination.
What are the possible side effects of brivaracetam? Brivaracetam may cause serious side effects, including: See " What is the most important information I should know about brivaracetam?" Nervous system problems. Drowsiness, tiredness, and dizziness are common with brivaracetam, but can be severe. See " What should I avoid while taking brivaracetam?" Brivaracetam can also cause problems with balance and coordination. Mental (psychiatric) symptoms. Brivaracetam 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 brivaracetam, and can be severe. People who take brivaracetam 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. Serious allergic reactions. Stop taking brivaracetam and call your healthcare provider right away if you have any of these signs of a serious allergic reaction: swelling of your face, mouth, lips, gums, tongue, throat, or neck trouble breathing Serious skin rashes. Brivaracetam may cause a severe rash with blisters and peeling skin. This may occur around the mouth, nose, eyes, and genitals or over much of the body. A mild rash may become a serious reaction and may cause death. Call your healthcare provider right away if you have a rash, skin blisters, sores in the mouth, or hives. Do not stop taking brivaracetam without first talking to your healthcare provider.
The most common side effects of brivaracetam in adults include:
	sleepiness dizziness	feeling tired nausea and vomiting
Side effects of brivaracetam 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 brivaracetam. 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 brivaracetam? Store brivaracetam injection at room temperature between 59°F to 86°F (15°C to 30°C). Keep brivaracetam and all medicines out of the reach of children.
General information about the safe and effective use of brivaracetam. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use brivaracetam for a condition for which it was not prescribed. Do not give brivaracetam 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 brivaracetam. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about brivaracetam that is written for health professionals .
What are the ingredients in brivaracetam? Active ingredient: brivaracetam 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.
Distributed by: PAI Pharma Greenville, SC 29605 www.paipharma.com Rev 10/2025 For more information, call PAI Pharma, at 1-800-845-8210.

Revised: 2/2026

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Version: 3

Effective Time: 20260223

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