Briviact Medication Guide Information

Read the Medication Guide that comes with BRIVIACT before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about BRIVIACT.

Pronunciation: (briv ee akt)
Generic: (brivaracetam)

Availability: tablets, oral solution, and injection for intravenous use

What is the most important information I should know about This Medication?

This Medication is a federally controlled substance (insert schedule after DEA review) because it can be abused or lead to dependence. Keep This Medication in a safe place to prevent misuse and abuse. Selling or giving away This Medication 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 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 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).

What is BRIVIACT?

BRIVIACT is a prescription medicine that is used with other medicines to treat partial-onset seizures in people 16 years of age and older with epilepsy. BRIVIACT may be given in the vein (intravenously) when This Medication is not able to be taken by mouth.

It is not known if This Medication is safe and effective in children younger than 16 years of age.

Who should not take BRIVIACT?

Do not take This Medication if you are allergic to brivaracetam or any of the inactive ingredients in This Medication. See the end of this Medication Guide for a complete list of ingredients in This Medication.

What should I tell my healthcare provider before starting BRIVIACT?

Before taking This Medication, 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
Have any other medical problems
Are pregnant or plan to become pregnant. It is not known if This Medication will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking This Medication. You and your healthcare provider will have to decide if you should take This Medication while you are pregnant. If you become pregnant while taking This Medication, 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 This Medication and other antiepileptic medicines during pregnancy.
Are breastfeeding or plan to breastfeed. It is not known if This Medication passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take This Medication.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. This Medication may affect the way other medicines work, and other medicines may affect how This Medication 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 This Medication?

Take This Medication exactly as your healthcare provider tells you.
Your healthcare provider will tell you how much BRIVIACT to take and when to take it.
Your healthcare provider may change your dose if needed. Do not change your dose without talking to your healthcare provider.
Take This Medication with or without food.
Swallow BRIVIACT tablets whole with a liquid. Do not chew or crush This Medication tablets before swallowing.
If your healthcare provider has prescribed This Medication oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of This Medication oral solution. Do not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
This Medication injection can be given to you by intravenous (IV) infusion into your vein, as prescribed by your healthcare provider.
If you take too much This Medication, call your Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away.

What should I avoid while taking This Medication?

Do not drive or operate machinery until you know how This Medication affects you. This Medication may cause drowsiness, tiredness, dizziness, and problems with your balance and coordination.

What are the possible side effects of This Medication?

BRIVIACT may cause serious side effects, including:

See “What is the most important information I should know about This Medication?”
Nervous system problems. Drowsiness, tiredness, and dizziness are common with BRIVIACT, but can be severe. See “What should I avoid while taking This Medication?” BRIVIACT can also cause problems with balance and coordination.
Mental (psychiatric) symptoms. This Medication 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 This Medication, and can be severe. People who take This Medication 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 This Medication include:

Sleepiness
Dizziness
Feeling tired
Nausea and vomiting

These are not all the possible side effects of This Medication. 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?

Store This Medication at room temperature between 59°F to 86°F (15°C to 30°C).
Do not freeze This Medication oral solution.
Safely throw away any opened bottle of This Medication oral solution after 5 months of first opening the bottle, even if there is medicine left in the bottle.
Keep This Medication and all medicines out of the reach of children.

General information about the safe and effective use of This Medication.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use This Medication for a condition for which it was not prescribed. Do not give This Medication 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 This Medication. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about This Medication that is written for health professionals.

What are the ingredients in This Medication?

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:

10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide
25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide
50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide
75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide

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), glacial acetic acid, sodium chloride, and water for injection.

Manufactured for UCB, Inc., Smyrna, GA 30080. This Medication is a registered trademark of the UCB Group of Companies. ©2016, UCB, Inc., Smyrna, GA 30080. All rights reserved. For more information, go to www.BRIVIACT.com or call 1-844-599-2273.

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