Uses of Brivaracetam Injection:

• It is used to treat seizures.

What do I need to tell my doctor BEFORE I take Brivaracetam Injection?

• If you are allergic to brivaracetam injection; any part of brivaracetam injection; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are on dialysis, talk with your doctor.

This is not a list of all drugs or health problems that interact with brivaracetam injection.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take brivaracetam injection with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Brivaracetam Injection?

For all patients taking brivaracetam injection:

• Tell all of your health care providers that you take brivaracetam injection. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how brivaracetam injection affects you.
• Do not stop taking brivaracetam injection all of a sudden without calling your doctor. You may have a greater risk of seizures. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
• This medicine may cause behavior changes and mental or mood problems. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

Children:

• This medicine is not approved for use in children. However, the doctor may decide the benefits of taking brivaracetam injection outweigh the risks. If your child has been given brivaracetam injection, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving brivaracetam injection to your child.

How is this medicine (Brivaracetam Injection) best taken?

Use brivaracetam injection as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given into a vein for a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• If seizures are worse or not the same after starting brivaracetam injection.
• Hallucinations (seeing or hearing things that are not there).
• Change in balance.
• Trouble walking.
• Clumsiness.
• Not able to control eye movements.
• Patients who take brivaracetam injection may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.

What are some other side effects of Brivaracetam Injection?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Brivaracetam Injection?

• If you need to store brivaracetam injection at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about brivaracetam injection, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.