Brivaracetam Injection

Brivaracetam injection is used to treat partial onset seizures (seizures that involve only one part of the brain) in people who cannot take oral medication. Brivaracetam is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Brivaracetam injection comes as a solution (liquid) to be injected intravenously (into a vein) over a period of 2 to 15 minutes. It is given twice a day for as long as you are unable to take brivaracetam tablets or oral solution by mouth.

Your doctor may increase or decrease your dose depending on how well the medication works for you, and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with brivaracetam.

Brivaracetam may be habit forming. Do not use a larger dose, use it more often, or use it for a longer period of time than prescribed by your doctor.

Brivaracetam may help control your condition but will not cure it. Continue to use brivaracetam even if you feel well. Do not stop using brivaracetam injection without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop using brivaracetam, your seizures may become worse. Your doctor will probably decrease your dose gradually.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving brivaracetam injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you currently or have ever drunk large amounts of alcohol, used street drugs, or over-used prescription medications. Also tell your doctor if you have or have ever had depression, mood problems, suicidal thoughts or behavior, kidney disease that was treated with dialysis (treatment to clean the blood outside the body when the kidneys are not working well), or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving brivaracetam injection, call your doctor.
• you should know that brivaracetam may make you dizzy or drowsy, and may cause blurred vision or problems with coordination and balance. Do not drive a car, operate machinery, or participate in activities requiring alertness or coordination until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are receiving brivaracetam injection. Brivaracetam can make the side effects from alcohol worse.
• you should know that brivaracetam injection may cause suicidal thoughts and actions (thinking about or trying to harm yourself). Call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling asleep or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Unless your doctor tells you otherwise, continue your normal diet.

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Brivaracetam injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• nausea
• vomiting
• change in ability to taste food
• extreme tiredness or lack of energy
• feeling drunk
• pain near the place where brivaracetam was injected

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, stop taking brivaracetam injection and call your doctor immediately or get emergency medical treatment:

• swelling of the face, throat, tongue, lips, and eyes; difficulty swallowing or breathing; or hoarseness
• rash, hives, blistering or peeling skin, or sores in the mouth
• hallucinations (seeing things or hearing voices that do not exist)
• delusions (having strange thoughts or beliefs that have no basis in reality) such as thoughts that people are trying to harm you even if they are not

Brivaracetam injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• sleepiness
• extreme tiredness
• dizziness
• trouble keeping your balance
• blurred or double vision
• slowed heartbeat
• nausea
• feeling anxious

Do not let anyone else use your medication. Brivaracetam is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

Keep all appointments with your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Briviact^®