Brivaracetam Injection

Brivaracetam injection is used alone and in combination with other medications to control partial onset seizures (seizures that involve only one part of the brain) in adults, children, and infants 1 month of age or older 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 usually given twice a day for as long as you are unable to take brivaracetam tablets or oral solution by mouth.

You may receive brivaracetam injection in a hospital or you may use the medication at home. If you will be receiving brivaracetam injection at home, your healthcare provider will show you how to use the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions.

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 taking brivaracetam injection,

• tell your doctor and pharmacist if you are allergic to brivaracetam, any other medications, or any of the ingredients in brivaracetam injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril), levetiracetam (Elepsia, Keppra, Spritam), phenytoin (Dilantin, Phenytek), and rifampin (Rifadin, Rimactane). 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 taking brivaracetam, 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 taking brivaracetam. Brivaracetam can make the side effects from alcohol worse.
• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are using brivaracetam injection. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants like brivaracetam injection to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as 1 week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as brivaracetam injection, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should 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
• hoarseness
• 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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Briviact^®