Brivaracetam is an anti-epileptic drug, also called an anticonvulsant.

Brivaracetam is used to treat partial onset seizures in people with epilepsy.

Brivaracetam oral is for use in adults and children who are at least 4 years old. Brivaracetam injection is for use in people who are at least 16 years old.

Brivaracetam may also be used for purposes not listed in this medication guide.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Brivaracetam may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Brivaracetam injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Take brivaracetam oral with a full glass of water, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Brivaracetam doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

Do not stop using brivaracetam suddenly, even if you feel fine. Stopping suddenly may cause serious medical problems or increased seizures. Follow your doctor's instructions about tapering your dose.

Use all seizure medications as directed. Do not change your dose or dosing schedule without your doctor's advice. Tell your doctor if any of your medicines seem to stop working.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze. Throw away unused liquid after 5 months.

Keep track of your medicine. Brivaracetam is a drug of abuse and you should be aware if anyone is using it improperly or without a prescription.

Usual Adult Dose for Epilepsy:

Initial dose: 50 mg orally 2 times a day
-Based on individual patient tolerability and response, dose should be adjusted up or down
Maintenance dose: 25 mg to 100 mg orally twice a day based on clinical response and tolerability
Maximum dose: 200 mg/day

IV Administration:
-May be used when oral administration is temporarily not feasible
-Administer at the same dose and same frequency as oral formulations
-Experience with IV injection is limited to 4 consecutive days of treatment

Comments:
-When initiating therapy, gradual dose escalation is not required; following initiation, dose should be adjusted based on clinical response and tolerability.
-Tablets, oral solution and injection can be used interchangeably.

Use: For the treatment of partial-onset seizures

Usual Pediatric Dose for Epilepsy:

1 month to 16 years:
-Weight: Less than 11 kg: Initial dose: 0.75 to 1.5 mg/kg orally twice a day; Maintenance dose: 0.75 to 3 mg/kg orally twice a day
-Weight: 11 kg to less than 20 kg: Initial dose: 0.5 to 1.25 mg/kg orally twice a day; Maintenance dose: 0.5 to 2.5 mg/kg orally twice a day
-Weight: 20 kg to less than 50 kg: Initial dose: 0.5 to 1 mg/kg orally twice a day; Maintenance dose: 0.5 to 2 mg/kg orally twice a day
-Weight: 50 kg or greater: Initial dose: 25 to 50 mg orally twice a day; Maintenance dose: 25 to 100 mg orally twice a day

16 years of age and older:
Initial dose: 50 mg orally 2 times a day
Maintenance dose: 25 mg to 100 mg orally twice a day

IV Administration: May be used in patients 16 years or older when oral administration is temporarily not feasible
-Administer at the same dose and same frequency as oral formulations
-Experience with the IV injection is limited to 4 consecutive days of treatment

Comments:
-When initiating therapy, gradual dose escalation is not required; following initiation, dose should be adjusted based on clinical response and tolerability.
-Tablets, oral solution and injection can be used interchangeably.

Use: For the treatment of partial-onset seizures in patients 1 month or older

You should not use brivaracetam if you are allergic to it.

Tell your doctor if you have ever had:

• depression or other mood problems;

• suicidal thoughts or actions;

• liver disease; or

• alcoholism or drug addiction.

You may have thoughts about suicide while taking brivaracetam. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Follow your doctor's instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking this medicine without your doctor's advice, and tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of brivaracetam on the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Brivaracetam oral is not approved for use by anyone younger than 4 years old. Brivaracetam injection is for use in people who are at least 16 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or operating machinery until you know how brivaracetam will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Brivaracetam may cause serious side effects. Call your doctor at once if you have:

• severe dizziness or drowsiness;

• a light-headed feeling, like you might pass out;

• loss of balance or coordination;

• unusual thoughts or behavior; or

• hallucinations (seeing or hearing things that are not real).

Common side effects of brivaracetam may include:

• dizziness, drowsiness;

• nausea, vomiting; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

When you start or stop taking brivaracetam, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Other drugs may affect brivaracetam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your other medicines. Not all possible drug interactions are listed here.