Briviact

What is Briviact?

Briviact (brivaracetam) is an anti-epileptic drug (also called an anticonvulsant) that may be used to treat partial onset seizures in adults and children 1 month and older with epilepsy.

• Briviact is often used along with other seizure medicines to give better control over seizures.

Briviact works in the brain to help control seizures and is thought to target a specific protein called SV2A that helps nerve cells communicate with each other. By attaching to this protein, Briviact helps balance the brain’s electrical activity and this mechanism can stop the sudden bursts of electricity that cause seizures.

Briviact gained FDA approval on February 18, 2016. There is currently no Briviact generic available.

Is Briviact a controlled substance?

Briviact is a federally controlled substance (Schedule V) because it can be abused or lead to dependence.

Keep Briviact in a safe place to prevent misuse and abuse. Selling or giving away Briviact may harm others and is against the law. 

Briviact side effects

The most common side effects of Briviact are:

• sleepiness
• dizziness
• feeling tired
• nausea and vomiting.

Side effects of Briviact in children 1 month to less than 16 years of age are similar to those seen in adults.

Serious side effects and warnings

Briviact may cause the following serious side effects.

Suicidal thoughts and behaviors. 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
• new or worse depression
• feeling agitated or restless
• trouble sleeping (insomnia)
• acting aggressive, feeling angry, or being violent
• an extreme increase in activity and talking (mania)
• attempts to commit suicide
• new or worse anxiety
• panic attacks
• new or worse irritability
• acting on dangerous impulses
• 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. 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 seizures that will not stop (status epilepticus). 

Nervous system problems. Drowsiness, tiredness, and dizziness are common with Briviact but can be severe. Do not drive or operate machinery until you know how Briviact affects you. Briviact can also cause problems with balance and coordination.

Mental (psychiatric) symptoms. Briviact 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 Briviact and can be severe. People who take Briviact can also get psychotic symptoms such as hallucinations (seeing or hearing things that are not there), delusions (false or strange thoughts or beliefs), and unusual behavior.

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

These are not all the possible side effects of Briviact. 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.

Before taking this medicine

You should not use Briviact if you are allergic to brivaracetam, Briviact, or any of the inactive ingredients in the formulation you are taking/receiving.

Before taking Briviact, 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
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Briviact is not approved for use by anyone younger than 1 month of age.

Pregnancy

It is not known if Briviact will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Briviact. You and your healthcare provider will have to decide if you should take Briviact while you are pregnant. 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 do become pregnant while taking Briviact, 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 Briviact and other antiepileptic medicines during pregnancy.

Breastfeeding

Briviact passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Briviact.

How should I take Briviact?

Take Briviact exactly as prescribed by your doctor. 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.

• Briviact is usually taken/given 2 times a day.

Take Briviact oral tablets or oral solution with or without food.

• Swallow Briviact tablets whole with a liquid and do not chew or crush the tablets before swallowing.
• Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Briviact 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.

Briviact may be habit-forming and is a federally controlled substance (Schedule V). Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Do not stop using Briviact 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.

Briviact dosing information

Usual Briviact Adult Dose for Epilepsy

Initial oral dose: Briviact 50 mg orally 2 times a day

• Adjust the dose up or down based on individual patient tolerability and response.

Maintenance dose: 25 mg to 100 mg orally twice a day based on clinical response and tolerability

Maximum dose: 200 mg/day

IV Administration: Briviact 50 mg by IV injection over 2 to 15 minutes

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

Usual Briviact Child Dose for Epilepsy

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

Briviact ablets, oral solution, and injection can be used interchangeably.

1 month to 16 years

Weight: Less than 11 kg: Initial dose: Briviact 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: Briviact 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: Briviact 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: Briviact 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: Briviact 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.

What happens if I miss a dose?

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.

What happens if I take too much Briviact?

If you take too much Briviact call your Poison Control Center or go to the nearest emergency room right away. 

What to avoid

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

What other drugs will affect Briviact?

Other drugs may interact with brivaracetam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your other medicines. Especially tell your healthcare provider if you take:

• Rifampin — the dosage of Briviact may need to be increased
• Carbamazepine — the dosage of carbamazepine may need to be reduced
• Phenytoin — the dosage of phenytoin may need to be reduced.

Levetiracetam — Briviact had no added therapeutic benefit when coadministered with levetiracetam.

When you start or stop taking Briviact, your doctor may need to adjust the doses of any other medicines you take regularly.

Not all possible drug interactions are listed here. See the Briviact Prescribing Information for a full list of interactions. 

Storage

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

Briviact ingredients

Active ingredient: brivaracetam

Tablet inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, and magnesium stearate.

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.