Brivaracetam

What is Brivaracetam?

Brivaracetam (Briviact) is a relatively unique anticonvulsant used for the treatment of partial-onset seizures in patients 4 years of age and older.

What are the uses of this medicine?

• This medicine is used for the treatment of partial-onset seizures in patients 4 years of age and older.
• As the safety of Briviact injection in pediatric patients has not been established, Briviact injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).
• Children 4 years of age and older should only take Briviact by mouth.
• Briviact injection is only for use in people 16 years of age and older and may be given in the vein (intravenously) when Briviact is not able to be taken by mouth.

How does this medicine work?

• Brivaracetam (briv" a ra' se tam) is a pyrrolidine derivative related in structure to levetiracetam.
• Its mechanism of action is not known, but it, like levetiracetam, binds to the synaptic vesicle protein 2A (SV2A) in the brain and appears to act by preventing secondary spread of focal seizure activity and decreasing simultaneous neuronal firing.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known Hypersensitivity to brivaracetam or any of the inactive ingredients in Briviact (bronchospasm and angioedema have occurred).

What drug interactions can this medicine cause?

• Co-administration with rifampin decreases Briviact plasma concentrations.
• Co-administration with carbamazepine may increase exposure to carbamazepine-epoxide, the active metabolite of carbamazepine.
• Because Briviact can increase plasma concentrations of phenytoin, phenytoin levels should be monitored in patients when concomitant Briviact.
• Briviact had no added therapeutic benefit when co-administered with levetiracetam.

Is this medicine FDA approved?

• It was approved for use in the United States in 2016.

How should this medicine be used?

Recommended Dosage: Adults (16 Years and Older):

• The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day).
• Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).

Pediatric Patients (4 Years to less than 16 Years):

• The recommended dosage is based on body weight and is administered orally twice daily.

Patients with Hepatic Impairment

• For all stages of hepatic impairment, the recommended starting dosage for adults and pediatric patients weighing 50 kg or more is 25 mg twice daily (50 mg per day), and the recommended maximum dosage is 75 mg twice daily (150 mg per day).
• The recommended starting dosage for pediatric patients with hepatic impairment weighing 11 kg to less than 50 kg is 0.5 mg/kg twice daily (1 mg/kg per day). The maximum dosage for pediatric patients with hepatic impairment weighing 20 kg to less than 50 kg is 1.5 mg/kg twice daily (3 mg/kg per day).
• The maximum dosage for pediatric patients with hepatic impairment weighing 11 kg to less than 20 kg is 2 mg/kg twice daily (4 mg/kg per day).

Administration

• Take Briviact exactly as your healthcare provider tells you.
• 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.
• Take Briviact with or without food.
• Swallow Briviact tablets whole with a liquid. Do not chew or crush Briviact tablets before swallowing.
• If your healthcare provider has prescribed Briviact oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of Briviact oral solution. Do not use a household teaspoon or tablespoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
• Briviact injection can be given to you by intravenous (IV) infusion into your vein, as prescribed by your healthcare provider.
• If you take too much Briviact, call your Poison Control Center or go to the nearest emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg
• Oral solution: 10 mg/mL
• Injection: 50 mg/5 mL single-dose vial

This medicine is available in fallowing brand namesː

• Briviact

What side effects can this medication cause?

The most common side effects of this medicine include:

• sleepiness
• feeling tired
• dizziness
• nausea and vomiting

Briviact may cause serious side effects, including:

• Nervous system problems
• Mental (psychiatric) symptoms

What special precautions should I follow?

• Do not drive or operate machinery until you know how Briviact affects you. Briviact may cause drowsiness, tiredness, dizziness, and problems with your balance and coordination.
• Antiepileptic drugs (AEDs), including Briviact, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients for suicidal behavior and ideation.
• Briviact causes somnolence, fatigue, dizziness, and disturbance in coordination. Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on Briviact.
• Briviact causes psychiatric adverse reactions. Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms.
• Briviact can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported in patients taking Briviact. Advise patients to seek immediate medical care. Discontinue and do not restart Briviact if hypersensitivity occurs.
• As with most antiepileptic drugs, Briviact should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

What to do in case of emergency/overdose?

The following adverse reactions were reported with Briviact overdose: vertigo, balance disorder, fatigue, nausea, diplopia, anxiety, and bradycardia.

Management for overdosage:

• There is no specific antidote for overdose with Briviact.
• In the event of overdose, standard medical practice for the management of any overdose should be used.
• An adequate airway, oxygenation, and ventilation should be ensured; monitoring of cardiac rate and rhythm and vital signs is recommended.
• A certified poison control center should be contacted for updated information on the management of overdose with Briviact.
• There are no data on the removal of brivaracetam using hemodialysis, but because less than 10% of brivaracetam is excreted in urine, hemodialysis is not expected to enhance Briviact clearance.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risks associated with use of Briviact in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness of Briviact tablets and oral solution have been established in pediatric patients 4 years to less than 16 years of age.
• Safety of Briviact injection in pediatric patients has not been established.
• Safety and effectiveness in pediatric patients below the age of 4 years have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: brivaracetam
• Tablet inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, and magnesium stearate. The 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.
• Injection inactive ingredients: sodium acetate, trihydrate (1.64 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9.00 mg/mL), and water for injection.

Who manufactures and distributes this medicine?

• Manufactured for UCB Inc., Smyrna.

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
• Do not freeze Briviact injection or oral solution.
• Discard any unused Briviact oral solution remaining after 5 months of first opening the bottle.
• Briviact injection vials are single-dose only.

• Dailymed label info on Brivaracetam
• FDA Brivaracetam