Brivaracetam

Brivaracetam is an antiepileptic drug approved for the following use across its available formulations:

• Partial-onset seizures in patients 1 month of age and older — supported by brivaracetam tablets, brivaracetam oral solution, and brivaracetam injection, as well as the brand-name products Briviact (tablets, oral solution, and injection) and Brivaracetam oral Solution
• Can be used as the sole seizure medication (monotherapy) or alongside other antiepileptic drugs (adjunctive therapy)
• Brivaracetam injection (including Briviact injection) is specifically indicated for intravenous use when oral administration is temporarily not feasible — it is not a stand-alone oral alternative

Brivaracetam binds with high selectivity to a brain protein called synaptic vesicle protein 2A (SV2A). This protein sits on the tiny sacs (vesicles) that neurons use to release chemical messengers. By binding to SV2A, brivaracetam is believed to help dampen the abnormal bursts of electrical activity that cause seizures. The exact mechanism is not fully established, but the strong and selective affinity for SV2A is considered central to its anticonvulsant effect.

Brivaracetam is taken twice daily — morning and evening. Tablets and oral solution are taken by mouth; the injection is given intravenously by a healthcare professional only when oral dosing is not temporarily possible. Tablets may be taken with or without food, though eating a high-fat meal alongside a tablet may slow absorption (without meaningfully reducing the total amount that reaches your system).

• For adults and adolescents 16 and older, dosing is not weight-based — your prescriber sets the starting dose and adjusts based on how well it works and how well you tolerate it
• For children under 16, dosing is weight-based and administered twice daily
• Gradual dose increases when starting treatment are not required, but the dose may be adjusted over time
• Never stop brivaracetam abruptly — your prescriber will guide you on tapering if you need to stop

The most common side effects reported with brivaracetam include:

• Drowsiness or sedation — the most frequently reported effect, and more likely at higher doses
• Dizziness
• Fatigue
• Nausea or vomiting
• Problems with coordination or balance (including unsteady gait)
• Irritability
• Constipation
• Decreased appetite (seen in pediatric studies)

More serious reactions — including allergic reactions with throat swelling or trouble breathing, severe skin reactions, and significant psychiatric symptoms such as hallucinations or aggressive behavior — require prompt medical attention. Brivaracetam can also cause low white blood cell counts in rare cases, which your doctor may monitor.

• Suicidal thoughts and behavior: All antiepileptic drugs, including brivaracetam, increase the risk of suicidal thoughts or behavior. This risk can appear as soon as one week after starting treatment and applies across all ages. Watch for new depression, unusual mood changes, or talk of self-harm — and seek help immediately if these occur.
• Drowsiness and coordination problems: Brivaracetam can impair your ability to drive or use machinery. This risk is highest early in treatment. Do not drive until you know how the medication affects you.
• Psychiatric reactions: Irritability, anxiety, aggression, mood swings, depression, and — less commonly — hallucinations or psychotic behavior have all been reported. Tell your doctor about any behavioral changes.
• Serious allergic reactions: Bronchospasm (airway tightening) and angioedema (dangerous swelling of the face or throat) have occurred. If this happens, stop the medication and get emergency care right away.
• Serious skin reactions: Rare but life-threatening skin conditions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported. Stop brivaracetam at the first sign of a rash and contact your doctor immediately.
• Do not stop suddenly: Stopping brivaracetam abruptly can trigger a return or worsening of seizures. Taper the dose gradually under medical supervision.
• Tartrazine allergy: Brivaracetam 100 mg tablets contain FD&C Yellow No. 5 (tartrazine), which can trigger allergic reactions — particularly in people with aspirin sensitivity.

Brivaracetam interacts with several medications and substances. Tell your doctor about everything you take, including over-the-counter drugs and supplements:

• Rifampin (antibiotic): significantly lowers brivaracetam blood levels — your prescriber may need to double the brivaracetam dose
• Carbamazepine (antiepileptic): brivaracetam can raise levels of carbamazepine-epoxide, an active byproduct — a carbamazepine dose reduction may be needed if side effects arise
• Phenytoin (antiepileptic): brivaracetam can increase phenytoin blood levels — phenytoin should be monitored when brivaracetam is started or stopped
• Levetiracetam (antiepileptic): using brivaracetam together with levetiracetam showed no added seizure benefit in studies
• Alcohol: combining brivaracetam with alcohol significantly worsens effects on coordination, reaction time, alertness, and memory — avoid alcohol while taking this medication
• CYP2C19 inhibitors: drugs that inhibit the CYP2C19 enzyme can raise brivaracetam blood levels — a dose reduction may be needed

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• Do not take brivaracetam if you have had a prior allergic reaction to brivaracetam or any of its inactive ingredients — serious allergic reactions including airway problems have occurred
• Liver disease: dose adjustment is required for all stages of hepatic (liver) impairment; tell your prescriber about any liver problems
• End-stage kidney disease on dialysis: brivaracetam is not recommended — there are no safety data for this group
• Pregnancy: animal studies showed possible harm to the developing fetus; the risk in humans is not fully established. If you are pregnant or planning to become pregnant, discuss the risks and benefits with your doctor. Consider enrolling in the NAAED Pregnancy Registry (1-888-233-2334)
• Breastfeeding: brivaracetam passes into breast milk; the impact on a nursing infant is not well studied. Discuss the decision to breastfeed with your doctor
• Children under 1 month: safety and effectiveness have not been established in this age group
• Older adults: start at a lower dose if possible; older patients may have reduced liver, kidney, or heart function that affects how the drug is processed
• Aspirin sensitivity: brivaracetam 100 mg tablets contain tartrazine (FD&C Yellow No. 5), which may trigger allergic reactions in susceptible individuals, especially those sensitive to aspirin
• CYP2C19 genetic variation: people with certain genetic differences in the CYP2C19 enzyme process brivaracetam more slowly and may need a dose adjustment

Taking too much brivaracetam can cause drowsiness, dizziness, vertigo, fatigue, nausea, vision problems (double vision), loss of balance, anxiety, and slowed heart rate. There is no specific antidote. If an overdose is suspected, call a poison control center right away or seek emergency medical care — and make sure the airway is kept clear and heart rate and vital signs are monitored.

Brivaracetam increases the sedating effects of alcohol significantly — impairing coordination, alertness, attention, balance, and memory more than either substance alone. This effect was observed even at a dose double the highest recommended amount. At up to four times the maximum recommended dose, brivaracetam did not cause any clinically meaningful effects on the heart's electrical rhythm (QT interval).

Brivaracetam is absorbed quickly and nearly completely when taken by mouth, with peak blood levels reached in about an hour for tablets taken without food. A high-fat meal slows absorption but does not meaningfully change the total amount absorbed. The drug is only weakly bound to proteins in the blood and distributes evenly throughout body tissues. It is broken down mainly in the liver — primarily through an enzyme-driven process, with the CYP2C19 enzyme playing a secondary role — and over 95% of the drug and its inactive breakdown products leave the body through the urine within 72 hours. The half-life (the time for blood levels to drop by half) is approximately 9 hours.

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.