Briviact

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/16/2021
Briviact Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Briviact?

Briviact (brivaracetam) is an antiepileptic drug (AED) indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.

What Are Side Effects of Briviact?

Common side effects of Briviact include:

  • drowsiness,
  • sedation,
  • dizziness,
  • fatigue,
  • nausea,
  • vomiting,
  • loss of balance or coordination,
  • irritability, and
  • constipation

Antiepileptic drugs, including Briviact, may increase the risk of suicidal thoughts or behavior in patients taking these drugs. Tell your doctor immediately if this occurs.

Dosage for Briviact

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

What Drugs, Substances, or Supplements Interact with Briviact?

Briviact may interact with rifampin, carbamazepine, and phenytoin. Tell your doctor all medications and supplements you use.

Briviact During Pregnancy and Breastfeeding

Briviact is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Briviact passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Briviact (brivaracetam) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication

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.

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Briviact Consumer Information

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.

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 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.

Read the entire detailed patient monograph for Briviact (Brivaracetam Oral Solution and Intravenous Injection)

SLIDESHOW

What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Briviact Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in labeling:

  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Neurological Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity: Bronchospasm and Angioedema [see WARNINGS AND PRECAUTIONS]
  • Withdrawal of Antiepileptic Drugs [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In all controlled and uncontrolled trials performed in adult epilepsy patients, BRIVIACT was administered as adjunctive therapy to 2437 patients. Of these patients, 1929 were treated for at least 6 months, 1500 for at least 12 months, 1056 for at least 24 months, and 758 for at least 36 months. A total of 1558 patients (1099 patients treated with BRIVIACT and 459 patients treated with placebo) constituted the safety population in the pooled analysis of Phase 3 placebo-controlled studies in patients with partial-onset seizures (Studies 1, 2, and 3) [see Clinical Studies]. The adverse reactions presented in Table 2 are based on this safety population; the median length of treatment in these studies was 12 weeks. Of the patients in those studies, approximately 51% were male, 74% were Caucasian, and the mean age was 38 years.

In the Phase 3 controlled epilepsy studies, adverse events occurred in 68% of patients treated with BRIVIACT and 62% treated with placebo. The most common adverse reactions occurring at a frequency of at least 5% in patients treated with BRIVIACT doses of at least 50 mg/day and greater than placebo were somnolence and sedation (16%), dizziness (12%), fatigue (9%), and nausea and vomiting symptoms (5%).

The discontinuation rates due to adverse events were 5%, 8%, and 7% for patients randomized to receive BRIVIACT at the recommended doses of 50 mg, 100 mg, and 200 mg/day, respectively, compared to 4% in patients randomized to receive placebo.

Table 3 lists adverse reactions for BRIVIACT that occurred at least 2% more frequently for BRIVIACT doses of at least 50 mg/day than placebo.

Table 3: Adverse Reactions in Pooled Placebo-Controlled Adjunctive Therapy Studies in Adult Patients with Partial-Onset Seizures (BRIVIACT50 mg/day,100 mg/day,and200 mg/day)

Adverse Reactions BRIVIACT
(N=803) %
Placebo
(N=459) %
Gastrointestinal disorders
Nausea/vomiting symptoms 5 3
Constipation 2 0
Nervous system disorders
Somnolence and sedation 16 8
Dizziness 12 7
Fatigue 9 4
Cerebellar coordination and balance disturbances* 3 1
Psychiatric disorders
Irritability 3 1
* Cerebellar coordination and balance disturbances includes ataxia, balance disorder, coordination abnormal, and nystagmus.

There was no apparent dose-dependent increase in adverse reactions listed in Table 3 with the exceptionof somnolence and sedation.

Pediatric Patients(4 Years To Less Than 16 Years Of Age)

Safety of BRIVIACT was evaluated in two open-label, safety and pharmacokinetic trials in pediatric patients 4 years to less than 16 years of age. Across studies of pediatric patients with partial onset seizures, 149 patients 4 years to less than16 years of age received BRIVIACT oral solution or tablet, of whom 107 received BRIVIACT for at least 12 months. Adverse reactions reported in clinical studies of pediatric patients 4 years to less than16 years of age were generally similar to those seen in adult patients.

Hematologic Abnormalities

BRIVIACT can cause hematologic abnormalities. In the Phase 3 controlled adjunctive epilepsy studies, a total of 1.8% of BRIVIACT-treated patients and 1.1% of placebo-treated patients had at least one clinically significant decreased white blood cell count(<3.0x109/L),and0.3%ofBRIVIACT-treated patientsand0%ofplacebo-treatedpatientshadatleastoneclinically significant decreased neutrophil count (<1.0 x109/L).

Adverse Reactions With BRIVIACT Injection

Adverse reactions with BRIVIACT injection administered to adult patients were generally similar to those observed with BRIVIACT tablets. Other adverse events that occurred in at least 3% of patients who received BRIVIACT injection included dysgeusia, euphoric mood, feeling drunk, and infusion site pain.

Comparison By Sex

There were no significant differences by sex in the incidence of adverse reactions.

Read the entire FDA prescribing information for Briviact (Brivaracetam Oral Solution and Intravenous Injection)

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© Briviact Patient Information is supplied by Cerner Multum, Inc. and Briviact Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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