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?
Briviact may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- anxiety,
- mood changes,
- chest pain or pressure,
- fast or shallow breathing,
- dizziness,
- lightheadedness,
- double vision,
- drowsiness,
- dry mouth,
- general feeling of unwellness,
- irregular heartbeat,
- irritability,
- nausea,
- numbness of feet, hands, and around mouth,
- restlessness,
- spinning sensation,
- sleepiness,
- unusual drowsiness,
- thoughts of self-harm,
- trouble sleeping,
- unusually long or deep sleep,
- cough,
- difficulty swallowing,
- fever,
- noisy breathing,
- reddening of the skin, especially around the ears,
- shakiness, and
- poor coordination or muscle control
Get medical help right away if you have any of the symptoms listed above.
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.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
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.
IMAGES
See ImagesGet 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.
SLIDESHOW
What Is Epilepsy? Symptoms, Causes, and Treatments See SlideshowSIDE 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 4 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 4 lists adverse reactions for BRIVIACT that occurred at least 2% more frequently for BRIVIACT doses of at least 50 mg/day than placebo.
Table 4: Adverse Reactions in Pooled Placebo-Controlled Adjunctive Therapy Studies in Adult Patients with Partial- Onset Seizures (BRIVIACT 50 mg/day, 100 mg/day, and 200 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 4 with the exception of somnolence and sedation.
Pediatric Patients
Safety of BRIVIACT was evaluated in two open-label, safety and pharmacokinetic trials in pediatric patients 2 months to less than 16 years of age. Across studies of pediatric patients with partial onset seizures, 186 patients received BRIVIACT oral solution or tablet, of whom 123 received BRIVIACT for at least 12 months. Adverse reactions reported in clinical studies of pediatric patients were generally similar to those seen in adult patients. Decreased appetite was also observed in these pediatric trials.
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 (<3.0 x 109/L), and 0.3% of BRIVIACT-treated patients and 0% of placebo-treated patients had at least one clinically significant decreased neutrophil count (<1.0 x 109/L).
Adverse Reactions With BRIVIACT Injection
Adverse reactions with BRIVIACT injection administered to adults and pediatric patients 2 months to 16 years of age were generally similar to those observed with BRIVIACT tablets. Other adverse events that occurred in at least 3% of adult 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.
DRUG INTERACTIONS
Rifampin
Co-administration with rifampin decreases BRIVIACT plasma concentrations likely because of CYP2C19 induction [see CLINICAL PHARMACOLOGY]. Prescribers should increase the BRIVIACT dose by up to 100% (i.e., double the dosage) in patients while receiving concomitant treatment with rifampin [see DOSAGE AND ADMINISTRATION].
Carbamazepine
Co-administration with carbamazepine may increase exposure to carbamazepine-epoxide, the active metabolite of carbamazepine. Though available data did not reveal any safety concerns, if tolerability issues arise when co-administered, carbamazepine dose reduction should be considered [see CLINICAL PHARMACOLOGY].
Phenytoin
Because BRIVIACT can increase plasma concentrations of phenytoin, phenytoin levels should be monitored in patients when concomitant BRIVIACT is added to or discontinued from ongoing phenytoin therapy [see CLINICAL PHARMACOLOGY].
Levetiracetam
BRIVIACT provided no added therapeutic benefit to levetiracetam when the two drugs were co-administered [see Clinical Studies].
Drug Abuse And Dependence
Controlled Substance
BRIVIACT contains brivaracetam and is listed as a Schedule V controlled substance.
Abuse
In a human abuse potential study, single doses of BRIVIACT at therapeutic and supratherapeutic doses were compared to alprazolam (C-IV) (1.5 mg and 3 mg). BRIVIACT at the recommended single dose (50 mg) caused fewer sedative and euphoric effects than alprazolam; however, BRIVIACT at supratherapeutic single doses (200 mg and 1000 mg) was similar to alprazolam on other measures of abuse.
Dependence
There was no evidence of physical dependence potential or a withdrawal syndrome with BRIVIACT in a pooled review of placebo-controlled adjunctive therapy studies [see WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Briviact (Brivaracetam Oral Solution and Intravenous Injection)
QUESTION
If you have had a seizure, it means you have epilepsy. See Answer© 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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