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Briviact (brivaracetam) is an anti-epileptic drug, also called an anticonvulsant.
Briviact is used to treat partial onset seizures in people with epilepsy.
Briviact oral is for use in adults and children who are at least 4 years old. The injection is for use in people who are at least 16 years old.
Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
You should not use Briviact if you are allergic to brivaracetam.
Tell your doctor if you have ever had:
depression or other mood problems;
suicidal thoughts or actions;
liver disease; or
alcoholism or drug addiction.
You may have thoughts about suicide while taking this medicine. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
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 are pregnant, your name may be listed on a pregnancy registry to track the effects of brivaracetam on the baby.
It may not be safe to breast-feed while using brivaracetam. Ask your doctor about any risk.
Briviact oral is not approved for use by anyone younger than 4 years old. Briviact injection is for use in people who are at least 16 years old.
Take Briviact exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Brivaracetam may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.
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.
Take Briviact oral with a full glass of water, with or without food.
Swallow the tablet whole and do not crush, chew, or break it.
Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Brivaracetam doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.
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.
Use all seizure medications as directed. Do not change your dose or dosing schedule without your doctor's advice. Tell your doctor if any of your medicines seem to stop working.
Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze. Throw away unused liquid after 5 months.
Keep track of your medicine. Brivaracetam is a drug of abuse and you should be aware if anyone is using it improperly or without a prescription.
Usual Adult Dose for Epilepsy:
Initial dose: 50 mg orally 2 times a day
Maintenance dose: 25 mg to 100 mg orally twice a day based on clinical response and tolerability
IV Injection: May be used when oral administration is temporarily not feasible
-Administer at the same dose and same frequency as oral formulations
-Experience with IV injection is limited to 4 consecutive days of treatment
Comments:
-Gradual dose escalation is not required; dose should be adjusted based on clinical response and tolerability.
-Tablets, oral solution and injection can be used interchangeably.
Use: For the treatment of partial-onset seizures
Usual Pediatric Dose for Epilepsy:
4 to less than 16 years:
-Weight 11 kg to less than 20 kg: Initial dose: 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: 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: 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: 50 mg orally 2 times a day
Maintenance dose: 25 mg to 100 mg orally twice a day based on clinical response and tolerability
IV Injection: 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
Comments:
-Gradual dose escalation is not required; dose should be adjusted based on clinical response and tolerability.
-Tablets and oral solution can be used interchangeably.
-The use of IV injection in patients less than 16 years of age has not been studied and is not recommended.
Use: For the treatment of partial-onset seizures in patients 4 years of age or older
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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Get emergency medical help if you have signs of an allergic reaction to Briviact: 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 Briviact 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.
When you start or stop taking Briviact, your doctor may need to adjust the doses of any other medicines you take on a regular basis.
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. Not all possible drug interactions are listed here.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Briviact only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Briviact (www.drugs.com/briviact.html).
Note: This document contains side effect information about brivaracetam. Some of the dosage forms listed on this page may not apply to the brand name Briviact.
In SummaryCommon side effects of Briviact include: acute psychosis, balance impairment, dizziness, drowsiness, fatigue, sedated state, abnormal behavior, abnormal gait, aggressive behavior, agitation, anxiety, apathy, asthenia, ataxia, depressed mood, depression, hallucination, hypersomnia, lacrimation, lethargy, nervousness, nystagmus disorder, paranoid ideation, psychomotor agitation, vertigo, irritability, emotional lability, malaise, and restlessness. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to brivaracetam: oral solution, oral tablet
Other dosage forms:
Along with its needed effects, brivaracetam (the active ingredient contained in Briviact) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking brivaracetam:
More common
Less common
Incidence not known
Some side effects of brivaracetam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
For Healthcare Professionals
Applies to brivaracetam: intravenous solution, oral liquid, oral tablet
GeneralThe more commonly reported adverse events have included somnolence/sedation, dizziness, fatigue, and nausea/vomiting.
Nervous systemVery common (10% or more): Somnolence/sedation (up to 27%), dizziness and disturbances in gait and coordination (up to 16%); fatigue-related adverse reactions (i.e., fatigue, asthenia, malaise, hypersomnia, sedation, and lethargy)
Common (1% to 10%): Cerebellar coordination and balance disturbances, convulsion, vertigo
This drug causes dose-dependent increases in somnolence and fatigue-related adverse reactions (i.e., fatigue, asthenia, malaise, hypersomnia, sedation, and lethargy). In clinical trials, somnolence and fatigue-related adverse reactions were reported in 25%, 20%, 26%, and 27% of patients receiving at least 50 mg/day, 50 mg/day, 100 mg/day, and 200 mg/day, respectively. Adverse reactions related to dizziness, gait and coordination disturbances including vertigo, ataxia, nystagmus occurred in 16% of patients.
PsychiatricCommon (1% to 10%): Depression, anxiety, insomnia, irritability
Uncommon (0.1% to 1%): Suicidal ideation, psychotic disorder, aggression, agitation
Psychiatric adverse events have been commonly reported. During clinical trials, approximately 13% of patients (compared to 8% on placebo) reported psychiatric events which included irritability, anxiety, nervousness, aggression, belligerence, anger, agitation, restlessness, depression, depressed mood, tearfulness, apathy, altered mood, mood swings, affect lability, psychomotor hyperactivity, abnormal behavior, adjustment disorder, psychotic disorder, hallucinations, paranoia, acute psychosis and psychotic behavior. A total of 1.7% of adult patients discontinued treatment because of psychiatric reactions (compared to 1.3% of placebo). In pediatric trials, psychiatric events were generally similar.
LocalCommon (1% to 10%): Infusion site pain
HypersensitivityFrequency not reported: Hypersensitivity, bronchospasm, angioedema
MetabolicCommon (1% to 10%): Decreased appetite, decreased weight
HematologicCommon (1% to 10%): Decreased WBC
Uncommon (0.1% to 1%): Neutropenia
In clinical trials, at least 1.8% of patients had at least 1 clinically significant decreased WBC (compared to 1.1% of placebo).
GastrointestinalCommon (1% to 10%): Nausea, vomiting, constipation
RespiratoryCommon (1% to 10%): Upper respiratory tract infections, cough
ImmunologicCommon (1% to 10%): Influenza
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Briviact (www.drugs.com/briviact.html).
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