BRIVARACETAM

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Created Mar 2019 | Updated Oct 2020

BRIVARACETAM

  • [BRV]
  • [BRIVIACT]

BRIVIACT((2S)-2-[(4R)-2-OXO-4-PROPYLPYRROLIDIN-1-YL] BUTANAMIDE), UCB-34714

DEA CODE 2710: Schedule 5

Brivaracetam (UCB 34714, trade name Briviact), the 4-n-propyl analog of levetiracetam, is a racetam derivative with anticonvulsant properties. Briviact is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. Brivaracetam is believed to act by binding to the ubiquitous synaptic vesicle glycoprotein 2A (SV2A), like levetiracetam, but with 20-fold greater affinity. There is some evidence that racetams including levetiracetam and brivaracetam access the luminal side of recycling synaptic vesicles during vesicular endocytosis. They may reduce excitatory neurotransmitter release and enhance synaptic depression during trains of high-frequency activity, such as is believed to occur during epileptic activity.

Brivaracetam is a relatively unique anticonvulsant that is typically used in combination with other antiepileptic medications for partial onset seizures.

Liver:
Brivaracetam has been linked to rare instances of serum aminotransferase and alkaline phosphatase elevations during treatment and is suspected of causing rare cases of clinically apparent drug induced liver disease.

Brivaracetam Hepatotoxicity:
Prospective studies reported that chronic brivaracetam therapy was not accompanied by significant elevations in serum aminotransferase levels and clinically apparent liver injury was not observed. Brivaracetam has had limited general use, but has not been linked to instances of clinically apparent liver injury. Levetiracetam, an anticonvulsant with similar structure and mechanism of action, has been linked to rare instances of acute liver injury, generally arising within 1 to 20 weeks and presenting with a hepatocellular pattern of injury without immunoallergic or autoimmune features. Whether similar cases will be linked to brivaracetam is not known.

E Likelihood score: E (unlikely cause of clinically apparent liver injury).


How does Brivaracetam affect the brain?
Brain cells normally talk to each other using electrical signals and chemicals. Seizures can happen when the brain cells are not working or firing normally or working faster than normal. Most seizure medicines slow down these electrical discharges to stop seizures.

Brivaracetam works differently from most seizure medicines. It joins with a protein (called SV2A) that is involved with the release of certain chemicals called neurotransmitters in the brain. The exact way that these actions lead to decreased seizures is not fully known. Currently there are no other known uses for brivaracetam beyond seizure control.

Taking seizure medicines may increase the risk of having suicidal thoughts or actions.

Cautions:
  • Antiepileptic drugs increase the risk of suicidal behavior and ideation; monitor for the emergence or worsening of depression, unusual changes in mood or behavior, or suicidal thoughts, behavior, or self-harm; advise patients and caregivers/families to be alert for these behavioral changes and report them to their physician immediately
  • May cause psychiatric adverse reactions, including nonpsychotic and psychotic symptoms; advise patients and caregivers/families to be alert for these behavioral changes and report them to their physician immediately
  • May cause somnolence and fatigue (dose-dependent), dizziness, and disturbance in gait or coordination
  • Hypersensitivity reactions reported, including bronchospasm and angioedema
  • If discontinued, withdraw drug gradually because of the risk of increased seizure frequency and status epilepticus; if withdrawal is needed because of a serious adverse event, consider rapid discontinuation

Briviact (brivaracetam oral solution and intravenous injection)
Side Effects:
RxList
Common side effects of Briviact include:
  • drowsiness
  • sedation
  • dizziness
  • fatigue
  • nausea
  • vomiting
  • loss of balance or coordination
  • irritability
  • constipation

Brivaracetam is used along with other medications to control partial onset seizures (seizures that involve only one part of the brain) in adults and children 4 years of age and older. It works by decreasing abnormal electrical activity in the brain. Brivaracetam comes as a tablet and solution (liquid) to take by mouth. It is usually taken with or without food twice daily.

Brivaracetam may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.


BRIVIACT (brivaracetam) CV is a prescription medicine that can be used to treat partial-onset (focal) seizures in people 4 years of age and older. It is not known if BRIVIACT injection is safe for use in children. 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. It is not known if BRIVIACT is safe and effective in children younger than 4 years of age.

BRIVIACT is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep BRIVIACT in a safe place to prevent misuse and abuse. Selling or giving away BRIVIACT may harm others and is against the law. Like other antiepileptic drugs, BRIVIACT may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.

Briviact (brivaracetam)
Maximum Dosage:
Prescribers Digital Reference
Adults:200 mg/day PO or IV.
Geriactric200 mg/day PO or IV.
Adolescents:16 years and older: 200 mg/day PO or IV.
Adolescents:13 to 15 years weighing 50 kg or more: 200 mg/day PO; safety and efficacy of IV formulation have not been established.
Adolescents:13 to 15 years weighing 20 to 49 kg: 4 mg/kg/day PO; safety and efficacy of IV formulation have not been established.
Children:4 to 12 years weighing 50 kg or more: 200 mg/day PO; safety and efficacy of IV formulation have not been established.
Children:4 to 12 years weighing 20 to 49 kg: 4 mg/kg/day PO; safety and efficacy of IV formulation have not been established.
Children:4 to 12 years weighing 11 to 19 kg: 5 mg/kg/day PO; safety and efficacy of IV formulation have not been established.
Infants:Safety and efficacy have not been established.
Neonates:Safety and efficacy have not been established.

Important Information:
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.

Avoid driving or operating machinery until you know how brivaracetam will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Interactions:

Drug Interactions (279) Alcohol/Food Interactions (1) Disease Interactions (4)


What other drugs will affect Brivaracetam?
When you start or stop taking brivaracetam, your doctor may need to adjust the doses of any other medicines you take on a regular basis. Other drugs may affect 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.

A total of 279 drugs are known to interact with Brivaracetam.

Breastfeeding:
Summary of Use During Lactation:
Because no information is available on use of brivaracetam during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

If brivaracetam is required by the mother, it is not necessarily a reason to discontinue breastfeeding, but monitor the infant for drowsiness, agitation, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of drugs.

Measurement of infant serum levels may help rule out toxicity if there is a concern.

Alternate Drugs to Consider:

  • (Seizure Disorder) Carbamazepine
  • Divalproex
  • Gabapentin
  • Lamotrigine
  • Oxcarbazepine
  • Phenytoin
  • Valproic Acid

Pediatric:
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of brivaracetam in children 4 to 15 years of age.

Safety and efficacy have not been established in children younger than 4 years of age.

Geriatric:
Although appropriate studies on the relationship of age to the effects of brivaracetam have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving brivaracetam.

Other Medical Problems:
Make sure you tell your doctor if you have any other medical problems, especially:

  • Depression, or history of
  • Mental illness, history of - Use with caution. May make these conditions worse
  • Kidney disease, severe (eg, end-stage) having dialysis - Use is not recommended in patients with this condition
  • Liver disease - Use with caution. The effects may be increased because of slower removal of the medicine from the body

EMC PDF Briviact

Brivaracetam:
  • An anticonvulsant (antiepileptic)
  • Used to treat partial-onset seizures with or without secondary generalisation, in combination with other antiepileptic drugs.
  • Half-life of seven to eight hours with over 95% of a radioactive test dose recovered in the urine within 72 hours

In 2016, the European Commission, and then the U.S. Food and Drug Administration (FDA) approved brivaracetam under the trade name Briviact. The Drug Enforcement Administration (DEA) issued an interim final rule placing brivaracetam into schedule V of the Controlled Substances Act (CSA) effective March 2017. As of May 2016, brivaracetam is not approved in some other countries, such as Switzerland. It was also approved in Australia late 2016. In Canada it was approved in 2016 under the trade name Brivlera.

The most common adverse effects include sleepiness, dizziness, nausea and vomiting. More rarely, coordination problems and changes in behaviour can occur.

  
New Drug Review 2016 - The precise mechanism by which brivaracetam exerts its therapeutic activity is not known; however, the drug is bound with high affinity and selectivity by the synaptic vesicle protein 2A in ...
Saturday January 07, 2023 - medscape.com

Side effect(s) of Brivaracetam - Do not take more than the prescribed dose of the drug or share it with anyone as it may lead to addiction. Brivaracetam generic Brivaracetam is an anticonvulsant or antiepileptic drug which is ...
Monday March 26, 2018 - medindia.net

The Use of Newer Antiepileptic Drugs in Patients With Renal Failure - Brivaracetam is an orphan drug for the treatment of symptomatic myoclonus. It is a novel high-affinity SV2A ligand that also displays inhibitory activity at neuronal voltage-dependent sodium channels.
Tuesday January 24, 2023 - medscape.com

Lumateperone/CYP3A4 Inducers Interactions - Consult your healthcare professional before taking or discontinuing any drug or commencing any course of treatment. Serious. These medicines may interact and cause very harmful effects.
Monday August 30, 2021 - webmd.com

Brivaracetam API Market 2023 By Trends, Latest Research, Industry Competition Analysis, Revenue and Forecast Till 2028 - Jan 18, 2023 (The Expresswire) -- Final Report will add the analysis of the impact of Russia-Ukraine War and COVID-19 on this Brivaracetam API industry. "Brivaracetam API Market" Research Report ...
Tuesday January 17, 2023 - marketwatch.com

Ubrogepant/Moderate and Weak CYP3A4 Inducers Interactions - Consult your healthcare professional before taking or discontinuing any drug or commencing any course of treatment. Moderate. These medicines may cause some risk when taken together. Contact your ...
Sunday June 21, 2020 - webmd.com

Lupin receives USFDA's nod for generic version of Brivaracetam tablets - Lupin Ltd announced on Wednesday that the generic version of Brivaracetam tablets, which is used to treat partial-onset seizures, has been approved by the US Food and Drug Administration.
Wednesday December 21, 2022 - msn.com

USFDA gives final nod to Lupin’s seizure tablets - for its Abbreviated New Drug Application (ANDA) for Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. It is a generic equivalent of Briviact Tablets, 10 mg, 25 mg, 50 mg, 75 mg ...
Tuesday December 20, 2022 - msn.com

  
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