Brivaracetam

Brivaracetam is a prescription medication used to treat Partial-Onset Seizures. 

• Brivaracetam is available under the following different brand names: Briviact. 

Adult and pediatric dosage

Tablet: Schedule V

• 10mg
• 25mg
• 50mg
• 75mg
• 100mg

Oral solution: Schedule V

• 10mg/mL

Injection, solution: Schedule V

• 50mg/5mL single-dose vial

Partial-Onset Seizures

Adult dosage

• 50 mg orally/IV every 12 hours initially; based on individual patient tolerability and therapeutic response, adjust dose between to 25-100 mg orally/IV twice daily (50-200 mg/day)
• Injection may be used for patients when oral administration is temporarily not feasible; clinical study experience with injection is limited is limited to 4 consecutive days of treatment

Pediatric dosage

Tablets or oral solution

• Children younger than 1 month of age: Safety and efficacy not established. 
• Children from 1 month to less than 16 years of age
• Children weighing less than 11 kg: 0.75-1.5mg/kg orally/IV twice daily (1.5-3 mg/kg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between 0.75 mg-3 mg/kg orally/IV twice daily (1.5-6 mg/kg/day)
• Children weighing 11 kg to less than 20 kg: 0.5-1.25 mg/kg orally/IV twice daily (1-2.5 mg/kg/day) initially; based on individually patient tolerability and therapeutic response, adjust dose between 0.5-2.5 mg/kg orally/IV twice daily (1-5 mg/kg/day)
• Children weighing 20 kg to less than 50 kg: 0.5-1 mg/kg orally/IV twice daily (1-2 mg/kg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between 0.5-2 mg/kg orally/IV twice daily (1-4 mg/kg/day)
• Children weighing 50 kg or more: 25-50 mg orally/IV twice daily (50-100 mg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between 25-100 mg orally/IV twice daily (50-200 mg/day)
• Children 16 years of age or older: 50 mg orally/IV twice daily (100 mg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between 25-100 mg orally/IV twice daily (50-200 mg/day)

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Brivaracetam include:

• dizziness, 
• drowsiness, 
• nausea, 
• vomiting, and 
• tiredness 

Serious side effects of Brivaracetam include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• mood or behavior changes, 
• anxiety, 
• panic attacks, 
• trouble sleeping, 
• impulsiveness, 
• irritableness, 
• agitation, 
• hostility, 
• aggression, 
• restlessness, 
• hyperactivity (mentally or physically), 
• depression, 
• thoughts of self-harm, 
• severe dizziness, 
• drowsiness, 
• lightheadedness, 
• loss of balance or coordination, 
• unusual thoughts or behavior, and
• hallucinations

Rare side effects of Brivaracetam include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Brivaracetam has severe interactions with no other drugs.
• Brivaracetam has serious interactions with the following drugs:
  • lonafarnib
  • metoclopramide intranasal
  • selinexor
• Brivaracetam has moderate interactions with at least 16 other drugs.
• Brivaracetam has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity; bronchospasms and angioedema have occurred.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Brivaracetam?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Brivaracetam?”

Cautions

• 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
• Hypersensitivity reactions reported, including bronchospasm and angioedema; if a patient develops hypersensitivity reactions after treatment, the drug should be discontinued
• 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
• Suicidal Behavior
  • 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
  • Anyone considering prescribing an antiepileptic drug, such as this one, must balance risk of suicidal thoughts or behaviors with risk of untreated illness; epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior
  • Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated
• Drug interactions overview
  • CYP2C19 poor metabolizers and patients using inhibitors of CYP2C19 may require dose reduction
  • Strong CYP2C19 inducers (e.g., rifampin) require dose increase (see Dosage Modifications)
  • Coadministration with carbamazepine may increase exposure to carbamazepine-epoxide, the active metabolite of carbamazepine; though data did not reveal any safety concerns, if tolerability issues arise when coadministered, consider carbamazepine reducing the dose
  • Because brivaracetam can increase plasma concentrations of phenytoin, monitor phenytoin levels in patients when concomitant brivaracetam is added to or discontinued from ongoing phenytoin therapy
  • No added therapeutic benefit to levetiracetam when the two drugs were coadministered

Pregnancy and Lactation

• No adequate and well-controlled studies in pregnant women
• In animal studies, brivaracetam produced evidence of developmental toxicity at plasma exposures greater than clinical exposure
• Pregnancy Registry
  • Recommend that pregnant patients enroll in the North American Antiepileptic Drug Pregnancy Registry; this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves
  • Information on the registry can also be found at the Web site http://www.aedpregnancyregistry.org/
  • Unknown if distributed in human breast milk
  • Studies in rats have shown excretion in milk
  • Because many drugs are excreted into human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.