Brevipil
Generic Name
Brivaracetam
Manufacturer
UCB (original developer), various generic manufacturers
Country
Global, developed in Belgium
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| brevipil 50 mg tablet | ৳ 45.00 | ৳ 450.00 |
Description
Overview of the medicine
Brivaracetam (Brevipil) is an antiepileptic drug used for the treatment of partial-onset seizures with or without secondary generalization in patients aged 1 month and older. It acts by binding to synaptic vesicle glycoprotein 2A (SV2A) in the brain.
Uses & Indications
Dosage
Adults
Initial dose: 50 mg twice daily. Can be adjusted up to 100 mg twice daily (maximum 200 mg twice daily based on individual patient response and tolerability).
Elderly
No specific dose adjustment is required based on age alone, but consideration should be given to potential age-related decrease in renal function.
Renal_impairment
For patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis, a starting dose of 25 mg twice daily is recommended, with a maximum of 50 mg twice daily. No dose adjustment needed for mild to moderate impairment.
How to Take
Brevipil tablets should be taken orally, with or without food. They should be swallowed whole with a sufficient amount of liquid and not crushed or chewed.
Mechanism of Action
Brivaracetam exhibits high and selective affinity for synaptic vesicle glycoprotein 2A (SV2A) in the brain. The exact mechanism by which it exerts its antiepileptic effect is not fully understood, but it is believed to involve modulation of neurotransmitter release by binding to SV2A, which may reduce neuronal hyperexcitability.
Pharmacokinetics
Onset
Relatively rapid onset of action, with clinical effects observed soon after initiation.
Excretion
Mainly excreted by the kidneys, with approximately 95% of the administered dose recovered in urine. Less than 10% is excreted as unchanged drug.
Half life
Mean terminal half-life is approximately 9 hours, allowing for twice-daily dosing.
Absorption
Rapid and almost complete absorption from the gastrointestinal tract, with peak plasma concentrations typically achieved within 0.5 to 2 hours post-dose. Bioavailability is approximately 100%.
Metabolism
Primarily metabolized by hydrolysis of the amide moiety, mainly by hepatic amidase, and subsequently by hydroxylation. CYP2C19 is involved in the hydroxylation step, but it is not the major elimination pathway.
Side Effects
Contraindications
- Hypersensitivity to the active substance Brivaracetam or to any of the excipients, or to piracetam.
Drug Interactions
Phenytoin
Brivaracetam may lead to a mild increase in phenytoin plasma concentrations, but dose adjustment of phenytoin is generally not required.
Rifampicin
May decrease brivaracetam plasma concentrations due to induction of CYP2C19.
Carbamazepine
No significant pharmacokinetic interaction observed, but potential for additive CNS depressant effects.
Phenobarbital
No significant pharmacokinetic interaction observed, but potential for additive CNS depressant effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Symptoms reported include somnolence, dizziness, nausea, and ataxia. In case of overdose, general supportive measures should be implemented, including monitoring of vital signs and clinical status. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Studies in animals have shown reproductive toxicity. There are no adequate and well-controlled studies in pregnant women. Brevipil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Brivaracetam is excreted in human milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Brevipil therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Side Effects
Contraindications
- Hypersensitivity to the active substance Brivaracetam or to any of the excipients, or to piracetam.
Drug Interactions
Phenytoin
Brivaracetam may lead to a mild increase in phenytoin plasma concentrations, but dose adjustment of phenytoin is generally not required.
Rifampicin
May decrease brivaracetam plasma concentrations due to induction of CYP2C19.
Carbamazepine
No significant pharmacokinetic interaction observed, but potential for additive CNS depressant effects.
Phenobarbital
No significant pharmacokinetic interaction observed, but potential for additive CNS depressant effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Symptoms reported include somnolence, dizziness, nausea, and ataxia. In case of overdose, general supportive measures should be implemented, including monitoring of vital signs and clinical status. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Studies in animals have shown reproductive toxicity. There are no adequate and well-controlled studies in pregnant women. Brevipil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Brivaracetam is excreted in human milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Brevipil therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, as indicated on the packaging.
Availability
Available in pharmacies with a valid prescription
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Patented by UCB Pharma S.A.
Clinical Trials
Brivaracetam has undergone extensive clinical trials demonstrating its efficacy and safety as an adjunctive therapy for partial-onset seizures. Trials included adult, pediatric, and elderly populations.
Lab Monitoring
- No routine laboratory monitoring is specifically required. However, renal function should be monitored in patients with renal impairment.
- Liver function tests may be considered in patients with hepatic impairment.
Doctor Notes
- Counsel patients on the importance of strict adherence to the prescribed dosing regimen and not to discontinue abruptly.
- Monitor for emergent or worsening depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior, especially during the initial months of treatment or following dose changes.
- Caution patients about potential CNS depressant effects, including somnolence and dizziness, and advise regarding activities requiring mental alertness.
Patient Guidelines
- Take Brevipil exactly as prescribed by your doctor; do not stop taking it suddenly as this can increase seizure frequency.
- Report any unusual mood changes, depression, or suicidal thoughts to your doctor immediately.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Brevipil can cause dizziness, somnolence, and other central nervous system effects that may impair the ability to drive or operate machinery. Patients should be advised to exercise caution until they have gained sufficient experience to assess whether the medication affects their ability to perform such tasks.
Lifestyle Advice
- Avoid alcohol consumption while taking Brevipil, as it can increase CNS depressant effects.
- Maintain a regular sleep schedule and avoid activities that may trigger seizures.
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