Prescribing Details
Description
BiVARA® is a preparation of Brivaracetam which is an anticonvulsant. The precise mechanism by which Brivaracetam exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain which may contribute to the anticonvulsant effect.
Uses
No Data
Indications
BiVARA® is indicated for the treatment of partial onset seizures in patients 1 month of age and older.
Dosage and administration
Route of administration: BiVARA® is taken in oral route. It may be taken with or without food.
Monotherapy or adjunctive therapy
The recommended dose for patients 1 month of age and older is included in below table. In pediatric patients weighing less than 50 kg, the recommended dosing regimen is dependent upon body weight. When initiating treatment, gradual dose escalation is not required. Dose should be adjusted based on clinical response and tolerability.
Recommended dose for patients 1 month of age and older
|
Age and body weight |
Initial dose |
Minimum and maximum maintenance dose |
|
Adults (16 years and older) |
50 mg twice daily (100 mg per day) |
25 mg to 100 mg twice daily (50 mg to 200 mg per day) |
|
Pediatric patients weighing 50 kg or more |
25 mg to 50 mg twice daily (50 mg to 100 mg per day) |
25 mg to 100 mg twice daily (50 mg to 200 mg per day) |
|
Pediatric patients weighing 20 kg to less than 50 kg |
0.5 mg/kg to 1 mg/kg twice daily ( 1 mg/kg to 2 mg/kg per day) |
0.5 mg/kg to 2 mg/kg twice daily (1 mg/kg to |
| Pediatric patients weighing 11 kg to less than 20 kg | 0.5 mg/kg to 1.25 mg/kg twice daily (1 mg/kg to 2.5 mg/kg per day) |
0.5 mg/kg to 2.5 mg/kg twice daily (1 mg/kg to 5 mg/kg per day) |
| Pediatric patients weighing less than 11 kg | 0.75 mg/kg to 1.5 mg/kg twice daily (1.5 mg/kg to 3 mg/kg per day) |
0.75 mg/kg to 3 mg/kg twice daily (1.5 mg/kg to 6 mg/kg per day) |
Renal impairment: Dose adjustments are not required for patients with impaired renal function. Use of brivaracetam is not recommended in patients with end stage renal disease undergoing dialysis.
Hepatic impairment: The recommended dose for patients with hepatic impairment is included in below table.
Recommended dose for patients with hepatic impairment
|
Age and body weight |
Initial dose |
Minimum and maximum maintenance dose |
|
Adults (16 years and older) |
25 mg twice daily (50 mg per day) |
75 mg twice daily (150 mg per day) |
|
Pediatric patients weighing 50 kg or more |
||
|
Pediatric patients weighing 20 kg to less than 50 kg |
0.5 mg/kg twice daily (1 mg/kg per day) |
1.5 mg/kg twice daily (3 mg/kg per day) |
| Pediatric patients weighing 11 kg to less than 20 kg | 0.5 mg/kg twice daily (1 mg/kg per day) |
2 mg/kg twice daily (4 mg/kg per day) |
| Pediatric patients weighing less than 11 kg | 0.75 mg/kg twice daily (1.5 mg/kg per day) |
2.25 mg/kg twice daily (4.5 mg/kg per day) |
Or as directed by the physician.
Use in pregnancy & lactation
Pregnancy: Brivaracetam should not be used during pregnancy unless clinically necessary i.e. (if the benefit to the mother clearly outweighs the potential risk to the fetus).
Lactation: No data are available regarding the presence of brivaracetam in human milk, the effects on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for brivaracetam and any potential adverse effects on the breastfed infant from brivaracetam or from the underlying maternal condition.
Use in children and adolescents
Safety and effectiveness in pediatric patients below the age of 1 month have not been established.
Geriatric use
Precautions
Antiepileptic drugs (AEDs), including brivaracetam, increase the risk of suicidal thoughts or behavior. Patients treated with any AED should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior and/or any unusual changes in mood or behavior. Brivaracetam causes somnolence, fatigue, dizziness and disturbance in coordination. Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery. Brivaracetam causes psychiatric adverse reactions which included both non-psychotic symptoms (irritability, anxiety, nervousness, aggression, belligerence, anger, agitation, restlessness, depression, depressed mood, tearfulness, apathy, mood swings, psychomotor hyperactivity, abnormal behavior and adjustment disorder) and psychotic symptoms (psychotic disorder along with hallucination, paranoia, acute psychosis and psychotic behavior). As with most antiepileptic drugs, brivaracetam should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.
Side effects
The most common side effects are nausea/vomiting, constipation, somnolence and sedation, dizziness, fatigue, cerebellar coordination and balance disturbances and irritability.
Contraindications
Brivaracetam is contraindicated in patients with known hypersensitivity to brivaracetam or any other components of this product.
Drug interactions
Drug interaction with medication: Co-administration with rifampin decreases brivaracetam plasma concentrations likely because of CYP2C19 induction. Prescribers should increase the brivaracetam dose by up to 100% (i.e., double the dose) in patients while receiving concomitant treatment with rifampin. Co-administration with carbamazepine may increase exposure to carbamazepine-epoxide, the active metabolite of carbamazepine. If tolerability issues arise when co-administered, carbamazepine dose reduction should be considered. Because brivaracetam can increase plasma concentrations of phenytoin, phenytoin levels should be monitored in patients when concomitant brivaracetam is added to or discontinued from ongoing phenytoin therapy. Brivaracetam provided no added therapeutic benefit to levetiracetam when the two drugs were co-administered.
Drug interaction with food and others: Not applicable.
Overdose
The adverse reactions with brivaracetam overdose are vertigo, balance disorder, fatigue, nausea, diplopia, anxiety and bradycardia. There is no specific antidote for overdose with brivaracetam. In the event of overdose, standard medical practice for the management of any overdose should be used. An adequate airway, oxygenation and ventilation should be ensured; monitoring of cardiac rate and rhythm and vital signs is recommended.
Preparation
No Data
Pharmaceutical precautions
Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.
Presentation
BiVARA® 25 tablet: Each coated tablet contains Brivaracetam INN 25 mg.
BiVARA® 50 tablet: Each coated tablet contains Brivaracetam INN 50 mg.
BiVARA® oral solution: Each ml contains Brivaracetam INN 10 mg.
Package quantities
BiVARA® 25 tablet: Carton of 20 tablets in blister pack.
BiVARA® 50 tablet: Carton of 10 tablets in blister pack.
BiVARA® oral solution: Bottle of 50 ml.
