Loading…
BRIVLERA is a brand name for Brivaracetam, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults, adolescents and children 4 years of age and older: BRIVLERA (brivaracetam) is indicated as adjunctive therapy in the management of partial- onset seizures in patients 4 years of age and older with epilepsy who are not satisfactorily controlled with conventional therapy. BRIVLERA (brivaracetam) solution for…
Verbatim from this product's HC label. Tap a section to expand.
3 Pharmacokinetics, Special Populations and Conditions, Geriatrics). 2 CONTRAINDICATIONS • Patients who are hypersensitive to BRIVLERA (brivaracetam) or to any ingredient in the formulation or component of the container. For a complete listing, see the
). Hematologic BRIVLERA can cause hematologic abnormalities. 0 x 109/L). Hepatic/Biliary/Pancreatic There are limited clinical data on the use of BRIVLERA in adult patients with pre -existing hepatic impairment, and no clinical data in the pediatric population with hepatic impairment.
Dose decreases are recommended. In adults, a 25 mg twice daily (50 mg per day) starting dose should be considered. A maximum dose of 75 mg twice daily (150 mg per day) is recommended for all stages of hepatic impairment. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency).
Immune Hypersensitivity Bronchospasm and Angioedema:
BRIVLERA can cause hypersensitivity reactions. Rare cases of bronchospasm and angioedema have been reported in patients taking BRIVLERA. If a patient develops hypersensitivity reactions after treatment with BRIVLERA, the drug should be discontinued and an alternative considered.
Serious Dermatologic Reactions:
Multi-organ hypersensitivity syndrome (also known as Drug Reaction Eosinophilia and Systemic Symptoms or DRESS), is a serious condition sometimes induced by antiepileptic drugs. Typically, although not exclusively, DRESS initially presents with fever and rash, then with other organ system involvement that may or may not include eosinophilia, lymphadenopathy, hepatitis, nephritis, and/or myocarditis.
Because DRESS is variable in its expression, other organ system signs and symptoms not noted here may also occur. Organ involvement may be more severe than skin involvement. If any of these hypersensitivity reactions are suspected and an alternative cause cannot be established, BRIVLERA should be discontinued and alternative treatment started.
Neurologic Somnolence and Fatigue BRIVLERA causes dose-dependent increases in somnolence and fatigue-related adverse reactions (fatigue, malaise, hypersomnia, sedation, and lethargy). In the Phase 3 controlled adjunctive epilepsy trials in adults, these events were reported in 25% of patie nts randomized to receive BRIVLERA at least 50 mg/day (20% at 50 mg/day, 26% at 100 mg/day, and 27% at 200 mg/day) compared to 14% of placebo-treated patients.
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency ).
Patients with Hepatic Impairment:
In adults, and children and adolescents weighing 50 kg or more, a reduced starting dose of 25 mg twice daily (50 mg per day) should be considered. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). The recommended dosing for pediatrics with hepatic impairment is shown in Table 1.
Pediatrics (<4 years of age):
The safety and efficacy of BRIVLERA in children aged less than 4 years have not been established.
Geriatrics (≥65 years of age):
There was an insufficient number of patients 65 years of age and older in the double-blind placebo controlled epilepsy studies in adults (29 elderly patients aged between 65 and 80 years completed Phase 3 clinical trials) to adequately assess the safety and efficacy of BRIVLERA in this population.
3 Pharmacokinetics, Special Populations and Conditions, Geriatrics). Discontinuation As with all antiepileptic drugs, BRIVLERA should be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. , for adults and pediatrics over 50 kg: taper it gradually by 50 mg/day on a weekly basis.
After 1 week of treatment at 50 mg/day, a final week of treatment at the dose of 20 mg/day is recommended). 3 Reconstitution BRIVLERA Solution for Injection BRIVLERA solution for injection can be administered intravenously in adults without further dilution or may be mixed with the diluents listed below.
Withdraw the exact amount of BRIVLERA solution for injection required for administration. 5 mg/mL brivaracetam in diluent <BRIVLERA><brivaracetam> Page 7 of 44 As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration.
• Patients who are hypersensitive to BRIVLERA (brivaracetam) or to any ingredient in the formulation or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Brivaracetam in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The risk is greatest early in treatment but can occur at any time (see 8 ADVERSE REACTIONS). Dizziness and Disturbance in Gait and Coordination BRIVLERA causes adverse reactions related to dizziness and disturbance in gait and coordination (dizziness, vertigo, balance disorder, ataxia, nystagmus, gait disturbance, and abnormal coordination).
In the Phase 3 controlled adjunctive epilepsy trials in adults, these events were reported in 16% of patients randomized to receive BRIVLERA at least 50 mg/day (16% at 50 mg/day, 14% at 100 mg/day, and 18% at 200 mg/day) compared to 10% of placebo- <BRIVLERA><brivaracetam> Page 11 of 44 treated patients.
The risk is greatest early in treatment but can occur at any time (see 8 ADVERSE REACTIONS). Psychiatric Behavioural Disorders BRIVLERA causes both psychotic and non-psychotic adverse reactions which are not dose- dependent. In the Phase 3 controlled adjunctive epilepsy trials in adults, psychiatric events were reported in approximately 13% of patients randomized to receive BRIVLERA at least 50 mg/day compared to 8% of placebo-treated patients.
) occurred in 12% of the patients treated with BRIVLERA at least 50 mg/day compared to 7% of placebo-treated patients. 3% of patients who received placebo. In the Phase 3 controlled epilepsy studies in adults, irritability, depression, and anxiety symptoms occurred in 2% of BRIVLERA-treated patients and 1% of placebo-treated patients.
While psychiatric events observed in open-label pediatric trials were generally similar to those observed in adults, irritability and aggression were approximately double the incidence rates seen in adults, and the most frequent terms in pediatrics.
Psychomotor hyperactivity was also reported at notably higher rates than in adults. , hallucinations, delusions, paranoia). 5 Post-Market Adverse Reactions, Psychosis/Psychotic Disorder). Suicidal Ideation and Behaviour Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
All patients treated with antiepileptic drugs, irrespective of indication, should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
An FDA meta-analysis of randomized placebo controlled trials, in which antiepileptic drugs were used for various indications, has shown a small increased risk of suicidal ideation and behaviour in patients treated with these drugs.
The mechanism of this risk is not known. There were 43,892 patients treated in the placebo controlled clinical trials that were included in the meta-analysis. Approximately 75% of patients in these clinical trials were treated for […]
Solution showing haziness, particulate matter, precipitate, discolouration or leakage should not be used. Discard unused portions. The clinical study experience of intravenous BRIVLERA is limited to 4 days of consecutive treatment. See 11 STORAGE, STABILITY AND DISPOSAL.
4 Administration BRIVLERA Tablets BRIVLERA tablets should be swallowed whole with liquid. BRIVLERA tablets should not be chewed or crushed. BRIVLERA Oral Solution When using BRIVLERA oral solution, no dilution is necessary. BRIVLERA oral solution may also be administered using a nasogastric tube or gastrostomy tube.
BRIVLERA Solution for Injection It may be administered as a bolus injection or as a 15-minute IV infusion. 5 Missed Dose Should patients miss a dose, they should be instructed to take BRIVLERA as soon as they remember and take the following dose at the usual morning or evening time.
This may avoid the brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures from occurring. 5 OVERDOSAGE Signs, Symptoms, and Laboratory Findings of Acute Overdose in Humans There is limited clinical experience with BRIVLERA (brivaracetam) overdose in humans.
During pre-marketing clinical trials of BRIVLERA, the types of adverse events experienced by patients exposed to acute BRIVLERA overdose were mostly similar to those observed in patients administered therapeutic doses of the drug. Somnolence and dizziness have been reported in a patient taking a single dose of 1400 mg of BRIVLERA, which is the highest known non-lethal overdose.
The following additional adverse reactions were reported with BRIVLERA overdose: vertigo, balance disorder, fatigue, nausea, diplopia and anxiety. Treatment or Management of Overdose There is no specific antidote for overdose with BRIVLERA.
In the event of overdose, standard For management of a suspected drug overdose, contact your regional poison control centre. <BRIVLERA><brivaracetam> Page 8 of 44 medical practice for the management of any overdose should be used. An adequate airway, oxygenation, and ventilation should be ensured; monitoring of cardiac rhythm and vital sign measurement is recommended.
A certified poison control centre should be contacted for updated information on the management of overdose with BRIVLERA. There is no data on the potential removal of BRIVLERA using hemodialysis. Since less than 10% of BRIVLERA is excreted in urine, hemodialysis is not expected to significantly enhance BRIVLERA clearance.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2: Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Nonmedicinal Ingredients Oral Tablets / 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg / bottle anhydrous lactose, betadex (β-cyclodextrin), croscarmellose sodium, lactose monohydrate, and magnesium stearate and additional ingredients listed below: 10 mg tablets: polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide 25 mg and 100 mg tablets: black iron oxide polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, yellow iron oxide 50 mg tablets: polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, yellow iron oxide 75 mg tablets: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, yellow iron oxide Oral Oral solution / 10 mg/mL / bottle anhydrous citric acid, carboxymethylcellulose sodium, glycerin, methylparaben, raspberry flavour, purified water, sodium citrate, sorbitol solution, […]