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AURO-BRIVARACETAM 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: Auro-Brivaracetam (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. 1.1 Pediatrics Pediatrics (< 4…
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 Auro-Brivaracetam or to any ingredient in the formulation or component of the container. For a complete listing, see the
). Hematologic Auro-Brivaracetam can cause hematologic abnormalities. 0 x 109/L). Hepatic/Biliary/Pancreatic There are limited clinical data on the use of brivaracetam 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 Auro-Brivaracetam Product Monograph Page 10 of 43 Bronchospasm and Angioedema: Auro-Brivaracetam can cause hypersensitivity reactions. Rare cases of bronchospasm and angioedema have been reported in patients taking brivaracetam.
If a patient develops hypersensitivity reactions after treatment with Auro-Brivaracetam, 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, Auro- Brivaracetam should be discontinued and alternative treatment started.
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 Auro-Brivaracetam Product Monograph Page 6 of 43 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 brivaracetam 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 brivaracetam in this population.
3 Pharmacokinetics, Special Populations and Conditions, Geriatrics). Discontinuation As with all antiepileptic drugs, Auro-Brivaracetam 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). 4 Administration Auro-Brivaracetam Tablets Auro-Brivaracetam tablets should be swallowed whole with liquid.
Auro-Brivaracetam tablets should not be chewed or crushed. 5 Missed Dose Should patients miss a dose, they should be instructed to take Auro-Brivaracetam as soon as they remember and take the following dose at the usual morning or evening time.
• Patients who are hypersensitive to Auro-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.
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Neurologic Somnolence and Fatigue Auro-Brivaracetam 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 patients randomized to receive brivaracetam 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.
The risk is greatest early in treatment but can occur at any time (see 8 ADVERSE REACTIONS). Dizziness and Disturbance in Gait and Coordination Auro-Brivaracetam 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 brivaracetam 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-treated patients.
The risk is greatest early in treatment but can occur at any time (see 8 ADVERSE REACTIONS). Psychiatric Behavioural Disorders Auro-Brivaracetam 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 brivaracetam at Auro-Brivaracetam Product Monograph Page 11 of 43 least 50 mg/day compared to 8% of placebo-treated patients.
) occurred in 12% of the patients treated with brivaracetam 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 brivaracetam-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 […]
This may avoid the brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures from occurring. 5 OVERDOSAGE For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1- 844-764-7669).
Signs, Symptoms, and Laboratory Findings of Acute Overdose in Humans Auro-Brivaracetam Product Monograph Page 7 of 43 There is limited clinical experience with brivaracetam overdose in humans. During pre- marketing clinical trials of brivaracetam, the types of adverse events experienced by patients exposed to acute brivaracetam 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 brivaracetam, which is the highest known non-lethal overdose. The following additional adverse reactions were reported with brivaracetam overdose: vertigo, balance disorder, fatigue, nausea, diplopia and anxiety.
Treatment or Management of Overdose There is no specific antidote for overdose with Auro-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 rhythm and vital sign measurement is recommended.
A certified poison control centre should be contacted for updated information on the management of overdose with Auro-Brivaracetam. There is no data on the potential removal of brivaracetam using hemodialysis. Since less than 10% of brivaracetam is excreted in urine, hemodialysis is not expected to significantly enhance brivaracetam clearance.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2: Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-Medicinal Ingredients Auro-Brivaracetam Product Monograph Page 8 of 43 Oral Tablets /10 mg, 25 mg, 50 mg, 75 mg, and 100 mg/ bottle Anhydrous lactose, croscarmellose sodium, lactose monohydrate, magnesium stearate and additional ingredients listed below: 10 mg tablets: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide and talcum.
25 mg tablets: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, talcum, titanium dioxide and yellow iron oxide. 50 mg tablets: macrogol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide and yellow iron oxide. 75 mg tablets: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide talcum, titanium dioxide and yellow iron oxide.
100 mg tablets: black iron oxide, macrogol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide and yellow iron oxide. Auro-Brivaracetam (brivaracetam) tablets Auro-Brivaracetam tablets are supplied as follows: 10 mg Tablets: Auro-Brivaracetam tablets 10 mg are white to off-white, round shaped, film- coated tablets debossed with “IT” on one side and “10” on other side.
25 mg Tablets: Auro-Brivaracetam tablets 25 mg are light grey to grey, oval shaped, film- coated tablets debossed with “IT” on one side and “25” on other side. 50 mg Tablets: Auro-Brivaracetam tablets 50 mg are light orange to orange, oval shaped, film- coated tablets debossed with "IT" on one side and "50" on other side.
75 mg Tablets: Auro-Brivaracetam tablets 75 mg are light purple to purple, oval shaped, film- coated tablets debossed with “IT” one side and “75” on other side. 100 mg Tablets: Auro-Brivaracetam tablets 100 mg are light pink to pink, oval shaped, film- coated tablets debossed with "IT" on one side and "100" on other side.
Auro-Brivaracetam tablets are supplied in white HDPE bottles of 60 tablets. Auro-Brivaracetam Product Monograph Page 9 of 43 7 WARNINGS AND PRECAUTIONS General Withdrawal of […]