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ZDS-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: ZDS-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 ZDS-Brivaracetam or to any ingredient in the formulation or component of the container. For a complete listing, see the
). Hematologic ZDS-Brivaracetam can cause hematologic abnormalities. 3% of brivaracetam -treated patients and 0% of placebo-treated patients had at least one clinically significant decreased neutrophil count (<1 x 109/L). ZDS-Brivaracetam Product Monograph Page 9 of 43 Unclassified / Non classifié 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 Bronchospasm and Angioedema:
ZDS-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 ZDS-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, ZDS- 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 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, ZDS-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 ZDS-Brivaracetam tablets should be swallowed whole with liquid.
ZDS-Brivaracetam tablets should not be chewed or crushed. 5 Missed Dose Should patients miss a dose, they should be instructed to take ZDS-Brivaracetam as soon as they remember and take the following dose at the usual morning or evening time.
• Patients who are hypersensitive to ZDS-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 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 Brivaracetam causes adverse reactions related to dizziness and disturbance in gait and coordination (dizziness, vertigo, balance disorder, ataxia, nystagmus, gait disturbance, and ZDS-Brivaracetam Product Monograph Page 10 of 43 Unclassified / Non classifié 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 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 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 ZDS-Brivaracetam Product Monograph Page 11 of 43 Unclassified / Non classifié used for various indications, has shown a small increased risk of suicidal ideation and behaviour in patients treated with these […]
This may avoid the brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures from occurring. 5 OVERDOSAGE ZDS-Brivaracetam Product Monograph Page 7 of 43 Unclassified / Non classifié 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 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 ZDS-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 ZDS-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 Nonmedicinal Ingredients Oral Tablets / 25 mg, 50 mg, 75 mg, and 100 mg /Blister Croscarmellose sodium, FD&C blue #1, FD&C yellow #5, ferric oxide yellow, GMDCC (glyceryl mono and dicaprylocaprate), GMCC Type 1 (glyceryl monocaprylocaprate), Glycerol of FA (glycerol esters of fatty acids), lactose anhydrous, lactose monohydrate, magnesium stearate, polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide.
ZDS-Brivaracetam tablets are supplied as follows: 25 mg:
Light green, oval, biconvex, film coated tablets debossed with “25” on one side and plain on other side. ZDS-Brivaracetam Product Monograph Page 8 of 43 Unclassified / Non classifié 50 mg: Light green, oval, biconvex, film coated tablets debossed with “50” on one side and plain on other side.
75 mg: Light green, oval, biconvex, film coated tablets debossed with “75” on one side and plain on other side. 100 mg: Light green, oval, biconvex, film coated tablets debossed with “100” on one side and plain on other side. ZDS-Brivaracetam tablets are supplied in PVC/PVDC-Aluminium and PVC/Aclar-Aluminium blister packs of 14, 56 (4 x 14 count blister), 60 (6 x 10 count blister) and 100 (10 x 10 count blister) tablets.
2 Recommended Dose and Dosage Adjustment). Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity and 16 NON-CLINICAL TOXICOLOGY, Genotoxicity for discussion on animal data. Driving and Operating Machinery Brivaracetam treatment has been associated with somnolence, dizziness, fatigue, and disturbance in coordination.
Patients should be monitored for such signs and symptoms and advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of ZDS-Brivaracetam on their ability […]