brivaracetam

brivaracetam is an FDA-registered drug product whose active ingredient is BRIVARACETAM. It is labelled by Novadoz Pharmaceuticals LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 72205-267, application ANDA214921, label effective 20260814. It is one of 7 FDA drug label records sharing the active ingredient BRIVARACETAM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BRIVARACETAM are most often described in connection with: brivaracetam tablets, treatment partial-onset, seizures patients, month age. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. ( 1 )

2 DOSAGE AND ADMINISTRATION Adults (16 Years and Older ): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day). Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day). (2.1) Pediatric Patients (1 Month to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily (2.1) Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment. (2.5) 2.1 Dosage Information Monotherapy or Adjunctive Therapy The recommended dosage for patients 1 month of age and older is included in Table 1. 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. Dosage should be adjusted based on clinical response and tolerability. Table 1: Recommended Dosage for Patients 1 Month of Age and Older Age and Body Weight Initial Dosage Minimum and Maximum Maintenance Dosage 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 4 mg/kg per day) 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) 2.2 Administration Instructions for Brivaracetam Tablets Brivaracetam tablets can be initiated with oral administration. Brivaracetam tablets may be taken with or without food. Brivaracetam Tablets Brivaracetam tablets should be swallowed whole with liquid. Brivaracetam tablets should not be chewed or crushed. 2.4 Discontinuation of Brivaracetam Tablets Avoid abrupt withdrawal from brivaracetam tablets in order to minimize the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.6) and Clinical Studies (14) ] . 2.5 Patients with Hepatic Impairment The recommended dosage for patients with hepatic impairment is included in Table 2 [see Use in Specific Populations (8.7 ) and Clinical Pharmacology (12.3 )]. Table 2: Recommended Dosage for Patients with Hepatic Impairment Age and Body Weight I nitial Dosage M ax imum Maintenance Dosage 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) 2.6 Co-administration with Rifampin Increase the brivaracetam tablets dosage in patients on concomitant rifampin by up to 100% (i.e., double the dosage) [ see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ] .

4 CONTRAINDICATIONS Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam tablets (bronchospasm and angioedema have occurred) [see Warnings and Precautions (5.4) ] . Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam. (4)

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: Suicidal Behavior and Ideation [ see Warnings and Precautions (5.1)] Neurological Adverse Reactions [see Warnings and Precautions (5.2)] Psychiatric Adverse Reactions [see Warnings and Precautions (5.3)] Hypersensitivity: Bronchospasm and Angioedema [see Warnings and Precautions (5.4)] Serious Dermatologic Reactions [see Warnings and Precautions (5.5) ] Withdrawal of Antiepileptic Drugs [see Warnings and Precautions (5.6) ] Adults: Most common adverse reactions (at least 5% for brivaracetam and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea/vomiting. (6.1) Pediatric Patients: Most common adverse reactions are similar to those seen in adult patients. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In all controlled and uncontrolled trials performed in adult epilepsy patients, brivaracetam was administered as adjunctive therapy to 2437 patients. Of these patients, 1929 were treated for at least 6 months, 1500 for at least 12 months, 1056 for at least 24 months, and 758 for at least 36 months. A total of 1558 patients (1099 patients treated with brivaracetam and 459 patients treated with placebo) constituted the safety population in the pooled analysis of Phase 3 placebo-controlled studies in patients with partial-onset seizures (Studies 1, 2, and 3) [see Clinical Studies (14)] . The adverse reactions presented in Table 4 are based on this safety population; the median length of treatment in these studies was 12 weeks. Of the patients in those studies, approximately 51% were male, 74% were Caucasian, and the mean age was 38 years. In the Phase 3 controlled epilepsy studies, adverse events occurred in 68% of patients treated with brivaracetam and 62% treated with placebo. The most common adverse reactions occurring at a frequency of at least 5% in patients treated with brivaracetam doses of at least 50 mg/day and greater than placebo were somnolence and sedation (16%), dizziness (12%), fatigue (9%), and nausea and vomiting symptoms (5%). The discontinuation rates due to adverse events were 5%, 8%, and 7% for patients randomized to receive brivaracetam at the recommended doses of 50 mg, 100 mg, and 200 mg/day, respectively, compared to 4% in patients randomized to receive placebo. Table 4 lists adverse reactions for brivaracetam that occurred at least 2% more frequently for brivaracetam doses of at least 50 mg/day than placebo. Table 4: Adverse Reactions in Pooled Placebo-Controlled Adjunctive Therapy Studies in Adult Patients with Partial-Onset Seizures (Brivaracetam 50 mg/day, 100 mg/day, and 200 mg/day) Adverse Reactions Brivaracetam (N=803) % Placebo (N=459) % Gastrointestinal disorders Nausea/vomiting symptoms 5 3 Constipation 2 0 Nervous system disorders Somnolence and sedation 16 8 Dizziness 12 7 Fatigue 9 4 Cerebellar coordination and balance disturbances* 3 1 Psychiatric disorders Irritability 3 1 * Cerebellar coordination and balance disturbances includes ataxia, balance disorder, coordination abnormal, and nystagmus. There was no apparent dose-dependent increase in adverse reactions listed in Table 4 with the exception of somnolence and sedation. Pediatric Patients Safety of brivaracetam was evaluated in two open-label, safety and pharmacokinetic trials in pediatric patients 2 months to less than 16 years of age. Across studies of pediatric patients with partial onset seizures, 186 patients received brivaracetam oral solution or tablet, of whom 123 received brivaracetam for at least 12 months. Adverse reactions reported in clinical studies of pediatric patients were generally similar to those seen in adult patients. Decreased appetite was also observed in these pediatric trials. Hematologic Abnormalities Brivaracetam can cause hematologic abnormalities. In the Phase 3 controlled adjunctive epilepsy studies, a total of 1.8% of brivaracetam-treated patients and 1.1% of placebo-treated patients had at least one clinically significant decreased white blood cell count (<3.0 x 10 9 /L), and 0.3% of brivaracetam-treated patients and 0% of placebo-treated patients had at least one clinically significant decreased neutrophil count (<1.0 x 10 9 /L). Comparison by Sex There were no significant differences by sex in the incidence of adverse reactions. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of brivaracetam. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and Subcutaneous Tissue Disorders: Serious dermatologic reactions (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis) [see Warnings and Precautions (5.5) ]

FDA lists 7 drug label records with BRIVARACETAM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is brivaracetam used for?
1 INDICATIONS AND USAGE Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. ( 1 )

Who makes brivaracetam?
Novadoz Pharmaceuticals LLC is the labeler of record for brivaracetam. 7 FDA label records share the active ingredient BRIVARACETAM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does brivaracetam come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is brivaracetam prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BRIVARACETAM?
Yes. 7 FDA drug label records list BRIVARACETAM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has brivaracetam been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.