Brivaracetam Oral Solution 10 mg/mL Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Other antiepileptics class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Brivaracetam is used to treat partial onset seizures (seizures that involve only one part of the brain). Brivaracetam is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Read the full MedlinePlus article ↗- Brivaracetam — sold as Briviact and available generically — is prescribed to treat partial-onset seizures. These are seizures that start in one specific area of the brain. It can b...
- You take brivaracetam twice a day — roughly every 12 hours, like morning and evening. Tablets can be taken with or without food, which is convenient. A high-fat meal might slow dow...
- How do I take it, and does it matter if I take it with food?
- The most common things people notice are drowsiness, dizziness, fatigue, and sometimes nausea — especially when first starting the medication. These are usually manageable. That sa...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Brivaracetam — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
-
UNII K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII 9E0S3UM200
A sugar alcohol solution derived from glucose that stays liquid without forming crystals. It functions as a sweetener, humectant (moisture-retaining agent), and solvent in liquid medications and syrups.
-
UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
-
UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.264 | $79.14 / 300 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.3952 | $118.56 / 300 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Brivaracetam 10 mg/mL 00121-1074-10 | PAI | 1 bottle | $0.264 | AA | Availability likely | — |
| Brivaracetam Oral Solution 10 mg/mLthis 67877-0904-58 | Ascend | 1 bottle | $0.264 | AA | Availability likely | — |
| Brivaracetam 10 mg/mL 70748-0411-01 | Lupin | 1 bottle | $0.264 | AA | Availability likely | — |
| Brivaracetam oral Solution 10 mg/mL 71921-0410-72 | Florida | 1 bottle | $0.264 | AA | Availability likely | — |
| brivaracetam 10 mg/mL 72205-0033-73 | Novadoz | 1 bottle | $0.264 | AA | Availability likely | — |
| Briviact 10 mg/mL 50474-0870-15 | UCB, | 1 bottle | $4.810 | AA | Availability likely | +1723% |
| brivaracetam 10 mg/mL 72673-0031-10 | Zhejiang | 1 bottle | — | AA | FDA listed | — |
| Brivaracetam 10 mg/mL 59651-0995-03 | Aurobindo | 300 ml | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 67877-0904-58 You're viewing this | 1 BOTTLE in 1 CARTON (67877-904-58) / 300 mL in 1 BOTTLE | 2026-02-23 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Brivaracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE & 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 )
2.1Dosage 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)
2.2Administration Instructions for Brivaracetam Oral Solution Brivaracetam oral solution can be initiated with oral administration. Brivaracetam oral solution may be taken with or without food. Brivaracetam Oral Solution A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately.
A household teaspoon or tablespoon is not an adequate measuring device. When using brivaracetam oral solution, no dilution is necessary. Brivaracetam oral solution may also be administered using a nasogastric tube or gastrostomy tube.
Discard any unused brivaracetam oral solution remaining after 5 months of first opening the bottle.
2.4Discontinuation of Brivaracetam Oral Solution Avoid abrupt withdrawal from brivaracetam oral solution in order to minimize the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions ( 5.6 ) and Clinical Studies ( 14 )].
2.5Patients 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 Initial Dosage Maximum 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)
2.6Co-administration with Rifampin Increase the brivaracetam oral solution 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 )].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Oral Solution • 10 mg/mL: slightly viscous, clear, colorless to yellowish, raspberry-flavored liquid. Oral solution: 10 mg/mL ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam oral solution (bronchospasm and angioedema have occurred) [see Warnings and Precautions ( 5.4 )] . Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam oral solution. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation. ( 5.1 ) Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on brivaracetam oral solution. ( 5.2 ) Psychiatric Adverse Reactions: Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms.
( 5.3 ) Hypersensitivity: Bronchospasm and Angioedema: Advise patients to seek immediate medical care. Discontinue and do not restart brivaracetam oral solution if hypersensitivity occurs. ( 5.4 ) Serious Dermatologic Reactions: Discontinue brivaracetam oral solution unless an alternative etiology is established ( 5.5 ) Withdrawal of Antiepileptic Drugs: brivaracetam oral solution should be gradually withdrawn.
( 5.6 )
5.1Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including brivaracetam oral solution, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo.
In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed.
The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. Table 3 shows absolute and relative risk by indication for all evaluated AEDs.
Table 3: Risk of Suicidal Thoughts or Behaviors by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1,000 Patients Drug Patients with Events Per 1,000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1,000 Patients Epilepsy 1.0 3.4 3.5
2.4Psychiatric 5.7 8.5 1.5
2.9Other 1.0 1.8 1.9
0.9Total 2.4 4.3 1.8
1.9The relative risk for suicidal thoughts or behavior was higher in clinical trials in patients with epilepsy than in clinical trials in patients with psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing brivaracetam oral solution or any other AED must balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increas…
🤒 Adverse Reactions ▾
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 oral solution 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 Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 oral solution was administered as adjunctive therapy to 2,437 patients. Of these patients, 1,929 were treated for at least 6 months, 1,500 for at least 12 months, 1,056 for at least 24 months, and 758 for at least 36 months.
A total of 1,558 patients (1,099 patients treated with brivaracetam oral solution 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 oral solution and 62% treated with placebo. The most common adverse reactions occurring at a frequency of at least 5% in patients treated with brivaracetam oral solution 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 oral solution 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 oral solution that occurred at least 2% more frequently for brivaracetam oral solution 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 oral solution 50 mg/day, 100 mg/day, and 200 mg/day) Adverse Reactions Brivaracetam Oral Solution (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 oral solution was evaluated in two open-label, safety and pharmacokinetic trials in pediatric patients 2 months to less than 16 years of age. Acro…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Rifampin: Because of decreased concentrations, increasing brivaracetam oral solution dosage in patients on concomitant rifampin is recommended. ( 2.6 , 7.1 ) Carbamazepine: Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant brivaracetam oral solution. ( 7.2 ) Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant brivaracetam oral solution.
( 7.3 ) Levetiracetam: Brivaracetam oral solution had no added therapeutic benefit when co-administered with levetiracetam. ( 7.4 )
7.1Rifampin Co-administration with rifampin decreases brivaracetam oral solution plasma concentrations likely because of CYP2C19 induction [see Clinical Pharmacology ( 12.3 )] . Prescribers should increase the brivaracetam oral solution dose by up to 100% (i.e., double the dosage) in patients while receiving concomitant treatment with rifampin [see Dosage and Administration ( 2.6 ) ] .
7.2Carbamazepine Co-administration with carbamazepine may increase exposure to carbamazepine-epoxide, the active metabolite of carbamazepine. Though available data did not reveal any safety concerns, if tolerability issues arise when co-administered, carbamazepine dose reduction should be considered [see Clinical Pharmacology ( 12.3 )] .
7.3Phenytoin Because brivaracetam oral solution can increase plasma concentrations of phenytoin, phenytoin levels should be monitored in patients when concomitant brivaracetam oral solution is added to or discontinued from ongoing phenytoin therapy [see Clinical Pharmacology ( 12.3 )] .
7.4Levetiracetam Brivaracetam oral solution provided no added therapeutic benefit to levetiracetam when the two drugs were co-administered [see Clinical Studies ( 14 )].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )
8.1Pregnancy Risk Summary Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with brivaracetam oral solution use during pregnancy. In animal studies, brivaracetam produced evidence of developmental toxicity (increased embryofetal mortality and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, and long-term neurobehavioral changes in rat offspring) at maternal plasma exposures greater than clinical exposures [see Data] .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data Oral administration of brivaracetam (0, 150, 300, or 600 mg/kg/day) to pregnant rats during the period of organogenesis did not produce any significant maternal or embryofetal toxicity. The highest dose tested was associated with maternal plasma exposures (AUC) approximately 30 times exposures in humans at the maximum recommended dose (MRD) of 200 mg/day. Oral administration of brivaracetam (0, 30, 60, 120, or 240 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in embryofetal mortality and decreased fetal body weights at the highest dose tested, which was also maternally toxic.
The highest no-effect dose (120 mg/kg/day) was associated with maternal plasma exposures approximately 4 times human exposures at the MRD. When brivaracetam (0, 150, 300, or 600 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, decreased growth, delayed sexual maturation (female), and long-term neurobehavioral changes were observed in the offspring at the highest dose. The highest no-effect dose (300 mg/kg/day) was associated with maternal plasma exposures approximately 7 times human exposures at the MRD.
Brivaracetam was shown to readily cross the placenta in pregnant rats after a single oral (5 mg/kg) dose of 14 C-brivaracetam. From 1 hour post dose, radioactivity levels in fetuses, amniotic fluid, and placenta were similar to those measured in maternal blood.
8.2Lactation Risk Summary Data from published literature indicate that brivaracetam is present in human milk. There is insufficient information on the effects of brivaracetam on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for brivaracetam oral solution and any potential adverse effects on the breastfed infant from brivaracetam oral solution or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness of brivaracetam oral solution have been established in pediatric patients 1 month to less than 16 years of age. Use of brivaracetam oral solution in these age groups is supported by evidence from adequate and well-controlled studies of brivaracetam oral solution in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in pediatric patients 2 months to less than 16 years of age [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ) , and Clinical Studies ( 14 )].
Safety and effectiveness in pediatric patients below the age of 1 month have not been established. Juvenile Animal Toxicity Data The potential adverse effects of brivaracetam on postnatal growth and development were investigated in juvenile rats and dogs. Oral administration (0, 150, 300, or 600 m…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with brivaracetam oral solution use during pregnancy. In animal studies, brivaracetam produced evidence of developmental toxicity (increased embryofetal mortality and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, and long-term neurobehavioral changes in rat offspring) at maternal plasma exposures greater than clinical exposures [see Data] .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data Oral administration of brivaracetam (0, 150, 300, or 600 mg/kg/day) to pregnant rats during the period of organogenesis did not produce any significant maternal or embryofetal toxicity. The highest dose tested was associated with maternal plasma exposures (AUC) approximately 30 times exposures in humans at the maximum recommended dose (MRD) of 200 mg/day. Oral administration of brivaracetam (0, 30, 60, 120, or 240 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in embryofetal mortality and decreased fetal body weights at the highest dose tested, which was also maternally toxic.
The highest no-effect dose (120 mg/kg/day) was associated with maternal plasma exposures approximately 4 times human exposures at the MRD. When brivaracetam (0, 150, 300, or 600 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, decreased growth, delayed sexual maturation (female), and long-term neurobehavioral changes were observed in the offspring at the highest dose. The highest no-effect dose (300 mg/kg/day) was associated with maternal plasma exposures approximately 7 times human exposures at the MRD.
Brivaracetam was shown to readily cross the placenta in pregnant rats after a single oral (5 mg/kg) dose of 14 C-brivaracetam. From 1 hour post dose, radioactivity levels in fetuses, amniotic fluid, and placenta were similar to those measured in maternal blood.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of brivaracetam oral solution have been established in pediatric patients 1 month to less than 16 years of age. Use of brivaracetam oral solution in these age groups is supported by evidence from adequate and well-controlled studies of brivaracetam oral solution in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in pediatric patients 2 months to less than 16 years of age [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ) , and Clinical Studies ( 14 )].
Safety and effectiveness in pediatric patients below the age of 1 month have not been established. Juvenile Animal Toxicity Data The potential adverse effects of brivaracetam on postnatal growth and development were investigated in juvenile rats and dogs. Oral administration (0, 150, 300, or 600 mg/kg/day) to rats during the neonatal and juvenile periods of development (approximately equivalent to neonatal through adolescent development in humans) resulted in increased mortality, decreased body weight gain, delayed male sexual maturation, and adverse neurobehavioral effects at the highest dose tested and decreased brain size and weight at all doses.
Therefore, a no-effect dose was not established; the lowest dose tested in juvenile rats was associated with plasma exposures (AUC) approximately 2 times those in children and adolescents at the recommended maintenance dose. In dogs, oral administration (0, 15, 30, or 100 mg/kg/day) throughout the neonatal and juvenile periods of development induced liver changes similar to those observed in adult animals at the highest dose but produced no adverse effects on growth, bone density or strength, neurological testing, or neuropathology evaluation.
The overall no-effect dose (30 mg/kg/day) and the no-effect dose for adverse effects on developmental parameters (100 mg/kg/day) were associated with plasma exposures approximately equal to and 4 times, respectively, those in children and adolescents at the recommended maintenance dose.
🧓 Geriatric Use ▾
8.5Geriatric Use There were insufficient numbers of patients 65 years of age and older in the double-blind, placebo-controlled epilepsy trials (n=38) to allow adequate assessment of the effectiveness of brivaracetam oral solution in this population. In general, dose selection for an elderly patient should be judicious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology ( 12.3 )] .
🆘 Overdosage ▾
10 OVERDOSAGE There is limited clinical experience with brivaracetam oral solution overdose in humans. Somnolence and dizziness were reported in a patient taking a single dose of 1,400 mg (14 times the highest recommended single dose) of brivaracetam. The following adverse reactions were reported with brivaracetam oral solution overdose: vertigo, balance disorder, fatigue, nausea, diplopia, anxiety, and bradycardia.
In general, the adverse reactions associated with brivaracetam oral solution overdose were consistent with the known adverse reactions. There is no specific antidote for overdose with brivaracetam oral solution. 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. A certified poison control center should be contacted for updated information on the management of overdose with brivaracetam oral solution. There are no data on the removal of brivaracetam using hemodialysis, but because less than 10% of brivaracetam is excreted in urine, hemodialysis is not expected to enhance brivaracetam oral solution clearance.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The precise mechanism by which brivaracetam oral solution 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.
12.2Pharmacodynamics Interactions with Alcohol In a pharmacokinetic and pharmacodynamic interaction study in healthy subjects, co-administration of brivaracetam oral solution (single dose 200 mg [2 times greater than the highest recommended single dose]) and ethanol (continuous intravenous infusion to achieve a blood alcohol concentration of 60 mg/100 mL during 5 hours) increased the effects of alcohol on psychomotor function, attention, and memory. Co-administration of brivaracetam oral solution and ethanol caused a larger decrease from baseline in saccadic peak velocity, smooth pursuit, adaptive tracking performance, and Visual Analog Scale (VAS) alertness, and a larger increase from baseline in body sway and in saccadic reaction time compared with brivaracetam oral solution alone or ethanol alone.
The immediate word recall scores were generally lower for brivaracetam oral solution when co-administered with ethanol. Cardiac Electrophysiology At a dose 4 times the maximum recommended dose, brivaracetam oral solution did not prolong the QT interval to a clinically relevant extent.
12.3Pharmacokinetics Brivaracetam tablets, oral solution, and injection can be used interchangeably. Brivaracetam exhibits linear and time-independent pharmacokinetics at the approved doses. The pharmacokinetics of brivaracetam are similar when used as monotherapy or as adjunctive therapy for the treatment of partialonset seizures.
Absorption Brivaracetam is highly permeable and is rapidly and almost completely absorbed after oral administration. Pharmacokinetics is dose-proportional from 10 to 600 mg (a range that extends beyond the minimum and maximum single-administration dose levels described in Dosage and Administration [see Dosage and Administration ( 2.1 )] ). The median T max for tablets taken without food is 1 hour (range 0.25 to 3 hours).
Co-administration with a high-fat meal slowed absorption, but the extent of absorption remained unchanged. Specifically, when a 50 mg tablet was administered with a high-fat meal, C max (maximum brivaracetam plasma concentration during a dose interval, an exposure metric) was decreased by 37% and T max was delayed by 3 hours, but AUC (area under the brivaracetam plasma concentration versus time curve, an exposure metric) was essentially unchanged (decreased by 5%). Distribution Brivaracetam is weakly bound to plasma proteins (≤20%).
The volume of distribution is
0.5L/kg, a value close to that of the total body water. Brivaracetam is rapidly and evenly distributed in most tissues. Elimination Metabolism Brivaracetam is primarily metabolized by hydrolysis of the amide moiety to form the corresponding carboxylic acid metabolite, and secondarily by hydroxylation on the propyl side chain to form the hydroxy metabolite.
The hydrolysis reaction is mediated by hepatic and extra-hepatic amidase. The hydroxylation pathway is mediated primarily by CYP2C19. In human subjects possessing genetic variations in CYP2C19, production of the hydroxy metabolite is decreased 2-fold or 10-fold, while the blood level of brivaracetam itself is increased by 22% or 42%, respectively, in individuals with one or both mutated alleles.
CYP2C19 poor metabolizers and patients using inhibitors of CYP2C19 may require dose reduction. An additional hydroxy acid metabolite is created by hydrolysis of the amide moiety on the hydroxy metabolite or hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9). None of the 3 metabolites are pharmacologically active.
Excretion Brivaracetam is eliminated primarily by metabolism and by excretion in the urine. More than 95% of the dose, including metabolites, is…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The precise mechanism by which brivaracetam oral solution 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Brivaracetam Oral Solution 10 mg/mL is a slightly viscous, clear, colorless to yellowish, raspberry flavored liquid filled in amber colored bottle. It is supplied as follows: 300 mL Bottle NDC 67877-904-58
16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Do not freeze brivaracetam oral solution. Discard any unused brivaracetam oral solution remaining after 5 months of first opening the bottle.
📋 Description ▾
11 DESCRIPTION The chemical name of brivaracetam is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H -pyrrol-1-yl] butanamide. Its molecular formula is C 11 H 20 N 2 O 2 and its molecular weight is 212.29. The chemical structure is: Brivaracetam is a white or almost white powder.
It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane.
Oral Solution Brivaracetam oral solution contains 10 mg of brivaracetam per mL. The inactive ingredients are carboxymethylcellulose sodium, citric acid anhydrous, glycerin, methylparaben, raspberry flavor, sodium citrate dihydrate, sorbitol solution, sucralose and purified water. briva-str
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). The Medication Guide accompanies the product and can also be accessed by calling 1-877-272-7901. Suicidal Behavior and Ideation Counsel patients, their caregivers, and/or families that antiepileptic drugs, including brivaracetam oral solution, may increase the risk of suicidal thoughts and behavior, and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm.
Advise patients, their caregivers, and/or families to report behaviors of concern immediately to a healthcare provider [see Warnings and Precautions ( 5.1 )] . Neurological Adverse Reactions Counsel patients that brivaracetam oral solution causes somnolence, fatigue, dizziness, and gait disturbance. These adverse reactions, if observed, are more likely to occur early in treatment but can occur at any time.
Advise patients not to drive or operate machinery until they have gained sufficient experience on brivaracetam oral solution to gauge whether it adversely affects their ability to drive or operate machinery [see Warnings and Precautions ( 5.2 )] . Psychiatric Adverse Reactions Advise patients that brivaracetam oral solution causes changes in behavior (e.g., aggression, agitation, anger, anxiety, and irritability) and psychotic symptoms. Instruct patients to report these symptoms immediately to their healthcare provider [see Warnings and Precautions ( 5.3 )] .
Hypersensitivity: Bronchospasm and Angioedema Advise patients that symptoms of hypersensitivity including bronchospasm and angioedema can occur with brivaracetam oral solution. Instruct them to seek immediate medical care should they experience signs and symptoms of hypersensitivity [see Warnings and Precautions ( 5.4 )] . Serious Dermatologic Reactions Advise patients of the early signs and symptoms of serious dermatologic adverse reactions and to report any occurrence immediately to a healthcare provider [see Warnings and Precautions ( 5.5 )].
Withdrawal of Antiepileptic Drugs Advise patients not to discontinue use of brivaracetam oral solution without consulting with their healthcare provider. Brivaracetam oral solution should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus [see Warnings and Precautions ( 5.6 )] . Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during brivaracetam oral solution therapy.
Lactation Counsel patients that brivaracetam, the active ingredient in brivaracetam oral solution, is present in breast milk. Instruct patients to discuss with their healthcare provider if they are breastfeeding or intend to breastfeed [see Use in Specific Populations ( 8.2 )]. Dosing Instructions Counsel patients that brivaracetam oral solution may be taken with or without food .
Advise patients that the dosage of brivaracetam oral solution should be measured using a calibrated measuring device and not a household teaspoon. Instruct patients to discard any unused brivaracetam oral solution after 5 months of first opening the bottle [see Dosage and Administration ( 2.2 )]. Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA.
Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921