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BRIVARACETAM 10 mg/mL Solution

by Lupin Pharmaceuticals, Inc. · 1 BOTTLE in 1 CARTON (70748-411-01) / 300 mL in 1 BOTTLE

NDC 70748-0411-01

🏷️ FDA NDC (as labeled) 70748-411-01 billing pads the product segment with a zero

Rx only Generic On market CV

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 70748-411-01

Product NDC 70748-411

11-digit billing NDC 70748041101

NCPDP billing unit ML — per mL (volume)

RxCUI 1739785

UNII U863JGG2IA

Application # ANDA220164

SPL Set ID 260468dd-a604-488a-a47b-b6d82edcca37

Mechanism of action Epoxide Hydrolase Inhibitors

DEA schedule CV

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-02-23

Route ORAL

Dosage form SOLUTION

Substance BRIVARACETAM

GPI-14 72600015002020

GCN Seq No 075593

GCN 40712

HICL code 043088

Ingredient (HICL) Brivaracetam

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H4

Therapeutic class — intermediate (HIC2) Anticonvulsants

HIC3 code H4B

Therapeutic class — specific (HIC3) Anticonvulsants

AHFS code 28:12.92.00

AHFS class Anticonvulsants, Miscellaneous

FDB label name BRIVARACETAM 10 MG/ML ORAL SOL

FDB brand name Brivaracetam

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AA · RLD · RS

Why two NDCs? The FDA registers this code as 70748-411-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70748-0411-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Other antiepileptics class.

Drug family (ATC) Other antiepileptics

How it works Epoxide Hydrolase Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLupin Pharmaceuticals, Inc.

Application holderLUPIN INC

FDA applicationANDA220164 (ANDA)

Labeler code70748

First marketedFeb 2026

DEA scheduleCV

Product typeHuman Prescription Drug

Portfolio404 products on file

🔎 All NDCs from Lupin Pharmaceuticals, Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BRIVARACETAM 10 MG/ML ORAL SOL Ingredient Brivaracetam

📖 What it is MedlinePlus · NLM

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 ↗

📗 Our plain-language guide HelloPharmacist

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...

📖 Read our full Brivaracetam guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Brivaracetam — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Brivaracetam (50 interactions) — ranked by severity →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

FlavorRaspberry

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 7CVR7L4A2D
A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
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 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

NADAC price history (per mL) — tap or hover for the price & month

▼ Down 3% over the last 4 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 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/mL 67877-0904-58	Ascend	1 bottle	$0.264	AA	Availability likely	—
Brivaracetam 10 mg/mLthis 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	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2026

On the market since

Feb 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔓

Generic on the market

this product is a generic

✅This is a generic drug

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?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Brivaracetam — the program that covers self-administered drugs. 5 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Brivaracetam. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Total Part D spend

$3.08M

Claims incl. refills

4.1K

Beneficiaries

3.6K

Spend / beneficiary

$843.69

Spend / claim

$748.88

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Brivaracetam — the ingredient across all brands.

Top reported reactions

Seizure1,962

Therapy Interrupted334

Overdose272

Somnolence250

Fatigue249

Product Availability Issue237

Fall229

Reporter sex

Serious outcomes

Death245

Disabling45

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
70748-0411-01 You're viewing this	1 BOTTLE in 1 CARTON (70748-411-01) / 300 mL in 1 BOTTLE	2026-02-23	Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🎯 Indications and Usage 42 words ▾

1 INDICATIONS AND 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.

⏱️ Dosage and Administration ~3 min read ▾

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 )

2.1Dosage 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 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 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 24 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Solution 10 mg/mL: slightly viscous, clear, colorless to yellowish, raspberry-flavored liquid. Oral solution: 10 mg/mL ( 3 )

⛔ Contraindications 40 words ▾

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.

⚠️ Warnings and Cautions ~3 min read ▾

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. ( 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 should be gradually withdrawn.

( 5.6 )

5.1Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including brivaracetam, 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 to 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 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1000 Patients Epilepsy 1 3.4 3.5

2.4Psychiatric 5.7 8.5 1.5

2.9Other 1 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 increased risk of suicidal thoughts and behavior.

Sho…

🤒 Adverse Reactions ~3 min read ▾

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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 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 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 Cerebellar coordination and balance disturbances includes ataxia, balance disorder, coordination abnormal, and nystagmus.

3 1 Psychiatric disorders Irritability 3 1 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 le…

🔄 Drug Interactions ~1 min read ▾

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.

( 7.3 ) Levetiracetam: Brivaracetam had no added therapeutic benefit when co- administered with levetiracetam. ( 7.4 )

7.1Rifampin Co-administration with rifampin decreases brivaracetam plasma concentrations likely because of CYP2C19 induction [see Clinical Pharmacology (12.3) ] . Prescribers should increase the brivaracetam 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 can increase plasma concentrations of phenytoin, phenytoin levels should be monitored in patients when concomitant brivaracetam is added to or discontinued from ongoing phenytoin therapy [see Clinical Pharmacology (12.3) ] .

7.4Levetiracetam Brivaracetam provided no added therapeutic benefit to levetiracetam when the two drugs were co-administered [see Clinical Studies (14) ] .

👥 Use in Specific Populations ~3 min read ▾

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 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 to 4% and 15 to 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 and any potential adverse effects on the breastfed infant from brivaracetam or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness of brivaracetam have been established in pediatric patients 1 month to less than 16 years of age. Use of brivaracetam in these age groups is supported by evidence from adequate and well-controlled studies of brivaracetam 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) ] .

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use ~1 min read ▾

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 80 words ▾

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 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 164 words ▾

10 OVERDOSAGE There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness were reported in a patient taking a single dose of 1400 mg (14 times the highest recommended single dose) of brivaracetam. The following adverse reactions were reported with brivaracetam overdose: vertigo, balance disorder, fatigue, nausea, diplopia, anxiety, and bradycardia.

In general, the adverse reactions associated with brivaracetam overdose were consistent with the known adverse reactions. There is no specific antidote for overdose with 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 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. 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 clearance.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism by which brivaracetam 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 (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 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 alone or ethanol alone.

The immediate word recall scores were generally lower for brivaracetam when co-administered with ethanol. Cardiac Electrophysiology At a dose 4 times the maximum recommended dose, brivaracetam 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 partial- onset 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 excreted in the urine within 72 hours after intake. Fecal excretion accounts for l…

🧬 Mechanism of Action 40 words ▾

📦 How Supplied / Storage and Handling 108 words ▾

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. It is supplied in amber glass bottles: 300 mL bottles NDC 70748-411-01

16.2Storage and Handling Store at 25°C (77°F); excursions permitted between 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.

📦 Storage and Handling 43 words ▾

📋 Description 115 words ▾

11 DESCRIPTION The chemical name of brivaracetam is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-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 to off-white crystalline powder.

It is freely soluble in water, in ethanol, in methanol, in glacial acetic acid, in acetonitrile and in acetone. It is soluble in toluene. Oral Solution Brivaracetam oral solution contains 10 mg of brivaracetam per mL.

The inactive ingredients are sodium citrate (trisodium citrate dihydrate), anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, non-crystallizing sorbitol solution, anhydrous glycerol, raspberry flavor, and purified water. Raspberry flavor also contains maltodextrin, propylene glycol and modified waxy maize starch. Image

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). The Medication Guide can be accessed on www.lupin.com, or by calling 1-800-399-2561. 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 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 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 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. 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 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 therapy [see Use in Specific Populations (8.1) ] .

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 [see Dosage and Administration (2.2) ] .

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) ] . LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc.

Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States. Manufactured by: Novel Laboratories, Inc.

400 Campus Drive Somerset NJ 08873 United States. Revised: 02/2026 SAP Code: 283149 Image

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Brivaracetam (briv" a ra' se tam ) CV oral solution What is the most important information I should know about brivaracetam oral solution? Brivaracetam oral solution is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep brivaracetam oral solution in a safe place to prevent misuse and abuse.

Selling or giving away brivaracetam oral solution may harm others and is against the law. Like other antiepileptic drugs, brivaracetam oral solution may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, feeling angry, or being violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood Suicidal thoughts or actions can be caused by things other than medicines.

If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions? • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop brivaracetam oral solution without first talking to a healthcare provider. • Stopping brivaracetam oral solution suddenly can cause serious problems. • Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus). What is brivaracetam oral solution? Brivaracetam oral solution is a prescription medicine used to treat partial-onset seizures in people 1 month of age and older.

It is not known if brivaracetam oral solution is safe and effective in children younger than 1 month of age. Who should not take brivaracetam oral solution? Do not take brivaracetam oral solution if you are allergic to brivaracetam or any of the ingredients in brivaracetam oral solution.

See the end of this Medication Guide for a complete list of ingredients in brivaracetam oral solution. What should I tell my healthcare provider before starting brivaracetam oral solution? Before taking brivaracetam oral solution, tell your healthcare provider about all of your medical conditions, including if you: • have or had depression, mood problems, or suicidal thoughts or behavior. • have liver problems. have abused or been dependent on prescription medicines, street drugs, or alcohol. • are pregnant or plan to become pregnant.

It is not known if brivaracetam oral solution will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking brivaracetam oral solution. You and your healthcare provider will have to decide if you should take brivaracetam oral solution while you are pregnant. • are breastfeeding or plan to breastfeed.

Brivaracetam passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take brivaracetam oral solution. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Brivaracetam oral solution may affect the way other medicines work, and other medicines may affect how brivaracetam oral solution works. Do not start a new medicine without first talking with your healthcare provider. Know the medicines you take.

Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. How should I take brivaracetam oral solution? • Take brivaracetam oral solution exactly as your healthcare…

Glossary — plain-language definitions of medical terms used in this label:

case series: A report describing what happened to a small group of patients, with no comparison group.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

Active ingredient: The part of a medicine that produces its intended effect on the body.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

aggression: Hostile or violent feelings or behavior directed toward other people.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

controlled substance: A medicine regulated by law because it can be misused or lead to dependence, with special rules for prescribing and storage.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

CYP2C9: A liver enzyme that breaks down certain medicines, including some blood thinners and anti-inflammatory drugs.

depression: A lasting low mood with loss of interest that affects everyday life.

diplopia: Double vision, or seeing two images of a single object.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

maintenance dose: The regular ongoing dose taken to keep a steady, effective amount of medicine in the body over time.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

misuse: Using a medicine differently from how it was prescribed or directed, whether on purpose or by mistake.

monotherapy: Treatment using a single medicine by itself.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

nystagmus: Rapid, involuntary back-and-forth movements of the eyes that a person cannot control.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

pharmacodynamic interaction: When two medicines affect the body in the same or opposite ways, changing the overall effect without changing each other's blood levels.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pooled analysis: Combining the results of several separate studies into one larger group to look at the overall pattern.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

status epilepticus: A seizure that lasts a long time, or repeated seizures without recovery in between, which is a medical emergency.

suicidal behavior: Actions a person takes to try to end their own life, or steps taken in preparation for it.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 70748-0390-01 · Lupin 70748-0425-01 · Lupin →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

BRIVARACETAM 10 mg/mL Solution

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12 CLINICAL PHARMACOLOGY

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