brivaracetam
Pharmaranks rates Brivaracetam 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Brivaracetam is a medication used to treat Seizures.
Generic · by Aurobindo Pharma Ltd
Generic of Briviact
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Brivaracetam
- Form
- Injectable, Solution
- Strength
- Brivaracetam 100MG · Brivaracetam 10MG · Brivaracetam 25MG · Brivaracetam 50MG · Brivaracetam 75MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- seizures
- Manufacturer
- Aurobindo Pharma Ltd
- What the pharmacy pays
- ~$0.26 per ml — not your price
- FDA application
- ANDA214848
What is Brivaracetam?
From the FDA label: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 to off-white powder. It is very soluble in water, 0.1N HCl and 0.1N NaOH, also very soluble in pH 4.5 and pH 6.8 at 37 o C, slightly soluble in isopropyl ether, almost insoluble in n-hexane. Brivaracetam tablets are for oral administration and contain the following inactive ingredients: anhydrous lactose, croscarmellose sodium, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol–part hydrolyzed, talc and titanium dioxide. In addition 100 mg contains black iron oxide. Chemical Structure
How to use
Brivaracetam is sold in more than one form (Injectable and Solution), and each is dosed differently. The instructions below come from the FDA label for application ANDA214848 — follow the label that came with the product you were actually prescribed.
Adults (16 Years and Older): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day). Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day). ( 2.1 ) Pediatric Patients (1 Month to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily ( 2.1 ) Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment. ( 2.5 ) 2.1 Dosage Information Monotherapy or Adjunctive Therapy The recommended dosage for patients 1 month of age and older is included in Table 1. In pediatric patients weighing less than 50 kg, the recommended dosing regimen is dependent upon body weight. When initiating treatment, gradual dose escalation is not required. Dosage should be adjusted based on clinical response and tolerability. Table 1: Recommended Dosage for Patients 1 Month of Age and Older Age and Body Weight Initial Dosage Minimum and Maximum Maintenance Dosage Adults (16 years and older) 50 mg twice daily (100 mg per day) 25 mg to 100 mg twice daily (50 mg to 200 mg per day) Pediatric patients weighing 50 kg or more 25 mg to 50 mg twice daily (50 mg to 100 mg per day) 25 mg to 100 mg twice daily (50 mg to 200 mg per day) Pediatric patients weighing 20…
Side effects
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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In all controlled and uncontrolled trials performed in adult epilepsy patients, brivaracetam was administered as adjunctive therapy to 2437 patients. Of these…
Warnings
Important safety information
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 if hypersensitivity occurs. ( 5.4 ) Serious Dermatologic Reactions : Discontinue brivaracetam unless an alternative etiology is established ( 5.5 ) Withdrawal of Antiepileptic Drugs: Brivaracetam should be gradually withdrawn. ( 5.6 ) 5.1 Suicidal 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 1.0 3.4 3.5 2.4 Psychiatric 5.7 8.5 1.5 2.9 Other 1.0 1.8 1.9 0.9 Total 2.4 4.3 1.8 1.9 The 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 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. Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. 5.2 Neurological Adverse Reactions Brivaracetam causes somnolence, fatigue, dizziness, and disturbance in coordination. Patients should be monitored for these signs and symptoms and advised 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. Somnolence and Fatigue Brivaracetam causes dose-dependent increases in somnolence and fatigue-related adverse reactions (fatigue, asthenia, malaise, hypersomnia, sedation, and lethargy) [see Adverse Reactions (6.1) ] . In the Phase 3 controlled adjunctive epilepsy trials, these events were reported in 25% of patients randomized to receive brivaracetam at least 50 mg/day (20% at 50 mg/day, 26% at 100 mg/day, and 27% at 200 mg/day) compared to 14% of patients who received placebo. The risk is greatest early in treatment but can occur at any time. Dizziness and Disturbance in Gait and Coordination Brivaracetam causes adverse reactions related to dizziness and disturbance in gait and coordination (dizziness, vertigo, balance disorder, ataxia, nystagmus, gait disturbance, and abnormal coordination) [see Adverse Reactions (6.1) ] . In the Phase 3 controlled adjunctive epilepsy trials, these events were reported in 16% of patients randomized to receive brivaracetam at least 50 mg/day compared to 10% of patients who received placebo. The risk is greatest early in treatment but can occur at any time. 5.3 Psychiatric Adverse Reactions Brivaracetam causes psychiatric adverse reactions. In the Phase 3 controlled adjunctive epilepsy trials, psychiatric adverse reactions were reported in approximately 13% of patients who received brivaracetam (at least 50 mg/day) compared to 8% of patients who received placebo. Psychiatric events included both non-psychotic symptoms (irritability, anxiety, nervousness, aggression, belligerence, anger, agitation, restlessness, depression, depressed mood, tearfulness, apathy, altered mood, mood swings, affect lability, psychomotor hyperactivity, abnormal behavior, and adjustment disorder) and psychotic symptoms (psychotic disorder along with hallucination, paranoia, acute psychosis, and psychotic behavior). A total of 1.7% of adult patients treated with brivaracetam discontinued treatment because of psychiatric reactions compared to 1.3% of patients who received placebo. Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults [see Adverse Reactions (6.1) and Use in Specific Populations (8.4) ] . 5.4 Hypersensitivity: Bronchospasm and Angioedema Brivaracetam can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported in patients taking brivaracetam. If a patient develops hypersensitivity reactions after treatment with brivaracetam, the drug should be discontinued. Brivaracetam is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients [see Contraindications (4) ] . 5.5 Serious Dermatologic Reactions Serious dermatologic reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with brivaracetam. Time to onset of the serious dermatologic reaction ranged from 3 to 45 days after brivaracetam initiation in reported cases. Brivaracetam should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest a serious dermatologic reaction, use of brivaracetam should not be resumed and alternative therapy should be considered. 5.6 Withdrawal of Antiepileptic Drugs As with most antiepileptic drugs, brivaracetam should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus [see Dosage and Administration (2.4)…
Who should not take Brivaracetam
Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam tablets (bronchospasm and angioedema have occurred) [see Warnings and Precautions (5.4) ] . Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam tablets. ( 4 )
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Rifampin: Because of decreased concentrations, increasing brivaracetam 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. ( 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 ) 7.1 Rifampin 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) ] . 7.2 Carbamazepine 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) ] . 7.3 Phenytoin 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) ] . 7.4 Levetiracetam Brivaracetam provided no added therapeutic benefit to levetiracetam when the two drugs were co-administered [see Clinical Studies (14) ] .
Storing Brivaracetam, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Discard any unused brivaracetam oral solution remaining after 5 months of first opening the bottle.”
- “Instruct patients to discard any unused brivaracetam oral solution after 5 months of first opening the bottle [see Dosage and Administration (2.”
- “Discard any unused brivatacetum oral solution remaining after 5 months of first opening the bottle.”
- “Discard any unused brivaracetam oral solution oral solution remaining after 5 months of first opening the bottle.”
- “Discard any unused brivaracatam oral solution remaining after 5 months of first opening the bottle.”
- “Instruct patients to discard any unused brivaracetam oral solution after 5 months of first opening the bottle [see Dosage and Administration ( 2.”
- “Do not freeze brivaracetam oral solution.”
- “Do not freeze brivaracetam injection.”
May treat (source: NIH RxClass)
Dosage forms
Injectable and Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Brivaracetam treat?
- Brivaracetam (Brivaracetam) may be used to treat seizures, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Brivaracetam rated?
- pharmaranks gives Brivaracetam a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Brivaracetam cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.26 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Brivaracetam?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Brivaracetam. To pay less, Brivaracetam is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Brivaracetam?
- Brivaracetam is marketed by Aurobindo Pharma Ltd. You can see Aurobindo Pharma Ltd's full profile, rating, and other products on pharmaranks.
- Is Brivaracetam a brand-name or generic drug?
- Brivaracetam is a generic medication; its active ingredient is Brivaracetam. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Brivaracetam available over the counter?
- No. Brivaracetam is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Brivaracetam come in?
- Brivaracetam is currently marketed as injectable and solution, per the FDA's National Drug Code Directory.
- Is Brivaracetam FDA-registered?
- Brivaracetam is on record with the U.S. FDA under application number ANDA214848. You can verify this on its official FDA label.
- Has Brivaracetam been recalled by the FDA?
- Brivaracetam has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Brivaracetam safe?
- There's no single safe-or-not verdict. pharmaranks gives Brivaracetam a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Brivaracetam?
- Brivaracetam's side effects are taken directly from its FDA label. From the label: 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:… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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68/100