Brivaracetam Injection
Generic Name: brivaracetam injection
Brand Names:
Brivaracetam
11 DESCRIPTION The chemical name of brivaracetam (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 crystalline 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.
Overview
11 DESCRIPTION The chemical name of brivaracetam (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 crystalline 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.
Uses
1 INDICATIONS AND USAGE Brivaracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. ( 1 )
Dosage
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 ) Injection: for intravenous use only when oral administration is temporarily not feasible; dosing is the same as oral regimen. ( 2.1 , 2.3 ) Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment.
Side Effects
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.
Interactions
7 DRUG 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) ] .
Warnings
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 if hypersensitivity occurs. 4 CONTRAINDICATIONS Hypersensitivity to brivaracetam or any of the inactive ingredients in Brivaracetam (bronchospasm and angioedema have occurred) [see Warnings and Precautions (5.4) ] . Hypersensitivity to brivaracetam or any of the inactive ingredients in Brivaracetam. ( 4 )
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as brivaracetam, during pregnancy. Encourage patients who are taking brivaracetam, during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.
Storage
16.2 Storage 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 injection or oral solution. Brivaracetam injection vials are single-dose only [see Dosage and Administration (2.3) ] .
Frequently Asked Questions
What is Brivaracetam Injection used for?▼
1 INDICATIONS AND USAGE Brivaracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. ( 1 )
What are the side effects of Brivaracetam Injection?▼
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.
Can I take Brivaracetam Injection during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as brivaracetam, during pregnancy. Encourage patients who are taking brivaracetam, during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.
What are the important warnings for Brivaracetam Injection?▼
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 if hypersensitivity occurs. 4 CONTRAINDICATIONS Hypersensitivity to brivaracetam or any of the inactive ingredients in Brivaracetam (bronchospasm and angioedema have occurred) [see Warnings and Precautions (5.4) ] . Hypersensitivity to brivaracetam or any of the inactive ingredients in Brivaracetam. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.