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Brivaracetam (briviact ®)

BRIVIACT ® (brivaracetam) injection
[ Usual Diluents ] [ Standard Dilution ] [ Storage and Stability ]
DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  

Drug UPDATES:   [Drug information  /  PDF]  
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

 

Usual Diluents top of page

NS,  D5W, LR

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate] top of page

[Prescribed dose ]
[25-100mg]  [10-50 ml]  [2 to  15 minutes]
May also be given undiluted.  Dilution above allows for the use of
a pvc bag and pump to control the infusion e.g. 50mg/50ml @10 ml/hr.

Hepatic Impairment: For all stages of hepatic impairment, the recommended starting dosage is 25 mg twice daily; maximum dosage is 75 mg twice daily.

BRIVIACT injection may be used when oral administration is temporarily not feasible. BRIVIACT injection should be administered at the same dosage and same frequency as BRIVIACT tablets and oral solution. The clinical study experience with BRIVIACT injection is limited to 4 consecutive days of treatment.

BRIVIACT injection is for single dose only.

Stability data:
Stability
Refrigerated		 Stability
Room Temp.		 Reconstituted
Vial/Powder		 Notes
Room temp only. Do not freeze. Solution: The diluted solution should not be stored for more than 4 hours at room temperature and may be stored in polyvinyl chloride (PVC) bags BRIVIACT injection is for single dose only.  Discard any unused portion of the BRIVIACT injection vial contents.

WARNINGS  top of page

See warnings and precautions below.

DESCRIPTION  top of page

Description:
The chemical name of BRIVIACT (brivaracetam) is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl] butanamide.
Initial U.S. Approval: 2016

CLINICAL PHARMACOLOGY: top of page

Mechanism of Action:
The precise mechanism by which BRIVIACT 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.

INDICATIONS AND USAGE  top of page

BRIVIACT is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.

CONTRAINDICATIONS top of page

Contraindications::
Hypersensitivity to brivaracetam or any of the inactive ingredients in BRIVIACT.

PRECAUTIONS top of page

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 BRIVIACT. (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 BRIVIACT if hypersensitivity occurs. (5.4)

Withdrawal of Antiepileptic Drugs: BRIVIACT should be gradually withdrawn. (5.5)

ADVERSE REACTIONS top of page

ADVERSE REACTIONS:

Most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea/vomiting. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION: The recommended starting dosage is 50 mg twice daily. 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)
BRIVIACT injection may be used when oral administration is temporarily not feasible.
Hepatic Impairment: For all stages of hepatic impairment, the recommended starting dosage is 25 mg twice daily; maximum dosage is 75 mg twice daily.

2.1 Dosage Information

When initiating treatment, gradual dose escalation is not required. The recommended starting dosage 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)

BRIVIACT injection may be used when oral administration is temporarily not feasible. BRIVIACT injection should be administered at the same dosage and same frequency as BRIVIACT tablets and oral solution.

The clinical study experience with BRIVIACT injection is limited to 4 consecutive days of treatment.

2.3 Preparation and Administration Instructions for BRIVIACT Injection

BRIVIACT injection is for intravenous use only.

Preparation

BRIVIACT injection can be administered intravenously without further dilution or may be mixed with diluents listed below.

Diluents
 
0.9% Sodium Chloride injection, USP
 
Lactated Ringer's injection
 
5% Dextrose injection, USP

Administration

BRIVIACT injection should be administered intravenously over 2 to 15 minutes.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Product with particulate matter or discoloration should not be used. BRIVIACT injection is for single dose only.

Storage and Stability

The diluted solution should not be stored for more than 4 hours at room temperature and may be stored in polyvinyl chloride (PVC) bags. Discard any unused portion of the BRIVIACT injection vial contents.

2.4 Discontinuation of BRIVIACT

Avoid abrupt withdrawal from BRIVIACT in order to minimize the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.5) and Clinical Studies (14)].

2.5 Patients with Hepatic Impairment

For all stages of hepatic impairment, the recommended starting dosage is 25 mg twice daily (50 mg per day) and the recommended maximum dosage is 75 mg twice daily (150 mg per day) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

2.6 Co-administration with Rifampin

Increase the BRIVIACT dosage in patients on concomitant rifampin by up to 100% (i.e., double the dosage)

HOW SUPPLIED  top of page

DOSAGE FORMS AND STRENGTHS:

Tablets: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg (3)
Oral solution: 10 mg/mL (3)
Injection: 50 mg/5 mL single-dose vial (3)

Storage and Stability top of page

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 BRIVIACT injection or oral solution.

Discard any unused BRIVIACT oral solution remaining after 5 months of first opening the bottle.

BRIVIACT injection vials are single-dose only
Brivaracetam (briviact ®)

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