Brivaracetam

Optional dilutionFull monograph review pending

Historical dilution reference. Verify the preparation against the label for the product in hand.

Original GlobalRPh article: Brivaracetam (briviact ®) (opens in a new tab)Original source URL: https://globalrph.com/dilution/brivaracetam-briviact/ Retrieved 2026-11-04

Historical source details

Original publication date: unavailable in the retrieved article.

Source location and file checksums

Original source URL: https://globalrph.com/dilution/brivaracetam-briviact/ (opens in a new tab)
Source date: Not established in the retrieved source
Retrieved: 2026-11-04T19:46:23.588223+00:00
Source location: div.post-content
Packaged content SHA-256: 1d65173ef0159c56c5b824d751657fa1d4762aab0b7b1c154129f3fc522f8a78
Original response SHA-256: 524839b53133ef3def412b9d77a07be39ef40575fa47a672e7a4eea4089132e1
Source body SHA-256: d40647a150c0d6a4a51863e638b77649200974d9fc99fec175c81617afa20ac9

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 Return to article top

NS, D5W, LR

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate] Return to article top

[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 Return to article top

See warnings and precautions below.

DESCRIPTION Return to article top

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: Return to article top

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 Return to article top

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

CONTRAINDICATIONS Return to article top

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

PRECAUTIONS Return to article top

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 Return to article top

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 Return to article top

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)

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 Return to article top

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 Return to article top

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

Open this historical article on its own

U.S. label preparation

Briviact injection, IV presentation · Optional dilution

Preparation: Give undiluted or dilute in 0.9% sodium chloride, 5% dextrose or lactated Ringer's.
Administration and handling: Administer over 2 to 15 minutes.

Product and source details

UCB, Inc. · NDA205837

Product NDC: 50474-970

SPL effective 2026-11-05 | SPL version 28. Checked 2026-11-13.

Source for this summary: U.S. prescribing information. Use the full label for dose selection, contraindications, preparation tables and monitoring.

Reviewed product information

Applies to

Briviact 50 mg/5 mL vial, adult intermittent IV infusion.

Preparation sources checked 2026-11-13.

Infusion Fluid

The intermittent infusion can be prepared in 0.9% sodium chloride or 5% dextrose.

Sources and exact locations

Claim ID: IVR-73-BRIVARACETAM-001

Review basis: Separately authored institutional guidance

Source 1
Briviact injection, IV presentation U.S. prescribing information (opens in a new tab)
Exact location: 2.3
Publisher: UCB, Inc. / DailyMed
Source family: U.S. product labeling 3cf2f439-0e97-443e-8e33-25ecef616f6c
Retrieved: 2026-11-13
Source 2
Brivaracetam adult IV guide (opens in a new tab)
Exact location: Infusion fluids
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13

Infusion Time

For an adult intermittent infusion, 15 minutes is supported by both sources.

Sources and exact locations

Claim ID: IVR-73-BRIVARACETAM-002

Review basis: Separately authored institutional guidance

Source 1
Briviact injection, IV presentation U.S. prescribing information (opens in a new tab)
Exact location: 2.3
Publisher: UCB, Inc. / DailyMed
Source family: U.S. product labeling 3cf2f439-0e97-443e-8e33-25ecef616f6c
Retrieved: 2026-11-13
Source 2
Brivaracetam adult IV guide (opens in a new tab)
Exact location: Intermittent intravenous infusion
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13

Product identifiers and clinical review status

U.S. label preparation available. Full monograph review pending.

Selected product identity

Matched to the selected IV presentation.

View product identifiers and primary-label provenance

Selected product scope: Briviact 50 mg/5 mL vial, adult intermittent IV infusion.
Labeler: UCB, Inc.
Application number(s): NDA205837
NDC(s): 50474-970
DailyMed Set ID: 3cf2f439-0e97-443e-8e33-25ecef616f6c
SPL version: 28
Label printed revision date: Not established
SPL effective date: 2026-11-05
Retrieved: 2026-11-13
Downloaded XML SHA-256: 3889e2e5433bdda0a0a355154e6a1a33ad4b3e6247b100049481e0fa9d22b681

What remains to be completed

Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.

Open the original GlobalRPh site monograph (historical; not revalidated) (opens in a new tab)

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