Briumvi (ublituximab-xiiy) MFR
1. Drug Identification
Brand Name: BRIUMVI®
Generic Name: ublituximab-xiiy
Classification: Anti-CD20 monoclonal antibody for multiple sclerosis treatment
2. Dosage Forms and Strengths
Dosage Form: Solution for intravenous infusion
Strength: 150 mg/6 mL (25 mg/mL) in a single-dose vial
3. Storage Conditions (Unopened Vials)
Store refrigerated at 2°C to 8°C (36°F to 46°F)
Keep in original carton to protect from light
Do not freeze
Do not shake
4. Preparation and Administration Instructions
Pre-medication Requirements
Before each BRIUMVI infusion, administer:
Methylprednisolone (or equivalent) 100 mg IV, approximately 30 minutes prior
Antihistamine (diphenhydramine 50 mg or equivalent), approximately 30 minutes prior
Antipyretic (acetaminophen 650 mg or equivalent), approximately 30 minutes prior
Initial Dose (Day 1)
Calculate required dose: 150 mg
Withdraw 6 mL from one BRIUMVI vial (150 mg)
Withdraw 6 mL 0.9% Sodium Chloride Injection, USP from the 250 mL infusion bag and discard.
Dilute in 250 mL 0.9% Sodium Chloride Injection, USP
Gently invert to mix; do not shake
Administer over approximately 4 hours
Second and Subsequent Doses
Calculate required dose: 450 mg
Withdraw 18 mL 0.9% Sodium Chloride Injection, USP from the 250 mL infusion bag and discard.
Withdraw 18 mL BRIUMVI solution from the vials (6 mL/vial).
Dilute in 250 mL 0.9% Sodium Chloride Injection, USP
Gently invert to mix; do not shake
Administer over approximately 1 hour
5. Special Compounding Considerations
No reconstitution required (solution is ready to use)
Handle gently - do not shake vials
Swirl gently to mix when preparing dilution
6. Diluent Information
Diluent: 0.9% Sodium Chloride Injection, USP only
No other diluents have been studied
7. Diluent Amount
250 mL of 0.9% Sodium Chloride Injection, USP per infusion
8. Reconstituted Concentration
Not applicable (solution is provided ready to use)
9. Compatible Solutions
0.9% Sodium Chloride Injection, USP only
10. IV Bag Size
250 mL bag specified for all doses
11. Dilution Concentration Range
Final concentration will vary based on dose:
Initial (150 mg): 0.6 mg/mL
Second and subsequent doses (450 mg): 1.8 mg/mL
12. Special Equipment Needs
Use an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (0.2 or 0.22 micron pore size)
13. Filter Requirements
In-line, sterile, non-pyrogenic, low protein-binding filter (0.2 or 0.22 micron pore size) required
14. Final Appearance
Clear to slightly opalescent, colorless to slightly yellow solution
Free from visible particles
15. Stability of Opened/Reconstituted Vials
Single-use vials; discard unused portion
Do not reuse vials
16. Stability of Diluted Solution
Prepared infusion solution should be administered immediately
If not administered immediately, store up to 24 hours refrigerated at 2°C to 8°C (36°F to 46°F)
Allow to reach room temperature before administration
Can be stored at room temperature for up to 8 hours, including infusion time
17. Light Protection
Keep vials in original carton to protect from light until time of use
Protection from light not specifically required during administration
18. Hazard Assessment
Not classified as hazardous
Pregnancy Category: No human data. Based on animal data, may cause fetal harm.
Females of reproductive potential should use effective contraception during treatment and for 6 months after the last dose
19. Oncology Use
Not indicated for oncology use
Indicated for relapsing forms of multiple sclerosis (MS)
Reference Information
Package Insert Revision Date: December 2022
Reference ID: 5101565
FDA Approval Letter Date: 2023
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761238s000lbl.pdf
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