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)

  1. Calculate required dose: 150 mg
  2. Withdraw 6 mL from one BRIUMVI vial (150 mg)
  3. Withdraw 6 mL 0.9% Sodium Chloride Injection, USP from the 250 mL infusion bag and discard.
  4. Dilute in 250 mL 0.9% Sodium Chloride Injection, USP
  5. Gently invert to mix; do not shake
  6. Administer over approximately 4 hours

Second and Subsequent Doses

  1. Calculate required dose: 450 mg
  2. Withdraw 18 mL 0.9% Sodium Chloride Injection, USP from the 250 mL infusion bag and discard.
  3. Withdraw 18 mL BRIUMVI solution from the vials (6 mL/vial).
  4. Dilute in 250 mL 0.9% Sodium Chloride Injection, USP
  5. Gently invert to mix; do not shake
  6. 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