How is Briumvi dosed for relapsing multiple sclerosis?
Briumvi (ublituximab-xiiy) is given as an intravenous infusion for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The standard regimen starts with two initial doses followed by maintenance infusions.
What does the initial dosing schedule look like?
- Day 1: 150 mg infusion over 4 hours.
- Day 15: 450 mg infusion over 4 hours.
This two-dose induction phase targets rapid B-cell depletion.
How often are maintenance doses given?
After the initial doses, patients receive 450 mg infusions every 24 weeks (about 6 months), each over 1 hour. Infusions start at least 24 weeks after Day 1.
What premedication is required before infusions?
Premedicate with:
- 100 mg methylprednisolone (or equivalent) 30 minutes to 1 hour before each infusion.
- An antihistamine like diphenhydramine 30 minutes to 1 hour prior.
- Optional antipyretic (e.g., acetaminophen) for additional symptom control.
For the Day 1 low-dose infusion, a reduced steroid dose (e.g., 60 mg) may be considered.
How are infusion times and monitoring handled?
| Infusion | Dose | Duration | Notes |
|----------|------|----------|-------|
| Day 1 | 150 mg | 4 hours | Premedicate; monitor for reactions. |
| Day 15 | 450 mg | 4 hours | Premedicate; monitor. |
| Maintenance (Week 24 onward) | 450 mg | 1 hour | Premedicate; shorter time due to tolerability. |
Observe patients for at least 1 hour post-infusion. Interrupt or slow if infusion reactions occur; permanent discontinuation may be needed for severe cases.
What happens if a dose is missed?
Administer the next 450 mg dose as soon as possible, then resume every 24 weeks from that point. No additional induction is required.
Are there dose adjustments for kidney or liver issues?
No specific adjustments needed for renal or hepatic impairment. Use caution in active infections.
How does Briumvi dosing compare to Ocrevus?
Briumvi requires only two infusions in the first year ( totaling 600 mg), then one every 6 months, versus Ocrevus's two 300 mg doses every 6 months from the start. Briumvi's shorter maintenance infusion time (1 hour vs. ~3.5 hours total per cycle for Ocrevus) improves convenience.
Sources:
[1]: Briumvi Prescribing Information (TGA Biologics)
[2]: FDA Label for Briumvi