Ublituximab Intravenous Infusion for Adults

Who can administer

May be administered by registered competent doctor or nurse/midwife

Must be initiated and supervised by consultant neurologist
Monitor for signs and symptoms of progressive multifocal leukoencephalopathy (PML).
Hepatitis B Virus (HBV) screening should be performed in all patients before initiation of treatment. Patients with active HBV should not be started.
Must have access to facilities for managing hypersensitivity reactions including anaphylaxis. See QPulse document: Infusion related Patient reaction in nurse-led setting CLN-NM-0118.
Two pre-medications must be administered prior to each infusion to reduce the frequency and severity of Infusion Related Reactions (IRRs):
- 100 mg methylprednisolone IV or 10-20 mg dexamethasone po (or equivalent) approximately 30-60 minutes prior to each infusion
- Antihistamine (e.g. Cetirizine) approximately 30-60 minutes prior to each infusion;
- Paracetamol may also be considered.
Administration is contraindicated in patients with an active infection or known active malignancies.
It is recommended to verify the patient's immune status before dosing since severely immunocompromised patients should not be treated.

Briumvi 150 mg per 6ml vial

Already in solution

Dilute further prior to administration

Sodium chloride 0.9%

Intermittent intravenous infusion ONLY (administer using an electronically controlled infusion device)

	Amount and volume	Infusion rate	Duration
First infusion	150mg added to 250ml	Start at 10mL per hour for first 30 mins Increase to 20mL per hour for next 30 mins Increase to 35mL per hour for next 60 mins Increase to 100mL per hour for the remaining 2 hours	4 hours
Second infusion (2 weeks later)	450mg added to 250ml	Start at 100mL per hour for the first 30 mins Increase to 400mL per hour for the remaining 30 mins	1 hour
Subsequent infusions (once every 24 weeks)	450mg added to 250ml	Start at 100mL per hour for the first 30 mins Increase to 400mL per hour for the remaining 30 mins	1 hour

Amount and volume

Infusion rate

Duration

First infusion

150mg added to 250ml

Start at 10mL per hour for first 30 mins

Increase to 20mL per hour for next 30 mins

Increase to 35mL per hour for next 60 mins

Increase to 100mL per hour for the remaining 2 hours

4 hours

Second infusion
(2 weeks later)

450mg added to 250ml

Start at 100mL per hour for the first 30 mins

Increase to 400mL per hour for the remaining 30 mins

1 hour

Subsequent infusions
(once every 24 weeks)

450mg added to 250ml

Start at 100mL per hour for the first 30 mins

Increase to 400mL per hour for the remaining 30 mins

1 hour

Relapsing multiple sclerosis (RMS) with active disease

First dose of 150mg followed by 450mg 2 weeks later
Subsequent doses are a single 450mg infusion every 24 weeks
The first subsequent infusion should be administered 24 weeks after the first infusion.

Please also consult Medication Protocol: Management of Infusion Related Patient Reactions in nurse-led infusion settings in GUH CLN-NM-0118
Patients should be observed during infusions and monitored for at least one hour after the completion of the first two infusions. Subsequent infusions do not require monitoring post-infusion unless IRR and/or hypersensitivity has been observed.

Ublituximab may cause life threatening infections
Each patient must be given a special alert card (and patient information leaflet) that summarises the key safety information about ublituximab.
In order to improve the traceability of biological medicinal products the name and batch number of the administered product should be clearly recorded

Store between 2 and 8⁰C
Do not freeze

SPC 4/09/2025

Immunomodulatory drug