Dosing, administration and special warnings - Briumvi UK
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Dosing, administration and special warnings

This promotional website is intended for UK healthcare professionals.

Briumvi® (ublituximab) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.1 
BRIUMVI®
:
Dosing, administration and special warnings

BRIUMVI® is administered as a ~1-hour infusion, twice per year, following initiation of therapy 1,a

BRIUMVI® dosing and administration

Assessments prior to infusion

Administration and infusion rates

Preparing BRIUMVI® for infusion

aFollowing the starting dose. Day 1 infusion is 150 mg over approximately 4 hours; day 15 infusion is 450 mg over approximately 1 hour; subsequent infusions are 450 mg over approximately 1 hour, every 24 weeks. Infusion duration may take longer if the infusion is interrupted or slowed.1
BRIUMVI® is an intravenous infusion administered as follows:1

Approximatly 95%

of all BRIUMVI® 1-hour infusions were completed in approximately 1 hour without interruption in ULTIMATE I and II trials*

*± 5 minutes

aA minimum interval of 5 months should be maintained between each dose of BRIUMVI®

Patients should premedicate with a corticosteroid and an antihistamine to reduce the frequency and severity of IRRs. Infusion duration may take longer if the infusion is interrupted or slowed.1 The first ‘subsequent infusionʼ should be administered 24 weeks after the first infusion.

To reduce the frequency and severity IRRs, BRIUMVI® requires premedication. No systematic post-infusion surveillance is needed from the third infusion onwards1,a

Premedication

The following two premedications must be administered (orally, intravenously, intramusculaly, or subcutaneously) prior to each infusion:

• 100 mg methylprednisolone or 10–20 mg dexamethasone (or an equivalent) approximately 30–60 minutes prior to each infusion
• antihistamine approximately 30-60 minutes prior to each infusion.

In addition, premedication with an antipyretic (e.g. paracetamol) may also be considered.

Treatment

• Day 1 infusion: 150mg over approximately 4 hoursb

• Day 15 infusion: 450mg over approximately 1 hourb

• Subsequentinfusions (every 24 weeks after the starting dose): 450mg over approximately 1 hourb

• Patients treated with BRIUMVI® should be observed during infusions.

Post-infusion surveillance

1-hour post-infusion surveillance required on Day 1 and Day 15

Subsequent infusions do not require post-infusion surveillance unless IRRs and/or hypersensitivity was observed during previous infusions. Physicians should inform patients that IRRs can occur up to 24 hours after the infusion.

For guidance regarding posology for patients experiencing IRR symptoms, see section 4.2 of the SmPC1 .

aSubsequent post-infusion monitoring is required when IRRs and/or hypersensitivity has been observed with previous infusions.
bInfusion duration may take longer if the infusion is interrupted or slowed.1

Prior to the administration of BRIUMVI®, ensure that the appropriate assessments have been completed.1

Contraindications

Assessments before the first infusion of BRIUMVI®

• HBV screening should be performed in all patients before initiation of treatment as per local guidelines.

• Patients with active HBV (i.e. an active infection confirmed by positive results for HBsAg and anti-HB testing) should not be treated with BRIUMVI®.

• Patients with positive serology (i.e. negative for HBsAg and positive for HB core antibody (HBcAb+) or who are carriers of HBV (positive for surface antigen, HBsAg+) should consult liver disease experts before starting the treatment and should be monitored and managed following local medical standards to prevent reactivation of HBV.

  • It is recommended to verify the patient’s immune status (including immunoglobulins, lymphocytes and neutrophils) before dosing.
  • Severely immunocompromised patients (e.g. significant neutropenia or lymphopenia) should not be treated (sections 4.3 and 4.8 of the SmPC).
  • Administration must be delayed in patients with an active infection until the infection is resolved.
  • The safety of immunisation with live or live-attenuated vaccines, during or following therapy has not been studied. Vaccination with live-attenuated or live vaccines is not recommended during treatment and not until B-cell repletion (see section 5.1 of the SmPC).
  • All immunisations should be administered according to immunisation guidelines at least 4 weeks prior to treatment initiation for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to treatment initiation for inactivated vaccines.
  • Women of childbearing potential should use effective contraception while receiving BRIUMVI® and for at least 4 months after the last infusion (see sections 5.1 and 5.2 of the SmPC).
  • BRIUMVI® should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus.
    • Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy.
    • In infants of mothers treated with BRIUMVI® during pregnancy, live or live-attenuated vaccines should not be administered before the recovery of B-cell counts has been confirmed.

It is unknown whether BRIUMVI® is excreted in human milk. Human immunoglobulins are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breastfed infant cannot be excluded during this short period. Afterwards, BRIUMVI® could be used during breastfeeding, if clinically needed.

Understanding the correct dosage and infusion rates for your patients1
• Patients treated with BRIUMVI® should be observed during infusions for any symptom of IRRs.
• In addition, they should be observed for at least 1 hour after the completion of the first two infusions for any symptom of an IRR.
• From the third infusion onwards, post-infusion surveillance is required only when infusion reactions and/or hypersensitivity occurred during previous infusions.

aInfusion duration may take longer if the infusion is interrupted or slowed.
bThe first subsequent infusion should be administered 24 weeks after the first infusion. A minimum interval of 5 months should be maintained between each dose of BRIUMVI®.
cSolutions for intravenous infusion are prepared by dilution of the medicinal product into a 250 mL infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, to a final concentration of 0.6 mg/mL for the first and 1.8 mg/mL for the infusion and all subsequent infusions.

See the Summary of Product Characteristics for full dosing and administration instructions.

Download the Infusion Card

Adjustments in cases of IRRs

If there are signs of a life-threatening or disabling IRR during an infusion, the infusion must be stopped immediately, and the patient should receive appropriate treatment. Treatment with BRIUMVI® must be permanently discontinued in these patients.

If a patient experiences a severe IRR, the infusion should be interrupted immediately, and the patient should receive symptomatic treatment. The infusion should be restarted only after all symptoms have resolved. When restarting, begin at half of the infusion rate at the time of onset of the IRR. If the rate is tolerated, increase the rate as described in the table.

If a patient experiences a mild to moderate IRR, the infusion rate should be reduced to half the rate at the onset of the event. This reduced rate should be maintained for at least 30 minutes. If the reduced rate is tolerated, the infusion rate may then be increased as described in the table.

No dose reductions are recommended. In case of dose interruption or infusion rate reduction due to IRR, the total duration of the infusion would be increased, but not the total dose

If an infusion is missed, it should be administered as soon as possible; administration after a delayed or missed dose should not wait until the next planned dose. The treatment interval of 24 weeks (with a minimum of 5 months) should be maintained between doses.

No dose adjustment is considered necessary for patients over 55 years of age or patients with renal or hepatic impairment.

Preparing BRIUMVI® for infusion1

  • The product must be diluted before administration and is intended for single-use only.
  • BRIUMVI® should be prepared by a healthcare professional using aseptic technique.
  • The solution for intravenous administration is prepared by dilution of the product into an infusion bag containing 250 mL isotonic sodium chloride 9 mg/mL (0.9%) solution for injection.
  • One vial of BRIUMVI® contains 150 mg ublituximab in 6 mL (25 mg/mL).
  • Do not shake the vial.

Preparation of solution for the first infusion

1
Prepare an infusion bag containing 250 mL of 0.9% sodium chloride solution for injection and one vial (150mg/6mL) of BRIUMVI®.
2
Withdraw 6 mL BRIUMVI® solution from the vial.
3
Add 6 mL (150 mg) BRIUMVI® into an infusion bag containing 250 mL of 0.9% sodium chloride solution for injection.

Preparation of solution for the second and subsequent infusions

1
Prepare an infusion bag containing 250mL of 0.9% sodium chloride solution for injection and trhee vials (total 450 mg/18 mL) of BRIUMVI®.
2
Withdraw 18 mL BRIUMVI® solution from the vials (6 mL/vial).
3
Add 18 mL (450 mg) BRIUMVI® into an infusion bag containing 250 mL of 0.9% sodium chloride solution for injection.

Examine the BRIUMVI® solution

BRIUMVI® is a clear to opalescent, and colourless to slightly yellow solution.

Do not use the solution if it is
discoloured or if it contains
foreign particulate matter.

Bring the infusion bag to room temperature

Prior to the start of the intravenous infusion, the contents of the infusion bag should be at room temperature (20–25°C).

Use a dedicated infusion line

After dilution, BRIUMVI® is administered as an intravenous infusion through a dedicated line.

BRIUMVI® infusions should not be administered as an intravenous push or bolus.

Dilute solution for intravenous infusion

From a microbiological point of view, the prepared infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2–8°C and subsequently 8 hours at room temperature, unless dilution has taken place in controlled and validated aseptic conditions. If an intravenous infusion cannot be completed the same day, the remaining solution should be discarded.

Use of PVC or PO bags

No incompatibilities between ublituximab and PVC or PO bags and intravenous administration sets have been observed.

Storage

Store in a refrigerator (2–8°C). Do not shake or freeze. Keep the vial in the outer carton in order to protect the contents from light.

BRIUMVI® (ublituximab) 150 mg concentrate for solution for infusion

BRIUMVI® (ublituximab) is indicated for the treatment of adult patients with relapsing forms of MS (RMS) with active disease defined by clinical or imaging features.1

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Neuraxpharm by email: info-uk@neuraxpharm.com.

NXUK/0225/02 Date of preparation: October 2025

References
1BRIUMVI® Summary of Product Characteristics.
 
Abbreviations:
HBcAb, hepatitis B core antibody; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; IRRs, infusion-related reactions; PO, polyolefin; PVC, polyvinyl chloride; SmPC, Summary of Product Characteristics.