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DOSING & ADMINISTRATION

THE ONLY DMT THAT IS ADMINISTERED IN 1 HOUR, TWICE PER YEAR FOLLOWING THE STARTING DOSE1

Actor Portrayal. Image retouched using AI.

DOSING & ADMINISTRATION

THE ONLY DMT THAT IS ADMINISTERED IN 1 HOUR, TWICE PER YEAR FOLLOWING THE STARTING DOSE1

Actor Portrayal. Image retouched using AI.

DOSING & ADMINISTRATION

THE ONLY DMT THAT IS ADMINISTERED IN 1 HOUR, TWICE PER YEAR FOLLOWING THE STARTING DOSE1

Actor Portrayal. Image retouched using AI.

Convenient Dosing
and Administration

Assessment Prior
to Infusion

Administration and
Infusion Rates

Preparing BRIUMVI
for Infusion

Convenient Dosing
and Administration

Assessment Prior
to Infusion

Administration and
Infusion Rates

Preparing BRIUMVI
for Infusion

Convenient Dosing and Administration
Assessment Prior to Infusion
Administration and Infusion Rates
Preparing BRIUMVI for Infusion

BRIUMVI IS A 1‑HOUR MAINTENANCE INFUSION GIVEN EVERY 24 WEEKS1

Premedication(s): 30-60 minutes oral or IV

24 Weeks

BRIUMVI® (ublituximab-xiiy) Infusion Schedule Timeline image

With the third infusion and beyond, postinfusion monitoring is at physician discretion unless infusion reactions and/or hypersensitivity have been observed in association with the current or any prior infusion.

With the third infusion and beyond, postinfusion monitoring is at physician discretion unless infusion reactions and/or hypersensitivity have been observed in association with the current or any prior infusion.

BRIUMVI is the only anti‑CD20 with flexible postinfusion monitoring
with the third infusion and beyond1

95% of all BRIUMVI 1‑hour infusions were completed in 1 hour without interruption in clinical trials2,a

a±5 min.

95%

of all BRIUMVI 1‑hour infusions were completed in 1 hour without interruption in clinical trials2,a

a±5 min.

BRIUMVI® (ublituximab-xiiy) Dosing and Administration Guide thumbnail
Download the BRIUMVI
Dosing & Administration Guide
BRIUMVI® (ublituximab-xiiy) Dosing and Administration Guide thumbnail
Download the BRIUMVI
Dosing & Administration Guide

BRIUMVI MAY OFFER AN EFFICIENT ANTI-CD20 INFUSION EXPERIENCE

Premedication

  • Premedicate with 100 mg of methylprednisolone administered intravenously (or an equivalent oral dosage or equivalent corticosteroid) approximately 30 minutes prior to each BRIUMVI infusion to reduce the frequency and severity of infusion reactions. Premedicate with an antihistamine (eg, diphenhydramine) administered orally or intravenously approximately 30-60 minutes prior to each BRIUMVI infusion to further reduce the frequency and severity of infusion reactions
  • An antipyretic (eg, acetaminophen) may also be considered for use prior to administration

Treatment

  • 1-hour infusion following the starting dose
  • Day 1 infusion is 150 mg over 4 hours;
    Day 15 infusion is 450 mg over 1 hour;
    subsequent infusions are 450 mg over 1 hour, every 24 weeks

Flexible postinfusion monitoring

  • 1-hour postinfusion monitoring required on Day 1 and Day 15
With the third infusion and beyond, post-infusion monitoring is at physician discretion unless infusion reactions and/or hypersensitivity have been observed in association with the current or any prior infusion.

Premedication

  • Premedicate with 100 mg of methylprednisolone administered intravenously (or an equivalent oral dosage or equivalent corticosteroid) approximately 30 minutes prior to each BRIUMVI infusion to reduce the frequency and severity of infusion reactions. Premedicate with an antihistamine (eg, diphenhydramine) administered orally or intravenously approximately 30-60 minutes prior to each BRIUMVI infusion to further reduce the frequency and severity of infusion reactions.
  • An antipyretic (eg, acetaminophen) may also be considered for use prior to administration

Treatment

  • 1-hour infusion following the starting dose
  • Day 1 infusion is 150 mg over 4 hours;
    Day 15 infusion is 450 mg over 1 hour;
    subsequent infusions are 450 mg over 1 hour, every 24 weeks

Flexible postinfusion monitoring

  • 1-hour postinfusion monitoring required on Day 1 and Day 15
With the third infusion and beyond, post-infusion monitoring is at physician discretion unless infusion reactions and/or hypersensitivity have been observed in association with the current or any prior infusion.

Convenient Dosing
and Administration

Assessment Prior
to Infusion

Administration and
Infusion Rates

Preparing BRIUMVI
for Infusion

Convenient Dosing
and Administration

Assessment Prior
to Infusion

Administration and
Infusion Rates

Preparing BRIUMVI
for Infusion

Convenient Dosing and Administration
Assessment Prior to Infusion
Administration and Infusion Rates
Preparing BRIUMVI for Infusion

Prior to the administration of BRIUMVI, ensure that the appropriate assessments have been completed1

Assessments prior to the first dose of BRIUMVI:

HBV Screening

  • Prior to initiating BRIUMVI, perform HBV screening. BRIUMVI is contraindicated in patients with active HBV confirmed by positive results for hepatitis B surface antigen (HBsAg) and anti-HBV tests
  • For patients who are negative for HBsAg and positive for hepatitis B core antibody (HBcAb+) or are carriers of HBV (HBsAg+), consult liver disease experts before starting and during treatment with BRIUMVI

Serum Immunoglobulins

  • Prior to initiating BRIUMVI, perform testing for quantitative serum immunoglobulins. For patients with low serum immunoglobulins, consult immunology experts before initiating treatment with BRIUMVI

Vaccinations

  • Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of BRIUMVI for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines

Liver Function Tests

  • Prior to initiating BRIUMVI, obtain serum aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), alkaline phosphatase, and bilirubin levels

HBV Screening

  • Prior to initiating BRIUMVI, perform HBV screening. BRIUMVI is contraindicated in patients with active HBV confirmed by positive results for hepatitis B surface antigen (HBsAg) and anti-HBV tests
  • For patients who are negative for HBsAg and positive for hepatitis B core antibody (HBcAb+) or are carriers of HBV (HBsAg+), consult liver disease experts before starting and during treatment with BRIUMVI

Serum Immunoglobulins

  • Prior to initiating BRIUMVI, perform testing for quantitative serum immunoglobulins. For patients with low serum immunoglobulins, consult immunology experts before initiating treatment with BRIUMVI

Vaccinations

  • Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of BRIUMVI for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines

Liver Function Tests

  • Prior to initiating BRIUMVI, obtain serum aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), alkaline phosphatase, and bilirubin levels

Assessment before every infusion1:

Infection Assessment

  • Prior to every infusion of BRIUMVI, determine whether there is an active infection. In case of an active infection, delay infusion of BRIUMVI until the infection resolves

HBV, hepatitis B virus.

Convenient Dosing
and Administration

Assessment Prior
to Infusion

Administration and
Infusion Rates

Preparing BRIUMVI
for Infusion

Convenient Dosing
and Administration

Assessment Prior
to Infusion

Administration and
Infusion Rates

Preparing BRIUMVI
for Infusion

Convenient Dosing and Administration
Assessment Prior to Infusion
Administration and Infusion Rates
Preparing BRIUMVI for Infusion

Understanding the correct dosage and infusion rates for your patients1

Dose and volume of BRIUMVIVolume of 0.9% sodium chloride injection, USPaInfusion Rate (mL/hour)Durationb
First infusion
150 mg (6 mL)

250 mL
Start at 10 mL per hour for the first 30 minutes.
Increase to 20 mL per hour for the next 30 minutes.
Increase to 35 mL per hour for the next hour.
Increase to 100 mL per hour for the remaining 2 hours.
4h
Second infusion
(2 w later)
450 mg (18 mL)
250 mL
Start at 100 mL per hour for the first 30 minutes.
Increase to 400 mL per hour for the remaining 30 minutes.
1h
Subsequent infusions
(once every 24 w)c
450 mg (18 mL)
250 mL
Start at 100 mL per hour for the first 30 minutes.
Increase to 400 mL per hour for the remaining 30 minutes.
1h

Infusion rates for BRIUMVI. Dose modifications in response to infusion reactions depend on severity. Any change in rate will increase the total duration of the infusion but not the total dose.

USP, United States Pharmacopeia.

aWithdraw and discard the required volume of 0.9% sodium chloride injection, USP from the infusion bag following the preparation instructions.
bInfusion duration may take longer if the infusion is interrupted or slowed. cAdminister the first subsequent infusion 24 weeks after the first infusion.

BRIUMVI® (ublituximab-xiiy) Infusion Rate Card
Download the BRIUMVI
Infusion Rate Card
BRIUMVI® (ublituximab-xiiy) Infusion Rate Card
Download the BRIUMVI
Infusion Rate Card

DOSE MODIFICATIONS IN RESPONSE TO INFUSION REACTIONS DEPEND ON SEVERITY.1 ANY CHANGE IN RATE WILL INCREASE THE TOTAL DURATION OF THE INFUSION BUT NOT THE TOTAL DOSE

LIFE-THREATENING INFUSION REACTIONS

Stop infusion immediately and permanently discontinue BRIUMVI. Provide appropriate supportive treatment.

SEVERE INFUSION
REACTIONS

Immediately interrupt the infusion and administer appropriate supportive treatment, as necessary. Restart the infusion only after all symptoms have resolved. When restarting, begin at half of the infusion rate at the time of onset of the infusion reaction. If this rate is tolerated, increase the rate as described in the infusion rate table.

MILD TO MODERATE INFUSION REACTIONS

Reduce the infusion rate to half the rate at the onset of the infusion reaction and maintain the reduced rate for at least 30 minutes. If the reduced rate is tolerated, increase the rate as described in the infusion rate table.

LIFE-THREATENING INFUSION REACTIONS

Stop infusion immediately and permanently discontinue BRIUMVI. Provide appropriate supportive treatment.

SEVERE INFUSION
REACTIONS

Immediately interrupt the infusion and administer appropriate supportive treatment, as necessary. Restart the infusion only after all symptoms have resolved. When restarting, begin at half of the infusion rate at the time of onset of the infusion reaction. If this rate is tolerated, increase the rate as described in the infusion rate table.

MILD TO MODERATE INFUSION REACTIONS

Reduce the infusion rate to half the rate at the onset of the infusion reaction and maintain the reduced rate for at least 30 minutes. If the reduced rate is tolerated, increase the rate as described in the infusion rate table.

Convenient Dosing
and Administration

Assessment Prior
to Infusion

Administration and
Infusion Rates

Preparing BRIUMVI
for Infusion

Convenient Dosing
and Administration

Assessment Prior
to Infusion

Administration and
Infusion Rates

Preparing BRIUMVI
for Infusion

Convenient Dosing and Administration
Assessment Prior to Infusion
Administration and Infusion Rates
Preparing BRIUMVI for Infusion

PREPARING BRIUMVI FOR INFUSION

 

BRIUMVI MUST BE PREPARED BY A HEALTHCARE PROFESSIONAL USING ASEPTIC TECHNIQUE.1 PREPARE THE SOLUTION FOR INFUSION AS FOLLOWS:

BRIUMVI® (ublituximab-xiiy) infusion glass vial

BRIUMVI should be a clear to opalescent, colorless to slightly yellow solution.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the solution if discolored or if the solution contains discrete foreign particulate matter.

PREPARATION OF SOLUTION FOR THE FIRST INFUSION

Preparation of Solution for the first infusion four-step graphic

PREPARATION OF SOLUTION FOR THE SECOND AND SUBSEQUENT INFUSIONS

Preparation of Solution for the second and subsequent infusions four-step graphic

Mix diluted solution by gentle inversion. Do not shake.

NaCL, sodium chloride.

  • Store BRIUMVI in the refrigerator at 2-8 °C (36-46 °F)
  • Store BRIUMVI in the outer carton to protect from light
  • Do not freeze
  • Do not shake
  • Prior to the start of the IV infusion, the contents of the infusion bag should be at room temperature. It takes ~2 hours for the refrigerated solution to equilibrate to room temperature
  • Use the prepared infusion solution immediately. If the diluted solution is not administered immediately, store for up to:
    – 24 hours in the refrigerator at 2-8 °C (36-46 °F)
    – An additional 8 hours at room temperature up to 25 °C (77 °F), which includes equilibration time and infusion time
  • No incompatibilities between BRIUMVI and PVC or PO bags and IV administration sets have been observed
  • Store BRIUMVI in the refrigerator at 2-8 °C (36-46 °F)
  • Store BRIUMVI in the outer carton to protect from light
  • Do not freeze
  • Do not shake
  • Prior to the start of the IV infusion, the contents of the infusion bag should be at room temperature. It takes ~2 hours for the refrigerated solution to equilibrate to room temperature
  • Use the prepared infusion solution immediately. If the diluted solution is not administered immediately, store for up to:
    – 24 hours in the refrigerator at 2-8 °C (36-46 °F)
    – An additional 8 hours at room temperature up to 25 °C (77 °F), which includes equilibration time and infusion time
  • No incompatibilities between BRIUMVI and PVC or PO bags and IV administration sets have been observed

IV, intravenous; PO, polyolefin; PVC, polyvinyl chloride.

GET INFORMATION ON HOW TO ORDER BRIUMVI

See How to Order BRIUMVI

DISCOVER WHAT BRIUMVI PATIENT SUPPORT CAN OFFER YOUR ELIGIBLE PATIENTS

See BRIUMVI Patient Support

Important Safety Information

INDICATION: BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

CONTRAINDICATIONS: BRIUMVI is contraindicated in patients with:

  • Active HBV infection
  • A history of life-threatening infusion reaction to BRIUMVI

WARNINGS AND PRECAUTIONS

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.

Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.

Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

References: 1. BRIUMVI. Prescribing information. TG Therapeutics Inc; 2026. 2. Fox EJ, Steinman L, Hartung H-P, et al. Infusion-related reactions (IRRs) with ublituximab in patients with relapsing multiple sclerosis (RMS): post hoc analyses from the phase 3 ULTIMATE I and II studies. Presented at: 2022 American Academy of Neurology Annual Meeting; April 2-7, 24-26, 2022; Seattle, WA.

Important Safety Information
CONTRAINDICATIONS: BRIUMVI is contraindicated in patients with:
  • Active HBV infection
  • A history of life-threatening infusion reaction to BRIUMVI
 Indication
BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Click or scroll to see IMPORTANT SAFETY INFORMATION AND INDICATION