BRIUMVI is the only DMT that is administered as a 1-hour infusion,
twice per yeara

BRIUMVI is a 1-hour, 450-mg intravenous (IV) infusion given every 24 weeks following the starting dose1


of all BRIUMVI 1-hour infusions were completed in 1 hour without interruption in clinical trials*2

*± 5 minutes

Watch the BRIUMVI infusion training video
BRIUMVI offers flexible premedication and postinfusion monitoring options1
  • Corticosteroid and antihistamine premedications may be administered orally or intravenously 30 to 60 minutes prior to BRIUMVI infusion
  • An antipyretic (eg, acetaminophen)
    may also be considered for use prior to administration
  • 1-hour infusiona

Flexible postinfusion monitoring
  • 1-hour postinfusion monitoring required on Day 1 and Day 15

After the third infusion and beyond, postinfusion monitoring is at physician discretion unless infusion reactions and/or hypersensitivity have been observed on Day 1 or Day 15

aFollowing 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.
DMT=Disease modifying therapy

Prior to the administration of BRIUMVI, ensure that the appropriate assessments have been completed1
Assessments prior to the first dose of BRIUMVI1
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
  • 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
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

Pregnancy Testing (Recommended)
  • Pregnancy testing is recommended for females of reproductive potential prior to each infusion with BRIUMVI
Understanding the correct dosage and infusion rates for your patients1
Dose (mg) and volume (mL) of BRIUMVIVolume (mL) of 0.9% sodium chloride injection, USPaInfusion Rate (mL/hour)Durationb
First infusion150 mg
(6 mL)
250 mLStart 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
4 hours
Second infusion
(2 weeks later)
450 mg
(18 mL)
250 mLStart at 100 mL per hour for the first 30 minutes
Increase to 400 mL per hour for the remaining 30 minutes
1 hour
Subsequent infusions
(once every 24 weeks after first infusion)c
450 mg
(18 mL)
250 mLStart at 100 mL per hour for the first 30 minutes
Increase to 400 mL per hour for the remaining 30 minutes
1 hour

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.

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.

Life-threatening infusion reactions1

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

Severe infusion reactions1

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 reactions1

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.

Preparing BRIUMVI for infusion


BRIUMVI must be prepared by a healthcare professional using aseptic technique. Prepare the solution for infusion as follows1:

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

Prepare infusion bags for the first infusion (150 mg) using 1 vial (150 mg/6 mL) of BRIUMVI.


Withdraw 6 mL 0.9% NaCl injection, USP from the 250 mL infusion bag and discard.


Withdraw 6 mL BRIUMVI solution from the vial.


Add 6 mL (150 mg) BRIUMVI into the infusion bag containing 0.9% NaCl injection, USP.

Preparation of solution for the second and subsequent infusions

Prepare infusion bag for second infusion (450 mg) and subsequent infusions (450 mg) using 3 vials (150 mg/6 mL) of BRIUMVI.


Withdraw 18 mL 0.9% NaCl injection, USP from the 250 mL infusion bag and discard.


Withdraw 18 mL BRIUMVI solution from the vials (6 mL/vial).


Add 18 mL (450 mg) BRIUMVI into the infusion bag containing 0.9% NaCl injection, USP.

Mix diluted solution by gentle inversion. Do not shake.

NaCl=Sodium chloride

Prior to the start of the IV
infusion, the contents of the
infusion bag should be at
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°C to 8°C (36°F to 46°F)

An additional 8 hours at room
temperature up to 25°C (77°F)*

No incompatibilities between
BRIUMVI and PVC or PO bags
and IV administration sets
have been observed.

USP=United States Pharmacopeia
PVC=polyvinyl chloride

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References: 1. BRIUMVI. Prescribing information. TG Therapeutics Inc; 2022. 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 (AAN) Annual Meeting; April 2-7, 24-26, 2022; Seattle, WA.

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Indication and Important Safety Information


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.


Contraindication: BRIUMVI is contraindicated in patients with:

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


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): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies 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. A pregnancy test is recommended in females of reproductive potential prior to each infusion. 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.

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.