DOSING & ADMINISTRATION

BRIUMVI is the only DMT that is administered as a 1-hour infusion, twice per year following the starting dose1

BRIUMVI dosing and convenient administration

Assessments prior to infusion

Administration and infusion rates

Preparing BRIUMVI for infusion

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

95%

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

*± 5 minutes

Watch the BRIUMVI infusion training video (English)
Watch the BRIUMVI infusion training video (Spanish)

Download the Dosing & Administration Guide
BRIUMVI offers flexible premedication and post-infusion monitoring options1
Premedication
  • Pre-medicate 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. Pre-medicate with an antihistamine (e.g., 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 (e.g., 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 post-infusion monitoring
  • 1-hour post-infusion monitoring required on Day 1 and Day 15

After 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

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 icon
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
Test tubes icon
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
Vaccination icon
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
Assessment before every infusion1
Microscope icon
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

Fetus in womb icon
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.

Click here to download the Infusion Rate Card
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 dose1
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.

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) vial

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

Eye in magnifying glass icon

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
1

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

2

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

3

Withdraw 6 mL BRIUMVI solution from the vial.

4

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
5

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

6

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

7

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

8

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
USP=United States Pharmacopeia

Prior to the start of the IV
infusion, the contents of the
infusion bag should be at
room temperature.
Administer the diluted infusion solution through a dedicated line.

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)

 If the diluted solution is stored refrigerated, allow it to equilibrate to room temperature prior to administration (~ 2 hours).

The diluted solution can be stored for an additional 8 hours at room temperature up to 25°C (77°F), which includes the equilibration time and infusion time.

Do not freeze.

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

IV=intravenous
PVC=polyvinyl chloride
PO=polyolefin

Get information on how to
order BRIUMVI
See How to Order BRIUMVI
Discover what BRIUMVI Patient Support can offer your patients
See BRIUMVI Patient Support

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.

Have questions?
Call 1-833-BRIUMVI (1-833-274-8684) to speak with a BRIUMVI Patient Support
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TG Therapeutics Representative
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Indication and Important Safety Information

IMPORTANT SAFETY INFORMATION

Contraindication: 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): 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.

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.

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Indication and 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.

IMPORTANT SAFETY INFORMATION: Contraindication: BRIUMVI is contraindicated in patients with:

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

  • fever
  • chills
  • headache
  • flu-like symptoms
  • fast heartbeat
  • hives
  • itchy skin
  • dizziness

  • feeling faint
  • welling of tongue or throat
  • trouble breathing
  • wheezing
  • nausea
  • abdominal pain
  • throat irritation
  • redness of the face or skin

 

These infusion reactions can happen over 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion.

  • Infection:
    • Infections are a common side effect, and upper respiratory tract infections are one of the most common side effects of BRIUMVI. BRIUMVI increases your risk of getting infections caused by bacteria or viruses that may be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or painful urination. Your healthcare provider should delay your treatment with BRIUMVI until your infection is gone.
    • Hepatitis B virus (HBV) reactivation: Before starting treatment with BRIUMVI, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with BRIUMVI. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving BRIUMVI.
    • Weakened immune system: BRIUMVI taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
    • Progressive Multifocal Leukoencephalopathy (PML): PML may happen with BRIUMVI. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These symptoms may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, changes in thinking and memory which may lead to confusion, and personality changes.
  • Low immunoglobulins: BRIUMVI may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.


Before receiving BRIUMVI, tell your healthcare provider about all of your medical conditions, including if you:

  • have or think you have an infection.
  • take or plan to take medicines that affect your immune system. These medicines may increase your risk of getting an infection.
  • have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • have had a recent vaccination or are scheduled to receive any vaccinations.
    • You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with BRIUMVI. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with BRIUMVI and until your healthcare provider tells you that your immune system is no longer weakened.
    • When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with BRIUMVI. If you would like to receive any non-live vaccines while you are being treated with BRIUMVI, talk to your healthcare provider.
    • If you have a baby and you received BRIUMVI during your pregnancy, it is important to tell your baby’s healthcare provider about receiving BRIUMVI so they can decide when your baby should be vaccinated.
  • are pregnant, think that you might be pregnant, or plan to become pregnant. BRIUMVI may harm your unborn baby. You should use birth control (contraception) during treatment with BRIUMVI and for at least 6 months after your last infusion of BRIUMVI. Talk with your healthcare provider about what birth control method is right for you during this time.
  • are breastfeeding or plan to breastfeed. It is not known if BRIUMVI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take BRIUMVI.


Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of BRIUMVI?

The most common side effects of BRIUMVI include:

  • Infusion reactions, upper and lower respiratory tract infections, herpes infections, extremity pain, insomnia, and fatigue.


These are not all the possible side effects of BRIUMVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to TG Therapeutics at 1-877-TGTXINC (1-877-848-9462).

For more important information, go to www.briumvi.com or call 1-833-BRIUMVI (1-833-274-8684).