UNDERSTANDING SAFETY
BRIUMVI was tested alongside another treatment (teriflunomide*) in more than 1,000 people with relapsing multiple sclerosis (RMS) in 2 separate, 2-year clinical studies.
UNDERSTANDING SAFETY
BRIUMVI was tested alongside another treatment (teriflunomide*) in more than 1,000 people with relapsing multiple sclerosis (RMS) in 2 separate, 2-year clinical studies.
UNDERSTANDING SAFETY
BRIUMVI is the only B-cell therapy approved for people with RMS that is administered in a 1-HOUR INFUSION, TWICE PER YEAR.* If you are starting or switching treatment, there are many factors to consider. Learn more about BRIUMVI as a treatment option and talk to your healthcare provider about whether it might be right for you.
*Following the starting dose.
BRIUMVI has a well-studied safety profile and has now been studied for 5 years and counting
The safety of BRIUMVI was tested head-to-head against another treatment (teriflunomide*) in more than 1,000 people with relapsing multiple sclerosis (RMS) in 2 separate, 2-year clinical studies. The results from 545 people who received at least 1 dose of BRIUMVI and 548 people who received at least 1 dose of teriflunomide showed a comparable safety profile.
Most common side effects
Side effects for BRIUMVI with an incidence of at least 5% and greater than teriflunomide
| Side effects | BRIUMVI (N=545) % | teriflunomide (N=548) % |
|---|---|---|
| Infusion-related reactions | 48 | 12 |
| Upper respiratory tract infections | 45 | 41 |
| Lower respiratory tract infections | 9 | 7 |
| Herpes virus-associated infections | 6 | 5 |
| Pain in extremity | 6 | 4 |
| Insomnia | 6 | 3 |
| Fatigue | 5 | 4 |
| Side effects | BRIUMVI (N=545) % | teriflunomide (N=548) % |
|---|---|---|
| Infusion-related reactions | 48 | 12 |
| Upper respiratory tract infections | 45 | 41 |
| Lower respiratory tract infections | 9 | 7 |
| Herpes virus-associated infections | 6 | 5 |
| Pain in extremity | 6 | 4 |
| Insomnia | 6 | 3 |
| Fatigue | 5 | 4 |
- These are not all of the possible side effects of BRIUMVI. Talk to your healthcare provider about the possible side effects of BRIUMVI and ask if BRIUMVI may be right for you
- Overall infection rates of BRIUMVI & teriflunomide were similar. With BRIUMVI, most were mild to moderate and consisted of upper respiratory tract infection and urinary tract infection
- ~90% of people stayed on treatment throughout both clinical studies. This was similar for people taking BRIUMVI and people taking teriflunomide
*Teriflunomide is the active ingredient in AUBAGIO®. AUBAGIO® is a registered trademark of Sanofi or an affiliate.
BRIUMVI WAS WELL STUDIED IN 2 SEPARATE, 2-YEAR CLINICAL TRIALS
The safety profile of BRIUMVI was consistent with these clinical trials with an additional 3 years of people being on BRIUMVI
Because safety is so important, BRIUMVI continues to be studied in an open-label* extension study†
*A type of study where participants are aware of the type of treatment they’re being given. Interpreting results from open-label studies can be uncertain. They are not considered representative of results since participants chose whether to stay in the trial. No conclusions of clinical outcomes can be drawn.
†After the original 2-year BRIUMVI studies, 851 people continued to participate; 624 completed open-label extension Year 3 for further evaluation, where they all took BRIUMVI. The goal of this extended study was to evaluate the long-term efficacy and safety of BRIUMVI in RMS patients. (January 1, 2024, cut-off date.)
Infusion reactions were mostly mild to moderate and were less common with each infusion
<10% of people experienced infusion reactions after the first dose
In the studies, people were not given premedication to reduce fever prior to Dose 1; however, your healthcare provider may add a premedication to reduce fever (e.g. acetaminophen)
97%
of all BRIUMVI infusions were delivered without interruption in clinical trials
95%
of all BRIUMVI 1-hour infusions were completed in 1 hour* without interruption in clinical trials
*± 5 minutes
Learn more about the dosing schedule
for BRIUMVI
What to expect on your BRIUMVI
infusion day
JOIN THE THOUSANDS WHO ARE TAKING ON RMS WITH BRIUMVI
Discover how BRIUMVI is impacting real people with RMS.
Hear from people who have included it in their RMS treatment journey.
JOIN THE THOUSANDS WHO ARE TAKING ON RMS WITH BRIUMVI
Discover how BRIUMVI is impacting real people with RMS.
Hear from people who have included it in their RMS treatment journey.
JOIN THE THOUSANDS WHO ARE TAKING ON RMS WITH BRIUMVI
Discover how BRIUMVI is impacting real people with RMS.
Hear from people who have included it in their RMS treatment journey.
People featured on this page are taking BRIUMVI and have been compensated by TG Therapeutics for their time.
INDICATION AND IMPORTANT
SAFETY INFORMATION
Who should not receive BRIUMVI?
What is the most important information I should know about BRIUMVI?
- fever
- chills
- headache
- flu-like symptoms
- fast heartbeat
- hives
- itchy skin
- dizziness
- feeling faint
- swelling 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:
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?
Indication
