Indication and Important Safety Information
Who shouldnot receiveBRIUMVI?
Do not receive BRIUMVI ifyou have an active hepatitis B virus (HBV) infection.
Do not receive BRIUMVI ifyou have had a life-threatening allergic reaction to BRIUMVI. Tellyour healthcare provider if you have had an allergic reaction toBRIUMVI or any of its ingredients in the past.
What is the most importantinformation I should know about BRIUMVI?
BRIUMVI can cause serious sideeffects, including:
Infusion reactions:Infusion reactions are one of the most common side effects ofBRIUMVI, which can be serious and may require you to behospitalized. You will be monitored during your infusion and may bemonitored after each infusion of BRIUMVI for signs and symptoms ofan infusion reaction. Tell your healthcare provider if you get anyof these symptoms:
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These infusion reactions can happenover 24 hours after your infusion. It is important thatyou call your healthcare provider right away if you get any of thesigns or symptoms listed above after each infusion. If you get aninfusion reaction, your healthcare provider may need to stop or slowdown the rate of your infusion.
- Infection:
- Infections area common sideeffect, and upper respiratory tract infections areone of the most common side effects of BRIUMVI.BRIUMVI increases your risk of getting infectionscaused by bacteria or viruses that may belife-threatening or cause death. Tell yourhealthcare provider if you have an infection or haveany of the following signs of infection includingfever, chills, a cough that does not go away, orpainful urination. Your healthcare provider shoulddelay your treatment with BRIUMVI until yourinfection is gone.
- Hepatitis Bvirus (HBV)reactivation: Before starting treatment withBRIUMVI, your healthcare provider will do bloodtests to check for hepatitis B viral infection. Ifyou have ever had hepatitis B virus infection, thehepatitis B virus may become active again during orafter treatment with BRIUMVI. Hepatitis B virusbecoming active again (called reactivation) maycause serious liver problems including liver failureor death. Your healthcare provider will monitor youif you are at risk for hepatitis B virusreactivation during treatment and after you stopreceiving BRIUMVI.
- Weakenedimmune system:BRIUMVI taken before or after other medicines thatweaken the immune system could increase your risk ofgetting infections.
- ProgressiveMultifocalLeukoencephalopathy (PML): PML may happen withBRIUMVI. PML is a rare, serious brain infectioncaused by a virus that may get worse over days orweeks. PML can result in death or severe disability.Tell your healthcare provider right away if you haveany new or worsening neurologic signs or symptoms.These symptoms may include weakness on one side ofyour body, loss of coordination in arms and legs,vision problems, changes in thinking and memorywhich may lead to confusion, and personalitychanges.
- Lowimmunoglobulins: BRIUMVI may cause a decreasein some types of antibodies. Your healthcare provider willdo blood tests to check your blood immunoglobulinlevels.
Before receiving BRIUMVI, tell yourhealthcare provider about all of your medical conditions, includingif you:
- have orthink you have aninfection.
- take orplan to take medicines thataffect your immune system. These medicines may increase yourrisk of getting an infection.
- haveever had hepatitis B or are acarrier of the hepatitis B virus.
- have hada recent vaccination or arescheduled to receive any vaccinations.
- You shouldreceive anyrequired ‘live’ or ‘live-attenuated’ vaccines atleast 4 weeks before you start treatment withBRIUMVI. You should not receive ‘live’ or‘live-attenuated’ vaccines while you are beingtreated with BRIUMVI and until your healthcareprovider tells you that your immune system is nolonger weakened.
- When possible,you shouldreceive any ‘non-live’ vaccines at least 2 weeksbefore you start treatment with BRIUMVI. If youwould like to receive any non-live vaccines whileyou are being treated with BRIUMVI, talk to yourhealthcare provider.
- If you have ababy and youreceived BRIUMVI during your pregnancy, it isimportant to tell your baby’s healthcare providerabout receiving BRIUMVI so they can decide when yourbaby should be vaccinated.
- arepregnant, think that you mightbe pregnant, or plan to become pregnant. BRIUMVI may harmyour unborn baby. You should use birth control(contraception) during treatment with BRIUMVI and for atleast 6 months after your last infusion of BRIUMVI. Talkwith your healthcare provider about what birth controlmethod is right for you during this time.
- arebreastfeeding or plan tobreastfeed. It is not known if BRIUMVI passes into yourbreast milk. Talk to your healthcare provider about the bestway to feed your baby if you take BRIUMVI.
Tell your healthcare provider aboutall the medicines you take, including prescription andover-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effectsof BRIUMVI?
The most common side effects ofBRIUMVI include:
- Infusionreactions, upper and lowerrespiratory tract infections, herpes infections, extremitypain, insomnia, and fatigue.
These are not all the possible side effects ofBRIUMVI. Call your doctor for medical advice about side effects. You mayreport side effects to FDA at 1-800-FDA-1088. You may also report sideeffects to TG Therapeutics at 1-877-TGTXINC (1-877-848-9462).
For more important information, go to www.briumvi.com or call1-833-BRIUMVI (1-833-274-8684).
