Do not receive BRIUMVI if you have an active hepatitis B virus (HBV) infection.

Do not receive BRIUMVI if you have had a life-threatening allergic reaction to BRIUMVI. Tell your healthcare provider if you have had an allergic reaction to BRIUMVI or any of its ingredients in the past.

BRIUMVI can cause serious side effects, including:

• Infusion reactions: Infusion reactions are one of the most common side effects of BRIUMVI, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and may be monitored after each infusion of BRIUMVI for signs and symptoms of an infusion reaction. Tell your healthcare provider if you get any of these symptoms:

• 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 a history of liver problems.
• 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. It is not known if BRIUMVI will 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.

BRIUMVI may cause serious side effects, including:

• See “What is the most important information I should know about BRIUMVI?”
• Liver damage. BRIUMVI may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start BRIUMVI and while you take BRIUMVI if needed. Tell your healthcare provider right away if you have any symptoms of liver damage, such as:

• • yellowing of the skin and eyes (jaundice)
  • nausea
  • vomiting
  • unusual darkening of the urine
  • feeling tired or weak

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).

BRIUMVI is a prescription medication used to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.