Briumvi (ublituximab) injection belongs to a class of medications called monoclonal antibodies. Ublituximab works by decreasing the action of immune cells that may cause nerve damage.

Briumvi injection is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control), including :

• clinically isolated syndrome (first episode of neurologic symptoms)
• relapsing-remitting forms (course of disease where symptoms flare up from time to time)
• secondary progressive forms (course of disease where relapses occur more often).

Some side effects may occur during or after the Briumvi injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

If you've had hepatitis B, it may come back or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Briumvi may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Before taking this medicine

You should not use Briumvi if you are allergic to ublituximab, or if you have:

• an active hepatitis B infection.

To make sure Briumvi is safe for you, tell your doctor if you have ever had:

• an active or chronic infection;

• hepatitis B or are a carrier of the hepatitis B virus;

• received a recent vaccine or if you are scheduled to receive a vaccine; or

• if you plan to take medicines that affect your immune system.

You may need to have a negative pregnancy test before each infusion of Briumvi.

Ublituximab may harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using Briumvi and for at least 6 months after your last dose. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Use Briumvi exactly as prescribed by your docto. Read all medication guides or instruction sheets.

Briumvi is injected into a vein by a healthcare provider.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.

Your blood will be tested before and during treatment with Briumvi.

Usual Adult Dose for Multiple Sclerosis:

First Infusion:
150 mg IV over at least 4 hours
-Initiate infusion at a rate of 10 mL per hour for the initial 30 minutes.
-Increase the flow to 20 mL per hour for the next 30 minutes.
-Increase the flow to 35 mL per hour for the next hour.
-Increase the flow to 100 mL per hour for the remaining 2 hours.

Second Infusion (2 weeks after the first infusion):
450 mg IV over at least 1 hour
-Initiate infusion at a rate of 100 mL per hour for the first 30 minutes.
-Increase the flow to 400 mL per hour for the remaining 30 minutes.

Subsequent Infusions (24 weeks after the first infusion):
450 mg IV every 24 weeks over at least 1 hour
-Initiate infusion at a rate of 100 mL per hour for the first 30 minutes.
-Increase the flow to 400 mL per hour for the remaining 30 minutes.

Comments:
-Premedicate with an appropriate corticosteroid approximately 30 minutes prior to each infusion of this drug, an antihistamine 30-60 minutes prior to each infusion of this drug, and an additional antipyretic if required to reduce the frequency and severity of infusion reactions.
-Monitor for infusion reactions during and for at least one hour after the first two infusions; based on the physician's discretion, continue monitoring after subsequent infusions unless an infusion reaction and/or hypersensitivity have been observed during the current or any prior infusion.
-Verify pregnancy status in females of childbearing potential prior to each infusion.

Use: For the treatment of relapsing forms of multiple sclerosis in adults

You should not use Briumvi if you are allergic to ublituximab, or if you have:

• an active hepatitis B infection.

To make sure Briumvi is safe for you, tell your doctor if you have ever had:

• an active or chronic infection;

• hepatitis B or are a carrier of the hepatitis B virus;

• received a recent vaccine or if you are scheduled to receive a vaccine; or

• if you plan to take medicines that affect your immune system.

You may need to have a negative pregnancy test before each infusion of Briumvi.

Ublituximab may harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using Briumvi and for at least 6 months after your last dose. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Call your doctor for instructions if you miss an appointment for your Briumvi injection.

In a medical setting an overdose would be treated quickly.

Avoid receiving a "live" vaccine while you are being treated with Briumvi, and for at least 4 weeks before your treatment. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Avoid receiving a "non-live" vaccine for at least 2 weeks before your treatment with Briumvi.

Get emergency medical help if you have signs of an allergic reaction to Briumvi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or after the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

If you've had hepatitis B, it may come back or get worse. You may need liver function tests while using this medicine and for several months after you stop.

Briumvi may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Briumvi may cause serious side effects. Call your doctor at once if you have:

• pain and burning when you urinate; or

• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

Common Briumvi side effects may include:

• dizziness, nausea, light-headed, itchy, sweaty, headache, chest tightness, back pain, trouble breathing, or swelling in your face;

• cold sores around your mouth, skin sores or blisters, itching, tingling, burning pain in your thigh or lower back;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• pain in your hands and feet;

• sleep problems (insomnia); or

• tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with ublituximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.