Pronunciation: u-bli-tux-i-mab
Generic name: ublituximab
Brand name: Briumvi
Dosage form: injection for intravenous infusion
Drug class: CD20 monoclonal antibodies

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 10, 2024.

What is ublituximab?

Ublituximab (brand name Briumvi) is used to treat relapsing forms of multiple sclerosis (MS) in adults. A ublituximab infusion is usually given every 6 months by a healthcare provider, after an initial series of doses.

Ublituximab first gained FDA approval on December 28, 2022, under the brand name Briumvi. There is no ublituximab generic (more correctly called a biosimilar). The full biological name of ublituximab is ublituximab-xiiy.

Ublituximab uses

Ublituximab infusion is used to treat adults with various forms of multiple sclerosis (MS) 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).

How does ublituximab work?

Ublituximab's mechanism of action is not completely understood but is thought to involve binding to CD20, a protein that is present on the surface of pre-B and mature B lymphocytes. B lymphocytes are a type of white blood cell that are part of your immune system and are thought to play a key role in MS by contributing to inflammation and producing antibodies that attack the immune system.

Ublituximab-xiiy destroys these B cells, decreasing their levels for several months following each infusion. Briumvi relieves inflammation that causes damage to the myelin sheath (the protective covering surrounding nerves), relieving the symptoms of MS.

Ublituximab belongs to the drug class called CD20 monoclonal antibodies.

Ublituximab side effects

The most common ublituximab side effects are:

• Infusion reactions, which may include symptoms such as dizziness, nausea, light-headed, itchy, sweaty, headache, chest tightness, back pain, trouble breathing, or swelling in your face;

• cold sores around your mouth (herpes infections), 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.

Serious side effects and warnings

Ublituximab can cause the following serious side effects.

Infusion reactions. Infusion reactions are one of the most common side effects of ublituximab. Infusion reactions 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 ublituximab for signs and symptoms of an infusion reaction. Tell your healthcare provider if you get any of these symptoms:

• fever
• itchy skin
• wheezing
• chills
• dizziness
• nausea
• headache
• feeling faint
• abdominal pain
• flu-like symptoms
• swelling of the tongue or throat
• throat irritation
• fast heartbeat
• trouble breathing
• redness of the face or skin
• hives.

These infusion reactions can happen over 24 hours after your infusion. You must 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.

Infections. Infections are a common side effect, and upper respiratory tract infections are one of the most common side effects of ublituximab. Ublituximab 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 ublituximab until your infection is gone.

Hepatitis B virus (HBV) reactivation: Before starting treatment with ublituximab, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had a hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with ublituximab. 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 ublituximab.

Weakened immune system: ublituximab 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 ublituximab. 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, and changes in thinking and memory which may lead to confusion, and personality changes.

Low immunoglobulins: ublituximab may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Ublituximab may also cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction to ublituximab such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

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 the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking this medicine

You should not use ublituximab if you are allergic to ublituximab, Briumvi, or any of the inactive ingredients in the infusion.

Before receiving, tell your healthcare provider about all 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 ublituximab. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with ublituximab 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 ublituximab. If you would like to receive any non-live vaccines while you are being treated with ublituximab, talk to your healthcare provider.
  • If you have a baby and you received ublituximab during your pregnancy, it is important to tell your baby’s healthcare provider about receiving ublituximab so they can decide when your baby should be vaccinated.
• are pregnant, think that you might be pregnant, or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Ublituximab may harm your unborn baby. You should use birth control (contraception) during treatment with ublituximab and for at least 6 months after your last infusion of ublituximab. Talk with your healthcare provider about what birth control method is right for you during this time. You may need to have a negative pregnancy test before each infusion of ublituximab.

Pregnancy Registry. There is a pregnancy registry for women who take ublituximab during pregnancy. If you become pregnant while receiving ublituximab or within 6 months following the last dose of ublituximab, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Briumvi Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Either you or your healthcare provider can enroll you in this registry by calling 1-877-411- 4546 or visit www.briumvipregnancyregistry.com.

Breastfeeding

It is not known if ublituximab passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ublituximab.

How is ublituximab given?

Ublituximab is given through a needle placed in your vein (intravenous infusion) in your arm.

• Your healthcare provider may do a pregnancy test before each infusion of ublituximab.

Before treatment with ublituximab, you will receive a corticosteroid and an antihistamine medicine to help reduce the risk of infusion reactions by making them less frequent and less severe. You may also receive other medicines to help reduce the risk of an infusion reaction.

• Your first dose of ublituximab will last about 4 hours.
• Your second dose of ublituximab will be given 2 weeks after your first dose. This infusion will last about 1 hour.
• Your next doses of ublituximab will be given as 1 infusion every 24 weeks. These infusions will last about 1 hour.

Ublituximab dosing information

Usual Adult Ublituximab Dose for Multiple Sclerosis:

First Infusion: ublituximab 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): ublituximab 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): ublituximab 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 before 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 before each infusion.

What happens if I miss a dose?

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

What happens if I overdose?

In a medical setting, an overdose would be treated quickly.

What should I avoid while receiving ublituximab?

Avoid receiving a "live" vaccine while you are being treated with ublituximab, 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 ublituximab.

What other drugs will affect ublituximab?

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.

Ublituximab ingredients

Active ingredient: ublituximab-xiiy
Inactive ingredients: hydrochloric acid, polysorbate 80, sodium chloride, sodium citrate, Water for Injection, USP.

Who makes ublituximab?

TG Therapeutics, Inc., manufactures ublituximab under the brand name Briumvi.

Ublituximab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for ublituximab.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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