Class Name(s):

• 90:04.04 Monoclonal Antibodies

Pronunciation:

• (ue" bli tux' i mab)

Brand Name(s):

• Briumvi^®

WHY is this medicine prescribed?

Ublituximab-xiiy injection is used to treat 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). Ublituximab-xiiy injection is in a class of medications called monoclonal antibodies. It works by decreasing the action of immune cells that may cause nerve damage.

HOW should this medicine be used?

Ublituximab-xiiy injection comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a hospital or medical office. The first infusion is given over 4 hours. The second infusion is given over 1 hour 2 weeks later. After that, infusions are given over 1 hour every 24 weeks.

Ublituximab-xiiy injection can cause serious reactions, which can occur more than 24 hours after receiving a dose. A doctor or nurse will watch you closely during and for at least 1 hour after you receive a dose. You may be given other medications to prevent and treat these reactions. If you experience any of the following symptoms, tell your doctor or nurse immediately: fever; chills; headache; nausea; abdominal pain; flu-like symptoms; fast heartbeat; dizziness; feeling faint; rash; hives; itching; swelling of the face, eyes, mouth, throat, tongue, or lips; difficulty breathing or swallowing; wheezing, throat irritation; or flushing. Your doctor may need to slow down or delay or permanently stop your treatment if you experience these side effects.

Ublituximab-xiiy injection helps to control multiple sclerosis, but does not cure it.

You will be given the Medication Guide when you begin treatment with ublituximab-xiiy injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before receiving ublituximab-xiiy injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving ublituximab-xiiy. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had hepatitis B (HBV; a virus that infects the liver and can cause severe liver damage). Your doctor may tell you not to receive ublituximab-xiiy injection. Your doctor will order a blood test to see if you have an inactive hepatitis B infection before you start your treatment.
• tell your doctor if you have or have ever had liver problems.
• check with your doctor to see if you need to receive any vaccinations before receiving ublituximab-xiiy injection. Tell your doctor if you have received a vaccine within the past 4 weeks. Do not have any vaccinations without talking to your doctor.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You should not become pregnant while you are receiving ublituximab-xiiy injection and for 6 months after your final dose. If you can get pregnant, use birth control during your treatment and for 6 months after your final dose. Talk to your doctor about types of birth control that will work for you. If you become pregnant while you are receiving ublituximab-xiiy injection or within 6 months of your final dose, call your doctor immediately. Ublituximab-xiiy may harm the fetus.
• you should know that ublituximab-xiiy may decrease your ability to fight infection and increase the risk that you will get a serious infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. If you experience any of the following symptoms during or shortly after your treatment with ublituximab-xiiy injection, call your doctor immediately: fever; chills; sore throat; cough; frequent, urgent, or painful urination; or other signs of infection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Ublituximab-xiiy may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain in arms or legs
• difficulty falling sleeping or staying asleep
• tiredness

Some side effects can be serious. If you experience any of these symptoms or those in the HOW or SPECIAL PRECAUTIONS sections, call your doctor immediately:

• weakness on one side of the body, loss of coordination, vision problems, confusion, memory impairment, personality changes
• yellowing of the skin and eyes, nausea, vomiting, pain in the upper right part of the stomach, dark colored urine, extreme tiredness, or weakness

Ublituximab-xiiy may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to ublituximab-xiiy injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: November 15, 2025.