Ublituximab-xiiy injection

Brand Name(s): Briumvi®

WHY is this medicine prescribed?

Ublituximab-xiiy 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).

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 followed by a second infusion given over 1 hour 2 weeks later, and the following infusions are given over 1 hour every 24 weeks after that. Your doctor will monitor you for at least 1 hour after you receive your infusion.

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

Are there OTHER USES for this medicine?

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 and pharmacist if you are allergic to ublituximab-xiiy, any other medications, or any of the ingredients in ublituximab-xiiy injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• 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 an infection with Hepatitis B virus (HBV). Your doctor may tell you not to receive ublituximab-xiiy.
• check with your doctor to see if you need to receive any vaccinations before receiving ublituximab-xiiy. Tell your doctor if you have received a vaccine within the past 4 weeks. Do not have any vaccinations without talking to your doctor during your treatment.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you are female, you will need to take a pregnancy test before you start treatment and use birth control during your treatment and for 6 months after your final dose. Talk to your doctor about types of birth control that you can use to prevent pregnancy during this time. If you become pregnant while you are receiving ublituximab-xiiy injection, call your doctor immediately. Ublituximab-xiiy may harm the fetus.

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 sleeping
• tiredness

• fever, chills, headache, flu-like symptoms, fast heartbeat, hives, itchy skin, dizziness, feeling faint, tongue or throat swelling, redness of the skin
• cough, chest pain, wheezing, throat irritation, trouble breathing
• nausea, abdominal pain
• difficulty or pain while urinating, lower back pain
• weakness on one side of the body, loss of coordination, vision problems, confusion, memory impairment, personality changes

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 may order certain lab tests to check your body's response to ublituximab-xiiy.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry 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.

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