Ublituximab-xiiy injection

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.

Are there OTHER USES for this medicine?

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

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.

Ublituximab-xiiy injection can cause serious infusion reactions, which may occur more than 24 hours after receiving a dose. A doctor or nurse will watch you closely while you are receiving the infusion and for at least 1 hour after the infusion to be sure you are not having a serious reaction to the medication. Your doctor will probably treat you with other medications before each infusion to prevent infusion reactions. Tell your doctor or nurse if you experience any of the following symptoms during or after your infusion: 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. If you experience any of these symptoms, your doctor will slow down or stop your infusion and treat the symptoms of the reaction. If your reaction is severe, your healthcare provider may decide not to give you any more infusions of ublituximab-xiiy.

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

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 injection.

• tell your doctor if you have an infection.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you can get pregnant, 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.

• 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.

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 section, call your doctor immediately:

• fever, chills, cough, or other signs of infection
• 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 (https://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.

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.