Ublituximab-xiiy (ue-bli-TUX-i-mab - xiiy)

Treats multiple sclerosis.

Brand Name(s):

Briumvi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• Your doctor may give you other medicines (including allergy medicine, fever medicine, steroid) 30 to 60 minutes before receiving this medicine to prevent unwanted effects (including infusion reactions). Your doctor may also want you to stay for at least 1 hour after the first 2 infusions to check for unwanted effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ublituximab-xiiy works. Tell your doctor if you are using steroid medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Complete any required live or live-attenuated vaccines at least 4 weeks, or non-live vaccines at least 2 weeks, before starting this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control during treatment with this medicine and for 6 months after the last dose.
• Tell your doctor if you are breastfeeding, or if you have liver disease (including history of hepatitis B) or any type of active infection.
• This medicine may cause the following problems:
  • Infusion reactions, which can be life-threatening
  • Increase risk for infection, including hepatitis B or progressive multifocal leukoencephalopathy (PML)
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088