Ublituximab is used to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Ublituximab may also be used for purposes not listed in this medication guide.

Some side effects may occur during or after the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

If you've had hepatitis B, it may come back or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Ublituximab may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Ublituximab is injected into a vein by a healthcare provider.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.

Your blood will be tested before and during treatment with ublituximab.

Usual Adult Dose for Multiple Sclerosis:

First Infusion:
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):
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):
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 prior to 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 prior to each infusion.

Use: For the treatment of relapsing forms of multiple sclerosis in adults

You should not use ublituximab if you are allergic to it, or if you have:

• an active hepatitis B infection.

Tell your doctor if you have or have ever had:

• an active or chronic infection;

• hepatitis B or are a carrier of the hepatitis B virus;

• received a recent vaccine or if you are scheduled to receive a vaccine; or

• if you plan to take medicines that affect your immune system.

You may need to have a negative pregnancy test before each infusion of ublituximab.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using ublituximab and for at least 6 months after your last dose. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using ublituximab.

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

In a medical setting an overdose would be treated quickly.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or after the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

If you've had hepatitis B, it may come back or get worse. You may need liver function tests while using ublituximab and for several months after you stop.

Ublituximab may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Ublituximab may cause serious side effects. Call your doctor at once if you have:

• pain and burning when you urinate; or

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

Common side effects of ublituximab may include:

• dizziness, nausea, light-headed, itchy, sweaty, headache, chest tightness, back pain, trouble breathing, or swelling in your face;

• cold sores around your mouth, 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.

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 FDA at 1-800-FDA-1088.

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 affect ublituximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.