ublituximab

What is the most important information I should know about ublituximab?

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.

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.

What is ublituximab?

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.

What should I discuss with my healthcare provider before receiving ublituximab?

• 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.

How is ublituximab given?

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.

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

What happens if I miss a dose?

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving ublituximab?

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.

What are the possible side effects of ublituximab?

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 this medicine 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.

• 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 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.

What other drugs will affect ublituximab?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about ublituximab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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