Ublituximab

Generic name: Ublituximab
Brand names: Briumvi
Dosage form: intravenous solution (xiiy 150 mg/6 mL)
Drug class: CD20 monoclonal antibodies

Usage of 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.

Ublituximab side effects

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.

Before taking Ublituximab

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.

Relate drugs

How to use 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

Warnings

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.

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.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com'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. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com 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.