Ublituximab

What is Ublituximab?

• Ublituximab (Briumvi) is a recombinant chimeric monoclonal IgG1 antibody with reduced fucose content directed against CD20-expressing B-cells.

What are the uses of this medicine?

Ublituximab (Briumvi) is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS), including:

• clinically isolated syndrome
• relapsing-remitting disease
• active secondary progressive disease

How does this medicine work?

• A chimeric recombinant IgG1 monoclonal antibody directed against human CD20 with potential antineoplastic activity.
• Ublituximab specifically binds to the B cell-specific cell surface antigen CD20, thereby potentially inducing a B cell-directed complement dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC) against CD20-expressing B cells, leading to B cell apoptosis.
• CD20 is a non-glycosylated cell surface phosphoprotein that is exclusively expressed on B cells during most stages of B cell development and is often overexpressed in B-cell malignancies.
• Ublituximab has a specific glycosylation profile, with a low fucose content, that may enhance its ADCC response against malignant B cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have active hepatitis B virus (HBV) infection.
• have had a life-threatening allergic reaction to Briumvi.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Is this medicine FDA approved?

• It was approved for medical use in the United States in December 2022.

How should this medicine be used?

• Prior to initiating Briumvi, perform Hepatitis B virus (HBV) screening. Briumvi is contraindicated in patients with active HBV confirmed by positive results for Hepatitis B surface antigen [HBsAg] and anti-HBV tests.
• Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) prior to each infusion.
• Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of Briumvi.
• Pregnancy testing is recommended for females of reproductive potential prior to each infusion with Briumvi.

Recommended dosage:

• First Infusion: 150 mg intravenous infusion.
• Second Infusion: 450 mg intravenous infusion two weeks after the first infusion.
• Subsequent Infusions: 450 mg intravenous infusion 24 weeks after the first infusion and every 24 weeks thereafter.

Administration:

• Briumvi is given through a needle placed in your vein in your arm.
• Your healthcare provider may do a pregnancy test before each infusion of Briumvi.
• Before treatment with Briumvi, you will receive a corticosteroid and an antihistamine medicine to help reduce the risk of infusion reactions by making them less frequent and less severe. You may also receive other medicines to help reduce the risk of an infusion reaction.
• Your first dose of Briumvi will last about 4 hours.
• Your second dose of Briumvi will be given 2 weeks after your first dose. This infusion will last about 1 hour.
• Your next doses of Briumvi will be given as 1 infusion every 24 weeks. These infusions will last about 1 hour.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 150 mg/6 mL (25 mg/mL) in a single-dose vial

This medicine is available in fallowing brand namesː

• Briumvi

What side effects can this medication cause?

The most common side effects of this medicine in Adult Patients include:

• Infusion reactions, upper and lower respiratory tract infections, herpes infections, extremity pain, insomnia, and fatigue

Less common, but serious side effects may include:

• Infusion reactions
• Infections
• Hepatitis B virus (HBV) reactivation
• Weakened immune system
• Progressive Multifocal Leukoencephalopathy (PML)
• Low immunoglobulins

What special precautions should I follow?

• Briumvi can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. Inform patients about the signs and symptoms of infusion reactions and that infusion reactions can occur up to 24 hours after infusion. Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion reactions.
• Serious, including life-threatening or fatal, bacterial and viral infections have been reported in patients receiving Briumvi. Advise patients to contact their healthcare provider for any signs of infection during treatment or after the last infusion. Signs can include fever, chills, constant cough, or dysuria.
• Advise patients that Briumvi may cause reactivation of hepatitis B infection and that monitoring will be required if they are at risk.
• Advise patients that Progressive Multifocal Leukoencephalopathy (PML) has happened with drugs that are similar to Briumvi and may happen with Briumvi.
• Advise patients to complete any required live or live-attenuated vaccinations at least 4 weeks and, whenever possible, non-live vaccinations at least 2 weeks prior to initiation of Briumvi. Administration of live-attenuated or live vaccines is not recommended during Briumvi treatment and until B-cell recovery.
• Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with Briumvi, until B-cell repletion, and especially when recurrent serious infections are suspected. Consider discontinuing Briumvi in patients with serious opportunistic or recurrent serious infections, and if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
• Based on data from animal studies, Briumvi may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for at least 6 months after stopping Briumvi.
• It is not known if Briumvi passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Briumvi.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Briumvi may harm your unborn baby.
• You should use birth control (contraception) during treatment with Briumvi and for at least 6 months after your last infusion of Briumvi.
• Talk with your healthcare provider about what birth control method is right for you during this time.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ublituximab-xiiy.
• Inactive ingredients: hydrochloric acid, polysorbate 80, sodium chloride, sodium citrate, Water for Injection, USP.

Who manufactures and distributes this medicine?

Manufactured by: TG Therapeutics, Inc., Carrington Mill Blvd, Morrisville, NC

What should I know about storage and disposal of this medication?

• Store Briumvi vials refrigerated at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light.
• Do not freeze.
• Do not shake.

• Dailymed label info on Ublituximab
• FDA Ublituximab

Ublituximab Resources
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Ublituximab Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski