UBLITUXIMAB

Other

Brand names: BRIUMVI

Intravenous

Mechanism of Action

12.1 Mechanism of Action The precise mechanism by which ublituximab-xiiy exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ublituximab-xiiy results in cell lysis through mechanisms including antibody-dependent cellular cytolysis and complement-dependent cytolysis.

Indications

1 INDICATIONS AND USAGE BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS)

to include clinically isolated syndrome

relapsing-remitting disease

and active secondary progressive disease

in adults. BRIUMVI is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS)

to include clinically isolated syndrome

FDA Warnings

5 WARNINGS AND PRECAUTIONS Infusion Reactions : Management recommendations for infusion reactions depend on the type and severity of the reaction
Infections : Serious, including life-threatening and fatal infections, have occurred
Reduction in Immunoglobulins : 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 ( 2

Known Side Effects

8 documented side effects by frequency

Fatigue

1-10%

Headache

0.1-1%

General Unwellness

0.1-1%

Weakness

0.1-1%

UTI

0.1-1%

Drug Not Working

0.1-1%

Limb Pain

0.1-1%

Nausea

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous