Product Details

RUXIENCE 100MG 10ML VL EA

Manufacturer: Pfizer

MFG#: 00069-0238-01

NDC: 00069-0238-01

PID: 421711

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Additional Information

Product NameRuxience 100 mg/10 mL Vial
ApplicationTreatment of B-cell malignancies and autoimmune disorders
Active IngredientRituximab-pvvr
Mechanism of ActionCD20-directed cytolytic monoclonal antibody leading to B-cell depletion
Dosage FormIntravenous Injection
Strength100 mg/10 mL (10 mg/mL)
Onset of ActionB-cell depletion observed within weeks
Common Side EffectsInfusion reactions, fever, chills, nausea, fatigue
PrecautionsMonitor for infections, infusion reactions, and hematologic toxicities
PackagingSingle-dose vial
UsesTreatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis

Description

Ruxience (Rituximab-pvvr) 100 mg/10 mL vial is a biosimilar monoclonal antibody indicated for the treatment of various B-cell malignancies and autoimmune disorders. It is used in patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. As a CD20-directed cytolytic antibody, Ruxience specifically targets the CD20 antigen found on the surface of B lymphocytes, leading to B-cell depletion and immune modulation.

The active ingredient, rituximab-pvvr, binds to CD20, initiating immune-mediated cytotoxicity, complement-dependent cytotoxicity, and direct apoptosis of malignant and overactive B cells. This mechanism is effective in reducing tumor burden in hematologic malignancies and controlling autoimmune inflammation in diseases such as rheumatoid arthritis.

Ruxience is administered as an intravenous infusion, with dosing regimens tailored to the specific condition being treated. Premedication with corticosteroids, antihistamines, and antipyretics is recommended to reduce the risk of infusion-related reactions. Patients should be monitored for infections, hematologic toxicities, and infusion-related adverse events.

Frequently Asked Questions (FAQs)

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RUXIENCE 100MG 10ML VL EA is manufactured by Pfizer.

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