Description

TRUXIMA IV VIAL is a biosimilar formulation of rituximab, designed for intravenous infusion. It is a chimeric murine/human monoclonal antibody, classified as IgG1 kappa, and is produced by Celltrion Healthcare in collaboration with Teva Pharmaceuticals and Genentech (Roche). This formulation is intended for single-use and is provided in sterile, clear, colorless vials available in two concentrations: 100 mg/10 mL and 500 mg/50 mL.

Indications

TRUXIMA is approved for the treatment of several conditions, including:

• CD20-positive B-cell Non-Hodgkin’s Lymphoma (NHL)
• Chronic Lymphocytic Leukemia (CLL)
• Rheumatoid Arthritis (in combination with methotrexate)
• Granulomatosis with Polyangiitis (GPA)
• Microscopic Polyangiitis (MPA)
• Pemphigus Vulgaris (in certain regions)

Mechanism of Action

This biosimilar targets the CD20 antigen on B lymphocytes, leading to B-cell depletion through mechanisms such as complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis. This action is crucial in managing the conditions for which it is indicated.

Administration

Administered exclusively via intravenous infusion, TRUXIMA requires dilution in 0.9% sodium chloride or 5% dextrose in water. It must be administered by healthcare professionals in settings equipped with resuscitation facilities. Premedication with acetaminophen and antihistamines is necessary, with glucocorticoids recommended for certain indications.

Storage and Handling

• Store at 2°C to 8°C, away from light.
• Do not freeze.
• Use aseptic techniques during preparation.
• Compatible with polyvinyl chloride and polyethylene infusion bags.

Safety Information

Contraindications include known hypersensitivity to rituximab or murine proteins, severe active infections, and certain cardiac conditions. Potential risks involve infusion-related reactions, serious infections, and other severe conditions such as tumor lysis syndrome and mucocutaneous reactions.

Monitoring

Patients should be monitored for hepatitis B reactivation, infusion reactions, and other serious conditions. Regular monitoring of blood counts, cardiac and renal function, and vaccination status is advised.

Adverse Effects

Common adverse effects include infusion-related reactions, infections, hematologic changes, and musculoskeletal symptoms. More severe but less common effects involve cardiovascular and neurological symptoms.

Regulatory Status

TRUXIMA is approved by major regulatory bodies such as the FDA, EMA, and others, demonstrating clinical equivalence to reference rituximab products in efficacy and safety. It is a prescription-only medication, contributing significantly to the therapeutic landscape for its approved indications.