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TRUXIMA IV VIAL - Material: Glass Strength: 500MG/50ML

Product information

  • Quantity Unit Each
  • Product Code None

$302.65 incl GST

Description

TRUXIMA IV VIAL is a biosimilar formulation of rituximab, designed for intravenous infusion. It is a monoclonal antibody targeting the CD20 antigen on B lymphocytes, playing a crucial role in the treatment of various conditions. This product is available in two strengths: 100 mg/10 mL and 500 mg/50 mL, each provided as a clear, colorless, preservative-free concentrate.

Indications

TRUXIMA IV VIAL is indicated for adult patients with:

  • CD20-positive B-cell Non-Hodgkin’s Lymphoma (NHL)
  • Chronic Lymphocytic Leukemia (CLL)
  • Moderate to severe Rheumatoid Arthritis (RA)
  • Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
  • Pemphigus vulgaris

Administration

  • Route: Intravenous infusion only, requiring dilution before administration.
  • Preparation: Dilute in 0.9% sodium chloride or 5% dextrose in water.
  • Infusion Rates: Begin at 50 mg/h, with potential increments up to 400 mg/h.
  • Premedication: Includes acetaminophen and an antihistamine, with glucocorticoids as needed.

Mechanism of Action

The mechanism involves binding to the CD20 antigen, leading to B-cell depletion through complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis. This action is pivotal in managing the conditions for which it is indicated.

Storage

  • Store at 2°C to 8°C, protected from light.
  • Do not freeze.
  • Use single-use vials; discard any unused portion.

Contraindications

  • Known hypersensitivity to rituximab or its excipients
  • Severe active infections
  • Severe heart failure or uncontrolled cardiac conditions

Warnings and Precautions

  • Infusion-related reactions: May require careful monitoring and management.
  • Infections: Risk of serious infections, including hepatitis B reactivation and progressive multifocal leukoencephalopathy.
  • Cardiac events: Potential for arrhythmias and myocardial infarction.
  • Renal toxicity and gastrointestinal perforation: Particularly when used with chemotherapy.

Monitoring

  • Screen for hepatitis B prior to treatment.
  • Monitor blood counts, immunoglobulin levels, and potential adverse effects throughout therapy.

Adverse Effects

Common adverse effects include infusion-related reactions, infections, nausea, headache, and blood count changes. Serious effects may involve severe infusion reactions, tumor lysis syndrome, and mucocutaneous toxicities.

Special Populations

  • Elderly: No specific dose adjustment, though higher adverse event rates may occur.
  • Pediatrics: Approved for certain indications in some regions.

Legal Status

TRUXIMA IV VIAL is a prescription-only medicine, comparable to reference rituximab products with no significant differences in efficacy or safety. It should be administered by healthcare professionals equipped with appropriate medical support facilities.

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