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.