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Rituximab Safety Profile: A Seven-Year Retrospective Analysis From Southern India
Lakshmi Jayasree1, Princy L Palatty1, Laxmi Govindraj1
1Pharmacology, Amrita School of Medicine, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Ernakulam, IND.
Rituximab use is generally safe, with most adverse drug reactions (ADRs) being mild and manageable. Vigilant monitoring is crucial for early detection of severe complications like lung disease, especially during initial infusions.
Area of Science:
- Pharmacovigilance
- Clinical Pharmacology
- Immunology
Background:
- Rituximab is an important therapeutic agent used in treating various conditions, including malignancies and autoimmune diseases.
- Understanding the safety profile of rituximab through real-world data is crucial for clinical decision-making.
Purpose of the Study:
- To analyze the pattern, severity, and outcomes of adverse drug reactions (ADRs) associated with rituximab use.
- To assess the safety profile of rituximab in a regional pharmacovigilance center in Kerala, India.
Main Methods:
- Retrospective analysis of rituximab-associated ADRs reported between 2017 and 2023.
- Assessment of ADR causality using WHO-UMC criteria and severity using the Modified Hartwig Siegel Scale.
Main Results:
- 74 patients reported ADRs, predominantly in females and those aged 51-60 years.
- Most ADRs (69 cases) occurred during the first dose, with infusion reactions being most common.
- While most ADRs were mild (67 cases) and patients recovered (72), two cases of rituximab-induced lung disease were associated with higher mortality.
Conclusions:
- Rituximab exhibits an acceptable safety profile with manageable ADRs and a high recovery rate.
- The potential for severe complications like rituximab-induced lung disease necessitates vigilant monitoring, particularly during early treatment phases.
- Findings emphasize the importance of standardized protocols for ADR mitigation to enhance rituximab's real-world safety.
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