International Journal of Drug Development and Research

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Rituximab Associated Cellulitis: Pharmacovigilance Signal Review

Proceedings of Formulations 2021 & Pharmacovigilance 2021
September 15-16, 2021 WEBINAR

Turki Zaid Alozayb

AlMaarefa University, Saudi Arabia

Posters & Accepted Abstracts: Int J Drug Dev & Res


Rituximab is a chimeric mouse/human monoclonal antibody that is indicated primarily for the treatment of Non-Hodgkin’s lymphoma (NHL). Rituximab cell destruction activity is mediated via binding to surface antigen CD20 inducing signaling of apoptosis, complement activation, and cell-mediated cytotoxicity. Cellulitis is an infection of the skin. Patients with cellulitis for the most part present with agonizing, hot, and swollen skin. The reason for this review is to assess the risk of Cellulitis related to Rituximab use and to propose regulatory recommendations whenever required. On Aug 18, 2021, we performed a signal review utilizing World Health Organization (WHO) VigiBase, with literature screening to recover all related information to assess the causality between Cellulitis and Rituximab use. Causality assessment was done according to the WHO-UMC system for standardized case causality assessment. The disproportionality of the observed and the expected reporting rate for the Rituximab/Cellulitis pair is estimated using the information component (IC). Positive IC values reflect higher statistical association while negative values indicate less statistical association. The review resulted in 57 Individual Case Safety Reports (ICSRs). Out of 42 assessable ICSRs, 3 cases revealed probable association, and 25 cases revealed a possible association between Rituximab use and risk of Cellulitis. IC value of (1.1) revealed a positive statistical association. The weighted cumulative evidence identified from cases is sufficient to validate and suggest a causal association between Rituximab and Cellulitis. Therefore, health care professionals should be aware of this potential risk and may consider monitoring any signs or symptoms of Cellulitis in patients treated with Rituximab.

Biography :

Turki Zaid Alozayb has expertise as hospital pharmacist working alongside the medical team to improve patient care, he is responsible to ensure safe prescribing, preparation, dispensing of medications and provide information and educate the patient about the medication use, side effects and others to improve health care, he is holding Doctor of Pharmacy degree from AlMaarefa University, He also lisciened pharmacist by Saudi Commission for Health Specialists (SCFHS), He is certified in Medication safety and Pharmacovigilance and has a role as Patient safety champion, He was honored as best score of quality & highest medical clarification record.