Br J Clin Pharmacol. 2020 Aug 13. doi: 10.1111/bcp.14516. Online ahead of print.
AIM: This study aimed to compare the incidence of infusion site reactions (ISRs) induced by intravenous administration of brand-name and generic vinorelbine (VNR) for treating non-small cell lung cancer.
METHOD: This single-centre retrospective cohort study was conducted by medical chart review of VNR infusions. ISRs were defined as symptoms around the infusion site, including pain, redness, and swelling. ISRs requiring treatment were defined as ISRs requiring treatments including steroid ointments, vein re-puncture, and local steroid injections.
RESULTS: In all, 1973 VNR infusions were administered to 340 patients (brand-name, 141 patients; generic, 199 patients). ISRs and ISRs requiring treatment were observed in 161 and 100 patients, respectively. The ISR incidence per patient and per injection were significantly higher in generic VNR-treated patients than in brand-name VNR-treated patients (53.3% vs. 39.0%, P = 0.0112, and 15.0% vs. 9.9%, P = 0.0008, respectively). The frequency of ISRs requiring treatment was also significantly higher in the generic group (per patient: 36.7% vs. 19.2%, P = 0.0005; per injection: 11.3% vs. 5.5%, P < 0.0001). Multivariate analysis revealed that generic VNR was significantly associated with an increased risk of ISRs (per patient: adjusted odds ratio [AOR] 1.775, P = 0.0155; per injection: AOR 1.672, P = 0.004) and ISRs requiring treatment (per patient: AOR 2.422, P = 0.0012; per injection: AOR 2.286, P = 0.001).
CONCLUSION: Intravenous infusion of generic VNR was associated with an increased risk of ISRs. Further research is needed to elucidate the mechanism underlying the increased incidence of ISRs with generic VNR.