Neutropenia and infections1
Grade 3 or 4 neutropenia and infections have been reported in patients treated with VENCLYXTO in combination studies with rituximab or obinutuzumab and in monotherapy studies. Complete blood counts should be monitored throughout the treatment period. Dose interruptions or reductions are recommended for patients with severe neutropenia.
Serious infections, including sepsis with fatal outcome, have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections are to receive prompt treatment, including antimicrobials and dose interruption or reduction as appropriate.
CLL=chronic lymphocytic leukemia; 1L=first line; 2L+=second line + later lines of therapy; O+Clb=obinutuzumab + chlorambucil; HR=hazard ratio; CI=confidence interval; PFS=progression-free survival; BR=bendamustine + rituximab; VEN+R=VENCLYXTO + rituximab; VEN+O=VENCLYXTO + obinutuzumab.
[Placeholder for safety balance required by local regulations]
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Reference: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. <Current SmPC.>
GR-VNCCLL-200048 -JAN2021