COLUMVI

批准信原文要点

This Prior Approval sBLA provides for updates to include the risk of progressive multifocal leukoencephalopathy (PML) in the Warnings and Precautions (Subsection 5.3, Serious Infections), Adverse Reactions (Subsection 6.1), and Patient Counseling Information sections, and corresponding updates to the Medication Guide.

批准信原文要点

This Prior Approval sBLA provides for updates to the US Prescribing Information (USPI): Addition of the consideration of hemophagocytic lymphohistiocytosis (HLH) when cytokine release syndrome (CRS) is refractory to management in Section 5.1; Include HLH in Clinically relevant adverse reactions occurring in other clinical trials in Section 6.1.

批准信原文要点

This Prior Approval supplemental biologics application provides revisions to the United States Prescribing Information (USPI) to add “colitis” to 6.1, Clinical Trials Experience, and Section 2.3, Recommended Premedication and Prophylaxis advice to include “pneumocystis jirovecii pneumonia (PJP) and other opportunistic infections”.

批准信原文要点

This Prior Approval supplemental biologics application provides for updates to the US Prescribing Information (USPI) adding a syringe infusion option as an alternative to intravenous bag infusion. Specifically, Section 2.5 was updated from “Preparation and Administration” to “Preparation into an Intravenous Bag”; and Sections 2.6 (“Preparation of 2.5 mg Dose into an Intravenous Syringe”) and 2.7 (“ Storage and Administration”) were added to the USPI.