Blog Title
BLINCYTO
FDA Removes REMS Requirement for BLINCYTO®
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. The BLINCYTO® REMS was first approved by the FDA in 2014 and last updated in […]
Read MoreIMPORTANT: Please Read this FDA-Required Updated REMS Safety Information
FDA-REQUIRED UPDATED REMS SAFETY INFORMATION Risk of: • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal • Neurological Toxicities, which may be severe, life-threatening or fatal • Preparation and Administration Errors April 2020 The Food and Drug Administration (FDA) has required this safety notice as part of the BLINCYTO® REMS (Risk Evaluation and […]
Read More