Off-label Use of Medicines


The following resources were developed to assist clinicians and Drug and Therapeutics Committees regarding off-label use of Rituximab. They seek to assist the complex medical, ethical and regulatory management issues that arise when using Rituximab in an off-label manner.

Supporting documents for off-label Rituximab use

  • Patient Consent Form for Off-Label Use of Rituximab

    September 2023

  • Patient Fact Sheet for Off-Label Use of Rituximab in Auto-Immune Conditions

    September 2023

  • Safety Screening and Monitoring Information for Clinicians Using Rituximab in Auto-Immune Conditions

    May 2019

  • Acknowledgments

    These resources were developed by the NSW Therapeutic Advisory Group (TAG) Off-Label Rituximab Project Team (Dr Kate O’Connor, Consultant Clinical Immunologist and Allergist and Immunopathologist; and members of the NSW TAG secretariat, Dr Alexandra (Sasha) Bennett, Ms Judy Raymond and Ms Sarah Dinh) with support and advice regarding content from the NSW TAG Editorial Committee, chaired by Professor Sarah Hilmer. The contribution of the following experts is gratefully acknowledged: Professor Chris Liddle, Professor of Clinical Pharmacology and Hepatology Medicine, The University of Sydney’s Westmead Clinical School and Chair, Western Sydney LHD Drug and Therapeutics Committee; and, Associate Professor Sean Riminton, Clinical Immunologist, Department Head of Immunology, Concord Hospital.

    Resource development included: a) review of relevant published documents and guidelines; b) input from hospital health professionals with recognised expertise in governance and use of off-label medicines, medicines information and/or clinical pharmacy; and, c) external consultation with subject matter experts.

    NSW TAG acknowledges with thanks the assistance of individuals and organisations who provided comments and constructive suggestions during the external consultation process. The development of these resources was funded by NSW Health.

Guidelines and Publications Regarding Off-label Use of Medicines

Click here for documents provided to inform off–label use of medicines. They discuss clinical, safety, legal and ethical issues surrounding off–label use as well as those specific to the paediatric population.