POM: Prescription only medicine
This risk minimisation material is a condition of the marketing authorisation. Please ensure you are familiar with this document before prescribing nivolumab, or nivolumab in combination with ipilimumab, as it contains important safety information. In particular, it is aimed at increasing awareness of immune-related adverse reactions (irARs) with nivolumab monotherapy, or when nivolumab is used in combination with ipilimumab. It also provides information on treatment modifications for irARs, e.g. when to withhold or permanently discontinue treatment. This material was last updated in Apr-2019: Update to the information on managing Grade 3 diarrhoea/colitis in the "Early Diagnosis and Appropriate Management" and “Immune-Related Adverse Reactions and Treatment Modifications” sections. Treatment must also be permanently discontinued if Grade 3 diarrhoea or colitis occurs during the second phase of treatment with nivolumab monotherapy following combination therapy.
For Healthcare Professionals
This risk minimisation material is a condition of the marketing authorisation. Please ensure that you are familiar with this material as it contains important safety information that you need to be aware of before, during and after treatment with nivolumab or nivolumab in combination with ipilimumab. This educational material was UPDATED in Nov-2018. Changes to the material include an instruction for patients to tell their doctor before they start receiving nivolumab if they have received a bone marrow or stem cell transplant from another person (allogeneic)