Risk Minimisation Materials

Olumiant 2 mg and 4 mg Film-Coated Tablets guidance for Healthcare Professionals

Important Risk Minimization information for healthcare professionals prescribing Olumiant.

For Healthcare Professionals

Olumiant 2 mg and 4 mg Film-Coated Tablets Patient Alert Card

Olumiant 2 mg and 4 mg Film-Coated Tablets Patient Alert Card containing important safety information for patients.

Onpattro (patisiran) Educational Material for Healthcare Professionals

Educational Material for Healthcare Professionals to ensure safe use of Onpattro in the home setting.

For Healthcare Professionals

Onpattro (patisiran) Educational Material for Patients

Educational Material for patients for safe use of Onpattro in the home.

Opdivo (nivolumab) Important Risk Minimisation Information for Healthcare Professionals

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

Opdivo (nivolumab) Patient Alert Card

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)

ADR & AE Form

Adverse Event (AE)/Adverse Drug Reaction (ADR) Form

For Healthcare Professionals

Opsumit cover letter for HCP

Notification of updated risk management materials for Opsumit (macitentan).

For Healthcare Professionals

Opsumit HCP Brochure UK

Introduction to Opsumit, what its used for, indication and how it should be used

For Healthcare Professionals

Opsumit Patient Alert Card

It is important that you report immediately to your prescribing doctor any pregnancy or side effects that may occur during treatment with Opsumit.

For Healthcare Professionals

Opsumit Pregnancy Form

Pregnancy diagnostic form

For Healthcare Professionals

prescribers Checklist

Checklist for the physician before prescribing Opsumit to the patient.

For Healthcare Professionals

Ozurdex - Patient Guide

A patient guide to OZURDEX therapy