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Risk Minimisation Materials

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Idacio

Fresenius Kabi Ltd

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Idacio Paediatric Patient Alert Card

This card contains important safety information for caregivers of paediatric patients being treated with Idacio .

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Idacio Patient Alert Card

This contains important safety information for patients being treated with Idacio.

Ilaris

Novartis Pharmaceuticals UK Ltd

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Ilaris - Important information for patients with Gouty Arthritis

Patient alert card listing important information to consider before and during treatment with canakinumab for patients with Gouty Arthritis

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Ilaris - Important information for patients with Period Fever Syndromes

Patient alert card listing important information to consider before and during treatment with canakinumab for patients with Periodic Fever Syndromes CAPS, TRAPS, HIDS/MKD or FMF

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Ilaris - Important information for the patient with Still's Disease (including Adult Onset Still's Disease) and Systemic Juvenile Idiopathic Arthritis

Patient alert card listing important information to consider before and during treatment with canakinumab for patients with Still's Disease (including Adult Onset Still's Disease) and Systemic Juvenile Idiopathic Arthritis

Iluvien

Alimera Sciences Limited

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ILUVIEN® Administration Guide

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Guidance on the administration technique and important adverse events

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ILUVIEN® Administration Video

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This Physician training video provides visual and written instructions on the appropriate use of ILUVIEN including preparation, administration and aftercare.

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ILUVIEN® Patient Guide

A patient guide to ILUVIEN containing safety information.

Imjudo

AstraZeneca UK Limited

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IMJUDO Patient Card

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The purpose of the Imjudo Patient Card is to support patients and carers in understanding the risk of immune-mediated adverse reactions (imAR) and helps them recognise, act on and report relevant symptoms.

Imlygic

Amgen Ltd

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IMLYGIC Information for Patients and Close Contacts

This brochure contains important safety information you should know before and during IMLYGIC treatment. Please read this information carefully before and after each treatment. Please also read the IMLYGIC Package Leaflet. To request a copy of this guide, please contact Amgen Medical Information on +44 (0) 1223 436441

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IMLYGIC Patient Alert Card

This IMLYGIC patient alert card includes contact details of the IMLYGIC prescriber, treatment start date, IMLYGIC batch number and information on the potential development of herpetic lesions and the importance of reporting ADRs. To request a copy of the patient card, please contact Amgen Medical Information on +44 (0) 1223 436441

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IMLYGIC Physician's Brochure

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This educational brochure contains important information regarding the risks of transmission and herpetic complications, and safe use and handling of IMLYGIC.This brochure does not contain a comprehensive description of the risks associated with IMLYGIC. Please read the current Summary of Product Characteristics (SmPC) for IMLYGIC. To request a copy of the brochure, please contact Amgen Medical Information on +44 (0) 1223 436441

Imnovid

Bristol Myers Squibb Pharmaceuticals limited

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Imnovid® (pomalidomide) Algorithm

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This Algorithm provides high level steps for prescribing and dispensing of pomalidomide.

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Imnovid® (pomalidomide) Frequently Asked Questions

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The FAQs (Frequently Asked Questions) provides answers to common questions that healthcare professionals may have about the medication.

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Imnovid® (pomalidomide) Healthcare Professional’s Information Pack

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This pack contains the all the additional Risk Minimisation Materials required to prescribe and dispense pomalidomide. It also contains important reporting forms, information for patients, prescribing tools, and the Pharmacy Registration Form. It is a requirement of the Pregnancy Prevention Programme that all healthcare professionals ensure that they have read and understood risk minimisation materials before prescribing or dispensing pomalidomide for any patient.

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Imnovid® (pomalidomide) Information for Healthcare Professionals

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This brochure contains the information needed for prescribing and dispensing of pomalidomide, including information about the Pregnancy Prevention Programme. It is a requirement of the Pregnancy Prevention Programme that all healthcare professionals ensure that they have read and understood risk minimisation materials before prescribing or dispensing pomalidomide for any patient. Please also refer to the Summary of Product Characteristics (SmPC) for pomalidomide.

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Imnovid® (pomalidomide) Information for Patients

This brochure should be given to patients receiving treatment with pomalidomide, as it provides important information about the pomalidomide Pregnancy Prevention Programme, including what a patient needs to be aware of before, during and after taking pomalidomide and how to report side effects.

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Imnovid® (pomalidomide) Male Risk Awareness Form

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This Risk Awareness Form must be completed for each male patient prior to the initiation of their pomalidomide treatment. It is mandatory that male patients receive counselling and education to be made aware of the risks of pomalidomide. The aim of the Risk Awareness Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of pomalidomide.

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Imnovid® (pomalidomide) Patient Pocket Information Card

This card should be given to all patient as it reminds patients of the key educational information and risks of treatment with pomalidomide.

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Imnovid® (pomalidomide) Pharmacy Registration Form

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This Pharmacy Registration Form must be completed by the Chief Pharmacist or appointed deputy to be able to order and dispense pomalidomide. In order to ensure that the actions to minimise the risk of foetal exposure are carried out for all patients, dispensing of pomalidomide will only be allowed from pharmacies registered with BMS.

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Imnovid® (pomalidomide) Pregnancy Outcome Form

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The safe use of pomalidomide is of paramount importance. Any cases of suspected or confirmed pregnancy or foetal exposure should be immediately reported to BMS. You can also report the event via the Yellow Card website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Use this form to provide information about the outcome of pregnancy.

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Imnovid® (pomalidomide) Pregnancy Reporting Form

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The safe use of pomalidomide is of paramount importance. Any cases of suspected or confirmed pregnancy or foetal exposure should be immediately reported to BMS. You can also report the event via the Yellow Card website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

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Imnovid® (pomalidomide) Prescription Authorisation Form

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A newly completed Prescription Authorisation Form must accompany each pomalidomide prescription to confirm that the patient has been counselled about the teratogenic risk of pomalidomide and the required contraceptive methods, continues to use effective contraception and in the case of a woman of childbearing potential, is having a pregnancy test every 4 weeks before each prescription to ensure they are not pregnant. Completion of this information is mandatory for ALL patients.

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Imnovid® (pomalidomide) Woman of Childbearing Potential Risk Awareness Form

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This Risk Awareness Form must be completed for each woman of childbearing potential prior to the initiation of their pomalidomide treatment. It is mandatory that women of childbearing potential receive counselling and education to be made aware of the risks of pomalidomide. The aim of the Risk Awareness Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of pomalidomide.

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Imnovid® (pomalidomide) Woman of Non-Childbearing Potential Risk Awareness Form

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This Risk Awareness Form must be completed for each woman of non-childbearing potential prior to the initiation of their pomalidomide treatment. It is mandatory that women of non-childbearing potential receive counselling and education to be made aware of the risks of pomalidomide. The aim of the Risk Awareness Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of pomalidomide.

Imraldi

Biogen Biosimilars

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Imraldi Patient Reminder Card

This card contains select important safety information that patients need to know before and during treatment with Imraldi.

Increlex

Ipsen Ltd

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Increlex Dosing Guide

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How to use Increlex in the treatment of severe primary IGF-1 deficiency

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Increlex Hypoglycaemia Leaflet

Information for parents, caregivers, or for patients about hypoglycaemia and what to do if it occurs

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Increlex Instructions for Use

This leaflet is a quick reference guide to preparing and injecting Increlex®

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Increlex Patient Leaflet

Patient educational information about severe primary IGF-1 deficiency and how Increlex® can help

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Increlex Physician Leaflet

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Physician information about Increlex® This educational material is essential to ensure the safe and effective use of the product and appropriate management of the important selected risks, and it is advised therefore that it be read carefully before prescribing/dispensing/administering the product.

Inflectra

Pfizer Limited

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Inflectra Patient Reminder Card

The Reminder Card contains important safety information that you need to be aware of before and during treatment with Inflectra.

Insulatard

Novo Nordisk Limited

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Important Information for patients using Levemir® InnoLet (insulin detemir) and Insulatard® InnoLet (insulin isophane human)

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Patient letter:Novo Nordisk UK has decided to discontinue InnoLet, an injectable device for insulin delivery

Irbesartan+Hydrochlorothiazide

Aurobindo Pharma - Milpharm Ltd.

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Irbesartan/HCTZ- HCP letter- Hydrochlorothiazide and the risk of non-melanoma skin cancer

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The prescriber should inform the patients taking hydrochlorothiazide (HCTZ) containing medicines of the risk of non-melanoma skin cancer. Patients should be advised to limit the exposure to sunlight and UV rays and use adequate protection when exposed to sunlight and UV rays to minimise the risk of skin cancer

Isotretinoin

Ennogen Healthcare Ltd

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Isotretinoin Soft Capsules Acknowledgement of Risk Form

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Acknowledgement Form for Prescribing Isotretinoin to Female Patients. The potential for pregnancy must be assessed for all female patients prescribed Isotretinoin.

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Isotretinoin Soft Capsules Patient Reminder Card

Patient Reminder Card for Isotretinoin - Important information to know when taking isotretinoin and what you must do.

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Isotretinoin Soft Capsules Pharmacist Checklist

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Guidance for dispensing Oral Isotretinoin. Isotretinoin is strictly contraindicated during pregnancy and in women of childbearing potential, unless all conditions in the Isotretinoin Pregnancy Prevention Programme are fulfilled.

Ranbaxy (UK) Limited a Sun Pharmaceutical Company

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Patient Reminder Card-Isotretinoin

Patient Reminder Card for Isotretinoin - Important information to know when taking isotretinoin and what you must do.

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Pharmacist checklist-Isotretinoin

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Guidance for dispensing Oral Isotretinoin. Isotretinoin is strictly contraindicated during pregnancy and in women of childbearing potential, unless all conditions in the Isotretinoin Pregnancy Prevention Programme are fulfilled

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Prescriber checklist-Isotretinoin

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Acknowledgement Form for Prescribing Isotretinoin to Female Patients. The potential for pregnancy must be assessed for all female patients prescribed Isotretinoin.

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