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Risk Minimisation Materials

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Talvey

Janssen-Cilag Ltd, a Johnson & Johnson Company

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TALVEY HCP Educational Material

TALVEY HCP Educational Material


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Talvey Patient Card

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TALVEY Patient Card


Tasmar

Mylan

Tecartus

Gilead Sciences Ltd

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TECARTUS_Handling Guide

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Guide to handling and method of administration, and sampling recommendation for secondary malignancy: To minimize the potential risk of decrease in viability of the product loss of efficacy due to inappropriate preparation of the Tecartus infusion.


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TECARTUS_HCP Educational Guide

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Healthcare provider (HCP) educational material - To inform HCPs on how to monitor and manage symptoms associated with CRS and serious neurologic adverse reactions, and provide guidance on reporting these serious adverse reactions associated with Tecartus.


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TECARTUS_Patient Alert Card

Patient Alert Card - To inform patients of the risks of CRS and serious neurologic adverse reactions, associated with Tecartus.


Tecentriq

Roche Products Limited

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Tecentriq (atezolizumab) Patient Card

This material is provided by Roche Products Ltd as a licence requirement for this medicine and forms part of the Risk Management Plan


Tecvayli

Janssen-Cilag Ltd, a Johnson & Johnson Company

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TECVAYLI Patient Card

Patient Card for TECVAYLI for ICANs and CRS


Tegsedi

Akcea Therapeutics UK Ltd

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Patient Alert Card

Tegsedi Patient Alert Card


Tenofovir

Cipla EU Ltd

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Educational Material: TENOFOVIR DISOPROXIL FOR ADOLESCENT CHILDREN WITH CHRONIC HEPATITIS B

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RENAL RISK MINIMISATION MATERIAL: TENOFOVIR DISOPROXIL FOR ADOLESCENT CHILDREN WITH CHRONIC HEPATITIS B


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Educational material: TENOFOVIR DISOPROXIL FOR CHILDREN AND ADOLESCENTS WITH HIV-1

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RENAL AND BONE EFFECTS RISK MINIMISATION MATERIAL: TENOFOVIR DISOPROXIL FOR CHILDREN AND ADOLESCENTS WITH HIV-1


Dr. Reddy's Laboratories (UK) Ltd

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Renal and Bone Effects Risk Minimisation Material: Tenofovir Disoproxil for Children and Adolescents with HIV-1

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HIV-1 Renal & bone effects education brochure - children


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Renal Risk Minimisation Material Tenofovir Disoproxil for Adolescent Children with Chronic Hepatitis B

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HBV renal education brochure - children


Sandoz Limited

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Renal and bone effects risk minimisation material: Tenofovir disoproxil for children and adolescents with HIV-1

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This brochure provides important advice on the management of potential renal and bone effects of tenofovir disoproxil in HIV-1 infected children and adolescents aged 2 to <18 years, and on the dosing recommendations for tenofovir disoproxil in this population.


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Renal Risk Minimisation Material: Tenofovir Disoproxil for adolescent children with chronic hepatitis B

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This brochure provides important advice on the management of potential renal and bone effects of tenofovir disoproxil in adolescent patients with chronic hepatitis B aged 12 to <18 years, and on the dosing recommendations for tenofovir disoproxil in this population.


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TENOFOVIR DISOPROXIL FOR ADULTS WITH CHRONIC HEPATITIS B

RENAL RISK MINIMISATION MATERIAL: TENOFOVIR DISOPROXIL FOR ADULTS WITH CHRONIC HEPATITIS B


Tepkinly

AbbVie Ltd

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Patient Card, Tepkinly (epcoritamab)

Patient card to be carried at all times. For a hardcopy Patient Card please contact Medical Information via the contact details below.


Teriflunomide

Dr. Reddy's Laboratories (UK) Ltd

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Dr. Reddy's Teriflunomide Alert Card

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Patient Alert Card


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Dr. Reddy's Teriflunomide HCP Guide

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HEALTHCARE PROFESSIONAL EDUCATION/DISCUSSION GUIDE.


axunio Pharma GmbH

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Teriflunomide Healthcare Professional Education/Discussion Guide

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At first prescription, the prescriber/healthcare professional (HCP) should discuss with the patient the risks described within the discussion guide. The guide is aimed at increasing awareness about the potential risk of haematological effects and liver effects, risk of hypertension, serious infections and teratogenicity with teriflunomide and providing guidance on how to manage that risk. For hard copies of this information, please contact axunio Pharma via email to [email protected].


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Teriflunomide Patient Card

This patient card provides important information on the risks of teriflunomide. At first prescription, the prescriber should provide this card. Please show this card to any doctor or healthcare professional involved in your medical care (e.g., in case of an emergency). For hard copies, please contact axunio Pharma via email to [email protected].


Mylan

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TERIFLUNOMIDE MYLAN HEALTHCARE PROFESSIONAL EDUCATION/DISCUSSION GUIDE

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Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.


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TERIFLUNOMIDE MYLAN PATIENT CARD

Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.


Sandoz Limited

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Teriflunomide Sandoz 14 mg Film-coated Tablets - Healthcare Professional Guide

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Provides guidance to HCPs on the risks associated with teriflunomide and explains that patients should be regularly consulted about these risks. Potential risks are described as are monitoring methods. Risk of teratogenicity is described and that teriflunomide is contraindicated in pregnancy. Specific guidance on this subject is also offered.


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Teriflunomide Sandoz 14mg Film-coated Tablets - Patient Alert Card

This patient alert card provides important information to patients, on the risks of using teriflunomide. This includes a warning that teriflunomide should not be used during pregnancy and offers further guidance on this subject to women who are using teriflunomide.


Testosterone

Teva UK Limited

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Guidance on the administration of Testosterone

Important safety information Guidance on the administration of Testosterone Undecanoate


Thalidomide

Zentiva

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Prescription Authorisation Form WNCBP

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Prescription Authorisation Form for Women of Non Child Bearing Potential - Thalidomide 50mg


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Thalidomide HCP Information Guide

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Information for HCPs regarding the Thalidomide Pregnancy Prevention Programme


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Thalidomide Male Risk Awareness Form

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Risk awareness form for counselling the patient Thalidomide Pregnancy Prevention Programme


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Thalidomide Patient Card

Information for patients and HCP's on Thalidomide 50mg


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Thalidomide Patient Information Guide

Information for patients taking Thalidomide


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Thalidomide Pharmacy Registration Form

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Thalidomide Pharmacy Registration Form


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Thalidomide PPP User Guide FAQ

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Thalidomide Pregnancy Prevention Programme User Guide - frequently asked questions


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Thalidomide Prescription Authorisation Form - Male

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Thalidomide Prescription Authorisation Form - Male Pregnancy Prevention Programme


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Thalidomide Prescription Authorisation Form WCBP

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Thalidomide Prescription Authorisation Form Women Child Bearing Potential Pregnancy Prevention Programme


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Thalidomide Risk Awareness Form - WCBP

Risk awareness form for counselling Women of Child Bearing Potential Thalidomide Pregnancy Prevention Programme


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Thalidomide Risk Awareness Form - WNCBP

Risk awareness form for counselling Women of Non Child Bearing Potential Thalidomide Pregnancy Prevention Programme


Bristol Myers Squibb Pharmaceuticals limited

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Thalidomide BMS® Algorithm

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This Algorithm provides high level steps for prescribing and dispensing of Thalidomide BMS®.


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Thalidomide BMS® Frequently Asked Questions

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The FAQs (Frequently Asked Questions) section in the Thalidomide BMS Healthcare Professional Information Pack provides answers to common questions that healthcare professionals may have about the medication.


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Thalidomide BMS® Healthcare Professional’s Information Pack

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This pack contains the all the additional Risk Minimisation Materials required to prescribe and dispense Thalidomide BMS®. 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 Thalidomide BMS® for any patient.


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Thalidomide BMS® Information for Healthcare Professionals

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This brochure contains the information needed for prescribing and dispensing of Thalidomide BMS®, 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 Thalidomide BMS® for any patient. Please also refer to the Summary of Product Characteristics (SmPC) for Thalidomide BMS®.


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Thalidomide BMS® Information for Patients

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


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Thalidomide BMS® 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 Thalidomide BMS® treatment. It is mandatory that male patients receive counselling and education to be made aware of the risks of Thalidomide BMS®. 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 Thalidomide BMS®.


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Thalidomide BMS® 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 Thalidomide BMS®.


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Thalidomide BMS® 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 Thalidomide BMS®. In order to ensure that the actions to minimise the risk of foetal exposure are carried out for all patients, dispensing of Thalidomide BMS® will only be allowed from pharmacies registered with BMS.


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Thalidomide BMS® Prescription Authorisation Form

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A newly completed Prescription Authorisation Form must accompany each Thalidomide BMS® prescription to confirm that the patient has been counselled about the teratogenic risk of Thalidomide BMS® 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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Thalidomide BMS® 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 Thalidomide BMS® treatment. It is mandatory that women of childbearing potential receive counselling and education to be made aware of the risks of Thalidomide BMS®. 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 Thalidomide BMS®.


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Thalidomide BMS® 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 Thalidomide BMS® treatment. It is mandatory that women of non-childbearing potential receive counselling and education to be made aware of the risks of Thalidomide BMS®. 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 Thalidomide BMS®.


Tibsovo

Servier Laboratories Limited

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Patient Alert Card

Information for the patient treated for acute myeloid leukaemia This Patient Alert Card contains important information for you and healthcare professionals about Tibsovo


Toctino

Stiefel

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Alitretinoin Patient Card

To be given by the dermatologist, specialist dermatology nurses, or prescribing GP to reinforce the key safety messages around risks.


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Alitretinoin Pharmacist Checklist

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To be used as an aide memoire by pharmacists when dispensing oral retinoid medicines.


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Alitretinoin Prescriber Checklist

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To be used by the dermatologist, specialist dermatology nurse, or a prescribing GP with a special interest in dermatology to record the discussion of risks with the patient.


Tolvaptan

Teva UK Limited

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Tolvaptan Teva Training For Healthcare Professionals

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Healthcare professionals are required to complete training before prescribing Tolvaptan. Please follow the link to access the Tolvaptan Teva Training For Healthcare Professionals and to register your completion of this training. These materials provide important safety information on the risks of Tolvaptan Teva treatment, including liver toxicity, pregnancy prevention, monitoring requirements, dose and method of administration information, as well as the process for reporting adverse events. This training does not replace the Summary of Product Characteristics (SmPC), which should be read thoroughly before prescribing or dispensing Tolvaptan Teva. Patients should also be advised to read the Patient Information Leaflet (PIL).


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Tolvaptan Teva UK HCP Educational Guide

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Tolvaptan Teva is a specialist product for which additional training is available prior to prescribing. If you wish to undertake this training, please visit https://www.tevauk.com/hcp/tolvaptan-hcp/ to register and complete the training. This guide has been developed for prescribers and healthcare professionals (HCPs) involved in the treatment of patients using Tolvaptan Teva. This document summarises important information on the potential risk of hepatic toxicity and provides guidance on how to manage this risk. In addition, it provides important information about pregnancy prevention before and during the treatment with Tolvaptan Teva.


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Tolvaptan Teva UK Patient Alert Card

Tolvaptan Teva is a specialist product for which additional training is available prior to prescribing. If you wish to undertake this training, please visit https://www.tevauk.com/hcp/tolvaptan-hcp/ to register and complete the training. This patient alert card should be used by patients who have been prescribed medicines containing tolvaptan and should carry with them at all times when taking this medicine. This card contains important safety information that patient needs to be aware of before, during, and after treatment with Tolvaptan Teva.


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Tolvaptan Teva UK Patient/Carer Education Brochure

Tolvaptan Teva is a specialist product for which additional training is available prior to prescribing. If you wish to undertake this training, please visit https://www.tevauk.com/hcp/tolvaptan-hcp/ to register and complete the training. The guide should be provided to patients by the prescribing physician and includes a description of the risks of treatment, guidance on what to do in the event of risks occurring and an overview of treatment monitoring.


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Tolvaptan Teva UK Prescriber Checklist

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Tolvaptan Teva is a specialist product for which additional training is available prior to prescribing. If you wish to undertake this training, please visit https://www.tevauk.com/hcp/tolvaptan-hcp/ to register and complete the training. This material is provided by Teva UK Limited as a licence requirement for this medicine and forms part of the Risk Management Plan.


Toujeo

SANOFI

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Toujeo 300 units/ml, solution for injection in a pre-filled pen - Guide for Healthcare Professionals

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This document is submitted as a guide to avoid medication errors and includes information which must be written on each prescription for Toujeo and key safety elements when switching from or to an insulin with a different strength. For hard copies please contact our medical information department at 0800 035 25251 or email [email protected].


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Toujeo 300 units/ml, solution for injection in a pre-filled pen - Guide for patients and/or carers

This document includes information such as what Toujeo is and how to use it. It is to be used as a guide alongside the full Instructions For Use leaflet which accompanies the pen. For hard copies please contact our medical information department at 0800 035 2525 or email [email protected].


Treposuvi

AOP Orphan Ltd

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Treposuvi Solution for Infusion - Healthcare Professional Guide

This guide details the risk of central venous catheter related blood stream infections and sepsis associated with the intravenous route of administration of Treprosuvi Solution For Infusion


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Treposuvi Solution for Infusion - Patient Brochure

This guide details the risk of central venous catheter related blood stream infections and sepsis associated with the intravenous route of administration of Treposuvi Solution For Infusion


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Treposuvi Solution for Infusion - Patient Questionnaire

A questionnaire for patients treated with intravenous Treposuvi via an external infusion pump and central venous catheter (CVC)


Treprostinil

Dr. Reddy's Laboratories (UK) Ltd

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Healthcare Professional Guide

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Guidelines on the safe administration of Treprostinil Solution For Infusion by continuous intravenous infusion via an external infusion pump and central venous catheter (CVC) to prevent catheter‐related blood stream infections (CR‐BSI)


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Treprostinil Solution For Infusion Patient Questionnaire

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A questionnaire for patients treated with intravenous Treprostinil via an external infusion pump and central venous catheter


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Treprostinil Solution For Infusion Patient Brochure

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Administration of Treprostinil as intravenous infusion via an external pump and central venous catheter (CVC) (directly into a large vein)


Tillomed Laboratories Ltd

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Treprostinil Tillomed Solution for Infusion - Healthcare Professional Guide

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The guide details the risk of central venous catheter related blood stream infections and sepsis associated with the intravenous route of administration of Treprostinil Tillomed Solution For Infusion


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Treprostinil Tillomed Solution for Infusion - Patient Brochure

This guide details the risk of central venous catheter related blood stream infections and sepsis associated with the intravenous route of administration of Treprostinil Tillomed Solution For Infusion


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Treprostinil Tillomed Solution for Infusion - Patient Questionnaire

A questionnaire for patients treated with intravenous Treprostinil via an external infusion pump and central venous catheter (CVC)


Tresiba

Novo Nordisk Limited

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HCP Guide- Correct use of insulin degludec (Tresiba®) to minimise the risk of medication errors

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This healthcare professional guide contains important safety information regarding insulin degludec (Tresiba®), a basal insulin for the treatment of diabetes mellitus in adults, adolescents and children from 1 year.


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Tresiba® Patient Brochure- FlexTouch® 100U and FlexTouch® 200U Important Safety Information

The document provides important safety information regarding insulin degludec (Tresiba®), a basal insulin for the treatment of diabetes mellitus in adults, adolescents and children from 1 year. Tresiba® is introduced in two strengths — 100 units/mL and 200 units/mL — in the UK. As with all other insulin products, it is important not to risk mixing up different insulin strengths and this document provides information about this.


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Tresiba® Poster- FlexTouch® 100U and FlexTouch® 200U Important Safety Information

The document provides important safety information regarding insulin degludec (Tresiba®), a basal insulin for the treatment of diabetes mellitus in adults, adolescents and children from 1 year. Tresiba® is introduced in two strengths — 100 units/mL and 200 units/mL — in the UK. As with all other insulin products, it is important not to risk mixing up different insulin strengths and this document provides information about this.


Triumeq

ViiV Healthcare UK Ltd

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Abacavir Hypersensitivity Website for Healthcare Professionals

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Abacavir Hypersensitivity Website for Healthcare Professionals


Truvada

Gilead Sciences Ltd

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Truvada 200 mg/245 mg film-coated tablets (emtricitabine/tenofovir disoproxil fumarate) - PrEP Educational Materials - Checklist For Prescribers

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Checklist For Prescribers from the Physician educational pack for Truvada® (emtricitabine 200mg/ tenofovir disoproxil fumarate 245mg) for pre-exposure prophylaxis (PrEP) in patients at risk of sexually acquired HIV-1 infection


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Truvada 200 mg/245 mg film-coated tablets (emtricitabine/tenofovir disoproxil fumarate) - PrEP Educational Materials - Patient Leaflet

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Patient Leaflet from the Physician educational pack for Truvada® (emtricitabine 200mg/ tenofovir disoproxil fumarate 245mg) for pre-exposure prophylaxis (PrEP) in patients at risk of sexually acquired HIV-1 infection. It contains Important Information About Truvada® (emtricitabine/tenofovir disoproxil fumarate) to Reduce the Risk of Getting Human Immunodeficiency Virus (HIV) Infection for individuals who have been prescribed Truvada® for Pre-Exposure Prophylaxis (PrEP)


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Truvada 200 mg/245 mg film-coated tablets (emtricitabine/tenofovir disoproxil fumarate) - PrEP Educational Materials - Prescribers Leaflet

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Important Safety Information for Prescribers About Truvada® (emtricitabine/tenofovir disoproxil fumarate) for a Pre-exposure Prophylaxis (PrEP) Indication


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Truvada 200 mg/245 mg film-coated tablets (emtricitabine/tenofovir disoproxil fumarate) - PrEP Educational Materials - Reminder Card

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Reminder Card for patients from the Physician educational pack for Truvada® (emtricitabine 200mg/ tenofovir disoproxil fumarate 245mg) for pre-exposure prophylaxis (PrEP) in patients at risk of sexually acquired HIV-1 infection.


Truxima

Celltrion Healthcare UK Limited

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Truxima Patient Reminder Card

Patient Reminder Card


Tyenne

Fresenius Kabi Ltd

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Tyenne (tocilizumab) Dosing Guide

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This material is provided by Fresenius Kabi Ltd as a licence requirement for this medicine and forms part of the Risk Management Plan


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Tyenne (tocilizumab) Healthcare Professional Brochure

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This material is provided by Fresenius Kabi Ltd as a licence requirement for this medicine and forms part of the Risk Management Plan


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Tyenne (tocilizumab) Important Safety Information for Patients

Important safety information for patients and their caregivers understand the use of Tyenne (tocilizumab) therapy


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Tyenne (tocilizumab) Patient Alert Card

Patient alert card to help patients understand the risks associated with Tyenne (tocilizumab)


Tyruko

Sandoz Limited

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Tyruko 300 mg concentrate for solution for infusion: Patient Alert Card

A patient alert card intended to educate patients and carers on the risk of PML whilst on natalizumab treatment and for up to 6 months afterwards, on the nature of PML and to ensure they exercise vigilance regarding its development.


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Tyruko 300 mg Concentrate for Solution for Infusion: Physician’s Information and Management Guidelines

Physician Information and Management Guidelines intended to inform physicians on the risk and the nature of PML, risk factors for development of PML, its diagnosis and treatment, specific steps to be taken to minimize this risk and the identification and management of possible sequelae (e.g. immune reconstitution inflammatory syndrome [IRIS]).


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Tyruko 300 mg concentrate for solution for infusion: Treatment Continuation Form

A treatment continuation form intended to educate patients and carers on the risk of PML whilst on natalizumab treatment and for up to 6 months afterwards, on the nature of PML and to ensure they exercise vigilance regarding its development.


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Tyruko 300 mg concentrate for solution for infusion: Treatment Discontinuation Form

A treatment discontinuation form intended to educate patients and carers on the risk of PML whilst on natalizumab treatment and for up to 6 months afterwards, on the nature of PML and to ensure they exercise vigilance regarding its development.


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Tyruko 300 mg concentrate for solution for infusion: Treatment Initiation Form

A treatment initiation form intended to educate patients and carers on the risk of PML whilst on natalizumab treatment and for up to 6 months afterwards, on the nature of PML and to ensure they exercise vigilance regarding its development.


Tysabri

Biogen Idec Ltd

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Patient Alert Card

This alert card contains important safety information that you need to be aware of before, during and after stopping treatment with Tysabri (natalizumab). Hard copies can be requested by contacting Biogen at [email protected] or by telephone on 0800 008 7401.


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Physician Information and Management Guidelines for Patients with Multiple Sclerosis receiving TYSABRI Therapy

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This guidance document has been developed for those physicians initiating and supervising TYSABRI in accordance with the conditions of the Marketing Authorisation of the drug.


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Treatment Continuation Form

This form should be read carefully before continuing TYSABRI treatment for more than 2 years.


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Treatment Discontinuation Form

This form should be read carefully before discontinuing treatment with TYSABRI.


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Treatment Initiation Form

This form should be read carefully before starting treatment with TYSABRI.


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