Risk Minimisation Materials

Renal Risk Minimisation Material: Tenofovir Disoproxil for Adults with HIV

HIV renal education brochure - adults

For Healthcare Professionals

RENAL RISK MINIMISATION MATERIAL:TENOFOVIR DISOPROXIL FOR ADULTS WITH HIV

Submission of Risk Minimisation Materials (coordinated by BGMA) to agency - minimising the risks for Adults with HIV

Elidel Educational brochure for HCPs

Important information on the appropriate use of Elidel for HCPs

For Healthcare Professionals

Eliquis (apixaban) Patient Alert Card

This risk minimisation material has been developed for Eliquis for all indications. Patients prescribed Eliquis will receive a Patient Alert Card in the medication pack with the package leaflet. Please ensure that you are familiar with this material as it contains important safety information. In particular, it is aimed at increasing awareness about the potential risk of bleeding during treatment with Eliquis and providing guidance on how to manage that risk. As the card contains important information, the patient should be instructed to carry the Patient Alert Card at all times and show it to every healthcare professional including pharmacists. If you would like a hard copy of the Eliquis Prescriber Guide and/or Patient Alert Card and/or SmPC (5mg and 2.5mg) posted out to you, please contact BMS Medical Information (telephone: 0800 731 1736; e-mail: [email protected]). Please note that risk minimisation materials can only be delivered to UK registered healthcare premises.

Eliquis (apixaban) Prescriber Guide

This risk minimisation material has been developed for Eliquis for all indications. Please ensure that you are familiar with this material before prescribing Eliquis as it contains important safety information. In particular, it is aimed at increasing awareness about the potential risk of bleeding during treatment with Eliquis and providing guidance on how to manage that risk. If you would like a hard copy of the Eliquis Prescriber Guide and/or Patient Alert Cards and/or Summary of Product Characteristics (5mg and 2.5mg) posted out to you, please contact Bristol-Myers Squibb Medical Information (telephone: 0800 731 1736; e-mail: [email protected]) with your specific request. Please note that risk minimisation materials can only be delivered to UK registered healthcare premises.

For Healthcare Professionals

CHCs - Checklist for Prescribers

Combined Hormonal Contraceptives - checklist for prescribers

For Healthcare Professionals

CHCs - Q&A on Important Info for Women

Combined hormonal contraceptives: Q&As about the important information for women.

CHCs - Risk of Blood Clots with CHCs

Important Information for women about risk of blood clots with combined hormonal contraceptives.

Emerade Expiry Reminder

Expiry Reminder for Emerade, 150 micrograms; 300 micrograms; 500 micrograms, solution for injection in pre-filled pen.

How to use Emerade instruction video

Demonstration video for Emerade, 150 micrograms; 300 micrograms; 500 micrograms, solution for injection in pre-filled pen.

Checklist for Prescribers

Initiation of emtricitabine/tenofovir disoproxil for Pre-Exposure Prophylaxis (PrEP)

For Healthcare Professionals

Important Information about Emticitabine/Tenofovir Disproxil

Information for individuals who have been prescribed emtricitabine/ tenofovir disoproxil for Pre-Exposure Prophylaxis (PrEP)

For Healthcare Professionals

Important Safety Information for Prescribers

For Prescribers About emtricitabine/ tenofovir disoproxil for a Pre-Exposure Prophylaxis (PrEP) Indication

For Healthcare Professionals

Reminder Card

EMTRICITABINE/ TENOFOVIR DISOPROXIL FOR PrEP REMINDER CARD

For Healthcare Professionals

Checklist for Prescribers v2 Tenofovir PrEP

Initiation of emtricitabine/tenofovir disoproxil for Pre-Exposure Prophylaxis (PrEP) Complete checklist at each visit and file in individuals medical record.

For Healthcare Professionals

Important Information about Emtricitabine/Tenofovir Disoproxil To Reduce The Risk Of Getting Human Immunodeficiency Virus (HIV) Infection

Information for individuals who have been prescribed emtricitabine/tenofovir disoproxil for Pre-Exposure Prophylaxis (PrEP)

Important Safety Information for prescribers v2 Tenofovir PrEP

Emtricitabine/ tenofovir disoproxil is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and on men and women in heterosexual serodiscordant couples.

For Healthcare Professionals

Reminder Card v2 Tenofovir PrEP

You have been prescribed emtricitabine/ tenofovir disoproxil for PrEP (pre-exposure prophylaxis) to help reduce the risk of getting HIV-1 infection. For this medicine to work effectively it is important that you don’t miss doses. The recommended dose is one emtricitabine/ tenofovir disoproxil tablet each day. Take emtricitabine/ tenofovir disoproxil exactly as your doctor has told you.

Renal Risk Minimisation Material: Tenofovir Disoproxil for Adults with HIV

HIV renal education brochure - adults

For Healthcare Professionals

Emtricitabine/Tenofovir disoproxil Checklist for Prescribers

Emtricitabine/Tenofovir disoproxil Checklist for Prescribers

For Healthcare Professionals

Emtricitabine/Tenofovir Disoproxil Patient Brochure

Important Information About Emtricitabine/Tenofovir Disoproxil to Reduce the Risk of getting Human Immunodeficiency Virus (HIV) Infection

Emtricitabine/Tenofovir Disoproxil Prescriber's Brochure

Important Safety Information for Prescribers About Emtricitabine/Tenofovir Disoproxil for a Pre-exposure Prophylaxis (PrEP) Indication

For Healthcare Professionals

Emtricitabine/Tenofovir HIV Paediactrics Brochure

Emtricitabine/Tenofovir HIV Paediactrics Brochure advice for HCPs

For Healthcare Professionals

Patient Reminder Card for Emtricitabine/Tenofovir Disoproxil

Patient Reminder Card for Emtricitabine/Tenofovir disoproxil for PrEP (pre-exposure prophylaxis).

Important safety information for individuals using PrEPv2

This guide is intended for information only and should complement (not replace) the patient information leaflet supplied with your medicine. For a full list of side effects and other important information, please refer to the patient information leaflet provided in the box containing your medicine. Ask your healthcare provider if you have any questions.

For Healthcare Professionals

important safety information for prescribers v2 Tenofovir PrEP

Emtricitabine/ tenofovir disoproxil is indicated in combination with safer sex practices for preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and on men and women in heterosexual serodiscordant couples.

For Healthcare Professionals

Reminder card v2 Tenofovir PrEP

You have been prescribed emtricitabine/ tenofovir disoproxil for PrEP (pre-exposure prophylaxis) to help reduce the risk of getting HIV-1 infection. For this medicine to work effectively it is important that you don’t miss doses. The recommended dose is one emtricitabine/ tenofovir disoproxil tablet each day. Take emtricitabine/ tenofovir disoproxil exactly as your doctor has told you.

For Healthcare Professionals

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

Submission of Risk Minimisation Materials (coordinated by BGMA) to agency – minimising the risks of renal and bone effects for children and adolescents with HIV

RENAL RISK MINIMISATION MATERIAL:TENOFOVIR DISOPROXIL FOR ADULTS WITH HIV

Submission of Risk Minimisation Materials (coordinated by BGMA) to agency - minimising the risks for Adults with HIV

Renal Risk Minimisation Material Tenofovir Disoproxil for Adults with HIV

HIV renal education brochure - adults

For Healthcare Professionals

RENAL RISK MINIMISATION MATERIAL: TENOFOVIR DISOPROXIL FOR ADULTS WITH HIV

HIV-positive patients are at increased risk of renal impairment, requiring baseline and subsequent renal monitoring. For those adult patients on tenofovir disoproxil- based regimens specifc recommendations are detailed in this RMM.

For Healthcare Professionals

Enbrel MyClic HCP Flip Chart

Flip chart with step by step guide to using Enbrel 25mg & 50mg pre-filled pen - MyClic

For Healthcare Professionals

Enbrel Patient Alert Card

Patient Alert Card

Enbrel Patient Injection Instruction Guide

Patient Injection Instruction Guide

Entyvio (vedolizumab) HCP Educational Brochure

Information leaflet for HCPs Administering Entyvio

For Healthcare Professionals

Entyvio (vedolizumab) Patient Alert Card

To be provided to patients receiving treatment with Entyvio by a HCP

Envarsus – prolonged-release tacrolimus tablets

Educational materials for the healthcare professional (doctor or pharmacist) Please read the full Summary of Product Characteristics before prescribing Envarsus

For Healthcare Professionals

Envarsus Patient Card

Envarsus Prolonged-release tacrolimus tablets Patient Card

For Healthcare Professionals

Valproate Annual Risk Acknowledgement Form

For Hard copies of this information booklet please contact Sanofi medical information department on 0845 372 7101 or email [email protected]

Valproate- Healthcare professionals (HCPs) Educational material Pregnancy prevention programme

For Hard copies of this information booklet please contact Sanofi medical information department on 0845 372 7101 or email [email protected]

For Healthcare Professionals

Valproate- Patient Card-Contraception and Pregnancy Prevention

For Hard copies of this information booklet please contact Sanofi medical information department on 0845 372 7101 or email [email protected]

Valproate- Patient Guide-Educational material- Pregnancy prevention programme

For Hard copies of this information booklet please contact Sanofi medical information department on 0845 372 7101 or email [email protected]

Valproate- Poster- Dispensary- Pregnancy Prevention Programme

FOR DISPENSARY USE ONLY For hard copies please contact our medical information department at 0845 372 7101 or email [email protected] .

For Healthcare Professionals

Valproate- White Box Warning Labels

For Hard copies of this information booklet please contact Sanofi medical information department on 0845 372 7101 or email [email protected]

EpiPen® Carry Card

Carry Card for EpiPen® patients

EpiPen® Expiry Alert Service

Expiry Alert Service using text or email for EpiPen® patients

EpiPen® Trainer Pen Order Form

Trainer Pen order form

EpiPen® Travel Certificate

Travel Certificate for those carrying EpiPen®

Guide to Using Your EpiPen® & Trainer Pen

Guide to Using Your EpiPen® & Trainer Pen leaflet

HCP Prescription Checklist for EpiPen and EpiPen Jr

Checklist for EpiPen and EpiPen Jr

For Healthcare Professionals

HCP Booklet - valproate use in female patients

Healthcare Professional (HCP) educational material, Pregnancy Prevention Programme

For Healthcare Professionals

Patient Card - valproate use in female patients

Patient Card for valproate in female patients - Contraception and Pregnancy Prevention

Patient Guide - valproate use in female patients

Patient Guide booklet for valproate in female patients - educational material, Pregnancy Prevention Programme

Valproate - Annual Risk Acknowledgement Form

Checklist for prescribers related to valproate use in female patients

For Healthcare Professionals

Valproate - White Box Warning Labels

Warning labels for box

For Healthcare Professionals

Erelzi (Etanercept) Patient Alert Card

The patient alert card contains information on the following for patients treated with Erelzi: - Use in children and adolescents - Opportunistic infections and tuberculosis (TB) - Congestive Heart Failure (CHF).

Erivedge (vismodegib) HCP Reminder Card

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

For Healthcare Professionals

Erivedge (vismodegib) Patient Reminder Card

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

Erivedge (vismodegib) Pharmacist Dispensing Checklist

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

For Healthcare Professionals

Erivedge (vismodegib) Pharmacists Confirmation of Role Form

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

For Healthcare Professionals

Erivedge (vismodegib) Pregnancy Prevention Programme HCP Brochure

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

For Healthcare Professionals

Erivedge (vismodegib) Pregnancy Prevention Programme HCP Verification of Counselling Form

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

For Healthcare Professionals

Erivedge (vismodegib) Pregnancy Prevention Programme Patient Booklet

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

Erivedge (vismodegib) Prescriber Confirmation of Role Form

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

For Healthcare Professionals

Esbriet (pirfenidone) Safety Checklist for Prescribing Physicians

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

For Healthcare Professionals

Esmya (UPA) 5mg - UK DHPC 01.08.2018

This is a DHPC letter as approved by EMA and MHRA following EMA’s Pharmacovigilance Risk Assessment Committee (PRAC)’s Article 20 review of Esmya 5mg tablets (ulipristal acetate) which received EC approval on 26.07.2018.

For Healthcare Professionals

Pathologist' Guide - Esmya

Guide for pathologists dealing with gynaecological tissue which may have been exposed to Esmya (Ulipristal acetate) - revised July 2018.

For Healthcare Professionals

Patient Card - Esmya

This patient card will be present in the Esmya pack and is intended for the patient.

Physician's Guide to Prescribing - Esmya

Educational material for prescribers - revised July 2018

For Healthcare Professionals

Health Professionals’ Guide

Health Professionals’ Guide containing important information about Espranor

For Healthcare Professionals

Patients’ Guide - Information for HCP to give to patients prescribed Espranor

This is an Educational Material, for health professionals to give to patients prescribed Espranor

For Healthcare Professionals

Annex 2 -Checklist for prescribers

Please use this checklist in conjunction with the Summary of Product Characteristics during combined hormonal contraceptive (CHC) consultations to assess risk of Deep Vein Thrombosis (DVT)

Annex 3 IMPORTANT INFORMATION FOR WOMEN - one page summary

One page summary of risk of blood clots with combined hormonal contraceptives

Annex 4 leaflet for women

Leaflet with information on combined oral contraception to be given to patient by the physician

Rivastigmine patch (Exelon/Prometax) - Instructions for use and patient diary - for patients

Instructions for use and a patient diary including medication record sheets for patients that have been prescribed Exelon Patch or Prometax Patch (rivastigmine transdermal system) to ensure the correct use of the patch.

Exembol (Argatroban Monohydrate) RMM - Dear HCP Letter

The Dear healthcare professional letter reflects the differences in administration and packaging between the new presentation - Exembol 1mg.ml Solution for Infusion and the original presentation - Exembol Multidose 100mg/ml concentrate for Solution for Infusion.

For Healthcare Professionals

Exjade (deferasirox): Important information for patients about your treatment and possible side effects.

Please keep this document safe for future reference. This booklet is only intended for patients that have been prescribed deferasirox. It contains important information, including how to take deferasirox the right way, why monitoring your treatment is important, and which medicines you can take while on deferasirox.

Important Information to Remember About Exjade (deferasirox) Treatment.

This booklet provides detailed information on posology and monitoring of patients on deferasirox, to minimise key adverse effects including medication errors during treatment.

For Healthcare Professionals

EYLEA BRVO Patient Guide

Your guide to Eylea - for the treatment of visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO)

EYLEA CNV Patient Guide

Your guide to Eylea - for the treatment of visual impairment due to myopic choroidal neovascularisation (myopic CNV)

EYLEA CRVO Patient Guide

Your guide to Eylea - for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO)

EYLEA DMO Patient Guide

Your guide to Eylea - for the treatment of visual impairment due to diabetic macular oedema (DMO)

Eylea Prescriber Guide

Prescriber guide to intravitreal injections with Eylea.

For Healthcare Professionals

EYLEA WAMD Patient Guide

Your guide to Eylea - for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Educational material for Pharmacists & Patients

Checklist for Pharmacists and Patients