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Risk Minimisation Materials

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Lenalidomide

ADVANZ Pharma

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Healthcare Professional (HCP) Guide

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This brochure contains the information needed for the prescribing and dispensing of Lenalidomide, including information about the Pregnancy Prevention Programme (PPP). Please also refer for further information to the UK Summary of Product Characteristics (SmPC), which can be found on the UK electronic medicines compendium website: www.medicines.org.uk/emc/.


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Lenalidomide Adverse Event Form

Lenalidomide Adverse Event Form


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Lenalidomide Pregnancy Outcome Form

Lenalidomide Pregnancy Outcome Form


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Lenalidomide Pregnancy Report Form

Lenalidomide Pregnancy Report Form


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Lenalidomide RAF for Males

Lenalidomide Pregnancy Prevention Programme Male Risk Awareness Form

Risk Awareness Form for counselling the patient to ensure the patient is fully informed about the safe use of lenalidomide


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Lenalidomide RAF for WCBP

Lenalidomide Pregnancy Prevention Programme Woman of Childbearing Potential Risk Awareness Form

Risk Awareness Form for counselling the patient to ensure the patient is fully informed about the safe use of lenalidomide


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Lenalidomide RAF for WNCBP

Lenalidomide Pregnancy Prevention Programme Women of Non-Childbearing Potential

Risk Awareness Form for counselling the patient to ensure the patient is fully informed about the safe use of lenalidomide


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Patient Information Card

Information for Patients and Healthcare Professionals:

Lenalidomide is structurally related to thalidomide and is expected to cause severe birth defects or death to an unborn baby


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Patient Information Guide

Lenalidomide Pregnancy Prevention Programme

Information for Patients taking Lenalidomide


Amarox Limited

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Lenalidomide - Pathfinder Healthcare Professional (HCP) Guide

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Lenalidomide - Pathfinder Healthcare Professional (HCP) Guide


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Lenalidomide - Pathfinder Patient Guide

Lenalidomide Pregnancy Prevention Programme Information for Patients taking Lenalidomide

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Lenalidomide - Pathfinder Patient Pocket Information Card

Lenalidomide - Information for Patients and Healthcare Professionals

Glenmark Pharmaceuticals Europe Ltd

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Frequently Asked Questions (FAQs)

Frequently Asked Questions (FAQs)

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Important Contact Information

Important Contact Information

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Introduction to Lenalidomide Healthcare Professional’s Information Pack

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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 lenalidomide for any patient. Please also refer to the Summary of Product Characteristics (SmPC) for lenalidomide.

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Lenalidomide Adverse Event, Pregnancy and Pregnancy Outcome Report Forms

The safe use of lenalidomide is of paramount importance. Adverse events and cases of suspected or confirmed pregnancy or foetal exposure should be immediately reported to Glenmark Pharmaceuticals Europe Ltd. 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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Lenalidomide Information for Healthcare Professionals

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This brochure contains the information needed for prescribing and dispensing lenalidomide, including information about the Pregnancy Prevention Programme (PPP). Please also refer to the Summary of Product Characteristics (SmPC) for lenalidomide.

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Lenalidomide Information for Patients

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

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Lenalidomide Patient Alert Card

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

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Lenalidomide 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 lenalidomide. In order to ensure that the actions to minimise the risk of foetal exposure are carried out for all patients, dispensing of lenalidomide will only be allowed from pharmacies registered with Glenmark Pharmaceuticals Europe Ltd.

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Lenalidomide Prescription Authorisation Form

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A newly completed Prescription Authorisation Form must accompany each lenalidomide prescription to confirm that the patient has been counselled about the teratogenic risk of lenalidomide 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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Lenalidomide Treatment Checklists and Algorithm

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This checklist is to assist you with counselling a patient before they commence lenalidomide treatment in order to ensure it is used safely and correctly. The Algorithm provides high level steps for prescribing and dispensing of lenalidomide.

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Lenalidomide Treatment Initiation Forms

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Woman of Childbearing Potential Treatment Initiation Form must be completed for each woman of childbearing potential prior to the initiation of their lenalidomide treatment. Woman of Non-Childbearing Potential Treatment Initiation Form must be completed for each woman of non-childbearing potential prior to the initiation of their lenalidomide treatment. Male Treatment Initiation Form must be completed for each male patient prior to the initiation of their lenalidomide treatment.

Mylan

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Lenalidomide Adverse Event Form

Lenalidomide Adverse Event Form


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Lenalidomide HCP Prescribing and Dispensing Guide

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Lenalidomide Pregnancy Prevention Programme and information for HCPs prescribing or dispensing Lenalidomide


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Lenalidomide Male Risk Awareness Form

Male Risk Awareness Form for counselling the patient to ensure the patient is fully informed about the safe use of lenalidomide


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Lenalidomide Patient Card

Lenalidomide pocket information card for patients and HCPs


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Lenalidomide Patient Information Guide

Lenalidomide Pregnancy Prevention Programme: information for patients taking Lenalidomide


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Lenalidomide Pharmacist Registration Form

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The Pharmacist Registration Form must be completed by the Chief Pharmacist or appointed deputy to be able to order and dispense lenalidomide. In order to ensure that the actions to minimise the risk of foetal exposure are carried out for all patients, dispensing of lenalidomide will only be allowed from pharmacies registered with Mylan (a Viatris company).


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Lenalidomide Pharmacy Registration Form

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The Pharmacy Registration Form must be completed by the Chief Pharmacist or appointed deputy to be able to order and dispense lenalidomide. In order to ensure that the actions to minimise the risk of foetal exposure are carried out for all patients, dispensing of lenalidomide will only be allowed from pharmacies registered with Mylan (a Viatris company).


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Lenalidomide Pregnancy Outcome Form

Lenalidomide Pregnancy Outcome Form


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Lenalidomide Pregnancy Report Form

Lenalidomide Pregnancy Report Form


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Lenalidomide Prescriber Registration Form

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The Prescriber Registration Form must be completed by the prescriber to be able to order and dispense lenalidomide. In order to ensure that the actions to minimise the risk of foetal exposure are carried out for all patients, the prescribing of lenalidomide will only be allowed from prescribers registered with Mylan (a Viatris company).


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Lenalidomide Woman of Childbearing Potential Risk Awareness Form

Lenalidomide Woman of Childbearing Potential Risk Awareness Form for counselling the patient to ensure the patient is fully informed about the safe use of lenalidomide


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Lenalidomide Woman of Non-Childbearing Potential Risk Awareness Form

Lenalidomide Woman of Non-Childbearing Potential Risk Awareness Form for counselling the patient to ensure the patient is fully informed about the safe use of lenalidomide


Ranbaxy (UK) Limited a Sun Pharmaceutical Company

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Lenalidomide Pregnancy Outcome Form

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Pregnancy Outcome Form


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Lenalidomide Adverse Event Form

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Lenalidomide Adverse Event Form


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Lenalidomide HCP Information Guide

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Lenalidomide pregnancy prevention programme


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Lenalidomide Male Risk Awareness Form

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Lenalidomide Male Risk Awareness Form


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Lenalidomide Patient Card

Lenalidomide Patient Card


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Lenalidomide Patient Information Guide

Lenalidomide Patient Information Guide


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Lenalidomide Pregnancy Report Form

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Lenalidomide Pregnancy Report Form


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Lenalidomide Woman of Childbearing Potential Risk Awareness Form

Lenalidomide Woman of Childbearing Potential Risk Awareness Form


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Lenalidomide Women of Non-Childbearing Potential Risk Awareness Form

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Lenalidomide Women of Non-Childbearing Potential

Risk Awareness Form


Sandoz Limited

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Lenalidomide Healthcare Professional Guide

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Information for Healthcare Professionals Prescribing or Dispensing Lenalidomide: This guide contains the info needed for the prescribing and dispensing of lenalidomide, including information about the Pregnancy Prevention Programme and important safety information. This guide ensures you know what to do before prescribing and dispensing lenalidomide. If lenalidomide is taken during pregnancy it is expected to cause severe birth defects or death to an unborn baby. This Programme is designed to make sure that unborn babies are not exposed to lenalidomide. It is a requirement of the Pregnancy Prevention Programme that all healthcare professionals (HCPs) ensure that they have read and understood the Healthcare Professionals Information guide before prescribing or dispensing lenalidomide for any patient. You must ensure that your patients fully understand what you have told them about lenalidomide and that they have completed the Treatment Initiation Form, before starting treatment.

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Lenalidomide Patient Guide: Pregnancy Prevention Programme

This brochure contains information about: - Preventing harm to unborn babies. If lenalidomide is taken during pregnancy it is expected to cause severe birth defects or death to an unborn baby. - The Lenalidomide Pregnancy Prevention Programme, designed to ensure that unborn babies are not exposed to Lenalidomide. It will provide you with information about what to expect from your treatment, and explain the risks and your responsibilities. - Lenalidomide passes into men’s semen, and is expected to cause severe birth defects or death to an unborn baby. So there is a risk if you have unprotected sex with a woman who can become pregnant. - This brochure will help you understand what to do before, during and after taking lenalidomide. For your own health and safety, please read this brochure as well as the Package Leaflet that comes with your medicine, carefully. If you do not understand something, please ask your prescriber for further explanation.

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Lenalidomide Patient Pocket Information Card

Contains safety information regarding the risks to an unborn baby from Lenalidomide. Has information for the HCP to complete regarding treatment details and patient specifics (are they male or female, are they receiving counselling, contraception use). Contains emergency contact details.

Teva UK Limited

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HCP Lenalidomide RMM

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HCP Guide


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Patient Lenalidomide RMM

Patient Guide


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Risk Awareness Form - Male

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Risk Awareness Form - Male


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Risk Awareness Form - Women of Childbearing Potential

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Risk Awareness Form - Women of Childbearing Potential


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Risk Awareness Form - Women of Non-Childbearing Potential

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Risk Awareness Form - Women of Non-Childbearing Potential


Thornton & Ross Ltd

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Healthcare Professional (HCP) Guide

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


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Lenalidomide Adverse Event Form

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Form for reporting of adverse events during lenalidomide treatment


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Lenalidomide Male Risk Awareness Form

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Risk awareness form to assist with counselling of male patients prior to lenalidomide treatment.


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Lenalidomide Pregnancy Outcome Form

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Form to record pregnancy outcome


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Lenalidomide Pregnancy Report Form

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Form to report pregnancy cases in patients receiving lenalidomide


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Lenalidomide Women of Childbearing Potential Risk Awareness Form

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Risk awareness form to assist with counselling of female patients of childbearing potential prior to lenalidomide treatment.


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Lenalidomide Women of Non-Childbearing Potential Risk Awareness Form

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Risk awareness form to assist with counselling of female patients of non-childbearing potential prior to lenalidomide treatment


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Patient Guide

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


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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 lenalidomide.


Revlimid

Bristol Myers Squibb Pharmaceuticals limited

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Revlimid® (lenalidomide) Algorithm

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

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Revlimid® (lenalidomide) 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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Revlimid® (lenalidomide) Healthcare Professional’s Information Pack

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


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Revlimid® (lenalidomide) Information for Healthcare Professionals

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

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Revlimid® (lenalidomide) Information for Patients

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

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Revlimid® (lenalidomide) 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 lenalidomide treatment. It is mandatory that male patients receive counselling and education to be made aware of the risks of lenalidomide. 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 lenalidomide.

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Revlimid® (lenalidomide) 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 lenalidomide.

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

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Revlimid® (lenalidomide) Prescription Authorisation Form

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

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Revlimid® (lenalidomide) 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 lenalidomide treatment. It is mandatory that women of non-childbearing potential receive counselling and education to be made aware of the risks of lenalidomide. 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 lenalidomide.

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