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Risk Minimisation Materials

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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.

Pomalidomide

Amarox Limited

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Information for Healthcare Professionals Prescribing or Dispensing Pomalidomide

Information for Healthcare Professionals

Prescribing or Dispensing Pomalidomide


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Pomalidomide Adverse Event Form

Pomalidomide_Adverse Event Report Form


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Pomalidomide Information for Patients

Pomalidomide Patient Card


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Pomalidomide Male Risk Awareness Form

Pomalidomide Male Risk Awareness Form


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Pomalidomide Patient Information Guide

Pomalidomide Patient Information Guide


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Pomalidomide Pharmacist Registration Form

Pomalidomide Pharmacist Registration Form (screengrab)


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Pomalidomide Pregnancy Outcome Form

Pregnancy Outcome Form


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Pomalidomide Pregnancy Report Form

Pomalidomide Pregnancy Report Form


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Pomalidomide Women of Child Bearing Potential (WCBP) Risk Awareness Form

Pomalidomide Women of Child Bearing Potential (WCBP) Risk Awareness Form


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Pomalidomide Women of Non-ChildBearing Potential (WNCBP) Risk Awareness Form

Pomalidomide Women of Non-ChildBearing Potential (WNCBP) Risk Awareness Form


Thornton & Ross Ltd

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HCP Information Guide

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Information for Healthcare Professionals Prescribing or Dispensing Pomalidomide


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Patient Card

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Reminder card for patients taking pomalidomide


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Patient Information Guide

Information for Patients taking Pomalidomide


Wockhardt UK Ltd

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Adverse Event Form

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Adverse Event Form


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Information for Healthcare Professionals

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Information for Healthcare Professionals


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Information for Patients

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Information for Patients


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Male Risk Awareness Form

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Male Risk Awareness Form


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Patient Pocket Information Card

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Patient Pocket Information Card


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Pharmacist Registration Form (screengrab)

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Pharmacist Registration Form (screengrab)


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Pregnancy Outcome Form

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Pregnancy Outcome Form


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Pregnancy Reporting Form

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Pregnancy Reporting Form


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Women of ChildBearing Potential (WCBP) Risk Awareness Form

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Women of ChildBearing Potential (WCBP) Risk Awareness Form


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Women of Non-ChildBearing Potential (WNCBP) Risk Awareness Form

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Women of Non-ChildBearing Potential (WNCBP) Risk Awareness Form


Zentiva

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Pomalidomide Adverse Event report form

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Pomalidomide Adverse Event report form


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Pomalidomide HCP Information Guide

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Pomalidomide HCP Information Guide


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Pomalidomide Male Risk Awareness form

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Pomalidomide Male Risk Awareness form


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Pomalidomide Patient Card

Pomalidomide Patient card


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Pomalidomide Patient Information Guide

Pomalidomide Patient Information Guide


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Pomalidomide Pharmacy Registration Form

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Pomalidomide Pharmacy Registration Form


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Pomalidomide Pregnancy outcome form

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Pomalidomide Pregnancy outcome form


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Pomalidomide Pregnancy report form

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Pomalidomide Pregnancy report form


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Pomalidomide Risk Assessment form - WCBP

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Pomalidomide Risk Assessment form - Woman of Childbearing Potential


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Pomalidomide Risk Assessment form - WNCBP

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Pomalidomide Risk Assessment form - Woman of non Childbearing Potential


Pomalidomide Grindeks

Grindeks Kalceks UK

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Pomalidomide Adverse Event Form

Pomalidomide Adverse Event Form


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Pomalidomide Male Risk Awareness Form

Pomalidomide Male Risk Awareness Form


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Pomalidomide Patient Card

Pomalidomide Patient Card


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Pomalidomide Patient Information Guide

Pomalidomide Patient Information Guide


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Pomalidomide Pregnancy Outcome Form

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Pomalidomide Pregnancy Outcome Form


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Pomalidomide Pregnancy Prevention Programme

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Pomalidomide Pregnancy Prevention Programme


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Pomalidomide Pregnancy Report Form

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Pomalidomide Pregnancy Report Form


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Pomalidomide Women of Child Bearing Potential (WCBP) Risk Awareness Form

Pomalidomide Women of Child Bearing Potential (WCBP) Risk Awareness Form


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Pomalidomide Women of Non-Child Bearing Potential (WNCBP) Risk Awareness Form

Pomalidomide Women of Non-Child Bearing Potential (WNCBP) Risk Awareness Form


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