Risk Materials

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

Imnovid®▼ (pomalidomide) Adverse Event Form

The safe use of pomalidomide is of paramount importance. Complete the Adverse Event Form if your patient experiences an adverse event while being treated with pomalidomide and send the information to the Celgene Drug Safety Department. Adverse events can also be reported to the MHRA via the Yellow Card scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

For Healthcare Professionals

Imnovid®▼ (pomalidomide) Information for Healthcare Professionals

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

For Healthcare Professionals

Imnovid®▼ (pomalidomide) Information for Patients

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

Imnovid®▼ (pomalidomide) Male Treatment Initiation Form

This Treatment Initiation Form must be completed for each male patient, prior to the initiation of their pomalidomide treatment. It is mandatory that males receive counselling and education to be made aware of the risks of pomalidomide. The aim of the Treatment Initiation 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.

For Healthcare Professionals

Imnovid®▼ (pomalidomide) Patient Pocket Information Card

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

Imnovid®▼ (pomalidomide) Pharmacy Registration Form

This Pharmacy Registration Form must be completed by the Chief Pharmacist or appointed deputy to be able to order or dispense pomalidomide. It is a requirement of the Pregnancy Prevention Programme (PPP) that pharmacies wishing to purchase and dispense pomalidomide are registered with Celgene.

For Healthcare Professionals

Imnovid®▼ (pomalidomide) Pregnancy Report and Pregnancy Outcome Forms

The safe use of pomalidomide is of paramount importance. Use the Pregnancy Reporting Form to immediately notify Celgene of all suspected pregnancies in female patients or partners of male patients. Pregnancy reports should also be reported to the MHRA via the Yellow Card scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

For Healthcare Professionals

Imnovid®▼ (pomalidomide) Prescription Authorisation Form

A newly completed Prescription Authorisation Form MUST accompany EVERY pomalidomide prescription to confirm 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 child bearing 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.

For Healthcare Professionals

Imnovid®▼ (pomalidomide) Treatment Checklist and Algorithm

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

For Healthcare Professionals

Imnovid®▼ (pomalidomide) Woman of Childbearing Potential Treatment Initiation Form

This Treatment Initiation 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 Treatment Initiation 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.

For Healthcare Professionals

Imnovid®▼ (pomalidomide) Woman of Non-Childbearing Potential Treatment Initiation Form

This Treatment Initiation Form must be completed for each woman not of 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 Treatment Initiation 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.

For Healthcare Professionals

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