Risk Materials

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

Thalidomide Adverse Event Form

The safe use of thalidomide is of paramount importance. Adverse events (and cases of suspected or confirmed pregnancy or foetal exposure) should be reported to Celgene. Any adverse event 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

Thalidomide Information for Healthcare Professionals

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

For Healthcare Professionals

Thalidomide Information for Patients

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

Thalidomide Male Treatment Initiation Form

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

For Healthcare Professionals

Thalidomide Patient Pocket Information Card

This card must be provided to all patients to reinforce the safety information about thalidomide. It contains information on the risks of thalidomide if used during pregnancy, how to minimise these risks through the Pregnancy Prevention Programme, and what to do if a female patient or female partner of a male patient suspects they are pregnant, while on treatment with thalidomide.

Thalidomide Pharmacy Registration Form

This Pharmacy Registration Form must be completed by the Chief Pharmacist or appointed deputy to be able to order and dispense thalidomide. Dispensing of thalidomide will only be allowed from pharmacies registered with Celgene.

For Healthcare Professionals

Thalidomide Pregnancy Report and Pregnancy Outcome Forms

The safe use of thalidomide is of paramount importance. Any cases of suspected or confirmed pregnancy should be IMMEDIATELY reported to Celgene. Any suspected or confirmed pregnancy 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

Thalidomide Prescription Authorisation Form

A newly completed Prescription Authorisation Form must accompany each thalidomide prescription to confirm the patient has been counselled about the teratogenic risk of thalidomide 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

Thalidomide Treatment Checklist and Algorithm

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

For Healthcare Professionals

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

For Healthcare Professionals

Thalidomide Woman of Non-Childbearing Potential Treatment Initiation Form

This Treatment Initiation Form must be completed for each woman of non-childbearing potential, prior to the initiation of their thalidomide treatment. It is mandatory that women of non-childbearing potential receive counselling and education to be made aware of the risks of thalidomide. 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 thalidomide.

For Healthcare Professionals

Send us feedback

If you would like to make a comment or send us feedback on this material, click here.