Frequently Asked Questions (FAQs)

Important Contact Information

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.

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.

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.

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.

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

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.

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.

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.

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.