Risk Materials

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

Lenalidomide Adverse Event Form

The safe use of this product is essential. Adverse events or any cases of suspected/confirmed pregnancy or foetal exposure should always be reported to Accord. Any adverse events can also be reported direct to the MHRA via the Yellow card scheme website: www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store.

For Healthcare Professionals

Lenalidomide Healthcare Professional pack

This material contains the information needed by the healthcare professionals for prescribing and dispensing Lenalidomide, including information about the Pregnancy Prevention Programme (PPP). It is a requirement that the healthcare professional ensures they read and understand the PPP prior to prescribing and dispensing lenalidomide to ANY patient. Please also refer to the Summary of Product Characteristics (SmPC) for lenalidomide.

For Healthcare Professionals

Lenalidomide Information for Healthcare Professionals

This material contains the information needed by the healthcare professionals for prescribing and dispensing Lenalidomide, including information about the Pregnancy Prevention Programme (PPP). It is a requirement that the healthcare professional ensures they read and understand the PPP prior to prescribing and dispensing lenalidomide to ANY patient. Please also refer to the Summary of Product Characteristics (SmPC) for lenalidomide.

Lenalidomide Information for the Patients

This material should be given to each patient receiving treatment with lenalidomide as it provides important details about the Pregnancy Prevention Programme, including what the patient needs to be aware of before, during and after taking lenalidomide along with how to report any side effects.

Lenalidomide Male Treatment Initiation Form

This Treatment Initiation Form must be completed for each male patient prior to the initiation of their Lenalidomide treatment. It is mandatory that all males receive counselling and education to be made aware of the risks of lenalidomide. The aim is to protect the patient and any possible foetuses by ensuring the patient is fully informed of and understands the risk of teratogenicity and other adverse effects associated with the use of lenalidomide.

Lenalidomide Patient Information Card

The patient card must be given to patients receiving treatment with lenalidomide, as it provides important details about the Pregnancy Prevention Programme, including what they need to be aware of before, during and after taking lenalidomide and how to report side effects.

Lenalidomide Pharmacy Registration Form

The Pharmacy registration form must be completed by the chief Pharmacist or their appointed deputy to be able to order and dispense lenalidomide. Pharmacies will only be able to dispense lenalidomide if they are registered with Accord.

For Healthcare Professionals

Lenalidomide Pregnancy Form

The safe use of this product is essential. Any cases of suspected pregnancy or confirmed pregnancy should be IMMEDIATELY reported to Accord. Any adverse events can also be reported direct to the MHRA via the Yellow card scheme website: www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store.

Lenalidomide Pregnancy Outcome Form

The safe use of this product is essential. Any cases of suspected pregnancy or confirmed pregnancy should be IMMEDIATELY reported to Accord. Any adverse events can also be reported direct to the MHRA via the Yellow card scheme website: www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store.

Lenalidomide Prescription Authorisation Form

Each prescription of Lenalidomide must be accompanied by a newly completed Prescription Authorisation Form to confirm the patient has been counselled about the teratogenic risk of lenalidomide and the requirement for the use of contraception and the continuous use of an effective contraception whilst taking lenalidomide. Also, for woman of childbearing potential the confirmation of having a negative pregnancy test every 4-weeks, before each prescription to ensure they are not pregnant. Completion of this information is mandatory for ALL patients.

Lenalidomide Treatment Checklist and Algorithm

The lenalidomide checklist is to assist the healthcare professional with counselling a patient before they commence lenalidomide treatment to ensure it is used safety and correctly. The Algorithm provides high level steps for the process of Pharmacy registration and dispensing of lenalidomide.

Lenalidomide Women 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 lenalidomide treatment. It is mandatory that women of childbearing potential receive counselling and education to be made aware of the risks of Lenalidomide. Lenalidomide is contraindicated in women of childbearing potential unless all terms of counselling are met. 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 lenalidomide.

Lenalidomide Women 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 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 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 lenalidomide.

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