The Educational Health Care Professional’s Kit shall contain the following elements: • Brief background on lenalidomide and its licensed indication • Posology • The need to avoid foetal exposure due to teratogenicity of lenalidomide in animals and the expected teratogenic effect of lenalidomide in humans including a summary of the interim results of study CC-5013-TOX-004 • Obligations of the health care professional in relation to the prescribing of Revlimid o Need to provide comprehensive advice and counselling to patients o That patients should be capable of complying with the requirements for the safe use of Revlimid o Need to provide patients with appropriate patient educational brochure and patient card • Safety advice relevant to all patients o Description and management of neutropenia and thrombocytopenia including incidence rates from clinical trials o Description and management of thromboembolic risk including incidence rates from clinical trials o Use in patients with hepatic and/or renal impairment o Disposal of unwanted medicine o Local country specific arrangements for a prescription for Revlimid to be dispensed o Description of risk of hypothyroidism o Explanation of unknown risk of neuropathy with long term use • Description of the PPP and categorisation of patients based on sex and childbearing potential o Algorithm for implementation of PPP o Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure • Safety advice for women of childbearing potential o The need to avoid foetal exposure o Description of the PPP o Need for adequate contraception (even if woman has amenorrhoea) and definition of adequate contraception o Pregnancy test regime Advice on suitable tests Before commencing treatment During treatment based on method of contraception After finishing treatment o Need to stop Revlimid immediately upon suspicion of pregnancy o Need to tell treating doctor immediately upon suspicion of pregnancy • Safety advice for men o The need to avoid foetal exposure o The need to use condoms if sexual partner is a WCBP (even if man has had a vasectomy) During Revlimid treatment For one week following final dose. o That if his partner becomes pregnant whilst he is taking Revlimid or shortly after he has stopped taking Revlimid he should inform his treating doctor immediately • Requirements in the event of pregnancy o Instructions to stop Revlimid immediately upon suspicion of pregnancy o Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice o Local contact details for reporting of any suspected pregnancy 64 o Pregnancy reporting form • Check list for physicians ensuring that patients receive the appropriate counselling concerning the treatment, contraceptive methods and pregnancy prevention appropriate for their sex and childbearing status • Adverse event reporting forms
72 o De noodzaak om de behandelend arts onmiddellijk in te lichten bij verdenking van zwangerschap • Adviezen met betrekking tot de veiligheid voor mannen o De noodzaak om foetale blootstelling te vermijden o De noodzaak om condooms te gebruiken als de seksuele partner een vrouw is die zwanger kan worden (zelfs als de man vasectomie ondergaan heeft) Tijdens de behandeling met Revlimid Gedurende één week na de laatste dosis. o De man dient onmiddellijk de behandelend arts in te lichten als zijn partner zwanger wordt terwijl hij Revlimid neemt of kort nadat hij gestopt is met het innemen van Revlimid • Eisen in geval van zwangerschap o Instructies om onmiddellijk met Revlimid te stoppen bij verdenking van zwangerschap o Noodzaak voor beoordeling en advies door te verwijzen naar een arts die gespecialiseerd of ervaren is in teratologie en de diagnose daarvan o Lokale contactgegevens voor het melden van iedere verdenking van zwangerschap o Formulier voor het melden van zwangerschap • Checklist voor artsen om te garanderen dat patiënten afhankelijk van hun geslacht en de mogelijkheid om zwanger te worden de adequate counseling ontvangen voor wat betreft de behandeling, anticonceptiemethoden en voorkoming van zwangerschap • Formulieren voor het melden van bijwerkingen