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 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
2 o bolniki morajo biti sposobni upoštevati zahteve za varno uporabo zdravila Revlimid, o bolnikom je treba priskrbeti ustrezno izobraževalno brošuro in kartico bolnika; • varnostne nasvete, primerne za vse bolnike: o opis ter obravnavanje nevtropenije in trombocitopenije, vključno s stopnjo incidence v kliničnih študijah, o opis in obravnavanje trombemboličnega tveganja, vključno s stopnjo incidence v kliničnih študijah, o uporabo pri bolnikih z jetrno in/ ali ledvično okvaro, o odstranjevanje odvečnega zdravila, o lokalne, za državo značilne dogovore za predpisovanje in izdajanje zdravila Revlimid, o opis tveganja hipotiroidizma, o razlaga neznanega tveganja nevropatije pri dolgotrajni uporabi; • opis PPN- ja in razvrstitev bolnikov po spolu in zmožnosti zanositve: o algoritem za izvajanje PPN- ja, o opredelitev žensk v rodni dobi (ŽRD), in ukrepov, ki jih morajo zdravniki izvajati, kadar niso prepričani; • varnostne nasvete za ženske v rodni dobi: o potrebo po izogibanju fetalni izpostavljenosti, o opis PPN- ja, o potrebo po ustrezni kontracepciji (tudi, če ima ženska amenorejo) in opredelitev ustrezne kontracepcije, o režim testov nosečnosti: nasvete za ustrezne teste, pred začetkom zdravljenja, med zdravljenjem, glede na kontracepcijsko metodo, po končanem zdravljenju, o potrebo po takojšnji prekinitvi zdravljenja z zdravilom Revlimid pri sumu na nosečnost, o potrebo po takojšnjem obveščanju lečečega zdravnika pri sumu na nosečnost; • varnostne nasvete za moške: o potrebo po izogibanju fetalni izpostavljenosti, o potrebo po uporabi kondomov, če je spolna partnerka ŽRD (tudi, če je moški imel vazektomijo): med zdravljenjem z zdravilom Revlimid, še en teden po zadnjem odmerku, o če partnerka zanosi, medtem ko bolnik jemlje zdravilo Revlimid ali kmalu po prenehanju jemanja zdravila Revlimid, mora takoj obvestiti lečečega zdravnika; • zahteve v primeru nosečnosti: o navodila za takojšnjo prekinitev zdravljenja z zdravilom Revlimid pri sumu na nosečnost, o potrebo po napotitvi k zdravniku specialistu za teratologijo ali z izkušnjami v teratologiji na diagnozo, oceno in posvet, o podrobnosti za stike za poročanje kakršnegakoli suma na nosečnost, o obrazec za poročanje nosečnosti; • kontrolni seznam za zdravnike, ki zagotavlja, da je bil bolnik deležen ustreznega svetovanja o zdravljenju, kontracepcijskih metodah in preprečevanju nosečnosti, ki ustreza spolu in statusu zmožnosti zanositve • obrazce za poročanje o neželenih učinkih.