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 • Il- ħtieġa li tiġi evitata l- espożizzjoni tal- fetu minħabba t- teratoġeniċità ta ’ lenalidomide fl - annimali u l- effett teratoġeniku mistenni ta ’ lenalidomide fil- bnedmin, li jinkludi sommarju tar- riżultati interim ta ’ studju CC- 5013- TOX- 004 • Obbligazzjonijiet tal- professjonist fil- qasam tas- saħħa fir- rigward ta ’ l- għoti tar- riċetta ta ’ Revlimid o Il- ħtieġa li jipprovdi pariri komprensivi lill- pazjenti o Li l- pazjenti għandhom ikunu kapaċi li jkunu konformi mal- ħtiġijiet għall- użu sigur ta ’ Revlimid o Il- ħtieġa li jipprovdi lill- pazjent bil- pamflets edukattivi adattati għall- pazjent u l- kard tal- pazjent • Pariri rilevanti dwar is- sigurtà lill- pazjenti kollha o Deskrizzjoni u mmaniġġjar ta ’ newtropenja u tromboċitopenja li tinkludi rati ta ’ inċidenzi minn studji kliniċi o Deskrizzjoni u mmaniġġjar ta ’ riskju tromboembolitiku li tinkludi rati ta ’ inċidenzi minn studji kliniċi o Użu f’ pazjenti b’ indeboliment tal- fwied u/ jew renali o Rimi ta ’ mediċina mhux meħtieġa o Arranġamenti speċifiċi għall- pajjiż lokali għal riċetta biex jingħata Revlimid o Deskrizzjoni tar- riskju ta ’ ipotirojdiżmu o Spjegazzjoni ta ’ riskju mhux magħruf ta ’ newropatija b’ użu għal żmien fit- tul • Deskrizzjoni tal- PPP u l- kategorizzazzjoni ta ’ pazjenti bbażata fuq is- sess u l- potenzjal li jista ’ jkollhom it- tfal o Algorithm għall- implimentazzjoni tal- PPP o Definizzjoni ta ’ nisa li jista ’ jkollhom tfal (WCBP, Women of ChildBearing Potential) u azzjonijiet li t- tabib għandu jieħu jekk ma jkunx ċert • Pariri dwar is- sigurtà għal nisa ta ’ li jista ’ jkollhom it- tfal o Il- ħtieġa li tiġi evitata l- espożizzjoni tal- fetu o Deskrizzjoni tal- PPP o Il- ħtieġa għal kontraċezzjoni adegwata (anki jekk il- mara jkollha l- amenorrea) u definizzjoni ta ’ kontraċezzjoni adegwata o Kors tat- test tat- tqala Pariri dwar testijiet adattati Qabel tibda l- kura Matul il- kura bbażat fuq il- metodu ta ’ kontraċezzjoni Wara li tintemm il- kura o Il- ħtieġa li twaqqaf Revlimid immedjatament malli jkun hemm suspett ta ’ tqala o Il- ħtieġa li tgħid lit- tabib li jkun qed jipprovdi l- kura immedjatament malli jkun hemm suspett ta ’ tqala • Pariri dwar is- sigurtà għall- irġiel o Il- ħtieġa li tiġi evitata l- espożizzjoni tal- fetu o Il- ħtieġa li jużaw il- kondoms jekk is- sieħba sesswali hi WCBP (anki jekk ir- raġel kellu vasektomija) Matul il- kura b’ Revlimid Għal ġimgħa wara d- doża finali. o Li jekk is- sieħba toħroġ tqila waqt li jkun qed jieħu Revlimid jew ftit wara li jkun waqaf jieħu Revlimid, hu għandu jinforma lit- tabib li qed jikkurah immedjatament • Ħtiġijiet fil- każ ta ’ tqala o Struzzjonijiet biex twaqqaf Revlimid immedjatament malli jkun hemm suspett ta ’ tqala o Il- ħtieġa li tirreferi lil tabib li jkun speċjalizzat jew li għandu esperjenza fit - teratoloġija u d- dijanjosi tagħha għal evalwazzjoni u parir o Dettalji lokali tal- kuntatt biex tirrapporta kwalunkwe suspett ta ’ tqala o Formola tar- rappurtaġġ tat- tqala • Lista biex tiċċekkja għat- tobba biex tiżgura li l- pazjenti jirċievu l- parir adattat dwar il- kura, il - metodi ta ’ kontraċezzjoni u l- prevenzjoni tat- tqala skond is- sess tagħhom u l- istat li jista ’ jkollhom it- tfal • Formoli tar- rappurtaġġ għall- avvenimenti avversi 3 Pamflets edukattivi għall- pazjenti