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 Il- ħtieġa li jużaw il- kondoms jekk is- sieħba sesswali hi WCBP (anki jekk ir- raġel o 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