Benepali (etanercept): Brief training on additional Risk Minimisation Measures

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1 Benepali (etanercept): Brief training n additinal Risk Minimisatin Measures Slide Deck fr Healthcare Prfessinal (HCP) Training Versin 9.0; 22 January 2016 UK/IE 1

2 Benepali (etanercept) This medicine is subject t additinal mnitring. Reprting suspected adverse events r reactins after authrisatin f the medicinal prduct is imprtant. It allws cntinued mnitring f the benefit/risk balance f the medicinal prduct. HCPs are asked t reprt any suspected adverse events r reactins via the natinal reprting systems belw. Reprting f side effects Yu can reprt side effects directly via: UK: The Yellw Card Scheme website: Ireland: Adverse events can be reprted t HPRA Pharmacvigilance, Earlsfrt Terrace, IRL - Dublin 2, Tel: ; Fax: Website: medsafety@hpra.ie. 2

3 Training agenda Backgrund Training bjectives Educatinal materials fr HCPs Resurces available t HCPs fr training purpses Overview f additinal Risk Minimisatin Measures (RMMs) Patient Alert Card Reminders f Benepali cntraindicatins, special warnings and precautins f use Resurces fr patients References 3

4 Backgrund Benepali is a bisimilar medicinal prduct. Detailed infrmatin is available n the website f the Eurpean Medicines Agency In line with ther etanercept prducts, Benepali educatinal materials are t be implemented as part f the additinal Risk Minimisatin Measures (armms) Benepali 50 mg slutin fr injectin is available in A prefilled PEN (PFP) A prefilled SYRINGE (PFS) 4

5 Training bjectives Training n imprtant additinal risk minimisatin infrmatin fr HCPs Prevent pediatric ff-label use Prevent r reduce medicatin errrs fr pre-filled pen and pre-filled syringe Versin 8.0;

6 Educatinal materials fr HCPs This educatinal training material prvides additinal infrmatin essential fr ensuring the safe and effective use f the prduct and apprpriate management f the imprtant selected risks and therefre it is advised t be read carefully befre prescribing/dispensing/administering the prduct. The infrmatin in this slide deck des nt replace the full prescribing infrmatin in the Summary f Prduct Characteristics (SmPC), which shuld be read and understd befre prescribing Benepali. 6

7 Training resurces available t HCPs Basic Training (Risk Minimisatin) Prduct infrmatin SmPC Specific Training fr additinal RMMs Slide deck fr training f HCPs Reference Materials (fr Patients) Benepali Training Guide Patient Infrmatin Leaflet Label Patient alert cart (PAC) [cntained in the prduct pack] Quick Reference Guide (PFP) Quick Reference Guide (PFS) Training Pen Injectin demnstratin vide Please nte that these are being prvided separately and are utside f the scpe fr this HCP training. 7

8 Summary f RMM training Prevent Pediatric Off-Label Use Benepali is nt apprved fr use in children and adlescents less than 18 years f age Benepali is nly available at a dse which is unsuitable fr use in children and adlescents Other etanercept prducts suitable fr children are available Prevent/Reduce Medicatin Errrs fr the Pre-filled Pen and Pre-filled Syringe Patients are t be trained by the HCP using the Training Pen The Quick Reference Guide (PFP) and the Quick Reference Guide (PFS) prvide step-by-step illustrated instructins hw t handle and inject with the Benepali pre-filled pen and Benepali pre-filled syringe, respectively. 8

9 Patient Alert Card (PAC) HCPs are reminded that patients will als receive a PAC, lcated inside the Benepali bx, which prvides imprtant safety infrmatin abut: The risk f pprtunistic infectins and tuberculsis (TB) The risk f cngestive heart failure (CHF) Benepali is nt fr use in children. The PAC shuld be carried by patients during treatment and fr 2 mnths after the last dse. 9

10 Reminder f Benepali cntraindicatins, special warnings and precautins f use* Cntraindicatins Hypersensitivity t the active substance r t any f the excipients Sepsis r risk f sepsis Treatment with Benepali shuld nt be initiated in patients with active infectins, including chrnic r lcalised infectins Special warnings and precautins fr use: Tuberculsis (TB) All patients must be evaluated fr active and inactive ( latent ) TB befre initiatin f treatment, including detailed medical histry and apprpriate screening tests t be recrded n the PAC (see slide 9). If active TB is diagnsed, Benepali shuld nt be initiated. If latent TB is diagnsed, treatment fr latent TB must be started with anti-tb therapy befre the initiatin f Benepali, and in accrdance with lcal recmmendatins. *Please refer t Sectin 4.3 and 4.4 f Benepali SmPC 10

11 Reminder f Benepali special warnings and precautins f use* Other Special warnings and precautins fr use: Infectins Hepatitis B reactivatin Wrsening f hepatitis C Cncurrent treatment with anakinra Cncurrent treatment with abatacept Allergic reactins Immunsuppressin Vaccinatins Malignancies and lymphprliferative disrders Autantibdy frmatin Haematlgic reactins Neurlgical disrders Cmbinatin therapy Renal and hepatic impairment Cngestive heart failure Alchlic hepatitis Wegener's granulmatsis Hypglycaemia in patients treated fr diabetes *Please refer t Sectin 4.3 and 4.4 f Benepali SmPC 11

12 Resurces fr patients TRAINING GUIDE INJECTION DEMONSTRATION VIDEO If patients still have questins TELEPHONE SUPPORT DOCTOR OR HCP ASSISTANCE 12

13 References SmPC versin 02/2015 EPAR first published 28/01/2016 Marketing Authrisatin Hlder: Samsung Biepis UK Limited, 3000 Hillswd Drive, Chertsey, Surrey KT16 0RS United Kingdm. Manufacturer: Bigen (Denmark) Manufacturing ApS, Bigen Allé 1, 3400 Hillerød, Denmark 13

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