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Slide Deck for Healthcare Professional (HCP) Training

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Presentation on theme: "Slide Deck for Healthcare Professional (HCP) Training"— Presentation transcript:

1 Slide Deck for Healthcare Professional (HCP) Training
Benepali ® (etanercept): Brief training on additional Risk Minimisation Measures Slide Deck for Healthcare Professional (HCP) Training BEN-HCP Training-UK and IE-v10.0 May 2017 Version 10, 26.Jan.2017

2 Benepali ® (etanercept)
This medicine is subject to additional monitoring. Reporting suspected adverse events or reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse events or reactions via the national reporting systems below. Reporting of side effects You can report side effects directly via: UK: The Yellow Card Scheme website: Ireland: Adverse events can be reported to HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: ; Fax: Website: BEN-HCP Training-UK and IE-v10.0 May 2017

3 BEN-HCP Training-UK and IE-v10.0
Training agenda Background Training objectives Educational materials for HCPs Resources available to HCPs for training purposes Overview of additional Risk Minimisation Measures (RMMs) Patient Alert Card Reminders of Benepali contraindications, special warnings and precautions of use Resources for patients References BEN-HCP Training-UK and IE-v10.0 May 2017

4 BEN-HCP Training-UK and IE-v10.0
Background Benepali is a biosimilar medicinal product. Detailed information is available on the website of the European Medicines Agency In line with other etanercept products, Benepali educational materials are to be implemented as part of the additional Risk Minimisation Measures (aRMMs) Benepali solution for injection is available in 50mg prefilled PEN (PFP) 50mg prefilled SYRINGE (PFS) 25mg prefilled SYRINGE (PFS) BEN-HCP Training-UK and IE-v10.0 May 2017

5 BEN-HCP Training-UK and IE-v10.0
Training objectives Training on important additional risk minimisation information for HCPs Prevent paediatric off-label use in children and adolescents weighing less than 62.5kg Prevent or reduce medication errors for pre-filled pen and pre-filled syringe BEN-HCP Training-UK and IE-v10.0 May 2017

6 Educational materials for HCPs
This educational training material provides additional information essential for ensuring the safe and effective use of the product and appropriate management of the important selected risks and therefore it is advised to be read carefully before prescribing/dispensing/administering the product. The information in this slide deck does not replace the full prescribing information in the Summary of Product Characteristics (SmPC), which should be read and understood before prescribing Benepali. BEN-HCP Training-UK and IE-v10.0 May 2017

7 BEN-HCP Training-UK and IE-v10.0
Training resources available to HCPs Basic Training (Risk Minimisation) Reference Materials (for Patients) Specific Training for additional RMMs Product information SmPC Patient Information Leaflet Label Patient alert cart (PAC) [contained in the product pack] Benepali Training Guide Injection demonstration video Please note that these are being provided separately and are outside of the scope for this HCP training. Slide deck for training of HCPs Quick Reference Guide (PFP) Quick Reference Guide (PFS) Training Pen BEN-HCP Training-UK and IE-v10.0 May 2017

8 BEN-HCP Training-UK and IE-v10.0
Summary of RMM training Prevent Paediatric Off-Label Use Prevent/Reduce Medication Errors for the Pre-filled Pen and Pre-filled Syringe Benepali is not approved for use in children and adolescents weighing less than 62.5 kg Benepali is only available at a dose which is suitable for use in children and adolescents weighing 62.5 kg or more Paediatric patients who require a dose other than the available full fixed dose should not receive Benepali Administration of both 50mg and 25mg strengths are restricted to patients with a body weight of ≥62.5kg. Other etanercept products suitable for children weighing less than 62.5 kg are available Patients are to be trained by the HCP using the Training Pen The Quick Reference Guide (PFP) and the Quick Reference Guide (PFS) provide step-by-step illustrated instructions how to handle and inject with the Benepali pre-filled pen and Benepali pre-filled syringe, respectively. BEN-HCP Training-UK and IE-v10.0 May 2017

9 Patient Alert Card (PAC)
HCPs are reminded that patients will also receive a PAC, located inside the Benepali box, which provides important safety information about: The risk of opportunistic infections and tuberculosis (TB) The risk of congestive heart failure (CHF) Benepali is not approved for use in children and adolescents weighing less than 62.5 kg. The PAC should be carried by patients during treatment and for 2 months after the last dose. BEN-HCP Training-UK and IE-v10.0 May 2017

10 BEN-HCP Training-UK and IE-v10.0
Reminder of Benepali contraindications, special warnings and precautions of use* Contraindications Hypersensitivity to the active substance or to any of the excipients Sepsis or risk of sepsis Treatment with Benepali should not be initiated in patients with active infections, including chronic or localised infections Special warnings and precautions for use: Tuberculosis (TB) All patients must be evaluated for active and inactive (‘latent’) TB before initiation of treatment, including detailed medical history and appropriate screening tests to be recorded on the PAC (see slide 9). If active TB is diagnosed, Benepali should not be initiated. If latent TB is diagnosed, treatment for latent TB must be started with anti-TB therapy before the initiation of Benepali, and in accordance with local recommendations. *Please refer to Section 4.3 and 4.4 of Benepali SmPC BEN-HCP Training-UK and IE-v10.0 May 2017

11 Reminder of Benepali special warnings and precautions of use*
Other Special warnings and precautions for use: Infections Hepatitis B reactivation Worsening of hepatitis C Concurrent treatment with anakinra Concurrent treatment with abatacept Allergic reactions Immunosuppression Vaccinations Malignancies and lymphoproliferative disorders Autoantibody formation Haematologic reactions Neurological disorders  Combination therapy Renal and hepatic impairment Congestive heart failure Alcoholic hepatitis  Wegener's granulomatosis Hypoglycaemia in patients treated for diabetes *Please refer to Section 4.3 and 4.4 of Benepali SmPC BEN-HCP Training-UK and IE-v10.0 May 2017

12 Resources for patients
INJECTION DEMONSTRATION VIDEO TRAINING GUIDE If patients still have questions TELEPHONE SUPPORT DOCTOR OR HCP ASSISTANCE BEN-HCP Training-UK and IE-v10.0 May 2017

13 BEN-HCP Training-UK and IE-v10.0
References SmPC version 5/2017 EPAR first published 28/01/2016 Marketing Authorisation Holder: Samsung Bioepis UK Limited, 3000 Hillswood Drive, Chertsey, Surrey KT16 0RS United Kingdom. Manufacturer: Biogen (Denmark) Manufacturing ApS, Biogen Allé 1, 3400 Hillerød, Denmark BEN-HCP Training-UK and IE-v10.0 May 2017

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