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    This website is intended for healthcare professionals (HCPs) only. If you are an HCP, register free to access the full content.

    HEMLIBRA

     

     

    For routine prophylaxis of bleeding episodes in patients of all ages with congenital haemophilia A, classified as severe or with Factor VIII (FVIII) inhibitors1

    • HEMLIBRA®▼ (emicizumab)
    • Prescribing Info
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    You are here:

    1. Roche Medicines
    2. Rare Diseases
    3. HEMLIBRA®▼ (emicizumab)
    4. Publications
    HEMLIBRA

    Publications about HEMLIBRA and haemophilia A

    This page contains links to external guidance documents and the latest sponsored congress presentations from Roche/Chugai/Genentech. Additionally, you will find links to published manuscripts, containing clinical study data and safety information, for HEMLIBRA in haemophilia A.

    Please note that these lists are not exhaustive. For further information, or to request access for any previous Roche/Chugai sponsored congress poster or presentation or document that is not available on open access, please contact Roche medicinal information on 0800 328 1629 or via this form.

    Related links:

    • Efficacy
    • Safety
    • HEMLIBRA® Summary of Product Characteristics
    • Guidance documents

      The following links are to external resources, generated independently of Roche/Chugai.

      Treatment of bleeding episodes in haemophilia A complicated by a Factor VIII inhibitor in patients receiving emicizumab. Interim guidance from UKHCDO Inhibitor Working Party and Executive Committee
      (open access) Collins PW et al. Haemophilia 2018;24:344–47.

      Guidelines on the use of prophylactic factor replacement for children and adults with haemophilia A and B
      (open access) Rayment R et al. Br J Haem 2020;190:684–95.

    • Recent poster presentations from or supported by Roche/Chugai (ASH and NHF, 2020)

      Links to Roche/Chugai sponsored posters from the American Society of Hematology (ASH) Annual Meeting and the National Hemophilia Foundation (NHF) Conference, both held in 2020.

      ASH 2020:

      866. Real-world persistence with and adherence to emicizumab prophylaxis in persons with hemophilia A: a secondary claims database analysis
      Mahajerin A et al.
      1786. A phase IV, multicenter, open-label study of emicizumab prophylaxis in persons with hemophilia A with or without FVIII inhibitors undergoing minor surgical procedures
      Escobar M et al.
      1793. Analysis of hemophilia A outcomes and treatment patterns using real-world data from the Canadian Hemophilia Bleeding Disorder Registry
      Lee A et al.
      1800. Safety and efficacy of emicizumab in persons with hemophilia A with or without FVIII inhibitors: pooled data from four phase III studies (HAVEN 1–4)
      Callaghan MU et al.
      2532. Problem joints and their clinical and humanistic burden in children and adults with moderate and severe hemophilia A: CHESS Paediatrics and CHESS II
      McLaughlin P et al.
      2685. Real-world safety of emicizumab: the first interim analysis of the European Haemophilia Safety Surveillance (EUHASS) database
      Shang A et al.
      3449. An insight into the impact of hemophilia A on daily life according to disease severity: a preliminary analysis of the CHESS II study
      Noone D et al.
      3457. Impact of hemophilia A inhibitor on joint health and health-related quality of life from the Hemophilia Utilization Group Studies Part VIII in the U.S.
      Ullman MM et al.
       

      NHF 2020:

      15. Real-world treatment patterns, health outcomes and healthcare resource use among persons with hemophilia A
      Caplan EO et al. 

      23. A contemporary framework for understanding mortality in people with congenital hemophilia A (PwcHA)
      Pipe SW et al.

      25. An analysis of fatalities in persons with congenital hemophilia A reported in the FDA Adverse Event Reporting System (FAERS) database
      De Ford C et al.

      31. Characteristics of persons with hemophilia A treated with emicizumab with or without Factor VIII inhibitors
      Mahajerin A et al.

      32. A systematic review of mortality statistics and causes of death in people with congenital hemophilia A (PwcHA)
      Hay CRM et al.

      35. Summary of thrombotic or thrombotic microangiopathy events in persons with hemophilia A taking emicizumab
      Lee L et al.

      36. Bone and joint health markers in persons with hemophilia A (PwHA) treated with emicizumab in the HAVEN 3 clinical trial
      Kiialainen A et al.

    • Manuscripts for the HEMLIBRA clinical studies (HAVEN)

      Emicizumab prophylaxis in hemophilia A with inhibitors
      (open access) Oldenburg J et al. N Engl J Med 2017;377:809–18.

      Emicizumab prophylaxis in patients who have hemophilia A without inhibitors
      (open access) Mahlangu J et al. N Engl J Med 2018;379:811–22.

      A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors
      (open access) Young G et al. Blood 2019;134:2127–38.

      Efficacy, safety and pharmacokinetics of emicizumab prophylaxis given every 4 weeks in people with haemophilia A (HAVEN 4): a multicentre, open-label, non-randomised phase 3 study
      (not open access) Pipe SW et al. Lancet Haematol 2019;6:e295–e305.

    • Manuscripts assessing mortality in congenital haemophilia A

      Mortality in congenital hemophilia A – a systematic literature review
      (open access) Hay CRM et al. J Thromb Haemost 2021;19:6–20.

      Establishment of a framework for assessing mortality in persons with congenital hemophilia A and its application to an adverse event reporting database
      (open access) Pipe SW et al. J Thromb Haemost 2021;19:21–31.

      Application of a hemophilia mortality framework to the Emicizumab Global Safety Database
      (open access) Peyvandi F et al. J Thromb Haemost 2021;19:32–41.

    • Manuscripts discussing HEMLIBRA safety data

      In vitro studies show synergistic effects of a procoagulant bispecific antibody and bypassing agents
      (open access) Hartmann R et al. J Thromb Haemost 2018;16:1580–91.

      Emicizumab and thrombosis: the story so far
      (open access) Makris M et al. J Thromb Haemost 2019;17:1269–72.

      Safety analysis of rFVIIa with emicizumab dosing in congenital hemophilia A with inhibitors: experience from the HAVEN clinical program
      (open access) Levy GG et al. J Thromb Haemost 2019;17:1470–77.

      Spotlight on emicizumab in the management of hemophilia A: Patient selection and special considerations.
      (open access) Yada K & Nogami K. J Blood Med 2019;10:171–81.

      Emicizumab prophylaxis in patients with haemophilia A with and without inhibitors
      (open access) Ebbert PT et al. Haemophilia 2020;26:41–46.

      Invasive procedures in patients with haemophilia: review of low-dose protocols and experience with extended half-life FVIII and FIX concentrates and non-replacement therapies
      (open access) Hermans C et al. Haemophilia 2020;00:1–7. DOI: 10.1111/hae.13978.

      Concomitant use of rFVIIa and emicizumab in people with hemophilia A with inhibitors: current perspectives and emerging clinical evidence
      (open access) Linari S & Castaman G. Ther Clin Risk Manag 2020;16:461–9.

    ▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554. As HEMLIBRA® is a biological medicine, healthcare professionals should report adverse reactions by brand and batch number.

    For full details please refer to the HEMLIBRA® Summary of Product Characteristics.

    ASH, American Society of Hematology; FDA, Food and Drug Administration; FVIII, Factor VIII; rFVIIa, activated recombinant Factor VII; NHF, National Hemophilia Foundation; UKHCDO, United Kingdom Haemophilia Centre Doctors’ Organisation.

    Reference:

    1. HEMLIBRA SPC.

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    Date of preparation: January 2021

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    Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554. ▼Additional monitoring: Medicinal products associated with this symbol are subject to additional monitoring. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. For biological medicines, healthcare professionals should report adverse reactions by brand name and batch number. This is a promotional website intended for HCPs, designed, built and funded by Roche Products Ltd. Commentary and other materials, including external links, posted on this site are not intended to amount to advice on which reliance should be placed. We therefore disclaim all liability and responsibility arising from any reliance placed on such materials by any visitor to our site, or by anyone who may be informed of any of its contents. M-GB-00002434 Date of Preparation January 2021.