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.
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, these lists are not exhaustive. To request access to any previous Roche/Chugai sponsored content not available on open access, please contact Roche Medicinal Information on 0800 328 1629 or fill in the Roche information request form.
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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.Immune tolerance induction in severe haemophilia A: A UKHCDO inhibitor and paediatric working party consensus update
(open access) Hart DP et al. Haemophilia 2021;1-6
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Congress poster presentations from or supported by Roche/Chugai
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.
Lee A et al.
Callaghan MU et al.
McLaughlin P et al.
Shang A et al.
Noone D et al.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
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
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 treated with emicizumab in the HAVEN 3 clinical trial
Kiialainen A et al.
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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.
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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.
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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:
- HEMLIBRA Summary of Product Characteristics.
M-GB-00004695
Date of preparation: August 2021
