Publications containing safety information for HEMLIBRA in haemophilia A
Here you can find links to external guidance documents, the latest safety posters from Roche/Chugai and published manuscripts that contain safety information for HEMLIBRA in haemophilia A.
Please note that the following are links 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 safety posters from Roche/Chugai
Links to poster presentations from the National Hemophilia Foundation (NHF) 2020 Conference. To access any previous Roche/Chugai sponsored congress poster or presentation, please contact Roche medicinal information on 0800 328 1629 or via this form.
Real-world treatment patterns, health outcomes and healthcare resource use among persons with hemophilia A
Caplan EO et al. NHF 2020;15 [Poster Presentation].
A contemporary framework for understanding mortality in people with congenital hemophilia A (PwcHA)
Pipe SW et al. NHF 2020;23 [Poster Presentation].
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. NHF 2020;25 [Poster Presentation].
Characteristics of persons with hemophilia A treated with emicizumab with or without Factor VIII inhibitors
Mahajerin A et al. NHF 2020;31 [Poster Presentation].
A systematic review of mortality statistics and causes of death in people with congenital hemophilia A (PwcHA)
Hay CRM et al. NHF 2020;32 [Poster Presentation].
Summary of thrombotic or thrombotic microangiopathy events in persons with hemophilia A taking emicizumab
Lee L et al. NHF 2020;35 [Poster Presentation].
Bone and joint health markers in persons with hemophilia A (PwHA) treated with emicizumab in the HAVEN 3 clinical trial
Kiialainen A et al. NHF 2020;36 [Poster Presentation].
Links to published HEMLIBRA clinical studies and manuscripts, including HEMLIBRA safety data. Please note that this list is not exhaustive. Should you require further information, or wish to request a document that is not available on open access, please contact Roche medicinal information on 0800 328 1629 or via this form.
HEMLIBRA clinical studies:
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 including 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.
Emicizumab prophylaxis in patients with haemophilia A with and without inhibitors
(open access) Ebbert PT et al. Haemophilia 2020;26:41–46.
ST-segment elevation myocardial infarction (STEMI) and pulmonary embolism in a hemophilia A patient receiving emicizumab and recombinant activated factor VII
(open access) Gundabolu K et al. Haemophilia 2020;26:e5–e8.
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. DOI: 10.1111/hae.13978 (ePub ahead of print).
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.
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.
▼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 firstname.lastname@example.org or calling +44 (0)1707 367554. As HEMLIBRA® is a biological medicine, healthcare professionals should report adverse reactions by brand and batch number.
FDA, Food and Drug Administration; FVIII, Factor VIII; rFVIIa, activated recombinant Factor VII; NHF, National Hemophilia Foundation; TE, thrombotic events; TMA, thrombotic microangiopathy; UKHCDO, United Kingdom Haemophilia Centre Doctors' Organisation.
- HEMLIBRA SPC.
Date of preparation: September 2020