Advanced search
Publication Cover
Journal of Blood Medicine Volume 10, 2019 - Issue
Submit an article Journal homepage
108
Views
9
CrossRef citations to date
0
Altmetric
Original Research

Thrombotic events with recombinant activated factor VII (rFVIIa) in approved indications are rare and associated with older age, cardiovascular disease, and concomitant use of activated prothrombin complex concentrates (aPCC)

Madhvi Rajpurkar1 Carman and Ann Adams Department of Pediatrics, Children’s Hospital of Michigan/Wayne State University, Detroit, MI, USACorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0002-5884-6776
ORCID Icon,
Stacy E Croteau2 Department of Pediatrics, Boston Children’s Hospital/Harvard Medical School, Boston, MA, USA
,
Lisa Boggio3 Hemophilia and Thrombophilia Center, Rush University Medical Center, Chicago, IL, USA
&
David L Cooper4 Clinical Development and Medical Affairs – Biopharm, Novo Nordisk Inc., Plainsboro, NJ, USAORCID Iconhttps://orcid.org/0000-0002-4499-1526
ORCID Icon
Pages 335-340 | Published online: 18 Sep 2019

References

  • Abshire T, Kenet G. Recombinant factor VIIa: review of efficacy, dosing regimens and safety in patients with congenital and acquired factor VIII or IX inhibitors. J Thromb Haemost. 2004;2(6):899–909. doi:10.1111/j.1538-7836.2004.00759.x15140125
  • Abshire T, Kenet G. Safety update on the use of recombinant factor VIIa and the treatment of congenital and acquired deficiency of factor VIII or IX with inhibitors. Haemophilia. 2008;14(5):898–902. doi:10.1111/j.1365-2516.2008.01829.x18684126
  • Neufeld EJ, Negrier C, Arkhammar P, et al. Safety update on the use of recombinant activated factor VII in approved indications. Blood Rev. 2015;29 Suppl 1:S34–S41. doi:10.1016/S0268-960X(15)30006-026073367
  • Neufeld EJ, Negrier C, Benchikh El Fegoun S, Cooper DL, Rojas-Rios A, Seremetis S. Recombinant activated factor VII in approved indications: update on safety. Haemophilia. 2018;24(4):e275–e277. doi:10.1111/hae.1354730004625
  • Levi M, Levy JH, Andersen HF, Truloff D. Safety of recombinant activated factor VII in randomized clinical trials. N Engl J Med. 2010;363(19):1791–1800. doi:10.1056/NEJMoa100622121047223
  • Hardy JF, Belisle S, Van der Linden P. Efficacy and safety of recombinant activated factor VII to control bleeding in nonhemophiliac patients: a review of 17 randomized controlled trials. Ann Thorac Surg. 2008;86:1038–1048. doi:10.1016/j.athoracsur.2008.05.01318721620
  • Hsia CC, Zurawska JH, Tong MZY, Eckert K, McAlister VC, Chin-Yee IH. Recombinant activated factor VII in the treatment of non-haemophilia patients: physician under-reporting of thromboembolic adverse events. Transfus Med. 2009;19:43–49. doi:10.1111/j.1365-3148.2009.00913.x19302454
  • O’Connell KA, Wood JJ, Wise JJ, Lozier JN, Braun MM. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA. 2006;295:293–298. doi:10.1001/jama.295.3.29316418464
  • Lin Y, Stanworth S, Birchall J, Doree C, Hyde C. Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia. Cochrane Database Syst Rev. 2007; 2: Art. No.: CD005011.
  • Neufeld EJ, Saxena K, Kessler CM, Cooper DL, HTRS Investigators. Dosing, efficacy, and safety of recombinant factor VIIa (rFVIIa) in pediatric versus adult patients: the experience of the Hemostasis and Thrombosis Research Society (HTRS) Registry (2004-2008). Pediatr Blood Cancer. 2013;60(7):1178–1183. doi:10.1002/pbc.2447223335449
  • Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia A with inhibitors. N Engl J Med. 2017;377(9):809–818. doi:10.1056/NEJMoa170306828691557
  • Levy GG, Asikanius E, Kuebler P, Benchikh El Fegoun S, Esbjerg S, Seremetis S. Safety analysis of rFVIIa with emicizumab dosing in congenital hemophilia A with inhibitors: experience from the HAVEN clinical program. J Thromb Haemost. 2019 Epub ahead of print. doi:10.1111/jth.14491

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.