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https://www.readbyqxmd.com/read/27465000/idarucizumab-praxbind-formulary-review
#1
Jessica Buchheit, Prabashni Reddy, Jean M Connors
Idarucizumab (Praxbind), a humanized monoclonal antibody fragment was granted accelerated approval from the Food and Drug Administration in October 2015 as the first agent to reverse the effects of a novel oral anticoagulant. The drug is indicated for dabigatran reversal in patients requiring emergency surgery/urgent procedures or with life-threatening or uncontrolled bleeding. In a randomized study with healthy volunteers, compared with placebo, idarucizumab reduced the clotting times for all tests assays (assessed pre-, end of-, and 24 hours after infusion), while the results for the placebo group remained unchanged...
September 2016: Critical Pathways in Cardiology
https://www.readbyqxmd.com/read/27388764/idarucizumab-a-review-as-a-reversal-agent-for-dabigatran
#2
Yahiya Y Syed
Idarucizumab (Praxbind(®)), a humanized monoclonal antibody, is a specific reversal agent for the direct oral thrombin inhibitor dabigatran, available as its prodrug dabigatran etexilate (Pradaxa(®)). Idarucizumab is approved in several countries (including the USA, the EU, Canada and Australia) for use in adult patients on dabigatran when the reversal of its anticoagulant effects is required for emergency surgery/procedures or in the event of life-threatening or uncontrolled bleeding. In the ongoing pivotal RE-VERSE AD trial in these populations (n = 90), intravenous idarucizumab 5 g reversed dabigatran-induced prolongation of dilute thrombin time (dTT) and ecarin clotting time (ECT) within minutes...
August 2016: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
https://www.readbyqxmd.com/read/27227858/praxbind-available-as-antidote-to-bleeding-from-pradaxa
#3
Diane S Aschenbrenner
No abstract text is available yet for this article.
June 2016: American Journal of Nursing
https://www.readbyqxmd.com/read/26681901/pharmaceutical-approval-update
#4
Chris Fellner
Idarucizumab (Praxbind) to reverse the anticoagulant effects of dabigatran (Pradaxa); aripiprazole lauroxil (Aristada) for the treatment of schizophrenia; and insulin degludec injection (Tresiba) for diabetes.
December 2015: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/26651519/antibodies-to-watch-in-2016
#5
Janice M Reichert
The number of novel antibody therapeutics that received first marketing approvals in 2015 met expectations, with 6 (alirocumab (Praluent®), evolocumab (Repatha®), daratumumab (Darzalex®), dinutuximab (Unituxin®), idarucizumab (Praxbind®), mepolizumab (Nucala®)) granted first approvals as of mid-November*. Seven novel antibody therapeutics (begelomab, brodalumab, elotuzumab, ixekizumab, necitumumab, obiltoxaximab, reslizumab) are in regulatory review, and thus a similar number, if not more, are projected to gain first approvals in 2016...
2016: MAbs
https://www.readbyqxmd.com/read/26583604/idarucizumab-praxbind-an-antidote-for-dabigatran
#6
REVIEW
(no author information available yet)
No abstract text is available yet for this article.
November 23, 2015: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/26578027/idarucizumab-first-global-approval
#7
REVIEW
Celeste B Burness
Idarucizumab (Praxbind(®)) is a fully humanized, monoclonal antibody fragment developed by Boehringer Ingelheim as a specific antidote to reverse the anticoagulant effect of the direct oral thrombin inhibitor dabigatran etexilate (Pradaxa(®)). Idarucizumab received its first global approval, in the USA, in October 2015 for use in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding...
December 2015: Drugs
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