Postoperative Hemorrhages

Also known as: Postoperative Bleeding / Operative bleeding / Perioperative Bleeding / Procedural bleeding / Postoperative Hemorrhage / Hemorrhage, Postoperative / Procedural haemorrhage / Procedural hemorrhage / Post procedural hemorrhage / Post procedural haemorrhage / Post procedural bleeding / Bleeding postoperative / Post-operative haemorrhage / Postoperative haemorrhage

DrugDrug NameDrug Description
DB13884Albutrepenonacog alfaAlbutrepenonacog alfa (rIX-RFP) is a recombinant fusion protein that links a recombinant coagulation factor IX (rFIX) with a recombinant human albumin (rAlbumin).[A32547] It was developed by CSL Behring Canada, Inc and approved by Health Canada on April 26, 2017. It was also approved by FDA and EMA in 2016. It is currently marketed in the forms of 250, 500, 1000 and 2000 IU/vial.[L2305]
DB09329Antihemophilic Factor (Recombinant), PEGylatedAntihemophilic Factor (Recombinant), PEGylated, was approved by the FDA in December 2016 as the product _Adynovate_ [FDA label]. Antihemophilic Factor (Recombinant), PEGylated, is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of approximately 280 kDa) covalently conjugated with at least one molecule of polyethylene glycol (MW 20 kDa) [FDA label]. It has been created to increase the half-life of factor VIII, which decreases dose frequency and decreases the occurrence of bleeding events [A32067], [A32069], [FDA label]. PEGylation is the covalent attachment of a polyethylene glycol polymer, called PEG, to a drug or protein. PEGylation decreases factor VIII clearance and allowing for an increased duration of drug circulation in the plasma [L1529].
DB00025Antihemophilic factor, human recombinantHuman recombinant antihemophilic factor (AHF) or Factor VIII, 2332 residues, glycosylated, produced by CHO cells
DB11607Efmoroctocog alfaEfmoroctocog alfa is a fully recombinant factor VIII-Fc fusion protein (rFVIIIFc) with an extended half-life compared with conventional factor VIII (FVIII) preparations, including recombinant FVIII (rFVIII) products such as [DB13999][A31551]. It is an antihemorrhagic agent used in replacement therapy for patients with haemophilia A (congenital factor VIII deficiency). It is suitable for all age groups. Haemophilia A is a rare bleeding disorder associated with a slow clotting process caused by the deficiency of factor VIII. Patients with this disorder are more susceptible to recurrent bleeding episodes and excessive bleeding following minor traumatic injuries or surgical procedures [A31551]. Prophylactic treatment may dramatically improve the management of severe haemophilia A in the future by reducing joint bleeding and other hemorrhages that cause chronic pain and disability to patients [A31551, A31552]. Prophylaxis has also shown to reduce the formation of neutralizing anti-FVIII antibodies, or inhibitors [A31552]. Factor VIII is a blood coagulant factor involved in the intrinsic pathway to form fibrin, or a blood clot. Efmoroctocog alfa is a first commercially available rFVIII-Fc fusion protein (rFVIIIFc) where the conjugated molecule of rFVIII to polyethylene glycol is covalently fused to the dimeric Fc domain of human immunoglobulin G1, a long-lived plasma protein [FDA Label]. The B domain of factor VIII is deleted. In animal models of haemophilia, efmoroctocog alfa demonstrated an approximately two-fold longer t½ than commercially available rFVIII products [A31551]. Other drug products with similar structure and function to Efmoroctocog alfa include [DB13999], which is produced by recombinant DNA technology and is identical in sequence to endogenously produced Factor VIII, but does not contain the B-domain, which has no known biological function, and [DB13192], which is purified endogenous Factor VIII from human pooled blood and contains both A- and B-subunits. It is commonly marketed as Elocta or Eloctate for intravenous injection. To date, no confirmed inhibitory autoantibodies were seen in previously treated patients included in clinical studies and treatment-emergent adverse events were generally consistent with those expected in the patient populations being studied [A31551]. The extended half-life of efmoroctocog alfa provides several clinical benefits for patients, including reduced frequency of injections required and improved adherence to prophylaxis [A31551].
DB11608Eftrenonacog alfaEftrenonacog alfa is a long-acting recombinant fusion protein used in the treatment of hemophilia B. It is comprised of a single molecule of human factor IX (FIX) covalently linked to the constant region (Fc) domain of human IgG1 via recombinant DNA technology in a human embryonic kidney cell line (HEK293H) [A31556]. The presence of the Fc domain extends the terminal half-life which confers clinical benefits of prolonged therapeutic efficacy, less frequent intravenous injections for patient convenience and improved adherence to prophylaxis. Hemophilia B is a blood disorder with an incidence of approximately once every 30,000 male births in all populations and ethnic groups [A31557]. It is an X-linked genetic disease caused by mutation of the gene for coagulation protein factor IX (FIX), leading to decreased levels of endogenous factor IX and increased susceptibility to recurrent bleeding episodes caused spontaneously or as a result of accidental or surgical trauma [FDA Label]. When untreated, most patients die from bleeding complications before 25 years of age [A31557]. Eftrenonacog alfa acts as a replacement therapy to restore the levels of factor IX and allow normal hemostasis. Eftrenonacog alfa was developed and marketed as Alprolix for intravenous injection by Biogen. It was first approved by the FDA in March 2014 and later approved by the EMA in May 2016. Eftrenonacog alfa treatment demonstrated good tolerability with no reports of inhibitor development in clinical studies [A31556].
DB13933Nonacog beta pegolNonacog beta pegol is a recombinant coagulation factor IX derivative. It is produced without animal-derived materials and with an attached 40kDa polyethylene glycol (PEG) molecule for peptide activation by a site-directed glycoPEGylation. Once activated, the activation molecule with PEG are cleaved to leave the activated factor IX (Factor IXa).[A31496] Nonacog beta pegol was developed by Novo Nordisk, obtained EMA marketing authorisation in June 6, 2017.[L1099]
DrugDrug NameTargetType
DB13884Albutrepenonacog alfaCoagulation factor Xtarget
DB13884Albutrepenonacog alfaCoagulation factor VIIIenzyme
DB09329Antihemophilic Factor (Recombinant), PEGylatedvon Willebrand factortarget
DB09329Antihemophilic Factor (Recombinant), PEGylatedvon Willebrand factorcarrier
DB00025Antihemophilic factor, human recombinantCoagulation factor Xtarget
DB00025Antihemophilic factor, human recombinantPhytanoyl-CoA dioxygenase, peroxisomaltarget
DB00025Antihemophilic factor, human recombinantCoagulation factor IXtarget
DB00025Antihemophilic factor, human recombinantAsialoglycoprotein receptor 2target
DB00025Antihemophilic factor, human recombinant78 kDa glucose-regulated proteintarget
DB00025Antihemophilic factor, human recombinantCalreticulintarget
DB00025Antihemophilic factor, human recombinantCalnexintarget
DB00025Antihemophilic factor, human recombinantProtein ERGIC-53target
DB00025Antihemophilic factor, human recombinantProlow-density lipoprotein receptor-related protein 1target
DB00025Antihemophilic factor, human recombinantMultiple coagulation factor deficiency protein 2target
DB00025Antihemophilic factor, human recombinantvon Willebrand factortarget
DB00025Antihemophilic factor, human recombinantProthrombinenzyme
DB00025Antihemophilic factor, human recombinantVitamin K-dependent protein Cenzyme
DB11607Efmoroctocog alfavon Willebrand factortarget
DB13933Nonacog beta pegolCoagulation factor VIItarget
DB13933Nonacog beta pegolCoagulation factor VIIItarget
DB13933Nonacog beta pegolCoagulation factor Xtarget
DrugDrug NamePhaseStatusCount
DB11166Antithrombin Alfa1Terminated1
DB00302Tranexamic acid2Completed1
DB09106Hydroxyethyl Starch3Completed1
DB09153Sodium Chloride3Not Yet Recruiting1
DB00302Tranexamic acid3Completed1
DB00302Tranexamic acid3Not Yet Recruiting1
DB09106Hydroxyethyl Starch4Active Not Recruiting1
DB09153Sodium Chloride4Active Not Recruiting1
DB09153Sodium Chloride4Completed2
DB00302Tranexamic acid4Completed2
DB00302Tranexamic acid4Not Yet Recruiting1
DB00945Acetylsalicylic acidNot AvailableEnrolling by Invitation1
DB06692AprotininNot AvailableNo Longer Available1
DB00302Tranexamic acidNot AvailableUnknown Status1