Damoctocog Alfa Pegol: A Review in Haemophilia A

AbstractDamoctocog alfa pegol (Jivi®) is approved in the USA, EU, Japan and Canada for the treatment and prophylaxis of previously treated patients aged ≥ 12 years with haemophilia A. Formulated with a 60 kDa polyethylene glycol (PEG) moiety, damoctocog alfa pegol is an intravenously (IV) administered recombinant factor VIII (rFVIII) product with a longer terminal half-life than non-PEGylated FVIII and rFVIII products. In the multinational ph ase II/III PROTECT VIII trial, prophylaxis with damoctocog alfa pegol reduced the likelihood of bleeding in previously treated patients aged ≥ 12 years with severe haemophilia A, with dosing schedules ranging from twice weekly to once every 7 days. Interim data from the ongoing extension ph ase indicated that the reduced annualized bleeding rates (ABRs) were maintained for up to 5.2 years of prophylaxis with damoctocog alfa pegol. Damoctocog alfa pegol was also effective in treating bleeding episodes and in providing haemostatic control during surgery. Damoctocog alfa pegol was genera lly well tolerated in adult and adolescent patients with severe haemophilia A, with most adverse events considered to be unrelated to treatment. There were no new or confirmed cases of FVIII inhibitor development and anti-PEG antibodies, observed in some patients, were of low titre and transient. D amoctocog alfa pegol extends the available treatment options in previously treated adults and ado...
Source: Drugs - Category: Drugs & Pharmacology Source Type: research

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Publication date: Available online 19 July 2019Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Mohsin El Amrani, Anouk A.M. Donners, Gerard Graat, Eef G. Lentjes, Albert Huisman, Ruben E.A. Musson, Erik M. van MaarseveenAbstractPatients with hemophilia A are currently diagnosed and monitored by measuring the activity of coagulation factor VIII (FVIII) in plasma mostly with the one-stage clotting assay (OSA). Although the OSA is routinely available in many clinical laboratories, it has in some circumstances relatively low sensitivity and specificity. Therefore, the FVIII activity as a biomarker does not ...
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research
Condition:   Hemophilia A Interventions:   Biological: Damoctocog-alfa-pegol (BAY94-9027, Jivi);   Biological: Rurioctocog alfa pegol (Adynovi) Sponsor:   Bayer Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Authors: Escobar M, Santagostino E, Mancuso ME, Coppens M, Balasa V, Taylor JA, Iorio A, Negrier C Abstract Introduction: Prophylaxis with factor replacement therapy is the gold standard for the treatment of hemophilia, but this often requires frequent infusions. A number of long-acting factor products have been developed to reduce the burden on patients. Areas covered: This is an overview of information presented at two symposia held at the World Federation of Hemophilia and International Society on Thrombosis and Haemostasis - Scientific and Standardization Committee annual meetings. The pharmacokinetic, safety a...
Source: Expert Review of Hematology - Category: Hematology Tags: Expert Rev Hematol Source Type: research
Authors: Park N, Jang JS, Cha JH Abstract Peptic ulcer disease is the most common cause of acute gastrointestinal bleeding, followed by variceal bleeding, Mallory-Weiss syndrome, and malignancy. On the contrary, acquired hemophilia A is a very rare hemorrhagic disease, which usually manifests with musculocutaneous bleeding, caused by autoantibodies against coagulation factor VIII. A 78-year-old man presented to the Emergency Department with melena. Dieulafoy's lesions were observed on esophagogastroduodenoscopy, and endoscopic cauterization was performed. However, the patient complained of back pain and symptoms in...
Source: Clinical Endoscopy - Category: Gastroenterology Tags: Clin Endosc Source Type: research
Abstract The treatment or prevention of bleeding in patients with hemophilia A rely on replacement therapy with different factor VIII containing products or on the use of by-passing agents, i.e., activated prothrombin complex concentrates or recombinant activated factor VII. Emerging approaches include the use of bispecific anti-factor IXa/factor X antibodies, anti-Tissue Factor Pathway Inhibitor antibodies, interfering RNA to antithrombin, APC-specific serpins or gene therapy. The latter strategies however meet with short term clinical experience and potential adverse effects including the absence of tight tempor...
Source: Haematologica - Category: Hematology Authors: Tags: Haematologica Source Type: research
The usefulness of the activated partial thromboplastin time (APTT) waveform has been reported in hemophilia, acquired hemophilia and monitoring for anticoagulants.
Source: Thrombosis Journal - Category: Hematology Authors: Tags: Research Source Type: research
Abstract Emicizumab is a bispecific antibody to factor (F) IX/IXa and FX/FXa, which mimics FVIIIa cofactor function. Emicizumab prophylaxis significantly decreases bleeding events for patients with hemophilia A (PwHA). However, global hemostatic monitoring in emicizumab-treated PwHA remains poorly investigated. Using rotational thromboelastometry (ROTEM), we evaluated coagulation potentials of whole blood samples from seven emicizumab-treated PwHA who participated in ACE001JP/ACE002JP studies. Dose-dependent coagulation-enhancing effects of emicizumab to whole blood from PwHA mixed with an anti-FVIII C2 antibody i...
Source: International Journal of Hematology - Category: Hematology Authors: Tags: Int J Hematol Source Type: research
The “Joint Outcomes Study” (JOS) demonstrated improved joint outcomes for patients receiving primary prophylaxis versus on-demand therapy. The impact of primary prophylaxis on inpatient health care utilization is not well-defined. To evaluate changes in hospitalization care of children with hemophilia before and after the 2007 JOS publication, this study utilized the Pediatric Health Information System (PHIS) to evaluate admissions for patients with hemophilia A or B (age, 2 to 7) admitted between January 2002 and 2006 (pre-JOS) and January 2010 and 2014 (post-JOS). Discharge diagnosis codes and clinical transa...
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Online Articles: Original Articles Source Type: research
ConclusionThough personalized treatment can be formalized to some extent, it is expected that medical treatment skills and management by tacit knowledge are affected in individualized treatment based on standardized treatment. Medical institutions and medical staff are the main body sharing and deploying measures to disseminate and utilize medical devices, cooperating with them can be an effective management of standardized and individualized treatment.
Source: Personalized Medicine Universe - Category: Drugs & Pharmacology Source Type: research
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