Delving into the Latest Updates on Factor IX complex(Grifols) with Synapse

Overview

Basic Info

Drug Type

Non-recombinant coagulation factor

Synonyms

Alphanine, Alphanine Hp, Alphanine Sd

+ [4]

Target

F10 x factor IX x factor VII x thrombin

Mechanism

F10 modulators(Coagulation factor X modulators), factor IX modulators(Coagulation factor IX modulators), factor VII modulators(Coagulation factor VII modulators)

+ [1]

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

Hemophilia B

Inactive Indication-

Originator Organization

Grifols Biologicals, Inc.

Active Organization

Grifols Biologicals, Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (20 Jul 1981),

Hemophilia B

Regulation-

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Gene Sequence

Sequence Code 207242

EFFICACY AND SAFETY OF FACTOR IX (FIX) CONTAINED IN ALPHANINE® AND ITS PHARMACOKINETIC COMPARISON WITH BENEFIX® IN PATIENTS WITH SEVERE HEREDITARY HAEMOPHILIA B (Follow-up study of the trial IG404: EFFICACY AND SAFETY OF FACTOR IX (FIX) CONTAINED IN ALPHANINE IN PATIENTS WITH SEVERE HEREDITARY HAEMOPHILIA B)

Start Date15 Aug 2008

Sponsor / Collaborator

Grifols Biologicals, Inc.

100 Clinical Results associated with Factor IX complex(Grifols)

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100 Translational Medicine associated with Factor IX complex(Grifols)

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100 Patents (Medical) associated with Factor IX complex(Grifols)

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31

Literatures (Medical) associated with Factor IX complex(Grifols)

02 Sep 2019·International Journal of NeuroscienceQ4 · MEDICINE

Bilateral subthalmic nucleus deep brain stimulation with microelectrode recordings in the setting of mild inherited hemophilia B: a case report

Q4 · MEDICINE

Article

Author: Nazzaro, Jules M. ; Yacoub, Abdulraheem ; Mohyuddin, Ghulam Rehman

Hemophilia B is an X linked recessive deficiency of factor IX that presents with a range of clinical severity that co-relates with factor levels. Although guidelines exist to guide perioperative hemostasis in such patients, there is scarce data on elective high-risk neurosurgeries, resulting in a reluctance to offer these patients elective neurosurgeries. These patients thus rarely if ever undergo such procedures. We report a unique case of undiagnosed mild hemophilia B in a gentleman that was found incidentally at age 64 during pre-operative workup. This gentleman had intractable Parkinson's disease for which subthalmic deep brain stimulation was indicated. He was found to have a prolonged APTT on initial lab testing. After subsequent workup, and having excluded the presence of inhibitors, he was diagnosed with Hemophilia B. With the use of Factor IX concentrates (AlphaNine®) and close clinical, laboratory, and radiological monitoring a plan was made for this patient to undergo this procedure. Our patient successfully underwent subthalmic deep brain stimulation with microelectrode recordings and intraoperative test stimulation in a two-step procedure, followed by single channel implantable neurostimulator and extension wire implantations 2 weeks later. The successful peri-operative course of this patient using this novel approach is described, and the need for future data in this regard is emphasized.

01 May 2019·Vox Sanguinis

Three‐factor prothrombin complex concentrates for refractory bleeding after cardiovascular surgery within an algorithmic approach to haemostasis

Article

Author: Ghadimi, Kamrouz ; Welsby, Ian J. ; Hashmi, Nazish K. ; Raiff, Robert D. ; Barac, Yaron D. ; Srinivasan, Amudan J. ; Levy, Jerrold H. ; Li, Yi‐Ju ; Root, Adam G. ; Gaca, Jeffrey G. ; Ortel, Thomas L.

Background/ObjectivesProthrombin complex concentrates (PCC) are increasingly administered off‐label in the United States to treat bleeding in cardiovascular surgical patients and carry the potential risk for acquired thromboembolic side‐effects after surgery. Therefore, we hypothesized that the use of low‐dose 3‐factor (3F) PCC (20‐30 IU/kg), as part of a transfusion algorithm, reduces bleeding without increasing postoperative thrombotic/thromboembolic complications.Materials/MethodsAfter IRB approval, we retrospectively analysed 114 consecutive, complex cardiovascular surgical patients (age > 18 years), between February 2014 and June 2015, that received low‐dose 3F‐PCC (Profilnine®), of which seven patients met established exclusion criteria. PCC was dosed according to an institutional perioperative algorithm. Allogeneic transfusions were recorded before and after PCC administration (n = 107). The incidence of postoperative thromboembolic events was determined within 30 days of surgery, and Factor II levels were measured in a subset of patients (n = 20) as a quality control measure to avoid excessive PCC dosing.ResultsTotal allogeneic blood product transfusion reached a mean of 12·4 ± 9·9 units before PCC and 5·0 ± 6·3 units after PCC administration (P < 0·001). The mean PCC dose was 15·8 ± 7·1 IU/kg. Four patients (3·8%) each experienced an ischaemic stroke on postoperative day 1, 2, 4 and 27. Seven patients (6·5%) had acquired venous thromboembolic disease within 10 days of surgery. Median factor II level after transfusion algorithm adherence and PCC administration was 87%.Conclusions3F‐PCC use for refractory bleeding after cardiovascular surgery resulted in reduced transfusion of allogeneic blood and blood products. Adherence to this algorithmic approach was associated with an acceptable incidence of postoperative thrombotic/thromboembolic complications.

01 Jul 2016·Journal of Thrombosis and ThrombolysisQ4 · MEDICINE

Clinical effectiveness and safety outcomes associated with prothrombin complex concentrates

Q4 · MEDICINE

Article

Author: Coons, James C ; Saul, Melissa ; Smith, Roy E ; Hedges, Ashley

Prothrombin complex concentrates (PCCs) are indicated for urgent reversal of warfarin and used for reversal of novel oral anticoagulants, in patients with acute major bleeding or need for an urgent procedure. The research goal was to evaluate effectiveness and safety outcomes with PCC usage at our institution. A retrospective review of electronic medical records identified patients that received a PCC commercially available in the United States (KCentra(®) or Profilnine(®)) at twelve hospitals in a tertiary care health system from July 1, 2013 to April 30, 2014. A total of 193 patients received PCC, of which 184 patients received four-factor PCC. The patient population was 48 % male and 75 % Caucasian, with a mean age of 73 years old. Clinical outcomes of interest included time to achieve a target INR ≤1.3, time to Hgb >7 g/dL, and incidence of thromboembolism. A total of 143 patients were on warfarin (74.1 %) at baseline, whereas 18 patients (9.3 %) were taking a novel anticoagulant. Target INR of ≤1.3 was achieved in 125 patients (65.8 %), within a median time of 8.03 h (IQR 3.38-34.07). Among patients with a baseline Hgb <7 g/L (n = 13), the median time to Hgb >7 g/dL was 8.48 h (IQR 6.95-13.00). Eight patients (4.1 %) developed an acute venous thromboembolism following PCC administration. INR reversal was achieved in approximately two-thirds of patients, with a low incidence of venous thromboembolism. Four-factor PCC is a viable alternative to plasma.

100 Deals associated with Factor IX complex(Grifols)

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