MONONINE SUMMARY
Mononine®, Coagulation Factor IX (Human), is a sterile, stable, lyophilized concentrate of Factor IX prepared from pooled human plasma and is intended for use in therapy of Factor IX deficiency, known as Hemophilia B or Christmas disease. Mononine® is purified of extraneous plasma-derived proteins, including Factors II, VII and X, by use of immunoaffinity chromatography.
Mononine® is indicated for the prevention and control of bleeding in Factor IX deficiency, also known as Hemophilia B or Christmas disease.
Mononine® is not indicated in the treatment or prophylaxis of Hemophilia A patients with inhibitors to Factor VIII.
Mononine® contains non-detectable levels of Factors II, VII and X (<0.0025 IU per Factor IX unit using standard coagulation assays) and is, therefore, not indicated for replacement therapy of these clotting factors.
Mononine® is also not indicated in the treatment or reversal of coumarin-induced anticoagulation or in a hemorrhagic state caused by hepatitis-induced lack of production of liver dependent coagulation factors.
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NEWS HIGHLIGHTSMedia Articles Related to Mononine (Coagulation Factor IX Human)
Medical Diagnostic Device Employs Wireless Signals To Identify Brain Swelling Or Bleeding
Source: Medical Devices / Diagnostics News From Medical News Today [2013.05.15]
New technology developed at the University of California, Berkeley, is using wireless signals to provide real-time, non-invasive diagnoses of brain swelling or bleeding. The device analyzes data from low energy, electromagnetic waves, similar to the kind used to transmit radio and mobile signals...
New Design Mechanical Heart Valve Requires Low-Dose Anticoagulation Therapy, Decreases Bleeding Risk
Source: Medical Devices / Diagnostics News From Medical News Today [2013.05.08]
For more than 40 years, patients under 65 years of age requiring heart valve replacement have had to choose between a mechanical valve that offers life-long durability but requires aggressive warfarin anticoagulation or a biological (cow or pig) valve that will wear out in 10-20 years but does not require anticoagulation...
Kcentra Approved to Stop Severe Bleeding in Heart Patients
Source: MedicineNet Atrial Fibrillation Specialty [2013.05.01]
Title: Kcentra Approved to Stop Severe Bleeding in Heart Patients
Category: Health News
Created: 4/30/2013 12:35:00 PM
Last Editorial Review: 5/1/2013 12:00:00 AM
Some Antidepressants Linked to Bleeding Risk With Surgery
Source: MedicineNet fluoxetine Specialty [2013.04.30]
Title: Some Antidepressants Linked to Bleeding Risk With Surgery
Category: Health News
Created: 4/29/2013 4:35:00 PM
Last Editorial Review: 4/30/2013 12:00:00 AM
IUD May Be Best for Heavy Menstrual Bleeding
Source: MedicineNet Vaginal Bleeding Specialty [2013.01.10]
Title: IUD May Be Best for Heavy Menstrual Bleeding
Category: Health News
Created: 1/10/2013 11:00:00 AM
Last Editorial Review: 1/10/2013 12:00:00 AM
Published Studies Related to Mononine (Coagulation Factor IX Human)
A randomized, partially blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system in patients with acute coronary syndromes: design and rationale of the RADAR Phase IIb trial. [2011.02]
Anticoagulants are the cornerstone of current acute coronary syndrome (ACS) therapy; however, anticoagulation regimens that aggressively reduce ischemic events are almost uniformly associated with more bleeding... The objectives of RADAR are (1) to determine the safety of a range of levels of RB006 reversal with RB007 after catheterization, (2) to confirm whether a dose of 1 mg/kg RB006 results in near-complete inhibition of factor IXa in patients with ACS, and (3) to assess the efficacy of RB006 as an anticoagulant in patients with ACS undergoing percutaneous coronary intervention.
First clinical application of an actively reversible direct factor IXa inhibitor as an anticoagulation strategy in patients undergoing percutaneous coronary intervention. [2010.08.10]
CONCLUSIONS: This study demonstrates the clinical translation of a novel platform of anticoagulation targeting factor IXa and its active reversal to percutaneous coronary intervention and provides the basis for further investigation. CLINICAL TRIAL REGISTRATION:URL: http://www.clinicaltrials.gov. Unique identifier: NCT00715455.
Coagulation factors II, V, IX, X, XI, and XII, plasminogen, and alpha-2 antiplasmin and risk of coronary heart disease. [2010.04.30]
AIM: To examine whether plasma levels of coagulation factors II, V, IX, X, XI, and XII, plasminogen, and alpha-2 antiplasmin are associated with coronary heart disease (CHD) in a prospective case-cohort study... CONCLUSIONS: Positive associations of factors IX and XI, and alpha-2 antiplasmin with incident CHD were not strong and accounted for by classical coronary risk factors.
Effects of L-Carnitine supplement on plasma coagulation and anticoagulation factors in hemodialysis patients. [2010]
BACKGROUND: Hypercoagulability is an important risk factor for thrombosis and its complications in hemodialysis patients. This study was designed to investigate the effects of l-carnitine supplement on plasma coagulation and anticoagulation factors in hemodialysis patients... CONCLUSION: l-Carnitine supplement reduces serum CRP, a marker of systemic inflammation, and plasma fibrinogen, an inflammation-related coagulation factor, in hemodialysis patients. Therefore, l-carnitine may play an effective role in preventing cardiovascular diseases in these patients.
Coagulation factors IX through XIII and the risk of future venous thrombosis: the Longitudinal Investigation of Thromboembolism Etiology. [2009.10.01]
Higher levels of procoagulant factors and factor XII deficiency may be risk factors for first venous thromboembolism (VTE). We studied associations of coagulation factors IX through XIII with risk of future VTE in 2 general population samples... Among these procoagulant factors, only elevated factor XI was a risk factor for VTE.
Clinical Trials Related to Mononine (Coagulation Factor IX Human)
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B [Recruiting]
To provide safety and effectiveness information of BeneFIX during the post-marketing period
as required by Korea FDA regulations, to identify any potential drug related treatment
factors in Korean population including:
1) Unknown adverse reactions, especially serious adverse reactions; 2) Changes in the
incidences of adverse reactions under the routine drug uses.
3) Factors that may affect the safety of the drug 4) Factors that may affect the
effectiveness of the drug
Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients [Recruiting]
The purpose of this pivotal Phase 1/3 study is to determine the pharmacokinetic (PK)
parameters, the hemostatic efficacy, and the safety of BAX 326, a recombinant factor IX, in
previously treated patients (PTPs) with severe and moderately severe hemophilia B.
Study Evaluating On-Demand Treatment With BeneFIX in Chinese Subjects [Recruiting]
This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in
Chinese hemophilia B subjects
Gene Transfer for Subjects With Hemophilia B Factor IX Deficiency [Recruiting]
Hemophilia B is caused by a defect in the gene that produces the factor IX protein. Factor
IX protein is important in blood clotting. Patients with severe hemophilia B, have less than
1% of the normal factor IX. Such low levels can result in spontaneous bleeding episodes that
cause destruction of bone and tissue. The purpose of this research study is to determine the
safety of a new type of approach called gene transfer for the treatment of hemophilia B.
Since the factor IX gene was discovered, scientists have been working on ways to transfer
the normal factor IX gene into hemophilia B patients' cells to cause their cells to produce
normal factor IX protein. This type of approach is called gene transfer. The agents used to
bring a gene inside cells are called "vectors". Many vectors are derived from viruses. In
nature, viruses must get inside cells in order to reproduce. Adeno-associated virus (AAV)
will be used to transfer a normal gene for human clotting factor IX into subjects with
severe hemophilia B (AAV human Factor IX vector). In this study, AAV human Factor IX vector
will be injected into the liver using a catheter inserted into a large blood vessel (called
the proper hepatic artery or the right hepatic artery).
Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B [Recruiting]
The purpose of this study will be to determine if a once-weekly prophylaxis regimen of
BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.
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