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)
AHA: Low Bleeding Rates Observed in Dabigatran Dose-Ranging Trial (CME/CE)
Source: MedPage Today Cardiovascular [2009.11.19]
ORLANDO (MedPage Today) -- The oral anticoagulant dabigatran did not appear to markedly increase major bleeding rates among post-MI patients who were already being treated with aspirin and clopidogrel (Plavix), researchers said here.
Xanodyne Announces FDA Approval Of Lysteda(TM) (Tranexamic Acid) For Treatment Of Women With Heavy Menstrual Bleeding
Source: Pharma Industry / Biotech Industry News From Medical News Today [2009.11.17]
Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S. Food and Drug Administration (FDA) approval for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia.
Alternative to Warfarin May Cut Risk of Bleeding
Source: MedicineNet Atrial Fibrillation Specialty [2009.11.16]
Title: Alternative to Warfarin May Cut Risk of Bleeding
Category: Health News
Created: 11/15/2009 4:10:00 PM
Last Editorial Review: 11/16/2009
FDA Approves Lysteda To Treat Heavy Menstrual Bleeding
Source: Endocrinology News From Medical News Today [2009.11.14]
The U.S. Food and Drug Administration approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot. Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods.
Internal Bleeding
Source: MedicineNet Blood In Urine Specialty [2009.06.05]
Title: Internal Bleeding
Category: Diseases and Conditions
Created: 6/5/2009
Last Editorial Review: 6/5/2009
Published Studies Related to Mononine (Coagulation Factor IX Human)
Effects of soy consumption on oxidative stress, blood homocysteine, coagulation factors, and phosphorus in peritoneal dialysis patients. [2009.09]
OBJECTIVE: We studied the effects of soy consumption on oxidative stress, blood homocysteine, coagulation factors, and phosphorus in peritoneal dialysis patients... CONCLUSION: Soy consumption reduces plasma coagulation factor IX activity, which is a risk factor for thrombosis in peritoneal dialysis patients.
Comparison of the rates of joint arthroplasty in patients with severe factor VIII and IX deficiency: an index of different clinical severity of the 2 coagulation disorders. [2009.07.23]
Data from the Italian Hemophilia Centres were collected to perform a retrospective survey of joint arthroplasty in patients with severe hemophilia. Twenty-nine of 49 hemophilia centers reported that 328 of the 347 operations were carried out in 253 patients with severe hemophilia A (HA) and 19 in 15 patients with severe hemophilia B (HB)...
Thrombin generation and coagulation factor activities: evaluation and comparison with the international normalized ratio. [2009.07]
Oral anticoagulation therapy is monitored effectively by the international normalized ratio (INR). However, INR is perhaps not optimal in predicting risk of complications... In conclusion, neither CAT nor coagulation factor activities seem to provide additional information about the biological variation; however, larger clinical studies are needed to investigate the ability to predict complications in individual patients on oral anticoagulation therapy.
Prospective longitudinal study of coagulation profiles in children with hypoplastic left heart syndrome from stage I through Fontan completion. [2009.04]
OBJECTIVE: The risk for thrombosis is increased after the Fontan operation. It is unknown whether children with univentricular heart disease have an intrinsic coagulation anomaly or acquire a defect in coagulation during the course of the staged repair. This prospective, longitudinal study evaluated changes in coagulation profiles in a cohort of patients with hypoplastic left heart syndrome from stage I palliation through completion of the Fontan operation... CONCLUSION: This longitudinal study in patients with identical cardiac disease and staged surgical procedures confirms the increase in factor VIII level after the Fontan procedure. This is an acquired defect, and although the cause remains to be determined, monitoring factor VIII levels after the Fontan operation could indicate a subset of patients at risk for thrombosis.
Effect of elevated levels of coagulation factors on the risk of venous thrombosis in long-distance travelers. [2009.02.26]
Risk of venous thrombosis is increased after long-distance travel... Furthermore, the risk is greatly increased if other risk factors are present as well.
Clinical Trials Related to Mononine (Coagulation Factor IX Human)
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 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
Study Evaluating Allergic Reactions to Benefix in Hemophilia B Patients [Recruiting]
Based on the finding that anaphylactic reactions to Benefix ("FIX") are associated with a
specific IgE, a Basophil histamine release assay was selected to evaluate and demonstrate
subject sensitization to FIX.
A Post-marketing Surveillance (PMS) Study of Safety and Effectiveness in Patients With BeneFIX Treatment [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
Dose-Escalation Study Of A Self Complementary Adeno-Associated Viral Vector For Gene Transfer in Hemophilia B [Recruiting]
The purpose of this study is to determine the safety of giving a normal factor IX gene to
treat individuals who have an abnormal or no factor IX gene.
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