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Kogenate (Antihemophilic Factor (Recombinant)) - Summary



Kogenate® FS Antihemophilic Factor (Recombinant) is a sterile, stable, purified, nonpyrogenic, dried concentrate that has been manufactured using recombinant DNA technology. Kogenate FS is intended for use in the treatment of classical hemophilia (hemophilia A), and is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII (FVIII) gene has been introduced.1 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a highly purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as FVIII derived from human plasma. Compared to its predecessor product KOGENATE® Antihemophilic Factor (Recombinant), Kogenate FS incorporates a revised purification and formulation process that eliminates the addition of Albumin (Human).

Kogenate FS is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor FVIII. Kogenate FS provides a means of temporarily replacing the missing clotting factor in order to correct or prevent bleeding episodes, or in order to perform emergency or elective surgery in hemophiliacs.

In clinical studies with the predecessor productKOGENATE, some patients who developed inhibitors on study continued to manifest a clinical response when inhibitor titers were less than 10 Bethesda Units (BU) per mL. When an inhibitor is present, the dosage requirement for FVIII is variable. The dosage can be determined only by clinical response, and by monitoring circulating FVIII levels after treatment (see DOSAGE AND ADMINISTRATION). Because Kogenate FS has similar biological activity toKOGENATE it can be used in the same manner.

Kogenate FS does not contain von Willebrand's factor and therefore is not indicated for the treatment of von Willebrand's disease.

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Published Studies Related to Kogenate (Antihemophilic Factor)

Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy--International Kogenate-FS Study Group. [2000.06]
To add an increased level of safety to antihemophilic factor replacement therapy, a full-length, recombinant Factor VIII (rFVIII) product has been developed without human-derived plasma proteins during purification and formulation and using an additional solvent/detergent viral inactivation step...

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Clinical Trials Related to Kogenate (Antihemophilic Factor)

Russian Kogenate Pediatric Study [Completed]

Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A [Completed]

Study Evaluating The Safety Of Xyntha In Usual Care Settings [Terminated]
The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year period. Procedures completed throughout the study include collection of vital signs, physical exams, and laboratory assessments. Patients will be required to complete an infusion log for each Xyntha infusion.

ADVATE 2 mL Post-Authorization Safety Surveillance (PASS) [Recruiting]
This is a Post-Authorization Safety Surveillance (PASS) study designed to collect data on the safety and effectiveness of ADVATE reconstituted in 2 mL Sterile water for injection (SWFI) during routine clinical practice in children until 12 years of age. This surveillance study is a post-licensure commitment for ADVATE reconstituted in 2 mL SWFI.

EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan [Completed]
The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.

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Reports of Suspected Kogenate (Antihemophilic Factor) Side Effects

Chest Pain (4)Haemorrhage (3)Tachycardia (3)Anaphylactic Shock (3)Factor Viii Inhibition (3)Hyperhidrosis (3)Loss of Consciousness (3)Haemarthrosis (3)Hypotension (3)Pulse Absent (3)more >>

Page last updated: 2006-01-31

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