HEMOFIL M SUMMARY
HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 22 AHF International Units/mg of total protein. HEMOFIL M AHF contains a maximum of 12.5 mg/mL Albumin, and per AHF International Unit, 0.07 mg polyethylene glycol (3350), 0.39 mg histidine, 0.1 mg glycine as stabilizing agents, not more than 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein. See Clinical Pharmacology.
The use of HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.
HEMOFIL M AHF can be of significant therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3 However, in such uses, the dosage should be controlled by frequent laboratory determinations of circulating AHF.
HEMOFIL M AHF is not indicated in von Willebrand's disease.
Published Studies Related to Hemofil M (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...
Pharmacokinetic in vivo comparison using 1-stage and chromogenic substrate assays with two formulations of Hemofil-M. [1996.12]
In a study to demonstrate the safety and pharmacokinetics (half-life and recovery) of two different method M purified AHF (Hemofil-M) concentrates processed in the USA and Spain, two different methods of factor VIII assay (one-stage clotting and chromogenic) have been compared in vivo... Since most clinicians use the clotting assay, potency labelling using the chromogenic assay, will overestimate predicted Hemofil-M recovery by as much as 25%.
Pharmacokinetic properties of recombinant factor VIII compared with a monoclonally purified concentrate (Hemofil M). The Recombinate Study Group. [1992.10.05]
A recombinant FVIII preparation, Recombinate, was compared with a high-purity plasma-derived concentrate, Hemofil M, in 47 hemophilia A patients in a cross-over evaluation of pharmacokinetic properties. The recombinant material showed a significantly lower clearance, volume of distribution, and higher in vivo recovery, but a similar half-life to the plasma-based product.
Clinical Trials Related to Hemofil M (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.
Efficacy and Safety of ADVATE Standard Prophylaxis to Hemophilia A [Not yet recruiting]
Hemophilia A is an X-linked recessive, congenital bleeding disorder caused by deficient or
defective coagulation factor VIII (FVIII). Prophylaxis is recommended as the standard of
care for boys with severe haemophilia by WHO and World Federation Of Hemophilia (WFH). The
efficacy and safety of prophylaxis in preventing bleeds and arthropathy in patients with
hemophilia has been confirmed in well-designed clinical studies. To keep the factor level
above 1%, the standard dosage for patients with severe hemophilia A is 20-40 Units
/kg/infusion (average 30 Units /kg) every other day or three times a week. This dosage has a
very high consumption of factor, up to 5000-6000 international unit (IU)/kg/year. The high
consumption of factor and cost present a major barrier to use the standard prophylaxis in
many countries particularly in the developing world.
In China the majority of boys with severe hemophilia A can only pay for on-demand treatment
or low-dose prophylaxis. Ao after the affordability of patients was solved and many patients
will get more chance to receive standard prophylaxis.
This study is designed to evaluate the Annual Bleeding rate (ABR), joint health outcomes and
QoL outcomes in subjects using ADVATE(Recombinant Human Coagulation Factor VIII for
injection) standard prophylaxis under the conditions of routine practice.
Reports of Suspected Hemofil M (Antihemophilic Factor) Side Effects
General Physical Health Deterioration (3),
Hepatitis C (1),
Klebsiella Infection (1)
Page last updated: 2006-01-31