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.
Media Articles Related to Hemofil M (Antihemophilic Factor)
PRAC: Kogenate/Helixate Benefits Top Risks for Hemophilia A
Source: Medscape Today Headlines [2013.12.06]
The EMA committee says current evidence does not confirm an increased risk for inhibitor development with Kogenate Bayer and Helixate NexGen compared with other factor VIII products.
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)
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A [Completed]
The study will consist of two parts: a safety and efficacy period in which all subjects will
participate and a pharmacokinetic analysis period, in which 30 eligible subjects will
participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of
ReFacto AF in patients with Hemophilia A.
Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A [Terminated]
Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study
is to further monitor whether participants with severe Hemophilia A will develop inhibitors
or antibodies at the later stage when switched from their current recombinant therapy
produced from Chinese Hamster Ovary (CHO) cell line to KogenateŽ-FS raised in a Baby Hamster
Kidney cell line.
Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A [Active, not recruiting]
The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial
recovery (% increase [IU/dL] per IU/kg infused) and major single-infusion pharmacokinetic
parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not
have received treatment with a factor VIII concentrate for at least 3 days. Blood samples
will be drawn within 30 minutes pre-infusion and at 0. 25, 0. 5, 1, 3, 6, 9, 24, 28, 32 and 48
hours post-infusion. A washout period of at least 3 days, but no more than 30 days between
the last blood draw and the next infusion will be observed. During participation, subjects
will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII
A secondary objective is to investigate the relationship between pharmacokinetic parameters
at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and
von Willebrand factor antigen at baseline.
Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings [Recruiting]
The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and
other Factor VIII products.
Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A [Completed]
Reports of Suspected Hemofil M (Antihemophilic Factor) Side Effects
General Physical Health Deterioration (3),
Hepatitis C (1),
Klebsiella Infection (1)
Page last updated: 2013-12-06