- Male patients greater than or equal to 12 years of age with severe hemophilia A
(FVIII:C less than 1%).
- Treatment history of greater than 150 EDs to prior recombinant or plasma-derived FVIII
replacement products.
- Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII
replacement products.
- Serum albumin greater than or equal to the lower limit of normal (LLN).
- Platelet count greater than or equal to 100,000/µL.
- Prothrombin time (PT) less than or equal to1.25 × ULN, or international normalized
ratio (INR) less than or equal to 1.5.
- HIV positive subjects must have a CD4 count greater than 200/µL and HIV viral load
less than 200 particles/µL.
- Presence of any bleeding disorder in addition to hemophilia A.
- A positive FVIII inhibitor, according to the local laboratory, at screening; or any
Bethesda Inhibitor Titer greater than 0.6, regardless of the normal range for the
testing laboratory.
- Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI])
during the screening period.
- Prior exposure to moroctocog alfa (AF-CC).
- Known hypersensitivity to hamster protein.