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Read Important Information on Helixate® FS, Antihemophilic Factor (Recombinant)

Read Important Information on Helixate® FS, Antihemophilic Factor (Recombinant)

Twice-weekly Dosing May Meet Your Patients' Needs

Extended time to 1% Factor VIII level

4 to 5 days to 1% factor VIII level 50 IU/kg

Median time to trough levels of 1% FVIII has been estimated between 4 and 5 days, depending on dose and extrapolation method.

Study design

Information based on overall data from two AFSTYLA studies

A phase I/III, open-label, multicenter, crossover study in patients ≥12 years, and a phase III, open-label, multicenter study in patients <12 years.

Adult/adolescent study

The pharmacokinetics (PK) of AFSTYLA was evaluated in 91 (81 adults and 10 adolescents) previously treated patients (PTPs) with severe hemophilia A (<1% endogenous Factor VIII activity) following an intravenous injection of a single dose of 50 IU/kg.

Pediatric study

The PK of AFSTYLA was evaluated in 39 previously treated children (<12 years) with severe hemophilia A (<1% endogenous Factor VIII activity) following a 50 IU/kg intravenous injection of AFSTYLA.

Reference: 1. Data on file available from CSL Behring as DOF AFS-001.

Zero bleeds (median AsBR*) regardless of dosing regimen

The recommended starting regimen is

  • 20–50 IU/kg for patients ≥12 years
  • 30–50 IU/kg for patients <12 years

Adjust regimen based on patient response

  • Patients <12 years may require more frequent or higher doses

Proven protection with a low median dose

The median doses used in AFSTYLA clinical trials were

  • 2x weekly
    • 35 IU/kg for patients of all ages
  • 3x weekly
    • 30 IU/kg for patients ≥12 years
    • 32 IU/kg for patients <12 years

*Annualized spontaneous bleeding rate in clinical trials (IQR=0–2.4 for patients ≥12 years; 0–2.2 for patients <12 years).

Calculate your patient's
starting dose

Prescription calculator

Other dosing regimens

On-demand treatment

On-demand dosing chart

Perioperative management

Perioperative dosing chart
Dosing formula

The dose to achieve a desired in vivo peak increase in Factor VIII level may be calculated using the following formula:

Dosing Formula

The amount of AFSTYLA to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.

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