Twice-weekly Dosing May Meet Your Patients' Needs

AFSTYLA twice weekly* is predicted to provide protection with FVIII median trough levels of 1.9%†1

Predicted FVIII activity with simulated twice-weekly dosing 1

FVIII activity when dosed twice weekly†1

With twice-weekly dosing†1:

80% of patients could maintain >1% FVIII activity

  • A median 1.9% trough FVIII activity was predicted for patients treated with AFSTYLA (range: 0.58–8.0)1

When dosed three times weekly†1:

96% of patients could maintain >1% FVIII activity

  • A median 4.4% trough FVIII activity was predicted for patients treated with AFSTYLA (range: 1.1–17.3)1

*FDA approved for 2x–3x weekly dosing.
Median trough levels of simulated steady-state FVIII activity following doses of 50 IU/kg AFSTYLA in adolescents and adults.

1. Study design

Data derived from simulated steady-state analysis from a PK model developed based on the levels of FVIII activity in previously treated adolescent and adult patients who had FVIII activity <1 IU/dL and no FVIII inhibitors at screening. Patients had not received FVIII therapy for at least 4 days prior to being given AFSTYLA at 50 IU/kg. Blood samples for PK assessments were collected before infusion (predose) and up to 96 hours after infusion. A visual predictive check was performed to evaluate the performance of the final population PK model.

Twice-weekly dosing with AFSTYLA provides Jonathan with bleed protection as he plays with his friends

"One less infusion means a world of difference to a parent."

–Hector, whose son Jonathan switched to AFSTYLA

‡Testimonial is the speaker’s personal experience. Individual results may vary.

Zero bleeds (median AsBR§) regardless of dosing regimen

The recommended starting regimen for routine prophylaxis 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

FDA approved for dosing 2 to 3 times a week

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).

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Other dosing regimens

On-demand treatment

On-demand dosing chart

Perioperative management

Perioperative dosing chart

Reference: 1. Zhang Y, Roberts J, Tortorici M, et al. Population pharmacokinetics of recombinant coagulation factor VI 11-SingleChain in patients with severe hemophilia A. J Thromb Haemost. 2017;15(6):1106-1114.

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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