Long-lasting bleed protection
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About hemophilia A
Maintaining therapeutic factor trough levels between doses is critical to prevent bleeding in patients with hemophilia A.1
AFSTYLA offers long-lasting protection from bleeds, with clinical data demonstrating zero bleeds (median AsBR,* n=226) on prophylaxis regimen regardless of age.
AFSTYLA also offers 7 dosing strengths for optimal flexibility and efficiency, plus twice-weekly dosing available to meet your members’ needs.†
Additionally, formation of neutralizing antibodies (inhibitors) has been reported following administration of AFSTYLA; previously untreated patients are at greater risk. Zero inhibitors were observed in a clinical trial of 258 previously treated patients; however, in the clinical trial, 12 of the 24 previously untreated patients developed an inhibitor to FVIII. The most common adverse reactions reported in clinical trials (>0.5% of subjects) were FVIII inhibition in previously untreated patients, dizziness, and hypersensitivity.
AFSTYLA twice weekly† is predicted to provide protection with FVIII median trough levels of 1.9%.2‡Explore more clinical information here.
*AsBR in clinical trials (IQR=0-2.4 for patients aged ≥12 years and 0-2.2 for patients aged <12 years).
†FDA approved for 2x- to 3x-weekly dosing.
‡Median trough levels of simulated steady-state FVIII activity following doses of 50 IU/kg AFSTYLA in adolescents and adults.
AsBR, annualized spontaneous bleeding rate; FDA, US Food and Drug Administration; FVIII, factor VIII; IQR, interquartile range.
What is AFSTYLA?
AFSTYLA is a single-chain, recombinant FVIII (rFVIII) indicated in adults and children with hemophilia A for:
On-demand
treatment and control of
bleeding episodes
Routine prophylaxis
to reduce frequency of
bleeding episodes
Perioperative
management of bleeding
AFSTYLA is not indicated for the treatment of von Willebrand disease.
Please see full prescribing information for AFSTYLA.
What are the key benefits?
Twice-weekly dosing3§
Zero bleeds
Median AsBR4-6||
§FDA approved for 2x- to 3x-weekly dosing.
||AsBR in clinical trials (IQR=0-2.4 for patients aged ≥12 years and 0-2.2 for patients aged <12 years).
The value of AFSTYLA
AFSTYLA demonstrates significant economic benefits vs other long-acting rFVIII treatments, including7:
Comparable efficacy
and dosing frequency
Up to 18% reduction
in factor consumption¶
Lowest annual consumption#
Up to 38% savings
per patient per year
Lowest yearly cost#
Decreased risk of breakthrough bleeds associated with fewer hospital admissions and other positive outcomes4-6
¶Calculated mean annual consumption (for all dosing frequencies) based on a patient who weighs 70 kg.
#Based on results from a real-world patient chart study sourced from geographically diverse hemophilia treatment centers of AFSTYLA, Adynovate®, and Eloctate® (n=40 for each product). Data were gathered from May 2018 to July 2018, with data for some patients including 2+ years of treatment. Patients must have been treated prophylactically, on their current rFVIII treatment for 8 weeks or more, with an alignment of age and severity mix.
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