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About AFSTYLA

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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 annualized spontaneous bleeding rate [AsBR],* n=226) on prophylaxis regimen regardless of age.2

AFSTYLA also offers 7 dosing strengths for optimal flexibility and efficiency, plus twice-weekly dosing available to meet your members’ needs.2†

Additionally, zero inhibitors were observed in a clinical trial of 258 previously treated patients. The formation of neutralizing antibodies (inhibitors) to factor VIII (FVIII) has been reported following administration of AFSTYLA. The most common adverse reactions reported in clinical trials (>0.5%) were dizziness and hypersensitivity.2

AFSTYLA twice weekly is predicted to provide protection with FVIII median trough levels of 1.9%.3‡

Explore more clinical information here.
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*AsBR in clinical trials (interquartile range [IQR]=0-2.4 patients aged ≥12 years; 0-2.2 for patients aged <12 years).

US Food and Drug Administration (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.

What is AFSTYLA?

AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain, is indicated in adults and children with hemophilia A (congenital factor VIII [FVIII] deficiency) for2:

On Demand Icon

On-demand

treatment and control of bleeding episodes

Routine

Routine

prophylaxis to reduce frequency of bleeding episodes

Perioperative

Perioperative

management of bleeding

AFSTYLA is not indicated for the treatment of von Willebrand disease.

Please see full prescribing information for AFSTYLA.
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What are the clinical benefits?

2x

2x-weekly dosing

Zero bleed

Zero bleeds

Median AsBR5-7||

§Protection delivered with a low number of factor units for both 2x- or 3x-weekly dosing regimens.

||Decreased risk of breakthrough bleeds associated with fewer hospital admissions and other positive outcomes.

What are the economic benefits?

AFSTYLA demonstrates significant economic benefits vs other long-acting recombinant FVIII (rFVIII) treatments, including8:

Comparable

Comparable

Efficacy and dosing frequency
18%

Up to 18% reduction in factor consumption

Lowest annual consumption
38%

Up to 38% savings

Lowest yearly cost
  • Decreased risk of breakthrough bleeds associated with fewer hospital admissions and other positive outcomes5-7

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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The healthcare economic information provided herein is pursuant to Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) and Section 3037 of the 21st Century Cures Act (Public Law 114-255). It is intended for payors, formulary committees, or other similar entities with knowledge and expertise in the area of healthcare economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement.

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