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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‡

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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 dosing4§

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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Important Safety Information

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.

Important Safety Information

AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, is contraindicated in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis to AFSTYLA or its excipients, or hamster proteins.

AFSTYLA is for intravenous use only. AFSTYLA can be self-administered or administered by a caregiver with training and approval from a healthcare provider or hemophilia treatment center. Higher and/or more frequent dosing may be needed for patients under 12 years of age.

Hypersensitivity reactions, including anaphylaxis, are possible. Advise patients to immediately report symptoms of a hypersensitivity reaction. Should symptoms occur, immediately discontinue AFSTYLA and administer appropriate treatment.

Formation of neutralizing antibodies (inhibitors) has been reported following administration of AFSTYLA; previously untreated patients (PUPs) are at greater risk. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration.

Monitor plasma FVIII activity using a chromogenic assay or one-stage clotting assay. If one-stage clotting assay is used, multiply result by a conversion factor of 2 to determine FVIII activity level.

The most common adverse reactions reported in clinical trials (>0.5% of subjects) were Factor VIII inhibition in previously untreated patients (PUPs), dizziness, and hypersensitivity.

Indications

AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, is indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) 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.

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To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Srivastava A, Santagostino E, Dougall A, et al. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020;26(suppl 6):1-158. doi:10.1111/hae.14046 2. Afstyla. Prescribing information. CSL Behring Lengnau AG; 2021. 3. Zhang Y, Roberts J, Tortorici M, et al. Population pharmacokinetics of recombinant coagulation factor VIII-SingleChain in patients with severe hemophilia A. J Thromb Haemost. 2017;15(6):1106-1114. doi:10.1111/jth.13662 4. Data on file. Available from CSL Behring as DOF AFS-002. 5. Zhou ZY, Koerper MA, Johnson KA, et al. Burden of illness: direct and indirect costs among persons with hemophilia A in the United States. J Med Econ. 2015;18(6):457-465. doi:10.3111/13696998.2015.1016228 6. Dalton DR. Hemophilia in the managed care setting. Am J Manag Care. 2015;21(6)(suppl):S123-S130. 7. Mannucci PM. Half-life extension technologies for haemostatic agents. Thromb Haemost. 2015;113(1):165-176. doi:10.1160/TH14-04-0332 8. Simpson ML, Desai V, Maro GS, Yan S. Comparing factor use and bleed rates in U.S. hemophilia A patients receiving prophylaxis with 3 different long-acting recombinant factor VIII products. J Manag Care Spec Pharm. 2020;26(4):504-512. doi:10.18553/jmcp.2020.19318

AFSTYLA is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.

AFSTYLA® is a registered trademark of CSL Behring Lengnau AG.

Driven by Our Promise™ is a trademark of CSL Behring LLC.

All other trademarks are property of their respective owners.

©2022 CSL Behring LLC. The product information presented on this page is intended for US residents only.

USA-AFS-0090-FEB22

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