ASH Clinical News August 2016 | Page 43
For adult and pediatric patients with hemophilia A
Help Him REACH HIGHER With
Long-lasting Protection
AFSTYLA is the first and only recombinant Factor VIII that delivers proven,
long-lasting bleed protection with a novel single-chain design
WEEKLY
AVAILABLE
Flexibility to dose
2x or 3x weekly
ZERO
BLEEDS
COMPARABLE TO
(median AsBR*)
VIII
In all studied populations regardless
of dosing regimen
Identical to endogenous
Factor VIII once activated
NATURAL
FACTOR
Zero inhibitors observed—Low incidence of adverse reactions in clinical trials
The most common adverse reactions reported in clinical trials (>0.5%) were dizziness and hypersensitivity.
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*Annualized spontaneous bleeding rate in clinical trials (IQR=0–2.4 for patients ≥12 years).
Indications and Important Safety Information
AFSTYLA 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.
AFSTYLA is contraindicated in patients who have had life-threatening hypersensitivity reactions to AFSTYLA
or its excipients, or to 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. If symptoms occur, discontinue AFSTYLA and administer appropriate treatment.
Development of Factor VIII (FVIII) neutralizing antibodies (inhibitors) can occur. If expected FVIII activity levels are
not attained or bleeding is not controlled with appropriate dose, perform an assay to measure FVIII 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%) were dizziness and hypersensitivity.
AFSTYLA is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. AFSTYLA® is
a registered trademark of CSL Behring Recombinant Facility AG. Biotherapies for Life® is a registered
trademark of CSL Behring LLC.
©2016 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA
www.CSLBehring-us.com www.AFSTYLA.com AFS16-04-0025 5/2016