ASH Clinical News November 2015 | Page 23

Designed to prevent and control bleeds—

XYNTHA SOLOFUSE is a factor VIII that helps prepare your patients to
live actively
1.9 annualized bleeding rate (ABR)

In 94 previously treated patients (PTPs) aged 12 to 60 years, the median ABR for all bleeding
episodes was 1.9 (mean of 3.9)1,2
Study design: Open-label study of PTPs (mean age, 27.7 years; range, 12-60 years) with severe or moderately
severe hemophilia A (FVIII:C ≤2%; ≥150 previous exposure days) given XYNTHA 3 times per week (30 ± 5 IU/kg;
N=94) and on demand (investigator determined dose; n=53 [187 bleeding episodes]). Results reported here for
3 times per week administration are based on 89 patients accruing ≥50 exposure days to XYNTHA®.1,2

All-in-one reconstitution in a travel-anywhere kit
What your patients need to infuse on the go
Syringe

Plunger

Vented Blue Cap
Infusion Set
Bandage
Gauze Pad

Alcohol Swab
Travel Kit

See more at XYNTHAHCP.com

• Clinical response to XYNTHA may vary. If bleeding is not controlled
with the recommended dose of factor, determine the plasma level and
administer a dose of XYNTHA sufficient to achieve clinical response. If
the factor level does not increase or there is no response, suspect an
inhibitor and perform appropriate testing.
• Across all studies, the most common adverse reactions (≥10%) with
XYNTHA in previously treated adult and pediatric patients were
headache (26% of subjects), arthralgia (25%), fever (21%), and cough
(11%). Other adverse reactions reported in ≥5% of subjects were
diarrhea, vomiting, weakness, and nausea.
• XYNTHA is an injectable medicine administered by intravenous (IV)
infusion. Patients should be advised that local irritation may occur when
infusing XYNTHA after reconstitution in XYNTHA® SOLOFUSE®.

References: 1. Xyntha® Solofuse® Antihemophilic
Factor (Recombinant) Prescribing Information,
Wyeth Pharmaceuticals Inc. 2. Recht M, Nemes L,
Matysiak M, et al. Clinical evaluation of moroctocog
alfa (AF-CC), a new generation of B-domain
deleted recombinant factor VIII (BDDrFVIII) for
treatment of haemophilia A: demonstration of
safety, efficacy, and pharmacokinetic equivalence
to full-length recombinant factor VIII. Haemophilia.
2009;15(4):869-880.
Frisbee is a registered trademark of Wham-O.

Please see brief summary of full Prescribing Information for XYNTHA
and XYNTHA SOLOFUSE on next page.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

RUS780307-01 © 2015 Pfizer Inc.
October 2015

All rights reserved.