ReFacto Is Pharmacokinetically Equivalent to Advate® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (rAHF/PFM)

• In a comparative pharmacokinetic study, measured plasma drug concentrations over time for ReFacto and Advate were not significantly different²¹

Study design: Third-party, unblinded, randomized, multicenter, 2-period, crossover pharmacokinetic study of ReFacto and Advate administered intravenously as a bolus infusion at a dose of 50 ± 5 IU/kg to 17 previously treated patients with severe hemophilia A. Using the chromogenic substrate assay, factor VIII activity was assessed before each bolus infusion and then at specific times over the 48-hour period after infusion.²¹

ReFacto is a registered trademark of Wyeth Pharmaceuticals Inc. Advate Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method is a registered trademark of Baxter International Inc.

• Mean area under the plasma concentration-time curve from time zero to the last measurable concentration (IU•h/mL) is not significantly different between ReFacto (13.3 ± 4.0) and Advate (12.7 ± 3.7)²¹

Pharmacokinetics Equivalent to Full-Length Advate²¹

• The pharmacokinetic (PK) parameters of ReFacto and Advate were not significantly different²¹

Pharmacokinetics Equivalent to Plasma-Derived Factor VIII Products³⁴

• In a pharmacokinetic (PK) study of previously treated patients (PTPs) (n=18), recovery and half-life of ReFacto were similar to those of a plasma-derived product³⁴

• Incremental recovery with ReFacto ranged from 1.9 to 3.3 IU/dL factor VIII activity increase per IU/kg, which is comparable to that of a pdFVIII product³⁴

*Factor VIII potency was determined according to chromogenic assay.

ReFacto Mean Incremental Recovery Unchanged Over Time²¹

• Mean recovery and half-life were consistent when measured at baseline and at 12 months in PTPs (n=37)²¹

Indication
ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.

Important Safety Information

	•	As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions.
	•	The remote possibility exists for hypersensitivity to non-human mammalian proteins. Known hypersensitivity to mouse or hamster proteins may be a contraindication to the use of ReFacto.
	•	Allergic reactions such as hives, itching, difficulty breathing, rapid heart rate, light-headedness and anaphylaxis have been reported for all factor VIII products. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any of these symptoms occur.

Please see ReFacto Prescribing Information

The health information contained herein is provided for educational purposes only and is not meant to replace personal discussions between health care providers and patients. All decisions about patient care must be made with a health care provider who can assess the special needs of each individual patient.