Proven Efficacy With ReFacto

• Largest clinical trials of any factor VIII product at licensure²¹
  • Supported by 80,000 infusions and more than 75,000 exposure days^22,23
• Efficacy across a broad range of patient types^22,23:
  • Previously treated patients (PTPs)
  • Previously untreated patients (PUPs)
  • Patients of all ages: adults, children, infants, and newborns
• Efficacy in different treatment regimens^16,22,23:
  • On demand
  • Short-term routine prophylaxis
  • Surgery

Proven Efficacy in PTPs and PUPs and in All Treatment Regimens

On demand
In PTPs:

• 73% of bleeding episodes treated successfully with 1 infusion^22,23
• Hemostatic efficacy rated good/excellent by patients or caregivers in 95% of bleeding episodes^22,23*
• 97% to 99% of all infusions rated good/excellent by patients^22,23

In PUPs:

• 84% of bleeding episodes treated successfully in ≤2 infusions^22,23
• Hemostatic efficacy rated good/excellent by patients or caregivers in 94% of bleeding episodes^22,23*
• 92% to 95% of all infusions rated good/excellent by patients^22,23

In surgery

• Hemostatic efficacy rated good/excellent by surgeons in 99.6% of infusions in all patients¹⁶

*Rated at first infusion.

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.