How effective is ReFacto?
ReFacto has been proven effective in adults and children of all ages, including newborns.³⁶ The efficacy and safety profiles of ReFacto have been demonstrated in previously treated and previously untreated hemophilia A patients. In fact, the efficacy of ReFacto was confirmed in the largest clinical trial program for any hemophilia product at licensure.⁴¹

What is an inhibitor?
An inhibitor is an antibody that interferes with the factor VIII product's ability to help form a blood clot.^15,16

Have inhibitors been seen with ReFacto?
In clinical trials, the degree of inhibitor formation with ReFacto is similar to that seen with other recombinant factor VIII products.³⁶ During the pivotal previously treated patient (PTP) study with ReFacto, less than 1% (1 of 113) of previously treated patients developed an inhibitor.³⁶ In the previously untreated patient (PUP) study, 32% (32 of 101) of PUPs developed inhibitors, of which half were low-titer inhibitors.^43,44 Of the 15 previously untreated patients who developed high-level inhibitors and underwent immune tolerance induction therapy, only 4 had detectable inhibitors at the end of the study.^43,44

Low-titer inhibitors are common in previously untreated patients and in previously treated patients on factor VIII products, as are high-titer inhibitors in previously untreated patients. High-titer inhibitors, which are generally rare in previously treated patients, have been reported postmarketing in previously treated patients on ReFacto.

What are the common adverse events with ReFacto?
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.

Can I benefit from prophylaxis treatment?
Prophylaxis means treating to prevent bleeding episodes with regular infusions.^4,24 Be sure to ask your health care provider if prophylaxis treatment is right for you.

ReFacto is the only factor VIII product approved by the U.S. Food and Drug Administration (FDA) for short-term routine prophylaxis.^{36,37,38,39,40} The effect of routine prophylaxis on long-term morbidity and mortality is unknown.³⁶

Can ReFacto be used during surgery?
In clinical studies, ReFacto has been used successfully in surgery, including orthopedic procedures. In one study, doctors rated treatment with ReFacto as "excellent" or "good" in 99.6% of assessments.^43,44

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.