ReFacto is a recombinant (made from genetically recombined DNA) factor VIII product for hemophilia A that is administered intravenously (through a vein).

How can ReFacto benefit my life?
ReFacto has proven efficacy, viral safety, and advantages
of customized care that can let you tailor your therapy to your
needs.³⁶

Customized care with ReFacto means:

• The ReFacto R2 Kit for Rapid Reconstitution
• A broad range of vial sizes available, including the first 2000 IU vial^{36,37,39-41,46}
• Only 4 mL of reconstituted product³⁶
• Room-temperature storage^36*

*Not to exceed 77^°F (25^°C) for up to 3 months.

Why is a range of vial sizes important?
ReFacto offers a broad range of vial sizes—250 IU, 500 IU, 1000 IU, and 2000 IU—for maximum dosing flexibility. If you use 2000 IU or more regularly, the ReFacto 2000 IU vial allows you to use fewer vials per infusion for reduced infusion times. Because fewer vials may be needed, using ReFacto can also mean less to throw away and clean up.³⁶

What is the value of the low volume of reconstituted product?
ReFacto is reconstituted, or mixed, with a small volume (4 mL) of diluent (sodium chloride solution), regardless of the dosage strength per vial.³⁶ The low volume of reconstituted product is practical and convenient for fast infusions at home, at school, or on the road.

Why is room-temperature storage an advantage?
ReFacto can be stored at room temperature^† for up to 3 months.³⁶ Room-temperature storage means it's easier to take your factor with you wherever you go. At home, you would probably prefer to use your refrigerator space for other things. ReFacto lets you do just that. (After reconstitution, the product should be used within 3 hours.)

^†Up to 77^°F (25^°C). Avoid prolonged exposure to light during storage. Freezing should be avoided to prevent damage to the diluent vial. At the end of the 3-month period or at the time of the expiration date (whichever comes first), the product should be used or discarded but should not be placed back in the refrigerator.

ReFacto has no albumin added to the final formulation. What does this mean?
As with most recombinant products, ReFacto uses human serum albumin (HSA) to help the production cells grow. HSA is used in the cell culture only; no albumin is added during purification or in the final formulation.‡ This means that there is less chance of contamination by viruses that may be found in blood.^36,41

‡The Chinese hamster ovary cell line used to produce ReFacto is grown in culture medium that contains human serum albumin; no albumin is added during purification or in final formulation. Following purification, the albumin concentration is below the detection limit of the assay.

ReFacto is a "B-domain-deleted" product. What does this mean?
The factor VIII molecule is made of 3 portions, or domains: A, B, and C. The B-domain is not needed to stop bleeding and has been removed from ReFacto. The function of the B-domain is primarily for transport within the cell. The B-domain-deleted (BDD) molecule retains all the critical properties of the active form of factor VIII that are necessary to successfully stop bleeding. A much higher degree of homogeneity is expected when expressing a B-domain-deleted protein and may facilitate product consistency.^36,41,42

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.