What steps are taken for the viral safety of ReFacto?
At the start of the manufacturing process, the ReFacto cell bank is created and production cells are grown to create ReFacto (see steps 1–7, below). The second part of the process, the purification stage, consists of many steps to enhance viral safety (steps 8–10). As an added measure of viral safety, ReFacto is made with an extra solvent-detergent step designed to inactivate lipid-enveloped viruses (step 9). While human serum albumin (HSA) is used to help the production cells grow, there is no albumin added to the final formulation.^36,41,50,51*

ReFacto is manufactured with state-of-the-art techniques to optimize viral safety. It is made by recombinant technology, not from human blood products. This means that there is less risk of potential contamination by viruses that can be found in blood products.^36,41

1. Human gene for factor VIII isolated
2. The portion of the factor VIII gene encoding the B-domain is deleted
3. B-domain-deleted recombinant factor VIII (BDDrFVIII) gene inserted into production cell (Chinese hamster ovary cells)
4. Production cells grown in culture media that contain small amounts of human serum albumin
5. Production cells frozen and stored
6. Production cells taken from cell bank and thawed
7. Production cells grow inside bioreactors with human serum albumin in the culture medium
8. ReFacto is filtered away from production cells and then purified and concentrated by a chromatography step
9. ReFacto is processed through a solvent-detergent viral inactivation step
10. ReFacto is processed through monoclonal antibody purification and 3 more chromatography steps
11. ReFacto is then freeze-dried and packaged, and no albumin is added to the final product

^*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.

Can I use ReFacto if I am immunocompromised?
Yes. ReFacto is an option for immunocompromised patients. Because ReFacto is made using advanced recombinant technology and purification processes, it offers enhanced viral safety.^36,41,50,51 In fact, there has been no evidence of viral transmission with ReFacto.^41,45

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.