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Helixate® FS Frequently Asked Questions

Q. Are there any contraindications for Helixate® FS?

Q. Does Helixate® FS contain albumin?

Q. Does the cell culture medium contain any bovine-derived products?

Q. How should Helixate® FS be stored?

Q. Is Helixate® FS a recombinant product?

Q. Is Helixate® FS effective?

Q. Is Helixate® FS safe?

Q. Is Helixate® FS virally inactivated?

Q. How soon after reconstitution must Helixate® FS be administered?

Q. Other than sucrose, what is the purpose of the other excipients in the final formulation of Helixate® FS?

Q. Are there contraindications for Helixate® FS?
A. Known intolerance or allergic reactions to components of Helixate® FS, or known allergies to hamster and mouse proteins, may be a contraindication for Helixate® FS. Baby hamster kidney cells are used in the fermentation process to grow the recombinant factor VIII. Mouse antibody proteins (monoclonal antibody immunoaffinity chromatography are used in the purification process to remove factor VIII from the fermentation medium.

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Q. Does Helixate® FS contain albumin?
A. Unlike many other factor VIII concentrates (both plasma-derived and recombinant), Helixate® FS uses sucrose instead of albumin in the final product to stabilize the recombinant factor VIII molecule. However, human albumin is needed to protect and stabilize the recombinant factor VIII protein that is being secreted by the baby hamster kidney cells in the fermentation medium. Most of the albumin is removed during the many purification steps, but a minimal amount of albumin (.007 milligrams/mL) does remain in the product. This amount is 1000 times less than in the original Helixate® Antihemophilic Factor (Recombinant). No albumin is added during the purification or formulation steps.

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Q. Does the cell culture medium contain any bovine-derived products?
A. The cell culture medium does not contain any proteins derived from animal sources. For example, bovine insulin has been replaced with recombinant insulin. However, human plasma protein solution is still added to the cell culture medium.

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Q. How should Helixate® FS be stored?
A. When stored at refrigerator temperature, 2°–8°C (36°–46°F), Helixate® FS is stable for the period indicated by the expiration date on the label. Storage of lyophilized powder at room temperature (up to 25°C, or 77°F) may be done for three months—for example, in home treatment situations. Avoid freezing. Protect from extreme exposure to light.

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Q. Is Helixate® FS a recombinant product?
A. Helixate® FS is a recombinant factor VIII product manufactured using a baby hamster kidney (BHK) cell line. In the purification and formulation steps for Helixate® FS, the human albumin used as a factor stabilizer in original Helixate® Antihemophilic Factor (Recombinant) has been replaced with sucrose; however, a highly purified plasma protein is still used in the fermentation medium.

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Q. Is Helixate® FS effective?
A. Yes. Helixate® FS has similar biologic activity to original Helixate® Antihemophilic Factor (Recombinant) and to factor VIII from human plasma. In clinical studies involving surgeries for previously treated and untreated patients, 100% of patient responses to Helixate® FS were rated as excellent/good. In clinical studies involving previously treated and untreated patients, respectively, 93.5% and 90% of the bleeding episodes resolved with one or two treatments with Helixate® FS, and response to treatment was rated as excellent/good in 80.5% and 90%, respectively.

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Q. Is Helixate® FS safe?
A. Yes. In clinical studies involving previously treated patients, no inhibitor formation was detected. In clinical studies involving previously untreated patients, 15% developed inhibitors to Helixate® FS. To date, there have been no confirmed cases of viral transmissions with Helixate® FS. Adverse events, such as local injection-site reaction, nausea, dizziness, and rash were reported in <1% of patients.

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Q. Is Helixate® FS virally inactivated?
A. Helixate® FS uses a solvent/detergent process designed to help eliminate lipid-enveloped viruses (such as HIV, hepatitis B and C, and herpes). Helixate® FS also uses the patented monoclonal antibody (MAb) immunoaffinity chromatography purification process designed to help eliminate viruses. In this process, antibodies specific to a single target protein (such as factor VIII) are placed in a chromatography column. When the solution is passed through the column, the antibodies bind the target protein. To date, there have been no confirmed cases of viral transmissions with Helixate® FS.

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Q. How soon after reconstitution must Helixate® FS be administered?
A. Because there is no preservative in the product, Helixate® FS should be administered within three hours of reconstitution.

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Q. Other than sucrose, what is the purpose of the other excipients in the final formulation of Helixate® FS?
A. Helixate® FS is lyophilized, which means it is rapidly freeze-dried under high vacuum. When a solution is freeze-dried, crystals form. The sodium, chloride, and calcium chloride protect the product during the freeze-drying process, while the glycine and histidine stabilize the crystal matrix.

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