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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