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.
Back to Top
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.
Back to Top
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.
Back to Top
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.
Back to Top
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.
Back to Top
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.
Back to Top
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.
Back to Top
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.
Back to Top
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.
Back to Top
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.
Back to Top
