Frequently Asked Questions about Helixate FS

Q. Who should not use Helixate FS?

A. You should not use Helixate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Helixate FS. Baby hamster kidney cells are used in the fermentation process to produce recombinant factor VIII. Tell your healthcare provider if you are pregnant or breastfeeding because Helixate FS may not be right for you

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Q. Does Helixate FS contain albumin?

A. 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. No human or animal proteins such as albumin are added during the purification and formulation processes of Helixate FS.

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

A. The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources.

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Q. How should Helixate FS be stored?

A. Do not freeze Helixate FS.

Store Helixate FS at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, Helixate FS may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F.

Record the starting date of room temperature storage on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The product then expires after storage at room temperature, or after the expiration date on the product vial, whichever is earlier. Store vials in their original carton and protect them from extreme exposure to light.

Reconstituted product (after mixing dry products with wet diluent) must be used within 3 hours and cannot be stored.

Throw away any unused Helixate FS after the expiration date.

Do not use reconstituted Helixate FS if it is not clear to slightly cloudy and colorless.

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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. Please refer to efficacy data

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Q. Is Helixate FS safe?

A. 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. In the Joint Outcome Study, which was conducted to demonstrate the effectiveness of routine prophylaxis for prevention of joint damage in children, the incidence of new inhibitor development was 12.5%.

Postmarketing registries in previously untreated patients have shown inhibitor development rates of 31-50% which is comparable to previously reported inhibitor rates for FVIII products. Some of these registries showed a trend towards an increased risk of inhibitor development in PUPs as compared to another rFVIII product.

The most serious adverse reactions to Helixate FS are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to antihemophilic factor. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.

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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 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.

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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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Q. Is Helixate FS indicated for prophylaxis?

A. Yes, Helixate is indicated for:

– Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.

– Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.

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Q. What dosage strengths is Helixate FS available in?

A. Helixate FS is available in the following dosage strengths:

  • 250 IU/2.5-mL diluent*
  • 500 IU/2.5-mL diluent*
  • 1000 IU/2.5-mL diluent*
  • 2000 IU/5.0-mL diluent
  • 3000 IU/5.0-mL diluent


*250 IU, 500 IU, and 1000 IU require 2.5 mL diluent. 2000 IU and 3000 IU doses require 5.0 mL diluent.

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Important Safety Information

You should not use Helixate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Helixate FS.

Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.

You could have an allergic reaction to Helixate FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headed, dizziness, nausea or a decrease in blood pressure.

Your body can make antibodies, called "inhibitors," against Helixate FS, which may stop Helixate FS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

Other common side effects of Helixate FS are local injection-site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device. Tell your healthcare provider about any side effect that bothers you or does not go away.

Call your healthcare provider right away if bleeding is not controlled after using Helixate FS.

Indications

Helixate FS, Antihemophilic Factor (Recombinant), is medicine used to replace the clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

Helixate FS is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Helixate FS when you have surgery. Helixate FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis), and can reduce the risk of joint damage in children without preexisting joint damage when used regularly.

Helixate FS is not used to treat von Willebrand disease.

Please see the full Prescribing Information for HELIXATE FS, including approved patient labeling.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.