Product Features

Mix2Vial®: A simple way to mix Helixate FS for hemophilia A patients

Helixate FS is designed with a patient’s daily needs in mind. Mix2Vial is one design feature that may shorten preparation and reconstitution time by providing a quicker way to reconstitute Helixate FS.

Reconstitution made easy

  • The Mix2Vial needle-free transfer device
  • Simple process encourages self-infusion
  • Built-in filter
  • For use with all BD Luer-Lok™ syringes

Other patient-friendly features of Helixate FS

In addition to Mix2Vial, Helixate FS has many other benefits designed to make administration more convenient for hemophilia A patients. In particular, the 3000 IU/5 mL dose may shorten preparation time. For smaller doses, Helixate FS has one of the smallest diluent sizes available — 2.5 mL.

  • Dosing
    • One of the smallest diluent sizes available for 250 IU, 500 IU, and 1000 IU doses (2.5 mL)
    • 2000 IU/5.0 mL dose
  • High-dose vial
    • 3000 IU/5.0 ml dose allows infusion of higher doses without using multiple vials
  • Room temperature storage (up to 25°C [77°F])
    • You can store Helixate FS for up to 12 months at room temperature
    • Storage is easier both at home and on-the-go for hemophilia A patients.
      The starting date of room temperature storage should be clearly recorded on the unopened product carton. Once stored at room temperature, the product must not be returned to the refrigerator. The shelf-life then expires after the storage at room temperature, or the expiration date on the product vial, whichever is earlier. Do not use Helixate FS after the expiration date indicated on the vial.
  • Refrigeration Storage (+2°C to +8°C [36°F to 46°F])
    • You can store Helixate FS for up to 30 months in refrigerated storage
    • Do not use Helixate FS after the expiration date indicated on the vial.
    • Do not freeze.
  • Color-coded, peel-off labels
    • Special labels make identification and record-keeping simple
    • Log infusions and report information to HTCs


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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.