Helixate® FS
Antihemophilic Factor (Recombinant) Formulated with Sucrose
Helixate
® FS is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor VIII (FVIII).
Safety
- No albumin is used in the formulation or purification processes; however, the fermentation process still uses a highly purified plasma protein
- Solvent/detergent viral inactivation step
Confidence
- Native full-length FVIII molecule
- Demonstrated clinical performance; in 94% of bleeding episodes, results with Helixate® FS were rated as excellent or good with 1-2 infusions1
Convenience
- Simple reconstitution using the needleless Mix2VialTM
- Less risk of accidental injury
- Less time to prepare product
- Simple process encourages independence
- Built-in filter
- For use with all BD Luer-LokTM syringes
- Small 2.5 mL diluent for all strengths
- Color-coded panels
- Peel-off labels
- Improved infusion set
- Up to three months storage at room temperature (not to exceed
77°F [25°C]
Helixate® FS is manufactured by Bayer Corporation and distributed by ZLB Behring. The technical information within has been provided by Bayer. Mix2Vial is a trademark of Medimop Medical Projects Ltd. Luer-Lok is a trademark of Becton, Dickinson and Company.
| NDC Number | Product Description |
| 0053-8130-01 | Approximately 250 IU per bottle |
| 0053-8130-02 | Approximately 500 IU per bottle |
| 0053-8130-04 | Approximately 1000 IU per bottle |
Important Safety Information
Helixate® FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the treatment of hemophilia A.
The most frequently reported adverse events were local injection-site reactions, dizziness, and rash.
Known intolerance or allergic reactions to constituents of the preparation is a contraindication to the use of Helixate® FS. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Helixate® FS.
Please see the full prescribing information.
Reference: 1. Abshire TC, Brackmann HH, Scharrer I, et al, and the International Kogenate-FS Study Group. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy. Thromb Haemost. 2000;83:811-816.
CUSTOMER SUPPORT 1-800-683-1288 or
Customer Services
Frequently Asked Questions for Helixate® FS
To learn more about Helixate® FS, please visit www.HelixateFS.com
null 23 September 2008