These highlights do not include all the information needed to use Helixate FS safely and effectively. See full prescribing information for Helixate FS.
Helixate FS
[Antihemophilic Factor (Recombinant), Formulated with Sucrose]
For Intravenous Use, Lyophilized Powder for Reconstitution
Initial U.S. Approval: 1993
INDICATIONS AND USAGE
Helixate FS is an Antihemophilic Factor (Recombinant) indicated for: (1)
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Control and prevention of bleeding episodes in adults and children with hemophilia A.
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Peri-operative management in adults and children with hemophilia A.
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Routine prophylaxis to prevent or 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.
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Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.
Helixate FS is not indicated for the treatment of von Willebrand disease. (1)
DOSAGE AND ADMINISTRATION
For intravenous use only.
Each vial of Helixate FS contains the labeled amount of recombinant factor VIII in international units (IU, unit).
Control and prevention of bleeding episodes and peri-operative management (2.1):
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Dose (units) = body weight (kg) × desired factor VIII rise (IU/dL or % of normal) × 0.5 (IU/kg per IU/dL)
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Titrate doses to patient's clinical response.
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Determine treatment frequency based on type of bleeding episode.
For routine prophylaxis in adults: 25 units per kg three times a week (2.1).
For routine prophylaxis in children: 25 units per kg every other day (2.1).
DOSAGE FORMS AND STRENGTHS
Available as lyophilized powder in single use vials containing nominally 250, 500, 1000, 2000, and 3000 IU (3).
CONTRAINDICATIONS
Do not use in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (4).
WARNINGS AND PRECAUTIONS
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Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue treatment with Helixate FS and administer appropriate treatment ( 5.1).
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Development of activity-neutralizing antibodies can occur in patients receiving factor VIII-containing products, including Helixate FS. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration ( 5.2).
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When clotting is normalized by treatment with factor VIII, development of cardiovascular risk factors may be the same as the risk for non-hemophilic patients ( 5.3).
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Monitor plasma factor VIII levels during infusions when indicated ( 5.4).
ADVERSE REACTIONS
The most common adverse reactions (≥4%) in clinical trials are inhibitor formation (neutralizing antibodies) in previously untreated and minimally treated patients (PUPs and MTPs), skin-associated hypersensitivity reactions (e.g., rash, pruritus, urticaria), infusion site reactions (e.g., inflammation, pain), and central venous access device (CVAD) associated infections. (6)
To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)
USE IN SPECIFIC POPULATIONS
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Pregnancy: No human or animal data. Use only if clearly needed ( 8.1).
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Pediatric Use: Higher factor VIII clearance may occur in children (4.4–16 years). Dose adjustment may be needed ( 8.4).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2015
