Hemophilia A is his condition.
Helixate® FS is his connection.

Important Safety Information

Helixate® FS is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product.

Hypersensitivity reactions, including anaphylaxis have been reported with Helixate FS. Reported symptoms included facial swelling, flushing, hives, decrease in blood pressure, nausea, rash, restlessness, shortness of breath, tachycardia, tightness of the chest, tingling, urticaria, and vomiting. Discontinue Helixate FS if symptoms occur and administer immediate emergency treatment.

Neutralizing antibodies (inhibitors) have been reported following administration of Helixate FS. Carefully monitor patients for the development of factor VIII inhibitors, using appropriate clinical observations and laboratory tests. 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.

Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with factor VIII.

Serious adverse reactions seen with Helixate FS are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

The most common adverse reactions (≥4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions, infusion-site reactions, and central venous access device (CVAD)-associated infections.


HELIXATE FS, Antihemophilic Factor (Recombinant), is a recombinant Factor VIII indicated for:

  • On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.
  • Perioperative management of bleeding in adults and children with hemophilia A.
  • 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 prophylactic treatment 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.

Please see the full prescribing information for HELIXATE FS, including patient product information.

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.