While hemophilia A cannot be cured, it can be treated and successfully managed. The condition is mainly treated by increasing the level of factor VIII in the blood. This is done by an infusion (injection) of factor replacement therapy, also called factor VIII product.
There are two kinds of FVIII product: human plasma-derived and recombinant FVIII. The proteins used in recombinant factor are not taken from human blood, but are synthesized in a laboratory using recombinant DNA technology.
Replacement therapy
These medicines contain actual proteins to replace the ones that are missing. Replacement therapy is useful for major bleeding episodes in people who do not respond to desmopressin. The following therapies are part of CSL Behring's coagulation portfolio:
Helixate® FS Antihemophilic Factor (Recombinant)
Helixate FS is an advanced recombinant factor VIII (rFVIII) product for the treatment of hemophilia A that is formulated with sucrose—not albumin (albumin is a protein from human blood, which is used as a stabilizer in some other factor VIII therapies.) Helixate FS is proven safe and effective, undergoing rigorous viral inactivation.
Learn more about Helixate FS for the treatment of hemophilia A.
Please see the full prescribing information for Helixate FS.
Humate-P® Antihemophilic Factor/von Willebrand Factor Complex (Human)
Humate-P is for treatment and prevention of bleeding in adults with hemophilia A, and for treatment of bleeding episodes in adult and pediatric patients with von Willebrand disease. Humate-P is a safe and effective treatment for hemophilia A.
Learn more about Humate-P.
Please see the full prescribing information for Humate-P.
Stimate® (desmopressin acetate) Nasal Spray 1.5 mg/ml
There are two kinds of desmopressin nasal spray: low concentrate and high concentrate. The low concentrate nasal spray is used to treat diabetes insipidus and bed wetting and is not indicated for hemophilia A. Stimate Nasal Spray is the high concentrate form of desmopressin. Because it is sprayed into the nose and not injected, it can be much easier to use. Stimate is recommended for people with hemophilia A with factor VIII coagulant activity levels greater than 5%.
Please see the full prescribing information for Stimate.
Important Safety Information About Helixate FS
Helixate FS is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Helixate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.
The most serious adverse reactions 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.
Helixate FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.
Please see full prescribing information for Helixate FS.
Important Safety Information About Humate-P
Humate-P is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). Humate-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD, and patients with mild and moderate VWD for whom use of desmopressin is known or suspected to be inadequate. Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes.
Humate-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations.
Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Also monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery.
Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement. Caution should be exercised and antithrombotic measures considered, particularly in patients with known risk factors for thrombosis.
Humate-P is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
In patients receiving Humate-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions observed by >5% of subjects are allergic-anaphylactic reactions, including urticaria (hives), chest tightness, rash, pruritus (itching), and edema (swelling). For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding, and epistaxis (nosebleed).
Please see full prescribing information for Humate-P.
Important Safety Information About Stimate
Stimate Nasal Spray is indicated for patients with hemophilia A with Factor VIII coagulant activity levels greater than 5%. Desmopressin acetate is not indicated for the treatment of hemophilia A with Factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have Factor VIII antibodies.
Stimate Nasal Spray is indicated for patients with mild to moderate classic type 1 von Willebrand disease (VWD) with Factor VIII levels greater than 5%. Stimate Nasal Spray is not indicated for the treatment of severe classic VWD (Type I) and when there is evidence of an abnormal molecular form of Factor VIII antigen.
Stimate Nasal Spray is contraindicated in individuals with a known hypersensitivity to desmopressin or any of the components of Stimate. Stimate should not be used in patients with type 2B VWD, since platelet aggregation may be induced. Stimate Nasal Spray is for intranasal use only.
To reduce the potential for water intoxication or hyponatremia, especially in the young and the elderly, patients using desmopressin may be advised to reduce fluid intake, ingesting only enough to satisfy thirst. Your doctor will monitor for a rare occurrence of an extreme decrease in plasma osmolality that could result in seizures, possibly leading to coma.
Other adverse reactions reported with use of injectable and/or intranasal desmopressin acetate include headache, nausea, somnolence (sleepiness), dizziness, chest pain, palpitations and tachycardia (rapid heartbeat), and severe allergic reactions, including anaphylaxis.
Please see full prescribing information for Stimate.
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.
Last Updated:
5/19/2010 12:38 PM