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 for Helixate^® FS.

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.

Monoclate-P^® is contraindicated in patients with known hypersensitivity to mouse protein.

Products of this type are known to cause allergic reactions, mild chills, nausea or stinging at the infusion site. In some cases, inhibitors of FVIII may occur.

Monoclate-P^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease agent, cannot be completely eliminated.

Please see the full prescribing information for Monoclate-P^®.

Mononine^® is contraindicated in patients with known hypersensitivity to mouse protein.

The following adverse reactions may be observed after administration: headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, hives, stinging or burning at the infusion site, or other manifestations of allergic reactions, including anaphylaxis.

Mononine^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Since the use of Factor IX Complex concentrates has historically been associated with the development of thromboembolic complications, the use of Factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation.

Please see the full prescribing information for Mononine^®.

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 1) 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 decrease the potential for hyponatremia or water intoxication, especially in the young and the elderly, patients using desmopressin who are not in need of antidiuretic hormone for its antidiuretic effect should be cautioned to reduce fluid intake, ingesting only enough to satisfy thirst. Such patients should be monitored for the 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, dizziness, chest pain, palpitations and tachycardia, and severe allergic reactions, including anaphylaxis.

Please see the full prescribing information for Stimate^®.