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Stimate® Nasal Spray Important Safety Information
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. See full prescribing information for a complete list of adverse reactions.
Humate-P® Important Safety Information
Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, Humate-P® is indicated in adult patients for treatment and prevention of bleeding in 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.
Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, Humate-P® is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations.
Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement, especially in the setting of known risk factors for thrombosis. Caution should be exercised and antithrombotic measures should be considered.
Humate-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 (CJD) agent, cannot be completely eliminated.
Although few adverse reactions have been reported in patients receiving Humate-P®, the most commonly reported are allergic-anaphylactic reactions, including urticaria (hives), chest tightness, rash, pruritus (itching), edema (swelling), shock, chills and fever, and hypervolemia (abnormally high blood volume).
Please see full prescribing information for Humate-P®.