Formula & Concentration

(desmopressin acetate)

Manufacturer

CSL Behring

Indications

Before the initial therapeutic administration of Stimate® Nasal Spray, the physician should establish that the patient shows an appropriate change in the coagulation pro le following a test dose of intranasal administration of Stimate® Nasal Spray. Desmopressin acetate is also available as a solution for injection (DDAVP® Injection) when the intranasal route may be compromised. These situations include nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may also be inappropriate where there is an impaired level of consciousness.

Hemophilia A
Stimate® Nasal Spray is indicated for patients with hemophilia A with Factor VIII coagulant activity levels greater than 5%. Desmopressin acetate will also stop bleeding in patients with hemophilia A with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding. In the outpatient setting during two clinical trials where patients recorded bleeding episodes, Stimate® Nasal Spray provided effective hemostasis 100% of the time in 2 of the 5 patients. For those patients not responding in 100% of bleeding occasions, 45% (14 of 31) of bleeding episodes were effectively controlled with Stimate® Nasal Spray. 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.

von Willebrand’s Disease (Type I)
Stimate® Nasal Spray is indicated for patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%. Desmopressin acetate will also stop bleeding in mild to moderate von Willebrand’s disease patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas, mucosal bleeding or menorrhagia. In the outpatient setting during two clinical trials where patients recorded bleeding episodes, Stimate® Nasal Spray provided effective hemostasis 100% of the time in 75% of the patients (n=16). For those patients not responding in 100% of bleeding occasions, 78% (64 of 82) of bleeding episodes were effectively controlled with Stimate® Nasal Spray.

Patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and Factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked after initial administration of Stimate® Nasal Spray to ensure that adequate levels have been achieved.

Stimate® Nasal Spray is not indicated for the treatment of severe classic von Willebrand’s disease (Type I) and when there is evidence of an abnormal molecular form of Factor VIII antigen. See WARNINGS.

Product Options

Package Size

NDC #

Presentation

1.5 mg/ml

00053-6871-00

Spray