Before the initial therapeutic administration of Stimate® Nasal Spray, the physician should establish that the patient shows an appropriate change in the coagulation profile following a test dose of intranasal administration of Stimate® Nasal Spray.^2-4

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.^2,3

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.^2,3

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.

Hemophilia A and von Willebrand's Disease (Type I)

Stimate® Nasal Spray is administered by nasal insufflation, one spray per nostril, to provide a total dose of 300 mcg. In patients weighing less than 50 kg, 150 mcg administered as a single spray provided the expected effect on Factor VIII coagulant activity, Factor VIII ristocetin cofactor activity and skin bleeding time.^3-4 If Stimate® Nasal Spray is used preoperatively, it should be administered 2 hours prior to the scheduled procedure.^12,13

The necessity for repeat administration of Stimate® Nasal Spray or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than every 48 hours should be considered in treating each patient.

The nasal spray pump can only deliver doses of 0.1 mL (150 mcg) or multiples of 0.1 mL. If doses other than these are required, DDAVP®Injection may be used.

The spray pump must be primed prior to the first use. To prime pump, press down 4 times. The bottle should be discarded after 25 doses since the amount delivered thereafter per spray may be substantially less than 150 mcg of drug.

A 2.5 mL bottle with spray pump capable of delivering 25 doses of 150 mcg (NDC 0053-2453-00).

Store at room temperature not to exceed 25°C (77°F) for the period indicated by the expiration date on the label. Discard six months after being opened. Store bottle in upright position.

REFERENCES

2. RHÔNE-POULENC RORER STUDY RG-83884-142:Nasal Spray Desmopressin (DDAVP). A simple Technique for Treatment of Mild Hemophilia A and von Willebrand's disease.

3. RHÔNE-POULENC RORER STUDY RG-83884-143:Intranasal Desmopressin (DDAVP) by spray in Mild Hemophilia A and von Willebrand's disease Type I.

4. RHÔNE-POULENC RORER STUDY RG-83884-144:Evaluation of Intranasal Spray DDAVP in Patients with Mild or Moderate Hemophilia A or von Willebrand's disease: Inpatient Trial.

12. Chistolini A, Dragoni F, Ferrari A, La Verde G, Arcieri R, Mohamud AE and Mazzucconi MG: Intranasal DDAVP: Biological and clinical evaluation in mild Factor VIII deficiency. Haemostasis, 21:273-277, 1991.

13. Rose EH and Aledort LM: Nasal spray desmopressin (DDAVP) for mild hemophilia A and von Willebrand's disease. Ann. Int. Med., 114:563-568, 1991.

Revised July 2007. Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901. By: Ferring AB Limhamn, Sweden. FDA rev date: 10/24/2007

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