Stimate^®

(desmopressin acetate) Nasal Spray, 1.5 mg/mL

Q. Can Stimate^® be used to treat type 2B von Willebrand disease?

A. Stimate^® should not be used to treat patients with type 2B von Willebrand disease because Stimate^® can enhance platelet aggregation. Platelets tend to aggregate in patients with type 2B von Willebrand disease. Stimate^® is indicated for the treatment of hemophilia A with factor VIII activity levels greater than 5% and mild to moderate type 1 von Willebrand disease with factor VIII activity levels greater than 5%. Stimate^® is not indicated for the treatment of severe classic von Willebrand disease (type 3) and where there is evidence of an abnormal molecular form of factor VIII antigen.

Q. Can Stimate^® be administered more frequently than every 48 hours?

A. Stimate^® works by releasing stores of von Willebrand factor/factor VIII complex from the endothelial cells that line the blood vessels. If Stimate^® is given too frequently, the body does not have enough time to replenish its store of von Willebrand factor/factor VIII complex to the endothelial cells. Because of this there may be a decreased response known as tachyphylaxis.

Q. Can Stimate^® be used if frozen?

A. Stimate^® should not be used if it freezes because the integrity of the vial may be compromised. This could lead to inaccurate dosing or contamination of the product.

Q. Can Stimate^® be used in pediatric patients?

A. Stimate^® is approved for patients 11 months and older. Fluid intake should be restricted in very young patients to prevent hyponatremia.

Q. Can a dose of Stimate^® greater than 300 micrograms be given to obese patients?

A. No studies have been conducted using larger doses of Stimate^®. Therefore, we cannot recommend administering more than 2 sprays (150 mcg/spray).

Q. How many hours prior to surgery should Stimate^® be administered?

A. Stimate^® should be administered 2 hours prior to surgery. Make sure a test dose has been done well before scheduled surgery to insure the patient's response to Stimate^®.

Q. How often should Stimate^® be given to patients with von Willebrand disease during menses?

A single dose of Stimate^® at the start of menses is usually sufficient to control bleeding.

Q. How should Stimate^® be stored?

A. Stimate^® should be stored refrigerated at 2°-8°C (36°-46°F). When traveling, product will remain stable for up to 3 weeks when stored at room temperature, 22°C (72°F). Do not use product that has been frozen.

Q. What is the dose of Stimate^®?

A. The recommended adult dose of Stimate^® is 2 sprays, one per nostril. Because each spray delivers 150 mcg, the dose is 300 mcg. The dose for those weighing less than 50 kg is one spray (150 mcg). Fluid intake should be limited in the young and elderly in order to decrease the potential occurrence of water intoxication and hyponatremia.

Q. Why should a Stimate^® test dose be administered?

A. Stimate^® Nasal Spray is approved for use in patients who have mild hemophilia A or mild to moderate type 1 von Willebrand disease. Not all patients will respond therapeutically to Stimate^®; therefore, a test dose should be administered to the patient under controlled conditions such as in the office. Blood specimens should be obtained from the patient before the test dose is given and approximately 90 to 120 minutes after administration of the test dose. The usual adult dose is one spray in each nostril, for a total dose of 300 mcg. In patients weighing less than 50 kg, a single spray dose of 150 mcg should be given. Recommended laboratory tests to assess response include Factor VIII:C, VWF:Ag, and VWF:RCo, all compared to predosing baseline values.

A positive responder to the Stimate^® test dose should have approximately a two- to four-fold rise in the levels of factor VIII activity, von Willebrand antigen, and ristocetin cofactor activity. The physician should feel that adequate levels of these diagnostic values have been reached, so that they will be hemostatically effective for the patient.

Q. Why should the amount of fluids be restricted when administering Stimate^®?

A. Stimate^® is a highly concentrated form of desmopressin acetate.  Desmopressin acts as an antidiuretic, which means it decreases the excretion of urine. Therefore, patients (particularly the young and elderly) should limit their intake of fluids for 24 hours after administration of Stimate^® in order to decrease the risk of water intoxication and hyponatremia. This could lead to serious health issues such as seizures and coma.

Important Safety Information

Stimate^® Nasal Spray is not indicated for the treatment of severe classic von Willebrand disease (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 acetate or to any of the components of Stimate^®. Stimate^® should not be used in patients with type 2B von Willebrand disease since platelet aggregation may be induced.

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), water intoxication, hyponatremia (salt depletion), seizures possibly leading to coma, and severe allergic reactions, including anaphylaxis. See Full Prescribing Information for Stimate^® for a complete list.