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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.