Important Safety Information

Stimate Nasal Spray is indicated for patients with hemophilia A with Factor VIII coagulant activity levels greater than 5%. 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.

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 I) and when there is evidence of an abnormal molecular form of Factor VIII antigen.

Stimate^® Nasal Spray is contraindicated if you have a known hypersensitivity to desmopressin or any of the components of Stimate. Stimate should not be used by patients with type 2B VWD, since platelet aggregation may be induced. Stimate Nasal Spray is for intranasal use only.

To reduce the potential for water intoxication or hyponatremia, especially in the young and the elderly, patients using desmopressin may be advised to reduce fluid intake, ingesting only enough to satisfy thirst. Your doctor will monitor for a 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 (sleepiness), dizziness, chest pain, palpitations and tachycardia (rapid heartbeat), and severe allergic reactions, including anaphylaxis. See full prescribing information for a complete list of adverse reactions.

Please see full prescribing information.

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.