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Stimate ®

(Desmopressin acetate) Nasal Spray, 1.5 mg/mL
Full Prescribing Information for Stimate®        Important Safety Information

Stimate (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation.

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Important Safety Information for Stimate

Stimate® (desmopressin acetate) Nasal Spray, 1.5 mg/mL is a treatment used to stop some types of bleeding in people with mild hemophilia A or mild to moderate von Willebrand disease (VWD) Type 1. Stimate Nasal Spray should not be used in children under 11 months of age.

All patients using Stimate Nasal Spray are at risk of water intoxication, fluid overload and low sodium levels in the blood. Follow your healthcare provider’s instructions on limiting the amount of fluid you drink when using Stimate Nasal Spray, as too much fluid intake can lead to serious adverse reactions, including seizures, coma, and even death. Fluid restrictions are especially important for children and elderly patients, as they are at higher risk for these reactions.

See the patient information leaflet in the prescribing information for Stimate Nasal Spray for symptoms that could mean your blood sodium level is low—including headache, hallucinations, confusion, restlessness, weight gain and muscle spasms. Immediately report any of these symptoms to your physician or, if necessary, an emergency department. Also contact your doctor immediately if you have uncontrolled bleeding.

Before being prescribed Stimate Nasal Spray, make sure your doctor knows about all your medical conditions and about any medications you are taking. Use Stimate Nasal Spray exactly as your healthcare provider has instructed.

Side effects of Stimate Nasal Spray generally come from having too much water in the body. The most common include facial flushing, nasal congestion, runny nose, nose bleed, sore throat, cough, and upper respiratory infections. Tell your healthcare provider if you experience a side effect that does not go away.

Please see full prescribing information for Stimate Nasal Spray

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.

CRP16-05-0001 05/2016
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