Stimate

Stimate is an FDA-registered drug product whose active ingredient is DESMOPRESSIN ACETATE. It is labelled by Ferring Pharmaceuticals Inc. taken by nasal and marketed as a human prescription drug product. Identifiers on file: NDC 55566-3000, application NDA020355, label effective 20260722. It is one of 20 FDA drug label records sharing the active ingredient DESMOPRESSIN ACETATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DESMOPRESSIN ACETATE are most often described in connection with: factor viii, von willebrand, levels greater, maintain hemostasis, surgical procedures, traumatic injuries, hemarthroses intramuscular, hematomas mucosal. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE STIMATE is a vasopressin analog used for: Hemophilia A - for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. ( 1.1 ) von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. ( 1.2 ) Limitations of Use STIMATE is not indicated for: von Willebrand’s disease (severe Type I) - not indicated for the treatment of patients with severe Type I von Willebrand’s disease and when there is evidence of an abnormal molecular form of factor VIII antigen. ( 1.2 ) 1.1 Hemophilia A STIMATE is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5% without factor VIII antibodies to: Maintain hemostasis during surgical procedures and postoperatively Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. 1.2 von Willebrand’s Disease (Type I) STIMATE is indicated for patients with mild to moderate von Willebrand’s disease (Type I) with factor VIII levels greater than 5% to: Maintain hemostasis during surgical procedures and postoperatively Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, mucosal bleeding, or menorrhagia. Limitations of Use Desmopressin acetate is not indicated for the treatment of severe von Willebrand’s disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen [see Warnings and Precautions ( 5. 5 )].

2 DOSAGE AND ADMINISTRATION Instruct patients to prime pump prior to use. ( 2 ) Patients weighing at least 50 kg: 300 mcg (one spray in each nostril). ( 2.2 ) Patients weighing less than 50 kg: 150 mcg administered as a single spray ( 2.2 ) Should not be used in infants younger than 11 months. ( 2.2 ) Not indicated for patients who require less than a 150 mcg dose. ( 2.2 ) 2.1 Pretreatment Testing and On-Treatment Monitoring Hemophilia A Laboratory tests for assessing patient status include levels of Factor VIII coagulant, Factor VIII antigen and Factor VIII ristocetin cofactor (von Willebrand factor) as well as activated partial thromboplastin time. Factor VIII coagulant activity should be determined before giving STIMATE for hemostasis. If Factor VIII coagulant activity is present at less than 5% of normal, STIMATE should not be relied on. von Willebrand's Disease Laboratory tests for assessing patient status include levels of Factor VIII coagulant activity, VWF:RCo and VWF:Ag. Fluid Restriction Instruct patients about appropriate fluid restriction during STIMATE treatment. Fluid restriction should be observed, and fluid intake should be limited to a minimum, from 1 hour before desmopressin administration, until at least 24 hours after administration [see Warnings and Precautions ( 5.1 )]. 2.2 Recommended Dosage The recommended dosage for patients weighing at least 50 kg is 300 mcg intranasal spray (one spray in each nostril). The recommended dosage for patients weighing less than 50 kg is 150 mcg administered as a single intranasal spray. The use of STIMATE is not indicated for patients who require less than a 150 mcg dose or doses that are not multiples of 150 mcg because the spray pump can only deliver doses of 150 mcg [see Indications and Usage ( 1 )] . If other doses are required, DDAVP Injection may be used [see Warnings and Precautions ( 2.3 )] . If STIMATE is used preoperatively, it should be administered 2 hours prior to the scheduled procedure. The necessity for repeat administration of STIMATE 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 once every 48 hours should be considered in treating each patient. Must prime the spray pump prior to the first use. Instruct patients to: Prime STIMATE before initial use by releasing 6 sprays or until a fine mist appears. When STIMATE has not been used within 3 days, re-prime the pump by pressing down on the pump twice, or until you see a fine mist. Discard STIMATE 6 months after it is opened, after 25 sprays, or by the expiration date, whichever is sooner. Pediatric Patients STIMATE should not be used in infants younger than 11 months in the treatment of hemophilia A or von Willebrand’s disease. Use in infants and children will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication [see Warnings and Precautions ( 5.1 )] . 2.3 Switching Between Desmopressin Acetate Formulations Desmopressin acetate, for hemostatic use or therapeutic control of bleeding in patients with hemophilia A and mild to moderate von Willebrand’s disease (Type I), is also available as a solution for injection (DDAVP Injection). For surgical procedures, parenteral administration of desmopressin is primarily recommended. In situations where the intranasal route may be compromised, parenteral administration of desmopressin should be considered [see Warnings and Precautions ( 5.3 )] . When switching from the parenteral form of desmopressin to STIMATE, administer a test dose of intranasal to establish that the patient shows an appropriate change in the coagulation profile [see Dosage and Administration ( 2.2 )] .

4 CONTRAINDICATIONS STIMATE is contraindicated in patients with: Known hypersensitivity to desmopressin acetate or to any of the components of STIMATE. Severe allergic reactions and anaphylaxis have been reported [see Warnings and Precautions ( 5.4 )]. Hyponatremia or a history of hyponatremia [see Warnings and Precautions ( 5.1 )] . Type IIB von Willebrand's disease [see Warnings and Precautions ( 5.5 ) Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to desmopressin acetate or to any of the components of STIMATE ( 4 , 5.4 ) Hyponatremia or a history of hyponatremia ( 4 , 5.1 ) Type IIB von Willebrand's disease ( 4 , 5.5 ) Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion. ( 4 )

6 ADVERSE REACTIONS The following serious reactions are described below and elsewhere in the labeling: Hyponatremia [see Warnings and Precautions ( 5.1 )]. Hypotension and Hypertension [see Warnings and Precautions ( 5.2 )] . Altered Absorption in Patients with Changes in Nasal Mucosa [see Warnings and Precautions ( 5.3 )] . Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] . Increased Risk of Thrombosis in Patients with von Willebrand’s Disease Type IIB [see Warnings and Precautions ( 5.5 )] . The following adverse reactions have been identified during post-approval use of desmopressin acetate intranasal formulations. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Cardiac disorders : Tachycardia, palpitations Eye disorders : Eye redness, eye itchiness, light sensitivity Gastrointestinal disorders : Nausea*, abdominal cramps/pain*, dyspepsia General disorders and administration site conditions : Peripheral edema*, fatigue*, chills, chest pain Immune system disorders : Hypersensitivity reactions Investigations : Weight increased* Metabolism and nutrition disorders : Hyponatremia Nervous system disorders : Headache, somnolence, dizziness, insomnia, hyponatremic convulsions Psychiatric disorders : Confusional state* Respiratory, thoracic and mediastinal disorders : Nasal congestion, rhinitis, epistaxis, sore throat, cough, upper respiratory infections Skin and subcutaneous disorders : Pruritus Vascular disorders : Hypertension, hypotension, flushing *Reported in association with hyponatremia Adverse reactions that have been identified in patients administered STIMATE are headache, eye redness, tachycardia, flushing, nasal congestion, rhinitis, epistaxis, nausea and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

FDA lists 20 drug label records with DESMOPRESSIN ACETATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Stimate used for?
1 INDICATIONS AND USAGE STIMATE is a vasopressin analog used for: Hemophilia A - for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. ( 1.1 ) von Willebrand’s disease …

Who makes Stimate?
Ferring Pharmaceuticals Inc. is the labeler of record for Stimate. 20 FDA label records share the active ingredient DESMOPRESSIN ACETATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Stimate come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Stimate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DESMOPRESSIN ACETATE?
Yes. 20 FDA drug label records list DESMOPRESSIN ACETATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Stimate been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.