Data from FDA - Curated by EPG Health - Last updated 21 July 2017

Indication(s)

INDICATIONS AND USAGE Before the initial therapeutic administration of Stimate Nasal Spray, the physician should establish that the patient shows an appropriate change in the coagulation profile following a test dose of intranasal administration of Stimate Nasal Spray. Desmopressin acetate is also available as a solution for injection (DDAVP® Injection) when the intranasal route may be compromised. These situations include nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may also be inappropriate where there is an impaired level of consciousness. Hemophilia A Stimate Nasal Spray is indicated for patients with hemophilia A with Factor VIII coagulant activity levels greater than 5%. Desmopressin acetate will also stop bleeding in patients with hemophilia A with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding. In the outpatient setting during two clinical trials where patients recorded bleeding episodes, Stimate Nasal Spray provided effective hemostasis 100% of the time in 2 of the 5 patients. For those patients not responding in 100% of bleeding occasions, 45% (14 of 31) of bleeding episodes were effectively controlled with Stimate Nasal Spray. 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. von Willebrand's Disease (Type I) Stimate Nasal Spray is indicated for patients with mild to moderate classic von Willebrand's disease (Type I) with Factor VIII levels greater than 5%. Desmopressin acetate will also stop bleeding in mild to moderate von Willebrand's disease patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas, mucosal bleeding or menorrhagia. In the outpatient setting during two clinical trials where patients recorded bleeding episodes, Stimate Nasal Spray provided effective hemostasis 100% of the time in 75% of the patients 106 (n=16). For those patients not responding in 100% of bleeding occasions, 78% (64 of 82) of bleeding episodes were effectively controlled with Stimate Nasal Spray. Patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and Factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked after initial administration of Stimate Nasal Spray to ensure that adequate levels have been achieved. Stimate Nasal Spray is not indicated for the treatment of severe classic von Willebrand's disease (Type I) and when there is evidence of an abnormal molecular form of Factor VIII antigen. See WARNINGS .

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Advisory information

contraindications
CONTRAINDICATIONS None.
Special warnings and precautions
PRECAUTIONS General Desmopressin acetate has infrequently produced changes in blood pressure causing either a slight elevation in blood pressure or a transient fall in blood pressure and a compensatory increase in heart rate. The drug should be used with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease. Stimate Nasal Spray should be used with caution in patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure and renal disorders because these patients are prone to hyponatremia. There have been rare reports of thrombotic events (thrombosis, acute cerebrovascular thrombosis, acute myocardial infarction) following desmopressin acetate injection in patients predisposed to thrombus formation. No causality has been determined; however, the drug should be used with caution in these patients. Severe allergic reactions have been reported rarely. Fatal anaphylaxis has been reported in one patient who received intravenous DDAVP® (desmopressin acetate). It is not known whether antibodies to desmopressin acetate are produced after repeated administration. Since Stimate Nasal Spray is used intranasally, changes in the nasal mucosa such as scarring, edema, or other disease may cause erratic, unreliable absorption in which case Stimate Nasal Spray should be discontinued until the nasal problems resolve. For such situations, DDAVP® Injection should be considered. Information for Patients Patients should be informed that the bottle accurately delivers 25 sprays of 150 mcg each. Any solution remaining after 25 sprays should be discarded since the amount delivered thereafter may be substantially less than 150 mcg of drug. No attempt should be made to transfer remaining solution to another bottle. Patients should be instructed to read accompanying directions on use of the spray pump carefully before use. Patients should also be advised that if bleeding is not controlled, the physician should be contacted. 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 Nasal Spray for hemostasis. If Factor VIII coagulant activity is present at less than 5% of normal, Stimate Nasal Spray 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. Drug Interactions Although the pressor activity of desmopressin acetate is very low, its use with other pressor agents should be done only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDS, lamotrigine and carbamazepine) should be performed with caution. DDAVP® Injection has been used with epsilon aminocaproic acid without adverse effects. Carcinogenicity, Mutagenicity, Impairment of Fertility There have been no long-term studies in animals to assess the carcinogenic, mutagenic or impairment of fertility potential of Stimate Nasal Spray. Pregnancy Category B Reproduction studies performed in rats and rabbits by the subcutaneous route at doses up to 10 mcg/kg/day have revealed no evidence of harm to the fetus due to desmopressin acetate. This dose is equivalent to 10 times (for Factor VIII stimulation) or 38 times (for diabetes insipidus) the systemic human dose based on a mg/M2 surface area. There are no adequate and well-controlled studies in pregnant women. Several publications of desmopressin acetate's use in the management of diabetes insipidus during pregnancy are available; these include a few anecdotal reports of congenital anomalies and low birth weight babies. However, no causal connection between these events and desmopressin acetate has been established. A 15-year, Swedish epidemiologic study of the use of desmopressin acetate in pregnant women with diabetes insipidus found the rate of birth defects to be no greater than that in the general population. As opposed to preparations containing natural hormones, desmopressin acetate in antidiuretic doses has no uterotonic action and the physician will have to weigh the therapeutic advantages against the possible risks in each case. Nursing Mothers There have been no controlled studies in nursing mothers. A single study in postpartum women demonstrated a marked change in plasma, but little if any change in assayable DDAVP® in breast milk following an intranasal dose of 10 mcg. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Stimate Nasal Spray is administered to a nursing woman. Pediatric Use Use in infants and children will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. Stimate Nasal Spray should not be used in infants younger than 11 months in the treatment of hemophilia A or von Willebrand's disease; safety and effectiveness in children between 11 months and 12 years of age has been demonstrated. Geriatric Use Clinical studies of Stimate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. However, other post marketing experience has indicated the occurrence of hyponatremia with the use of desmopressin acetate and fluid overload. Therefore, in elderly patients fluid intake should be adjusted downward in an effort to decrease the potential occurrence of water intoxication and hyponatremia. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures, and that could lead to coma. Patients who do not have need of antidiuretic hormone for its antidiuretic effect should be cautioned to ingest only enough fluid to satisfy thirst, in an effort to decrease the potential occurrence of water intoxication and hyponatremia. As for all patients, dosing for geriatric patients should be appropriate to their clinical condition.
Adverse reactions
ADVERSE REACTIONS Infrequently, DDAVP® Injection has produced transient headache, nausea, mild abdominal cramps and vulval pain. These symptoms disappeared with reduction in dosage. Occasional facial flushing has been reported with the administration of DDAVP® Injection. Infrequently, high doses of intranasal DDAVP® have produced transient headache and nausea. Nasal congestion, rhinitis and flushing have also been reported occasionally along with mild abdominal cramps. These symptoms disappeared with reduction in dosage. Nosebleed, sore throat, cough and upper respiratory infections have also been reported. In addition to those listed above, the following have also been reported in clinical trials with Stimate Nasal Spray: Somnolence, dizziness, itchy or light-sensitive eyes, insomnia, chills, warm feeling, pain, chest pain, palpitations, tachycardia, dyspepsia, edema, vomiting, agitation and balanitis. DDAVP® Injection (desmopressin acetate) has infrequently produced changes in blood pressure causing either a slight elevation or a transient fall with a compensatory increase in heart rate. Severe allergic reactions including anaphylaxis have been reported rarely with DDAVP® Injection. Post Marketing There have been rare reports of convulsions from hyponatremia associated with concomitant use of desmopressin and the following medications: oxybutynin and imipramine. See WARNINGS for the possibility of water intoxication, hyponatremia and coma. To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Hemophilia A and von Willebrand's Disease (Type I) Stimate Nasal Spray is administered by nasal insufflation, one spray per nostril, to provide a total dose of 300 mcg. In patients weighing less than 50 kg, 150 mcg administered as a single spray provided the expected effect on Factor VIII coagulant activity, Factor VIII ristocetin cofactor activity and skin bleeding time. If Stimate Nasal Spray is used preoperatively, it should be administered 2 hours prior to the scheduled procedure. The necessity for repeat administration of Stimate Nasal Spray or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. 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. 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. The nasal spray pump can only deliver doses of 0.1 mL (150 mcg) or multiples of 0.1 mL. If doses other than these are required, DDAVP® Injection may be used. The spray pump must be primed prior to the first use. To prime pump, press down 4 times. The bottle should be discarded after 25 sprays since the amount delivered thereafter per spray may be substantially less than 150 mcg of drug.
Pregnancy and lactation
Nursing Mothers There have been no controlled studies in nursing mothers. A single study in postpartum women demonstrated a marked change in plasma, but little if any change in assayable DDAVP® in breast milk following an intranasal dose of 10 mcg. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Stimate Nasal Spray is administered to a nursing woman.

Interactions

Drug Interactions Although the pressor activity of desmopressin acetate is very low, its use with other pressor agents should be done only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDS, lamotrigine and carbamazepine) should be performed with caution. DDAVP® Injection has been used with epsilon aminocaproic acid without adverse effects.

More information

Category Value
Authorisation number NDA020355
Agency product number XB13HYU18U
Orphan designation No
Product NDC 0053-6871
Date Last Revised 06-07-2017
Type HUMAN PRESCRIPTION DRUG
Storage and handling Store at room temperature not to exceed 25°C (77°F) for the period indicated by the expiration date on the label. Discard six months after being opened. Store bottle in upright position.
Marketing authorisation holder CSL Behring LLC