Unless properly diagnosed and treated hyponatremia can be fatal. When Stimate Nasal Spray is administered, in particular in pediatric and geriatric patients, fluid . 0000002907 00000 n
For such situations, DDAVPPatients should be informed that the bottle accurately delivers 25 sprays of 150 mcg each. After 300 mcg of Stimate Nasal Spray, the percentage increase of Factor VIII and von Willebrand factor levels in patients with mild hemophilia A and von Willebrand's disease was less than observed after 0.3 mcg/kg of intravenous desmopressin acetate.Plasminogen activator activity increases rapidly after intravenous desmopressin acetate infusion, but there has been no clinically significant fibrinolysis in patients treated with desmopressin acetate.The effect of repeated intravenous desmopressin acetate administration when doses were given every 12 to 24 hours has generally shown a diminution of the Factor VIII activity increase noted after a single dose. If Factor VIII coagulant activity is present at less than 5% of normal, Stimate Nasal Spray should not be relied on.Laboratory tests for assessing patient status include levels of Factor VIII coagulant activity, VWF:RCo and VWF:Ag.Although the pressor activity of desmopressin acetate is very low, its use with other pressor agents should be done only with careful patient monitoring. If the dose is more than 1 spray, spray half the dose in each nostril. 0000009167 00000 n
DESMOPRESSIN - NASAL SPRAY 1.5MG/ML (dess-mow-PRESS-in) COMMON BRAND NAME(S): Stimate . 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.What is the most important information I should know about Stimate Nasal Spray?All patients using Stimate Nasal Spray are at risk for water intoxication, fluid overload and low sodium levels in the blood.
See Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with Stimate (desmopressin acetate). 0000005906 00000 n 0000006613 00000 n
0000009933 00000 n It is licensed and distributed by CSL Behring in the US. 0000004709 00000 n
Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. A single study in postpartum women demonstrated a marked change in plasma, but little if any change in assayable DDAVPUse in infants and children will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. when administered by the intranasal route as a 1.5 .
Late today (July 21, 2020), HFA and NHF learned of a pharmacy level product recall of Stimate (desmopressin) nasal spray manufactured by Ferring Pharmaceuticals, and distributed in the U.S. by CSL Behring.
However, no causal connection between these events and desmopressin acetate has been established. This medication is not used on a regular schedule. The half-life of Stimate® Nasal Spray was between 3.3 and 3.5 hours, over the range of intranasal doses, 150 to 450 mcg.Plasma concentrations of Stimate® Nasal Spray were maximal approximately 40 to 45 minutes after dosing. Tilt your head back … 0000001918 00000 n 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. trailer You can ask your healthcare provider or pharmacist for information about Stimate Nasal Spray that is written for health professionals. NHF and HFA notified the bleeding disorders community as soon as we learned of the recall on July 21, and NHF’s MASAC issued On July 30th, NHF and HFA received a joint communication from CSL Behring and Ferring that addressed some, but not all of the questions posed in the letter.In the letter, CSL Behring and Ferring stated that “routine testing obtained out-of-specification assay results in some vials of desmopressin nasal spray product marketed outside the US.
There is extra medicine in the bottle to allow for priming. To use the nasal spray: When used for the first time, the spray must be primed. Store bottle in upright position.Read this patient information leaflet before you start taking StimateCall your healthcare provider right away if you have any of the following symptoms while using Stimate Nasal Spray. If doses other than these are required, DDAVPThe spray pump must be primed prior to the first use. Tell your doctor if you have any of these changes inside the nose because he or she may need to adjust your treatment.Tell the doctor right away if you develop any illness that can cause water/mineral imbalance (including fever, Children may be more sensitive to the side effects of this drug, especially water/mineral imbalance and a low level of sodium in the blood.Some products that may interact with this drug are: tolvaptan, "If someone has overdosed and has serious symptoms such as passing out or Keep the bottle upright. 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. 0000003677 00000 n
See Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with Stimate (desmopressin acetate). 0000005906 00000 n 0000006613 00000 n
0000009933 00000 n It is licensed and distributed by CSL Behring in the US. 0000004709 00000 n
Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. A single study in postpartum women demonstrated a marked change in plasma, but little if any change in assayable DDAVPUse in infants and children will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. when administered by the intranasal route as a 1.5 .
Late today (July 21, 2020), HFA and NHF learned of a pharmacy level product recall of Stimate (desmopressin) nasal spray manufactured by Ferring Pharmaceuticals, and distributed in the U.S. by CSL Behring.
However, no causal connection between these events and desmopressin acetate has been established. This medication is not used on a regular schedule. The half-life of Stimate® Nasal Spray was between 3.3 and 3.5 hours, over the range of intranasal doses, 150 to 450 mcg.Plasma concentrations of Stimate® Nasal Spray were maximal approximately 40 to 45 minutes after dosing. Tilt your head back … 0000001918 00000 n 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. trailer You can ask your healthcare provider or pharmacist for information about Stimate Nasal Spray that is written for health professionals. NHF and HFA notified the bleeding disorders community as soon as we learned of the recall on July 21, and NHF’s MASAC issued On July 30th, NHF and HFA received a joint communication from CSL Behring and Ferring that addressed some, but not all of the questions posed in the letter.In the letter, CSL Behring and Ferring stated that “routine testing obtained out-of-specification assay results in some vials of desmopressin nasal spray product marketed outside the US.
There is extra medicine in the bottle to allow for priming. To use the nasal spray: When used for the first time, the spray must be primed. Store bottle in upright position.Read this patient information leaflet before you start taking StimateCall your healthcare provider right away if you have any of the following symptoms while using Stimate Nasal Spray. If doses other than these are required, DDAVPThe spray pump must be primed prior to the first use. Tell your doctor if you have any of these changes inside the nose because he or she may need to adjust your treatment.Tell the doctor right away if you develop any illness that can cause water/mineral imbalance (including fever, Children may be more sensitive to the side effects of this drug, especially water/mineral imbalance and a low level of sodium in the blood.Some products that may interact with this drug are: tolvaptan, "If someone has overdosed and has serious symptoms such as passing out or Keep the bottle upright. 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. 0000003677 00000 n