Desmopressin Acetate Prescribing Information
Desmopressin acetate injection can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death
Desmopressin acetate injection is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances
Prior to starting or resuming desmopressin acetate injection, ensure that the serum sodium concentration is normal. Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration. Use of desmopressin acetate injection without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia.
Monitor the serum sodium concentration within 1 week and approximately 1 month of initiating desmopressin acetate injection, and periodically thereafter
Patients with conditions associated with fluid and electrolyte imbalance (i.e., cystic fibrosis, heart failure, and renal disorders), geriatric and pediatric patients, patients receiving concomitant treatments that also cause hyponatremia (i.e., tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide diuretics and chlorpropamide), and patients with habitual or psychogenic polydipsia who may drink excessive amounts of water, may be at increased risk of hyponatremia
If hyponatremia occurs, desmopressin acetate injection may need to be temporarily or permanently discontinued and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia.
Desmopressin acetate injection can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death
Desmopressin acetate injection is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances
Prior to starting or resuming desmopressin acetate injection, ensure that the serum sodium concentration is normal. Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration. Use of desmopressin acetate injection without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia.
Monitor the serum sodium concentration within 1 week and approximately 1 month of initiating desmopressin acetate injection, and periodically thereafter
Patients with conditions associated with fluid and electrolyte imbalance (i.e., cystic fibrosis, heart failure, and renal disorders), geriatric and pediatric patients, patients receiving concomitant treatments that also cause hyponatremia (i.e., tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide diuretics and chlorpropamide), and patients with habitual or psychogenic polydipsia who may drink excessive amounts of water, may be at increased risk of hyponatremia
If hyponatremia occurs, desmopressin acetate injection may need to be temporarily or permanently discontinued and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia.
Prior to treatment with desmopressin acetate, assess serum sodium, urine volume and osmolality. Intermittently during treatment, assess serum sodium, urine volume and osmolality or plasma osmolality.
Prior to treatment with desmopressin acetate injection, verify that factor VIII coagulant activity levels are >5% and exclude the presence of factor VIII autoantibodies. Also assess serum sodium and aPTT prior to treatment. In certain clinical situations, it may be justified to try desmopressin acetate in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.
Prior to treatment with desmopressin acetate injection, verify that factor VIII coagulant activity levels are >5% and exclude severe von Willebrand’s disease (Type I) and presence of abnormal molecular form of factor VIII antigen. During treatment with desmopressin acetate injection, assess serum sodium, bleeding time, factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand antigen to ensure that adequate levels are being achieved.
Desmopressin acetate injection can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death
Desmopressin acetate injection is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances
Prior to starting or resuming desmopressin acetate injection, ensure that the serum sodium concentration is normal. Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration. Use of desmopressin acetate injection without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia.
Monitor the serum sodium concentration within 1 week and approximately 1 month of initiating desmopressin acetate injection, and periodically thereafter
Patients with conditions associated with fluid and electrolyte imbalance (i.e., cystic fibrosis, heart failure, and renal disorders), geriatric and pediatric patients, patients receiving concomitant treatments that also cause hyponatremia (i.e., tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide diuretics and chlorpropamide), and patients with habitual or psychogenic polydipsia who may drink excessive amounts of water, may be at increased risk of hyponatremia
If hyponatremia occurs, desmopressin acetate injection may need to be temporarily or permanently discontinued and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia.
Desmopressin acetate injection can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death
Desmopressin acetate injection is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances
Prior to starting or resuming desmopressin acetate injection, ensure that the serum sodium concentration is normal. Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration. Use of desmopressin acetate injection without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia.
Monitor the serum sodium concentration within 1 week and approximately 1 month of initiating desmopressin acetate injection, and periodically thereafter
Patients with conditions associated with fluid and electrolyte imbalance (i.e., cystic fibrosis, heart failure, and renal disorders), geriatric and pediatric patients, patients receiving concomitant treatments that also cause hyponatremia (i.e., tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide diuretics and chlorpropamide), and patients with habitual or psychogenic polydipsia who may drink excessive amounts of water, may be at increased risk of hyponatremia
If hyponatremia occurs, desmopressin acetate injection may need to be temporarily or permanently discontinued and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia.
Desmopressin acetate injection is a vasopressin analog used for:
- Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. ()
1.1 Central Diabetes InsipidusDesmopressin acetate injection is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.
Limitations of Use:Desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus.
- 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. ()
1.2 Hemophilia ADesmopressin acetate injection 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.
- 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. ()
1.3 von Willebrand’s Disease (Type I)Desmopressin acetate injection 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, or mucosal bleeding.
Limitations of UseDesmopressin 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 ].Limitations of Use - Desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. ()
1.3 von Willebrand’s Disease (Type I)Desmopressin acetate injection 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, or mucosal bleeding.
Limitations of UseDesmopressin 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 ]. - 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. ()
1.3 von Willebrand’s Disease (Type I)Desmopressin acetate injection 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, or mucosal bleeding.
Limitations of UseDesmopressin 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 ].
- Diabetes Insipidus: The daily dose is 2 mcg to 4 mcg administered as one or two divided doses by subcutaneous or intravenous injection. The dosage must be determined for each patient and adjusted according to the pattern of response. ()
2.1 Pretreatment Testing and On-Treatment MonitoringDiabetes InsipidusPrior to treatment with desmopressin acetate, assess serum sodium, urine volume and osmolality. Intermittently during treatment, assess serum sodium, urine volume and osmolality or plasma osmolality.
Hemophilia APrior to treatment with desmopressin acetate injection, verify that factor VIII coagulant activity levels are >5% and exclude the presence of factor VIII autoantibodies. Also assess serum sodium and aPTT prior to treatment. In certain clinical situations, it may be justified to try desmopressin acetate in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.
von Willebrand’s Disease (Type I)Prior to treatment with desmopressin acetate injection, verify that factor VIII coagulant activity levels are >5% and exclude severe von Willebrand’s disease (Type I) and presence of abnormal molecular form of factor VIII antigen. During treatment with desmopressin acetate injection, assess serum sodium, bleeding time, factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand antigen to ensure that adequate levels are being achieved.
For All Patients Receiving Repeated Doses:Restrict free water intake and monitor for hyponatremia. Ensure that serum sodium is normal prior to initiating or resuming treatment with desmopressin acetate injection. - Hemophilia A and von Willebrand’s Disease (Type I): 0.3 mcg/kg (to a maximum of 20 mcg) administered by intravenous infusion. Dilute dose as appropriate. ()
2.1 Pretreatment Testing and On-Treatment MonitoringDiabetes InsipidusPrior to treatment with desmopressin acetate, assess serum sodium, urine volume and osmolality. Intermittently during treatment, assess serum sodium, urine volume and osmolality or plasma osmolality.
Hemophilia APrior to treatment with desmopressin acetate injection, verify that factor VIII coagulant activity levels are >5% and exclude the presence of factor VIII autoantibodies. Also assess serum sodium and aPTT prior to treatment. In certain clinical situations, it may be justified to try desmopressin acetate in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.
von Willebrand’s Disease (Type I)Prior to treatment with desmopressin acetate injection, verify that factor VIII coagulant activity levels are >5% and exclude severe von Willebrand’s disease (Type I) and presence of abnormal molecular form of factor VIII antigen. During treatment with desmopressin acetate injection, assess serum sodium, bleeding time, factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand antigen to ensure that adequate levels are being achieved.
For All Patients Receiving Repeated Doses:Restrict free water intake and monitor for hyponatremia. Ensure that serum sodium is normal prior to initiating or resuming treatment with desmopressin acetate injection. - See Full Prescribing Information for instructions on reconstitution, preparation, and administration ().
2 DOSAGE AND ADMINISTRATION- Diabetes Insipidus: The daily dose is 2 mcg to 4 mcg administered as one or two divided doses by subcutaneous or intravenous injection. The dosage must be determined for each patient and adjusted according to the pattern of response.
- Hemophilia A and von Willebrand’s Disease (Type I): 0.3 mcg/kg (to a maximum of 20 mcg) administered by intravenous infusion. Dilute dose as appropriate.
- See Full Prescribing Information for instructions on reconstitution, preparation, and administration .
2.1 Pretreatment Testing and On-Treatment MonitoringDiabetes InsipidusPrior to treatment with desmopressin acetate, assess serum sodium, urine volume and osmolality. Intermittently during treatment, assess serum sodium, urine volume and osmolality or plasma osmolality.
Hemophilia APrior to treatment with desmopressin acetate injection, verify that factor VIII coagulant activity levels are >5% and exclude the presence of factor VIII autoantibodies. Also assess serum sodium and aPTT prior to treatment. In certain clinical situations, it may be justified to try desmopressin acetate in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.
von Willebrand’s Disease (Type I)Prior to treatment with desmopressin acetate injection, verify that factor VIII coagulant activity levels are >5% and exclude severe von Willebrand’s disease (Type I) and presence of abnormal molecular form of factor VIII antigen. During treatment with desmopressin acetate injection, assess serum sodium, bleeding time, factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand antigen to ensure that adequate levels are being achieved.
For All Patients Receiving Repeated Doses:Restrict free water intake and monitor for hyponatremia. Ensure that serum sodium is normal prior to initiating or resuming treatment with desmopressin acetate injection.2.2 Recommended DosageInitiate fluid restriction during treatment with desmopressin acetate injection
[see Warnings and Precautions , Use in Specific Populations ].Diabetes Insipidus:Treatment naïve patients:The recommended starting daily dosage is 2 mcg to 4 mcg administered as one or two divided doses by subcutaneous or intravenous injection. Do not dilute desmopressin acetate injection for the Diabetes Insipidus population. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. Adjust dose based upon response to treatment estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.Patients changing from intranasal desmopressin:The recommended starting dose of desmopressin acetate injection is 1/10ththe daily maintenance intranasal dose administered by subcutaneous or intravenous injection as one or two divided doses.Hemophilia A and von Willebrand’s Disease (Type I):
The recommended dosage is 0.3 mcg/kg actual body weight (to a maximum of 20 mcg) administered by intravenous infusion over 15 minutes to 30 minutes. If used preoperatively, administer 30 minutes prior to the procedure. If used to reduce spontaneous or traumatic bleeding, doses may be repeated after 8 hours to 12 hours and once daily thereafter, if needed, based upon clinical condition and von Willebrand factor and factor VIII levels. The necessity for repeat administration of desmopressin acetate or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient.Tachyphylaxis (lessening of response) with repeated administration (i.e., given more frequently than every 48 hours) may occur. The initial response is reproducible if desmopressin acetate is administered every 2 to 3 days.
2.3 Preparation and Administration for Patients with Hemophilia A and von Willebrand’s Disease (Type I)Prepare the solution for infusion using aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Withdraw the necessary volume of desmopressin acetate injection from the vial and dilute by adding to the infusion bag of 0.9% Sodium Chloride Injection, USP per Table 1. Dilute desmopressin acetate injection in sterile 0.9% Sodium Chloride Injection, USP and infuse slowly over 15 minutes to 30 minutes.
The volume of diluent is weight-based. See Table 1 for volume of diluent to use.
Table 1: Volume of Diluent Required
Patient Weight
Volume of 0.9% Sodium Chloride Injection, USP for dilution
10 kg or less
10 mL
More than 10 kg
50 mLMonitor blood pressure and pulse during infusion.
2.4 Switching Between Desmopressin Acetate FormulationsDesmopressin acetate is also available as nasal spray and tablet dosage forms.
When switching between formulations, the below text is meant as guidance for starting dose. However, dose should always be titrated individually according to the diuresis (antidiuretic response) and electrolyte status (serum sodium) of the patient.
When switching from desmopressin acetate nasal spray to desmopressin acetate injection, the starting dose is one-tenth times the desmopressin acetate nasal spray dose.
When switching from desmopressin acetate tablets to desmopressin acetate injection, titrate dose individually according to the diuresis (antidiuretic response) and electrolyte status (serum sodium) due to the large variability in both PK and PD. Monitor patients closely during the initial dose titration period.
Desmopressin acetate injection, USP is a sterile, aqueous, colorless solution available as:
- 40 mcg/10 mL (4 mcg/mL) in multiple-dose vial
- Pediatric Use: Initiate fluid intake restriction to prevent possible hyponatremia and water intoxication. ()
8.4 Pediatric UseThe safety and effectiveness of desmopressin acetate have been established in pediatric patients 3 months of age and older with hemophilia A and von Willebrand’s disease and pediatric patients aged 12 years and older with diabetes insipidus. The safety and effectiveness of desmopressin acetate have not been established in infants less than 3 months of age with hemophilia A or von Willebrand’s disease or pediatric patients under 12 years of age with diabetes insipidus. Use in infants and pediatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient and/or guardian
[see Warnings and Precautions ]. - Geriatric Use: Carefully select dose and monitor renal function more frequently. ()
8.5 Geriatric UseClinical studies of desmopressin acetate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min)
[see Contraindications , Use in Specific Populations , Clinical Pharmacology ].Use of desmopressin acetate injection in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient
[see Warnings and Precautions ].
Desmopressin acetate injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate injection
Hypersensitivity reactions including anaphylaxis have been reported with intravenous and intranasal desmopressin acetate, including cases of fatal anaphylaxis with intravenous desmopressin acetate. Desmopressin acetate injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate injection
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hyponatremia[see Contraindications, Warnings and Precautions ]
- Hypotension and Hypertension[see Warnings and Precautions ]
- Increased risk of thrombosis in patients with von Willebrand’s Disease Type IIB[see Warnings and Precautions ]
- Hypersensitivity reactions[see Warnings and Precautions ]
- Fluid retention[see Warnings and Precautions ]
The following adverse reactions have been identified during post-approval use of desmopressin acetate injection. 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.
Cardiovascular: Hypertension, hypotension, tachycardia, thrombotic events, fluid retention
Digestive: Nausea, abdominal cramps
Immune: Hypersensitivity reactions
Integumentary: Erythema, swelling, burning pain, facial flushing
Laboratory: Hyponatremia
Nervous: Headache, hyponatremic seizures
- Common adverse reactions are abdominal cramps, burning pain, erythema, facial flushing, fluid retention, headache, hypersensitivity reactions, hypertension, hyponatremia, hyponatremic seizures, hypotension, nausea, swelling, tachycardia, and thrombotic events.
Desmopressin acetate injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows:
Mol. Wt. 1183.34
Empirical Formula: C46H64N14O12S2·C2H4O2·3H2O
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.
Desmopressin acetate injection, USP is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate, USP which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride USP, chlorobutanol hemihydrate, USP (5 mg per mL), hydrochloric acid, NF and water for injection, USP. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.
Desmopressin acetate injection is contraindicated in patients with the following conditions due to an increased risk of hyponatremia:
- Moderate to severe renal impairment defined as a creatinine clearance below 50 mL/min [see Use in Specific Populations (,
8.5 Geriatric UseClinical studies of desmopressin acetate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min)
[see Contraindications , Use in Specific Populations , Clinical Pharmacology ].Use of desmopressin acetate injection in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient
[see Warnings and Precautions ].) and Clinical Pharmacology (8.6 Renal ImpairmentDesmopressin acetate is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with renal impairment than patients with normal renal function. Desmopressin acetate is contraindicated in patients with estimated CLcr by Cockcroft-Gault equation less than 50 mL/min
[see Contraindications , Clinical Pharmacology ].)].12.3 PharmacokineticsElimination
The geometric mean terminal half-life is 2.8 hours.Metabolism
Desmopressin is not metabolized by human CYP450 system.Excretion
After intravenous administration of 2 mcg, 52% of the dose was recovered in the urine within 24 hours as unchanged desmopressin.Drug Interaction StudiesIn vitrostudies in human liver microsome preparations have shown that desmopressin does not inhibit the human CYP450 system. Noin vivointeraction studies have been performed with desmopressin acetate injection.Specific PopulationsPatients with Renal Impairment
A pharmacokinetic study was conducted in subjects with normal renal function and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects each group) with a single 2 mcg dose of desmopressin acetate intravenous injection. The geometric mean terminal half-life was 2.8 hours in subjects with normal renal function, and 4, 6.6, and 8.7 hours in patients with mild, moderate, and severe renal impairment, respectively. In patients with mild, moderate and severe renal impairment, mean desmopressin area under the plasma drug concentration time curve (AUC) was 1.5 fold, 2.4 fold and 3.6 fold higher, respectively compared to that of subjects with normal renal function. - Hyponatremia or a history of hyponatremia [see Warnings and Precautions (), Drug Interactions (
5.1 HyponatremiaDesmopressin acetate injection can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death
[see Boxed Warning].Desmopressin acetate injection is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances
[see Contraindications , Drug Interactions ]. Avoid concomitant treatments that also cause hyponatremia.Prior to starting or resuming desmopressin acetate injection, ensure that the serum sodium concentration is normal. Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration. Use of desmopressin acetate injection without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia.
Monitor the serum sodium concentration within 1 week and approximately 1 month of initiating desmopressin acetate injection, and periodically thereafter
[see Dosage and Administration ]. Base the frequency of serum sodium monitoring on the patient’s risk of hyponatremia.Patients with conditions associated with fluid and electrolyte imbalance (i.e., cystic fibrosis, heart failure, and renal disorders), geriatric and pediatric patients, patients receiving concomitant treatments that also cause hyponatremia (i.e., tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide diuretics and chlorpropamide), and patients with habitual or psychogenic polydipsia who may drink excessive amounts of water, may be at increased risk of hyponatremia
[see Contraindications ].If hyponatremia occurs, desmopressin acetate injection may need to be temporarily or permanently discontinued and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia.
)], Use in Specific Populations (7.1 Other Drugs that may Increase Risk of HyponatremiaThe concomitant administration of desmopressin acetate injection with other drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, thiazide diuretics, NSAIDs, lamotrigine, sulfonylureas, particularly chlorpropamide, oxybutynin and carbamazepine), requires more frequent serum sodium monitoring. Monitor serum sodium more frequently in patients taking desmopressin acetate injection concomitantly with these drugs and when doses of these drugs are increased
[see Contraindications , Warnings and Precautions , Drug Interactions , Use in Specific Populations ].,8.4 Pediatric UseThe safety and effectiveness of desmopressin acetate have been established in pediatric patients 3 months of age and older with hemophilia A and von Willebrand’s disease and pediatric patients aged 12 years and older with diabetes insipidus. The safety and effectiveness of desmopressin acetate have not been established in infants less than 3 months of age with hemophilia A or von Willebrand’s disease or pediatric patients under 12 years of age with diabetes insipidus. Use in infants and pediatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient and/or guardian
[see Warnings and Precautions ].)].8.5 Geriatric UseClinical studies of desmopressin acetate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min)
[see Contraindications , Use in Specific Populations , Clinical Pharmacology ].Use of desmopressin acetate injection in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient
[see Warnings and Precautions ]. - Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Warnings and Precautions (.)]
5.1 HyponatremiaDesmopressin acetate injection can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death
[see Boxed Warning].Desmopressin acetate injection is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances
[see Contraindications , Drug Interactions ]. Avoid concomitant treatments that also cause hyponatremia.Prior to starting or resuming desmopressin acetate injection, ensure that the serum sodium concentration is normal. Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration. Use of desmopressin acetate injection without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia.
Monitor the serum sodium concentration within 1 week and approximately 1 month of initiating desmopressin acetate injection, and periodically thereafter
[see Dosage and Administration ]. Base the frequency of serum sodium monitoring on the patient’s risk of hyponatremia.Patients with conditions associated with fluid and electrolyte imbalance (i.e., cystic fibrosis, heart failure, and renal disorders), geriatric and pediatric patients, patients receiving concomitant treatments that also cause hyponatremia (i.e., tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide diuretics and chlorpropamide), and patients with habitual or psychogenic polydipsia who may drink excessive amounts of water, may be at increased risk of hyponatremia
[see Contraindications ].If hyponatremia occurs, desmopressin acetate injection may need to be temporarily or permanently discontinued and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia.
- Polydipsia [see Warnings and Precautions (.)]
5.1 HyponatremiaDesmopressin acetate injection can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death
[see Boxed Warning].Desmopressin acetate injection is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances
[see Contraindications , Drug Interactions ]. Avoid concomitant treatments that also cause hyponatremia.Prior to starting or resuming desmopressin acetate injection, ensure that the serum sodium concentration is normal. Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration. Use of desmopressin acetate injection without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia.
Monitor the serum sodium concentration within 1 week and approximately 1 month of initiating desmopressin acetate injection, and periodically thereafter
[see Dosage and Administration ]. Base the frequency of serum sodium monitoring on the patient’s risk of hyponatremia.Patients with conditions associated with fluid and electrolyte imbalance (i.e., cystic fibrosis, heart failure, and renal disorders), geriatric and pediatric patients, patients receiving concomitant treatments that also cause hyponatremia (i.e., tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide diuretics and chlorpropamide), and patients with habitual or psychogenic polydipsia who may drink excessive amounts of water, may be at increased risk of hyponatremia
[see Contraindications ].If hyponatremia occurs, desmopressin acetate injection may need to be temporarily or permanently discontinued and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia.
- Concomitant use with loop diuretics [see].
WARNING: HYPONATREMIADesmopressin acetate can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death[see Warnings and Precautions ].Desmopressin acetate is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids[see Contraindications (4) and Warnings and Precautions ].Ensure the serum sodium concentration is normal before starting or resuming desmopressin acetate. Measure serum sodium within 7 days and approximately 1 month after initiating therapy, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia[see Dosage and Administration and Warnings and Precautions ].If hyponatremia occurs, desmopressin acetate may need to be temporarily or permanently discontinued[see Warnings and Precautions ].WARNING: HYPONATREMIASee full prescribing information for complete boxed warning.- Desmopressin acetate can cause hyponatremia, which may be life-threatening if severe.
- Desmopressin acetate is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids.
- Ensure serum sodium concentration is normal before starting or resuming desmopressin acetate. Measure serum sodium within 1 week and approximately 1 month after starting therapy and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia.
- If hyponatremia occurs, interrupt or discontinue desmopressin acetate.
- Concomitant use with systemic or inhaled glucocorticoids [see.]
WARNING: HYPONATREMIADesmopressin acetate can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death[see Warnings and Precautions ].Desmopressin acetate is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids[see Contraindications (4) and Warnings and Precautions ].Ensure the serum sodium concentration is normal before starting or resuming desmopressin acetate. Measure serum sodium within 7 days and approximately 1 month after initiating therapy, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia[see Dosage and Administration and Warnings and Precautions ].If hyponatremia occurs, desmopressin acetate may need to be temporarily or permanently discontinued[see Warnings and Precautions ].WARNING: HYPONATREMIASee full prescribing information for complete boxed warning.- Desmopressin acetate can cause hyponatremia, which may be life-threatening if severe.
- Desmopressin acetate is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids.
- Ensure serum sodium concentration is normal before starting or resuming desmopressin acetate. Measure serum sodium within 1 week and approximately 1 month after starting therapy and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia.
- If hyponatremia occurs, interrupt or discontinue desmopressin acetate.
- During illnesses that can cause fluid or electrolyte imbalance, such as gastroenteritis, salt-wasting nephropathies, or systemic infection [see.]
WARNING: HYPONATREMIADesmopressin acetate can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death[see Warnings and Precautions ].Desmopressin acetate is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids[see Contraindications (4) and Warnings and Precautions ].Ensure the serum sodium concentration is normal before starting or resuming desmopressin acetate. Measure serum sodium within 7 days and approximately 1 month after initiating therapy, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia[see Dosage and Administration and Warnings and Precautions ].If hyponatremia occurs, desmopressin acetate may need to be temporarily or permanently discontinued[see Warnings and Precautions ].WARNING: HYPONATREMIASee full prescribing information for complete boxed warning.- Desmopressin acetate can cause hyponatremia, which may be life-threatening if severe.
- Desmopressin acetate is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids.
- Ensure serum sodium concentration is normal before starting or resuming desmopressin acetate. Measure serum sodium within 1 week and approximately 1 month after starting therapy and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia.
- If hyponatremia occurs, interrupt or discontinue desmopressin acetate.
Desmopressin acetate injection is contraindicated in patients with the following conditions because fluid retention increases the risk of worsening the underlying condition: - Heart failure
- Uncontrolled hypertension