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Desmopressin


General


Pronunciation

(des moe PRES in)


Brand Names: U.S.

  • DDAVP
  • DDAVP Rhinal Tube
  • Stimate

Indications


Use: Labeled Indications

Injection:

Diabetes insipidus: Antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus; management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Limitations of use: Desmopressin is ineffective for the treatment of nephrogenic diabetes insipidus.

Hemophilia A: For use in patients with hemophilia A with factor VIII coagulant activity levels >5% to maintain hemostasis during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure and to also stop bleeding due to spontaneous or trauma-induced injuries, such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

Limitations of use: Not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels ≤5%, for the treatment of hemophilia B, or in patients who have factor VIII antibodies. In certain clinical situations, it may be justified to try desmopressin with careful monitoring in patients with factor VIII levels between 2% and 5%.

Von Willebrand disease (type 1): For use in patients with mild to moderate classic von Willebrand disease (type 1) with factor VIII coagulant activity levels >5% to maintain hemostasis during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure and to stop bleeding due to spontaneous or trauma-induced injuries, such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

Limitations of use: Patients with von Willebrand disease who are least likely to respond are those with severe homozygous von Willebrand disease with factor VIII coagulant activity and factor VIII von Willebrand factor antigen levels <1%; other patients may respond (variable) depending on the type of molecular defect they have. Check bleeding time and factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen during administration of desmopressin to ensure that adequate levels are being achieved. Not indicated for the treatment of severe classic von Willebrand disease (type I) or when there is evidence of an abnormal molecular form of factor VIII antigen.

Uremic bleeding (Octostim [Canadian product]): Prevention or treatment of bleeding in patients with uremia.

Intranasal:

Diabetes insipidus (DDAVP Rhinal tube): Antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus; management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Limitation of use: Desmopressin is ineffective for the treatment of nephrogenic diabetes insipidus.

Hemophilia A (Stimate; Octostim [Canadian product]): For use in patients with hemophilia A with factor VIII coagulant activity levels >5% and to stop bleeding due to spontaneous or trauma-induced injuries, such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

Limitations of use: Not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels ≤5%, for the treatment of hemophilia B, or in patients who have factor VIII antibodies.

von Willebrand disease (type 1) (Stimate; Octostim [Canadian product]): For use in patients with mild to moderate classic von Willebrand disease (type 1) with factor VIII coagulant activity levels >5% and to stop bleeding due to spontaneous or trauma-induced injuries, such as hemarthroses, intramuscular hematomas, mucosal bleeding, or menorrhagia.

Limitations of use: Not indicated for the treatment of severe classic von Willebrand disease (type 1) or when there is evidence of an abnormal molecular form of factor VIII antigen.

Tablets:

Diabetes insipidus: Antidiuretic replacement therapy in the management of central diabetes insipidus; management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Limitation of use: Desmopressin is ineffective for the treatment of nephrogenic diabetes insipidus.

Nocturia (Nocdurna [Canadian product] only): Treatment of nocturia in adults with four or less nocturnal voids.

Primary nocturnal enuresis: Management of primary nocturnal enuresis, either alone or as an adjunct to behavioral conditioning or other nonpharmacologic intervention.


Contraindications


Known hypersensitivity to desmopressin acetate or any component of the formulations; hyponatremia or a history of hyponatremia; moderate-to-severe renal impairment (CrCl <50 mL/minute). There are no contraindications listed in the Stimate prescribing information.

Canadian labeling: Additional contraindications (not in US labeling): Note: May not be applicable to all available dosage forms; refer to manufacturer labeling for further detail. Type 2B or platelet-type (pseudo) von Willebrand 's disease; habitual or psychogenic polydipsia, cardiac insufficiency or other conditions requiring diuretic therapy; nephrosis or any other condition associated with impaired water excretion, severe hepatic dysfunction; primary nocturnal enuresis; sodium losing conditions


Dosing and Administration


Dosing: Adult

Diabetes insipidus: Note: Fluid restriction should be observed. Dosing should be individualized to response.

IV, SubQ: US labeling: 2 to 4 mcg daily (0.5 to 1 mL) in 2 divided doses or one-tenth (1/10) of the maintenance intranasal dose. Fluid restriction should be observed.

IM, IV, SubQ: Canadian labeling (DDAVP Injection only): 1 to 4 mcg (0.25 to 1 mL) once daily or one-tenth (1/10) of the maintenance intranasal dose. Fluid restriction should be observed.

Intranasal (100 mcg/mL nasal solution): Usual dose range: 10 to 40 mcg daily (0.1 to 0.4 mL) as a single dose or divided 2 to 3 times daily; adjust morning and evening doses separately for an adequate diurnal rhythm of water turnover. Most adults require 10 mcg (0.1 mL) twice daily. Note: The nasal spray pump can only deliver doses of 10 mcg (0.1 mL) or multiples of 10 mcg (0.1 mL); if doses other than this are needed, the rhinal tube delivery system is preferred. Fluid restriction should be observed.

Oral:

US labeling: Initial: 0.05 mg twice daily; total daily dose should be increased or decreased as needed to obtain adequate antidiuresis (range: 0.1 to 1.2 mg divided 2 to 3 times daily). Fluid restriction should be observed.

Canadian labeling: Initial: 0.1 mg 3 times daily; total daily dose should be increased or decreased as needed to obtain adequate antidiuresis (maximum: 1.2 mg/day in 3 divided doses). Fluid restriction should be observed.

Sublingual formulation [Canadian product]: DDAVP Melt: Initial: 60 mcg 3 times daily; total daily dose should be increased or decreased as needed to obtain adequate antidiuresis. Usual maintenance: 120 to 720 mcg equally divided 2 or 3 times daily. Fluid restriction should be observed.

Nocturia:Sublingual formulation [Canadian product]: Nocdurna:

Females: 25 mcg once daily at bedtime. Fluid intake should be limited 1 hour prior to dose until the next morning, or at least 8 hours after administration.

Males: 50 mcg once daily at bedtime; Note: In males ≥65 years, evaluate serum sodium within 4 to 8 days after initiation and at 1 month of treatment; discontinue therapy if sodium falls below normal range. Fluid intake should be limited 1 hour prior to dose until the next morning, or at least 8 hours after administration.

Primary nocturnal enuresis:

Oral: Initial: 0.2 mg at bedtime; dose may be titrated up to 0.6 mg to achieve desired response.

Sublingual formulation [Canadian product]: DDAVP Melt: Initial: 120 mcg administered 1 hour before bedtime; if bedwetting occurs after 3 days increase dose by 120 mcg/day. Dose may be further titrated up to a maximum of 360 mcg/day to achieve desired response. Fluid intake should be limited 1 hour prior to dose until the next morning, or at least 8 hours after administration. Treatment period is up to 3 months and then reassess with 1 week off treatment; if additional therapy is necessary, resume at same dosage prior to discontinuation.

Hemophilia A and von Willebrand disease (type 1):

IV: 0.3 mcg/kg by slow infusion; may repeat dose if needed (based on clinical response and laboratory results); if used preoperatively, administer 30 minutes before procedure. The Canadian labeling recommends a maximum IV dose of 20 mcg.

Intranasal (using high concentration spray [1.5 mg/mL]): <50 kg: 150 mcg (1 spray in a single nostril); ≥50 kg: 300 mcg (1 spray each nostril); repeat use is determined by the patients clinical condition and laboratory work. If using preoperatively, administer 2 hours before surgery.

Uremic bleeding: Octostim [Canadian product]: IV: 0.3 mcg/kg over 20 to 30 minutes (maximum dose: 20 mcg)

Uremic bleeding associated with acute or chronic renal failure (off-label use in US):IV: 0.4 mcg/kg over 10 minutes (Watson 1984)

Prevention of surgical bleeding in patients with uremia (off-label use in US):IV: 0.3 mcg/kg over 30 minutes (Mannucci 1983)


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Diabetes insipidus: Note: Fluid restriction should be observed in these patients; younger patients more susceptible to plasma osmolality shifts and possible hyponatremia. Dosing should be individualized to response.

Parenteral:

US labeling: Children ≥12 years and Adolescents: IV, SubQ: Refer to adult dosing.

Alternative recommendations (off-label): Infants and Children <12 years: IV, SubQ: No definitive dosing available. Adult dosing should not be used in this age group; adverse events such as hyponatremia-induced seizures may occur. Dose should be reduced. Some have suggested an initial dosage range of 0.1 to 1 mcg daily in 1 or 2 divided doses (Cheetham 2002). Initiate at low dose and increase as necessary. Closely monitor serum sodium levels and urine output; fluid restriction is recommended.

Canadian labeling (DDAVP Injection only): IM, IV, SubQ: Children and Adolescents: 0.4 mcg (0.1 mL) once daily or one-tenth (1/10) of the maintenance intranasal dose. Fluid restriction should be observed.

Intranasal (using 100 mcg/mL nasal solution:

Infants ≥3 months and Children ≤12 years: Usual dose range: 5 to 30 mcg daily (0.05 to 0.3 mL daily) as a single dose or divided 2 times daily; adjust morning and evening doses separately for an adequate diurnal rhythm of water turnover. Note: The nasal spray pump can only deliver doses of 10 mcg (0.1 mL) or multiples of 10 mcg (0.1 mL); if doses other than this are needed, the rhinal tube delivery system is preferred. Fluid restriction should be observed.

Adolescents: Refer to adult dosing.

Oral:

US labeling: Children ≥4 years and Adolescents: Refer to adult dosing.

Canadian labeling:

Children: Initial: 0.1 mg 3 times daily; total daily dose should be increased or decreased as needed to obtain adequate antidiuresis (maximum: 1.2 mg/day in 3 divided doses). Divide daily doses so that the evening dose is 2 times higher than the morning or afternoon dose to ensure adequate antidiuresis during the night. Fluid restriction should be observed.

Adolescents: Refer to adult dosing.

Sublingual formulation [Canadian product]: DDAVP Melt:

Children: Initial: 60 mcg 3 times daily; total daily dose should be increased or decreased as needed to obtain adequate antidiuresis. Usual maintenance: 120 to 720 mcg equally divided 2 to 3 times daily; divide daily doses so that the evening dose is 2 times higher than the morning or afternoon dose to ensure adequate antidiuresis during the night. Fluid restriction should be observed.

Adolescents: Refer to adult dosing.

Hemophilia A and von Willebrand disease (type 1):

IV: Infants ≥3 months, Children, and Adolescents: Refer to adult dosing.

Note: Adverse events such as hyponatremia-induced seizures have been reported especially in young children using this dosing regimen (Das 2005; Molnar 2005; Smith 1989; Thumfart 2005; Weinstein 1989). Fluid restriction and careful monitoring of serum sodium levels and urine output are necessary.

Intranasal (using high concentration spray [1.5 mg/mL]): Infants ≥11 months, Children, and Adolescents: Refer to adult dosing.

SubQ: Infants ≥3 months, Children, and Adolescents: Octostim [Canadian product]: Refer to adult dosing.

Primary nocturnal enuresis:

Oral:

US labeling: Children ≥6 years and Adolescents: Initial: 0.2 mg at bedtime. Dose may be titrated up to 0.6 mg to achieve desired response. Fluid intake should be limited 1 hour prior to dose until the next morning, or at least 8 hours after administration.

Canadian labeling: Children ≥5 years and Adolescents: Initial: 0.2 mg at bedtime; if bedwetting occurs after 3 days may increase dose by 0.2 mg/day up to a maximum of 0.6 mg/day. Fluid intake should be limited 1 hour prior to dose until the next morning, or at least 8 hours after administration. Treatment period is up to 3 months and then reassess with 1 week off treatment; if additional therapy is necessary, resume at same dosage prior to discontinuation.

Sublingual [Canadian product]: DDAVP Melt: Children ≥5 years and Adolescents: Refer to adult dosing.


Dosing: Renal Impairment

US labeling: CrCl <50 mL/minute: Use is contraindicated according to the manufacturers (except 1.5 mg/mL nasal spray); however, has been used in acute and chronic renal failure patients experiencing uremic bleeding or for prevention of surgical bleeding (off-label uses in US) (Mannucci 1983; Watson 1984).

Canadian labeling: Use is contraindicated in chronic renal insufficiency or other nephropathies (may not be applicable to all available dosage forms; refer to manufacturer labeling for additional detail).


Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer 's labeling.


Reconstitution

DDAVP injection: Hemophilia A and von Willebrand disease (type 1): Dilute solution for injection in 10 or 50 mL NS for IV infusion (10 mL for children ≤10 kg; 50 mL for children, adolescents, and adults >10 kg).

Octostim injection [Canadian product]: Dilute solution for injection in 10 mL or 50 mL NS for IV infusion (10 mL for children <10 kg; 50 mL for children, adolescents, and adults ≥10 kg).


Administration

IM (Canadian labeling [DDAVP Injection only]; not in US labeling), IV push, SubQ injection: Central diabetes insipidus: Withdraw dose from ampul into appropriate syringe size (eg, insulin syringe). Further dilution is not required. Administer as direct injection.

IV infusion:

Hemophilia A, von Willebrand disease (type 1), and prevention of surgical bleeding in patients with uremia (off-label in US) (Mannucci 1983): Infuse over 15 to 30 minutes; Octostim [Canadian product]: Infuse over 20 to 30 minutes; infusion should not be less than 20 minutes. If used preoperatively, administer 30 minutes prior to procedure.

Acute uremic bleeding (off-label in US) (Watson 1984a): May infuse over 10 minutes

Uremic bleeding: Octostim [Canadian product]): Bleeding time should be normalized by administering a test dose once bleeding disorder is diagnosed or at least 72 hours prior to surgical procedures. Infuse over 20 to 30 minutes. When used pre-operatively administer 30 minutes prior to procedure.

Intranasal: Ensure that nasal passages are intact, clean, and free of obstruction prior to administration.

DDAVP: Nasal pump spray: Delivers 0.1 mL (10 mcg); for doses <10 mcg or for other doses which are not multiples, use rhinal tube. DDAVP Nasal spray delivers fifty 10 mcg doses. For 10 mcg dose, administer in one nostril. Any solution remaining after 50 doses should be discarded. Pump must be primed prior to first use.

DDAVP Rhinal tube: Insert top of dropper into tube (arrow marked end) in downward position. Squeeze dropper until solution reaches desired calibration mark. Disconnect dropper. Grasp the tube 3/4 inch from the end and insert tube into nostril until the fingertips reach the nostril. Place opposite end of tube into the mouth (holding breath). Tilt head back and blow with a strong, short puff into the nostril (for very young patients, an adult should blow solution into the childs nose). Reseal dropper after use.

Octostim [Canadian product]: Gently blow nose to clear nasal passages. Prior to initial use, prime the pump by pressing down at least 5 times until an even spray appears. Spray is then ready for use. Dip tube inside bottle must always be submerged in the liquid when spraying. Tilt head back slightly and insert nasal applicator into one nostril. Hold breath as dose is administered. Repeat in opposite nostril if an additional spray is required. If used preoperatively, administer 2 hours prior to procedure. If spray pump is not used for 48 hours it must be primed again by pressing down a couple of times until an even spray appears. Pump will only deliver 150 mcg dose(s); if a different dose is needed, use the injection. Note: A test dose to measure response is recommended prior to initiating therapy.

Stimate: Press pump down 4 times to prime prior to initial use. Once ready, tilt pump, place nozzle tip in nostril, then spray. If pump has not been used for one week it must be primed again by pressing down once or until a fine mist is present. Discard after 25 sprays (excluding priming sprays). Note: A test dose to measure response is recommended prior to initiating therapy.

Oral:

Diabetes insipidus: Fluid restriction should be observed.

Primary nocturnal enuresis: Minimize fluid intake beginning 1 hour prior to administration and continue until the morning (for at least 8 hours).

May administer with or without food. Food may reduce/delay absorption although does not affect antidiuretic activity (Rittig 1998).

Sublingual [Canadian products]: Fluid restriction should be observed. For primary nocturnal enuresis or nocturia, minimize fluid intake beginning 1 hour prior to administration and continue until the morning (for at least 8 hours).

SubQ: Octostim [Canadian product]: May administer undiluted by direct injection.


Storage

DDAVP:

Nasal spray: Store at controlled room temperature of 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F). Keep nasal spray in upright position.

Rhinal Tube solution: Store refrigerated at 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F). May store at controlled room temperature of 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F) for up to 3 weeks.

Solution for injection: Store refrigerated at 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F).

Tablet: Store at controlled room temperature of 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F). Avoid excessive heat. Protect from light.

DDAVP Melt [Canadian product]: Store at 15 ‚ °C to 25 ‚ °C (59 ‚ °F to 77 ‚ °F) in original container. Protect from moisture.

Nocdurna [Canadian product]: Store at 25 ‚ °C (77 ‚ °F). Excursions permitted to 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F). Protect from moisture and light.

Octostim [Canadian product]:

Nasal spray: Store at 15 ‚ °C to 25 ‚ °C (59 ‚ °F to 77 ‚ °F). Store in upright position. Do not freeze.

Solution for injection: Store refrigerated at 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F). Do not freeze. Following dilution in NS may store at room temperature for up to 24 hours.

Stimate nasal spray: Store at room temperature not to exceed 25 ‚ °C (77 ‚ °F). Discard 6 months after opening bottle. Store bottle in upright position.


Dosage Forms/Strengths


Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection, as acetate:

DDAVP: 4 mcg/mL (1 mL)

DDAVP: 4 mcg/mL (10 mL) [contains chlorobutanol (chlorobutol)]

Generic: 4 mcg/mL (1 mL, 10 mL)

Solution, Injection, as acetate [preservative free]:

Generic: 4 mcg/mL (1 mL)

Solution, Nasal, as acetate:

DDAVP: 0.01% (5 mL) [contains benzalkonium chloride]

DDAVP Rhinal Tube: 0.01% (2.5 mL) [contains chlorobutanol (chlorobutol)]

Stimate: 1.5 mg/mL (2.5 mL) [contains benzalkonium chloride]

Generic: 0.01% (2.5 mL, 5 mL)

Tablet, Oral, as acetate:

DDAVP: 0.1 mg

DDAVP: 0.1 mg [DSC], 0.2 mg [scored]

Generic: 0.1 mg, 0.2 mg


Compatibility

Stable in NS.


Drug Interactions

Analgesics (Opioid): May enhance the adverse/toxic effect of Desmopressin. Monitor therapy

CarBAMazepine: May enhance the adverse/toxic effect of Desmopressin. Monitor therapy

ChlorproMAZINE: May enhance the adverse/toxic effect of Desmopressin. Monitor therapy

Demeclocycline: May diminish the therapeutic effect of Desmopressin. Monitor therapy

LamoTRIgine: May enhance the adverse/toxic effect of Desmopressin. Monitor therapy

Lithium: May diminish the therapeutic effect of Desmopressin. Desmopressin may increase the serum concentration of Lithium. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of Desmopressin. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the adverse/toxic effect of Desmopressin. Monitor therapy

Tolvaptan: May diminish the therapeutic effect of Desmopressin. Avoid combination

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Desmopressin. Monitor therapy


Monitoring Parameters

Blood pressure and pulse should be monitored during IV infusion

Note: For all indications, fluid intake, urine volume, and signs and symptoms of hyponatremia should be closely monitored especially in high-risk patient subgroups (eg, young children, elderly, patients with heart failure).

Diabetes insipidus: Urine specific gravity, plasma and urine osmolality, serum electrolytes

Hemophilia A: Factor VIII coagulant activity, factor VIII ristocetin cofactor activity, and factor VIII antigen levels, aPTT

von Willebrand disease: Factor VIII coagulant activity, factor VIII ristocetin cofactor activity, and factor VIII von Willebrand antigen levels, bleeding time

Nocturnal enuresis: Serum electrolytes if used for >7 days

Uremic bleeding: Octostim [Canadian product]): Bleeding time before and 1 hour after IV infusion.


Adverse Reactions


Frequency may not be defined (may be dose or route related).

Cardiovascular: Decreased blood pressure (IV), increased blood pressure (IV), flushing (facial)

Central nervous system: Headache (2% to 5%), dizziness (intranasal; ≤3%), chills (intranasal; 2%), nostril pain (intranasal; ≤2%)

Dermatologic: Skin rash

Endocrine & metabolic: Hyponatremia, water intoxication

Gastrointestinal: Abdominal pain (intranasal; 2%) gastrointestinal disease (intranasal; ≤2%), nausea (intranasal; ≤2%), abdominal cramps, sore throat

Hepatic: Increased serum transaminases (transient; associated primarily with tablets)

Local: Burning sensation at injection site, erythema at injection site, swelling at injection site

Neuromuscular & Skeletal: Weakness (intranasal; ≤2%)

Ophthalmic: Abnormal lacrimation (intranasal; ≤2%), conjunctivitis (intranasal; ≤2%), ocular edema (intranasal; ≤2%)

Respiratory: Rhinitis (intranasal; 3% to 8%), epistaxis (intranasal; ≤3%), cough, nasal congestion, upper respiratory tract infection

<1% (Limited to important or life-threatening): Abnormality in thinking, agitation, anaphylaxis (rare), balanitis, cerebral thrombosis (IV; acute), chest pain, coma, diarrhea, drowsiness, dyspepsia, edema, eye pruritus, hypersensitivity reaction (rare), insomnia, localized warm feeling, myocardial infarction (IV), pain, palpitations, photophobia, seizure, tachycardia, vomiting, vulvar pain


Warnings/Precautions


Concerns related to adverse effects:

- Allergic reactions: Severe allergic reactions have been reported with desmopressin; anaphylactic reactions have only occurred rarely with IV and intranasal administration.

- Hyponatremia: Desmopressin use may rarely lead to hyponatremia with associated signs and symptoms (eg, nausea/vomiting, headache, depressed reflexes, disorientation, irritability, muscle weakness/spasms/cramps) and extreme decreases in plasma osmolality, resulting in seizures, coma, respiratory arrest, and death. Risk factors for hyponatremia with desmopressin use include cystic fibrosis, renal dysfunction, heart failure, young age, advanced age, inappropriate high fluid intake, a higher than recommended dose, and concomitant use of medications known to either increase thirst or cause syndrome of inappropriate ADH secretion (SIADH). Fluid restriction during use is recommended. Monitor for signs/symptoms of hyponatremia.

- Hypotension: Severe hypotension may occur with rapid IV infusions.

- Thrombotic events: Acute cerebrovascular thrombosis and acute myocardial infarction have occurred (rare) with desmopressin injection; use with caution in patients predisposed to thrombus formation.

Disease-related concerns:

- Cardiovascular disease: Injection and intranasal desmopressin may cause a slight increase or transient decrease in blood pressure, and a compensatory increase in heart rate. Use with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease.

- Polydipsia (habitual or psychogenic): Use with caution in patients with habitual or psychogenic polydipsia. Patients consuming excessive amounts of water are at greater risk of hyponatremia. Use in these patients is contraindicated in Canadian labeling.

- Stress states/febrile illness: Lack of therapeutic effect has been observed in patients who have been febrile or stressed for several days; monitor for continued efficacy if indicated.

- Primary nocturnal enuresis: When using desmopressin for primary nocturnal enuresis, treatment should be interrupted if the patient experiences an acute illness (eg, fever, recurrent vomiting or diarrhea), vigorous exercise, or any condition associated with an increase in water consumption to prevent hyponatremia.

- von Willebrand disease type 2B: Patients with type 2B von Willebrand disease requiring hemostasis should not be treated with desmopressin since may result in platelet aggregation, thrombocytopenia, and possibly thrombosis.

Special populations:

- Elderly: Fluid intake should be adjusted downward in the elderly to decrease the possibility of water intoxication and hyponatremia.

- Pediatric: Fluid intake should be adjusted downward in very young patients to decrease the possibility of water intoxication and hyponatremia.

Dosage form specific issues:

- Intranasal: Consider alternative route of administration if changes in the nasal mucosa (scarring, edema) occur leading to unreliable absorption. Some patients may demonstrate a change in response after long-term therapy (>6 months) characterized as decreased response or a shorter duration of response.

- Tablet: Patients should be instructed to restrict fluid intake from 1 hour before to 8 hours after taking desmopressin tablets. Consider alternative route of administration (IV or intranasal) with inadequate therapeutic response at maximum recommended oral doses.


Pregnancy Risk Factor

B


Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Anecdotal reports suggest congenital anomalies and low birth weight. However, causal relationship has not been established. Desmopressin has been used safely throughout pregnancy for the treatment of diabetes insipidus (Brewster 2005; Schrier 2010). The use of desmopressin is limited for the treatment of von Willebrand disease in pregnant women (NHLBI 2007).


Actions


Pharmacology

Synthetic analogue of the antidiuretic hormone arginine vasopressin. In a dose dependent manner, desmopressin increases cyclic adenosine monophosphate (cAMP) in renal tubular cells which increases water permeability resulting in decreased urine volume and increased urine osmolality; increases plasma levels of von Willebrand factor, factor VIII, and t-PA contributing to a shortened activated partial thromboplastin time (aPTT) and bleeding time.


Absorption

Sublingual: Rapid


Metabolism

Unknown


Excretion

Urine (primarily)


Onset of Action

Intranasal: Antidiuretic: 15 to 30 minutes; Increased factor VIII and von Willebrand factor (vWF) activity (dose related): 30 minutes

Peak effect: Antidiuretic: 1 hour; Increased factor VIII and vWF activity: 1.5 hours

IV infusion: Increased factor VIII and vWF activity: 30 minutes (dose related)

Peak effect: 1.5 to 2 hours

Oral tablet: Antidiuretic: ~1 hour

Peak effect: 4 to 7 hours


Duration of Action

Intranasal, Injection, Oral tablet: ~6 to 14 hours


Half-Life Elimination

2 to 4 hours; Renal impairment: 9 hours


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience flushing, abdominal cramps, rhinitis, rhinorrhea, cough, or pharyngitis. Have patient report immediately to prescriber signs of low sodium (headache, trouble focusing, memory problems, illogical thinking, weakness, seizures, or change in balance), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), nausea, vomiting, mood changes, behavioral changes, hallucinations, loss of strength and energy, agitation, muscle pain, muscle weakness, muscle spasms, excessive weight gain, lack of appetite, shortness of breath, severe headache, severe dizziness, passing out, swelling of arms or legs, angina, coughing up blood, tachycardia, arrhythmia, severe nosebleeds, or injection site pain or irritation (HCAHPS).

- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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