Ddavp Injection

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders
  • Pituitary disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ddavp Injection Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Desmopressin acetate 4mcg/mL; soln for inj or IV infusion after dilution.

    Pharmacological Class

    Antidiuretic hormone.

    See Also

      How Supplied

      Amp (1mL)—10; Multi-dose vial (10mL)—1

      How Supplied

      DDAVP Injection is available as a sterile solution supplied as 4 mcg/mL in cartons of ten 1 mL single-dose, type 1 glass ampules and 40 mcg/10 mL (4 mcg/mL) in 10 mL multiple-dose vials, type 1 glass vial with rubber stopper and a flip off seal, each containing 4 mcg DDAVP per mL.

      Storage

      DDAVP Injection

      • Store refrigerated 2° to 8°C (36° to 46°F).

      Manufacturer

      Ferring Pharmaceuticals, Inc.

      Generic Availability

      YES

      Ddavp Injection Indications

      Indications

      To maintain hemostasis during surgical procedures and postoperatively and to reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding in patients with hemophilia A with factor VIII coagulant activity levels >5% without factor VIII antibodies; and patients with mild to moderate von Willebrand disease (Type I) with factor VIII levels >5%.

      Indications

      For patients with hemophilia A with factor VIII coagulant activity levels >5% without factor VIII antibodies maintain hemostasis during surgical procedures and postoperatively; and to reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. For patients with mild to moderate von Willebrand disease (Type I) with factor VIII levels >5% to maintain hemostasis during surgical procedures and postoperatively; and to reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

      Limitations of Use

      Not indicated for the treatment of severe von Willebrand disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen.

      Ddavp Injection Dosage and Administration

      Prior to Treatment Evaluations

      Hemophilia A

      • Verify that factor VIII coagulant activity levels are >5% and exclude the presence of factor VIII autoantibodies.
      • Assess serum sodium and aPTT.

      von Willebrand Disease (Type I)

      • 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.

      Adults and Children

      <3months: not recommended. ≥3months: 0.3micrograms/kg (max 20mcg) IV over 15–30mins. Pre-op: give 30mins before scheduled procedure. If used to reduce spontaneous or traumatic bleeding, may repeat doses after 8–12hrs and once daily thereafter based on clinical response. Repeated administration before 48hrs associated with tachyphylaxis.

      Ddavp Injection Contraindications

      Contraindications

      Moderate to severe renal impairment (CrCl <50mL/min). Hyponatremia, or history of. Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion. Polydipsia. Concomitant use with loop diuretics. Concomitant use with systemic or inhaled glucocorticoids. During illnesses that can cause fluid or electrolyte imbalance, such as gastroenteritis, salt-wasting nephropathies, or systemic infection. Heart failure. Uncontrolled hypertension.

      Ddavp Injection Boxed Warnings

      Boxed Warning

      Hyponatremia: Ensure serum sodium concentration is normal before starting or resuming DDAVP. May need to discontinue if hyponatremia occurs.

      Ddavp Injection Warnings/Precautions

      Warnings/Precautions

      Not for treating Hemophilia A with Factor VIII coagulant activity levels ≤5%, Hemophilia B, in patients with FVIII antibodies, or for Type IIB VWD, or severe Type 1 VWD and evidence of abnormal molecular form of FVIII antigen. Monitor fluid intake, urine volume plasma osmolality. Fluid/electrolyte imbalance (eg, cystic fibrosis). Adjust fluid intake downward (esp in children and elderly) to decrease risk of water intoxication, hyponatremia. Habitual or psychogenic polydipsia. Coronary artery insufficiency. Hypertension. Predisposition to thrombosis. Pregnancy (Cat.B). Nursing mothers.

      Warnings/Precautions

      Hyponatremia

      • Can cause hyponatremia, which may be life-threatening if not promptly diagnosed and treated.
      • Ensure that serum sodium concentration is normal prior to initiating or resuming treatment. 
      • Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration; use without concomitant fluid reduction may lead to fluid retention and hyponatremia.
      • Monitor serum sodium concentration within 1 week and approximately 1 month of initiating DDAVP Injection, and periodically thereafter.
      • Hyponatremia risk increased in patients with: Fluid and electrolyte imbalance (eg, cystic fibrosis, heart failure, renal disorder), habitual or psychogenic polydipsia who may drink excessive amounts of water.
      • Concomitant treatments that cause hyponatremia: Tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opioids, carbamazepine, lamotrigine, thiazide diuretics, chlorpropamide.
      • If hyponatremia occurs, DDAVP Injection may need to be temporarily or permanently discontinued and treatment for hyponatremia instituted.

      Hypotension and Hypertension

      • May cause hypotension (with compensatory increase in heart rate) or hypertension.
      • Monitor blood pressure, especially in patients with a history of coronary artery insufficiency and/or hypertensive cardiovascular disease.

      Increased Risk of Thrombosis With von Willebrand Disease Type IIB

      • May result in platelet aggregation, thrombocytopenia, and possibly thrombosis.

      Hypersensitivity Reactions

      • Hypersensitivity reactions including anaphylaxis have been reported.
      • It is not known whether antibodies to DDAVP Injection are produced after repeated injections.
      • Monitor for signs/symptoms of hypersensitivity; interrupt treatment and manage if a reaction occurs.
      • Permanently discontinue for serious hypersensitivity reaction.

      Fluid Retention

      • Can cause fluid retention, which can worsen underlying conditions that are susceptible to volume status.
      • Increased risk for patients with heart failure or uncontrolled hypertension.
      • Not recommended in patients at risk of increased intracranial pressure or with a history of urinary retention.

      Pregnancy Considerations

      Based on the available published literature and case reports, no drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes has been identified.

      Nursing Mother Considerations

      Desmopressin is poorly transferred into human breastmilk at negligible amounts (0.0001-0.005% of the dose administered). There is no information on the effects of desmopressin on the breastfed child or on milk production. Consider the benefits for the mother vs the potential risk to the breastfed infant.

      Pediatric Considerations

      The safety and effectiveness of DDAVP have not been established in infants less than 3 months of age with hemophilia A or von Willebrand disease.

      Use in 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.

      Geriatric Considerations

      Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

      More frequent monitoring of serum sodium in patients 65 years of age and older is recommended.

      Use in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient.

      Renal Impairment Considerations

      Desmopressin acetate is substantially excreted by the kidney. 

      DDAVP is contraindicated in patients with CrCl<50mL/min.

      Other Considerations for Specific Populations

      In certain clinical situations, it may be justified to try DDAVP in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.

      Ddavp Injection Pharmacokinetics

      Elimination

      Mean terminal half-life is 2.8 hours.

      Ddavp Injection Interactions

      Interactions

      Caution with other pressor agents, drugs that may increase the risk of water intoxication with hyponatremia (eg, tricyclic antidepressants, SSRIs, chlorpromazine, opiates, NSAIDs, lamotrigine, carbamazepine). Possible convulsions with oxybutynin, imipramine.

      Ddavp Injection Adverse Reactions

      Adverse Reactions

      Headache, nausea, flushing, abdominal cramps, vulval pain, inj site reaction, water intoxication, hyponatremia, rare: changes in BP, severe allergic reactions, thrombotic events (inj).

      Ddavp Injection Clinical Trials

      See Literature

      Ddavp Injection Note

      Not Applicable

      Ddavp Injection Patient Counseling

      Patient Counseling

      Inform patients that DDAVP may cause severe hyponatremia, which may be life-threatening, if it is not promptly diagnosed and treated.

      Inform patients about the signs/symptoms of hyponatremia, to undergo recommended serum sodium measurements, and to inform about new medications.

      Discuss adjustment of fluid intake and monitoring of urine output with patients.

      Ddavp Injection Generic Name & Formulations

      Legal Class

      Rx

      General Description

      Desmopressin acetate 4mcg/mL; soln for inj or IV infusion after dilution.

      Pharmacological Class

      Vasopressin (synthetic).

      See Also

      How Supplied

      Tabs—100; Amp (1mL)—10; Multi-dose vial (10mL)—1; Nasal spray—Contact generic supplier

      How Supplied

      DDAVP Injection is available as a sterile solution supplied as 4 mcg/mL in cartons of ten 1 mL single-dose, type 1 glass ampules and 40 mcg/10 mL (4 mcg/mL) in 10 mL multiple-dose vials, type 1 glass vial with rubber stopper and a flip off seal, each containing 4 mcg DDAVP per mL.

      Storage

      DDAVP Injection

      • Store refrigerated 2° to 8°C (36° to 46°F).

      Manufacturer

      Ferring Pharmaceuticals, Inc.

      Ddavp Injection Indications

      Indications

      Central (cranial) diabetes insipidus. Temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

      Limitations of Use

      Use is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus.

      Ddavp Injection Dosage and Administration

      Prior to Treatment Evaluations

      Central Diabetes Insipidus

      • Assess serum sodium, urine volume and osmolality.

       

      Adult

      2–4mcg/day SC or IV in 1 or 2 divided doses. If switching stabilized patient, use one-tenth of intranasal dose.

      Adult

      Administer 2–4mcg/day SC or IV in 1 or 2 divided doses. If switching stabilized patient, use one-tenth of intranasal dose.

      • Do not dilute DDAVP Injection for Diabetes Insipidus population.

      • Morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover.

      • Adjust dose based on: adequate duration of sleep and adequate, not excessive, water turnover.

      Children

      Not established.

      Elderly

      Use caution for dose selection in elderly patients, 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.

      Ddavp Injection Contraindications

      Contraindications

      Moderate to severe renal impairment (CrCl <50mL/min). Hyponatremia, or history of.

      Contraindications

      Moderate to severe renal impairment (CrCl <50mL/min). Hyponatremia, or history of. Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion. Polydipsia. Concomitant use with loop diuretics. Concomitant use with systemic or inhaled glucocorticoids. During illnesses that can cause fluid or electrolyte imbalance, such as gastroenteritis, salt-wasting nephropathies, or systemic infection. Heart failure. Uncontrolled hypertension.

      Ddavp Injection Boxed Warnings

      Boxed Warning

      Hyponatremia.

      Boxed Warning

      Hyponatremia

      • Ensure serum sodium concentration is normal before starting or resuming DDAVP. May need to discontinue if hyponatremia occurs.

      Ddavp Injection Warnings/Precautions

      Warnings/Precautions

      Monitor fluid intake, urine volume and osmolality. Fluid/electrolyte imbalance (eg, cystic fibrosis). Habitual or psychogenic polydipsia. Coronary artery insufficiency. Hypertension. Inj: Predisposition to thrombosis. Nasal mucosal abnormalities (nasal forms). Young children. Elderly. Pregnancy. Nursing mothers.

      Warnings/Precautions

      DDAVP Injection

      Hyponatremia

      • Can cause hyponatremia, which may be life-threatening if not promptly diagnosed and treated.

      • Ensure that serum sodium concentration is normal prior to initiating or resuming treatment. 

      • Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration; use without concomitant fluid reduction may lead to fluid retention and hyponatremia.

      • Monitor serum sodium concentration within 1 week and approximately 1 month of initiating DDAVP Injection, and periodically thereafter.

      • Hyponatremia risk increased in patients with: Fluid and electrolyte imbalance (eg, cystic fibrosis, heart failure, renal disorder), habitual or psychogenic polydipsia who may drink excessive amounts of water.

      • Concomitant treatments that cause hyponatremia: Tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opioids, carbamazepine, lamotrigine, thiazide diuretics, chlorpropamide.

      • If hyponatremia occurs, DDAVP Injection may need to be temporarily or permanently discontinued and treatment for hyponatremia instituted.

      Hypotension and Hypertension

      • May cause hypotension (with compensatory increase in heart rate) or hypertension.

      • Monitor blood pressure, especially in patients with a history of coronary artery insufficiency and/or hypertensive cardiovascular disease.

      Increased Risk of Thrombosis With von Willebrand Disease Type IIB

      • May result in platelet aggregation, thrombocytopenia, and possibly thrombosis.

      Hypersensitivity Reactions

      • Hypersensitivity reactions including anaphylaxis have been reported.

      • It is not known whether antibodies to DDAVP Injection are produced after repeated injections.

      • Monitor for signs/symptoms of hypersensitivity; interrupt treatment and manage if a reaction occurs.

      • Permanently discontinue for serious hypersensitivity reaction.

      Fluid Retention

      • Can cause fluid retention, which can worsen underlying conditions that are susceptible to volume status.

      • Increased risk for patients with heart failure or uncontrolled hypertension.

      • Not recommended in patients at risk of increased intracranial pressure or with a history of urinary retention.

      Pregnancy Considerations

      DDAVP Injection

      • Based on the available published literature and case reports, no drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes has been identified.

       

      Nursing Mother Considerations

      DDAVP Injection

      • Desmopressin is poorly transferred into human breastmilk at negligible amounts (0.0001-0.005% of the dose administered). There is no information on the effects of desmopressin on the breastfed child or on milk production. Consider the benefits for the mother vs the potential risk to the breastfed infant.

      Pediatric Considerations

      DDAVP Injection

      • The safety and effectiveness of DDAVP have not been established in infants less than 3 months of age with hemophilia A or von Willebrand disease.
      • Use in 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.

      Geriatric Considerations

      Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

      More frequent monitoring of serum sodium in patients 65 years of age and older is recommended.

      Use in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient.

      Renal Impairment Considerations

      Desmopressin acetate is substantially excreted by the kidney. 

      DDAVP is contraindicated in patients with CrCl<50mL/min.

      Other Considerations for Specific Populations

      In certain clinical situations, it may be justified to try DDAVP in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.

      Ddavp Injection Pharmacokinetics

      Elimination

      Renal. Mean terminal half-life is 2.8 hours.

      Ddavp Injection Interactions

      Interactions

      Caution with other pressor agents, drugs that may increase the risk of water intoxication with hyponatremia (eg, tricyclic antidepressants, SSRIs, chlorpromazine, opiates, NSAIDs, lamotrigine, carbamazepine). Possible convulsions with oxybutynin, imipramine.

      Ddavp Injection Adverse Reactions

      Adverse Reactions

      Headache, nausea, flushing, abdominal cramps, vulval pain, water intoxication, hyponatremia, nasal congestion or rhinitis (nasal forms), inj site reaction; rare: changes in BP, severe allergic reactions, seizures in children from plasma hypoosmolality, thrombotic events (inj).

      Ddavp Injection Clinical Trials

      See Literature

      Ddavp Injection Note

      Not Applicable

      Ddavp Injection Patient Counseling

      Patient Counseling

      DDAVP Injection

      • Inform patients that DDAVP may cause severe hyponatremia, which may be life-threatening, if it is not promptly diagnosed and treated.
      • Inform patients about the signs/symptoms of hyponatremia, to undergo recommended serum sodium measurements, and to inform about new medications.
      • Discuss adjustment of fluid intake and monitoring of urine output with patients.

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