SUMMARY
DDAVP® Injection (desmopressin acetate) 4 µg/mL is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation.
DDAVP® Injection is indicated for the following:
Hemophilia A:
DDAVP Injection 4 µg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%.
DDAVP will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure.
DDAVP will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.
DDAVP is not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have factor VIII antibodies.
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.
von Willebrand's Disease (Type I):
DDAVP Injection 4 µg/mL is indicated for patients with mild to moderate classic von Willebrand's disease (Type I) with factor VIII levels greater than 5%. DDAVP will often maintain hemostasis in patients with mild to moderate von Willebrand's disease during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure.
DDAVP will usually stop bleeding in mild to moderate von Willebrand's patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.
Those von Willebrand's disease patients who are least likely to respond are those with severe homozygous von Willebrand's disease with factor VIII coagulant activity and factor VIII von Willebrand factor antigen levels less than 1%. Other patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked during administration of DDAVP to ensure that adequate levels are being achieved.
DDAVP is not indicated for the treatment of severe classic von Willebrand's disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen. (See WARNINGS.)
Diabetes Insipidus: DDAVP Injection 4 µg/mL 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. DDAVP is ineffective for the treatment of nephrogenic diabetes insipidus.
DDAVP is also available as an intranasal preparation. However, this means of delivery can be compromised by a variety of factors that can make nasal insufflation ineffective or inappropriate. These include poor intranasal absorption, nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy, create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.
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NEWS HIGHLIGHTS
Published Studies Related to Ddavp Injection (Desmopressin)
An Open Randomized Controlled Trial of Desmopressin, and Pulse Dexamethasone as Adjunctive Therapy in Patients with Pulmonary Involvement Associated with Severe Leptospirosis. [2009.09.02]
Abstract Pulmonary involvement in leptospirosis is emerging as a common complication associated with severe leptospirosis. A prospective randomized controlled trial of desmopressin or high dose (pulse) dexamethasone as adjunctive therapy in 68 patients with pulmonary involvement associated with severe leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand...
Clinical study shows improved absorption of desmopressin with novel formulation. [2009.07]
PURPOSE: To create improved pharmaceutical formulations for nasal and sublingual administration of desmopressin and investigate their pharmacokinetic profiles in comparison with a commercial nasal liquid spray and finally to evaluate the volunteers' opinions on the different dosage forms... CONCLUSIONS: The nasal powder formulation is a promising new dosage form for the delivery of desmopressin and other compounds. The sublingual tablet has a beneficial means of production and may be further developed by decreasing its disintegration time.
Multisite management study of menorrhagia with abnormal laboratory haemostasis: a prospective crossover study of intranasal desmopressin and oral tranexamic acid. [2009.04]
The optimal management of menorrhagia among women with abnormal laboratory haemostasis is uncertain. In a crossover study, 116 women with menorrhagia [pictorial blood assessment chart (PBAC) score >100], negative gynaecological evaluation and abnormal laboratory haemostasis were randomly assigned to either intranasal desmopressin (IN-DDAVP) or tranexamic acid (TA) therapy for two menstrual cycles...
Desmopressin, as a "designer-drug," in the treatment of overactive bladder syndrome. [2009]
AIMS: This study looked at whether oral desmopressin, by decreasing kidney urine production, would prolong bladder filling-time thereby increasing the time to reach maximum capacity, thus reducing overactive bladder (OAB) symptoms, and providing an alternative method of treatment to OAB sufferers... CONCLUSIONS: Antidiuresis, using oral desmopressin tablets, is a novel, feasible and safe (short-term basis) method of treatment for adults with OAB, and could be considered in the armamentarium of drugs available for the treatment of OAB. (c) 2008 Wiley-Liss, Inc.
Combination therapy with desmopressin and an anticholinergic medication for nonresponders to desmopressin for monosymptomatic nocturnal enuresis: a randomized, double-blind, placebo-controlled trial. [2008.11]
OBJECTIVE: Desmopressin is an approved medical therapy for the treatment of monosymptomatic primary nocturnal enuresis. In cases of limited response to desmopressin, we have added anticholinergic therapy to desmopressin (combination therapy). To evaluate this treatment strategy, we examined the efficacy of combination therapy for primary nocturnal enuresis in desmopressin-nonresponders... CONCLUSIONS: This study represents the first prospective, placebo-controlled trial examining the effect of desmopressin in combination with long-acting, anticholinergic, bladder-relaxing therapy for monosymptomatic primary nocturnal enuresis.
Clinical Trials Related to Ddavp Injection (Desmopressin)
Desmopressin Response in the Young [Completed]
The purpose of this study is to determine whether desmopressin administered as a melt tablet
is effective in reducing the number of wet nights in children and adolescents who suffer from
bedwetting.
A 6-Week Open Label Cross-Over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE) [Active, not recruiting]
To evaluate the preference of subjects for MinirinĀ® oral lyophilisate treatment compared with
MinirinĀ® tablet treatment after 6 weeks.
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using
diary card data.
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a
PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2
formulations
Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis [Terminated]
Background: Pulmonary involvement in leptospirosis has been reported to be on the increase
and is emerging as the main cause of death due to leptospirosis in many countries, including
Thailand.
Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone
as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with
leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.
Interleukin-11 (IL-11) in Moderate or Mild Hemophilia A or Von Willebrand Disease (VWD) Unresponsive to Desmopressin Acetate (DDAVP) [Not yet recruiting]
The purpose of this study is to determine the biologic efficacy and safety of rhIL-11 when
given subcutaneously in adults with moderate or mild hemophilia A or Von Willebrand disease
unresponsive to DDAVP. Biologic efficacy will be measured by the number and percent increase
of VWD coagulation tests (FVIII: C, VWF: Ag, VWF: RCo, closure time, APTT, and VWF multimers)
to the normal range, or at least to 1. 5-3 time baseline, following dosing of rhIL-11 when
given daily for 4 days, and boosted by DDAVP infusion on day 4, in those in whom DDAVP is
not contraindicated. Safety will be measured by the frequency of adverse events, including
fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.
Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia [Recruiting]
The purpose of this study is to investigate the efficacy and safety of several doses of the
melt formulation of desmopressin in a broad population of adult patients with nocturia.
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Page last updated: 2009-10-20
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