"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
Hemophilia A: DDAVP Injection (desmopressin acetate injection) 4 mcg/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 (desmopressin acetate injection) 4 mcg/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 (desmopressin acetate injection) 4 mcg/mL is indicated as antidiuretic replacement therapy in the management of central (a href="/script/main/art.asp?articlekey=9250">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.
DOSAGE AND ADMINISTRATION
Hemophilia A and von Willebrand's Disease (Type I): DDAVP Injection (desmopressin acetate injection) 4 mcg/mL is administered as an intravenous infusion at a dose of 0.3 mcg DDAVP/kg body weight diluted in sterile physiological saline and infused slowly over 15 to 30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended. Blood pressure and pulse should be monitored during infusion. If DDAVP Injection (desmopressin acetate injection) 4 mcg/mL is used preoperatively, it should be administered 30 minutes prior to the scheduled procedure.
The necessity for repeat administration of DDAVP or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than every 48 hours should be considered in treating each patient.
Diabetes Insipidus: This formulation is administered subcutaneously or by direct intravenous injection. DDAVP Injection (desmopressin acetate injection) 4 mcg/mL dosage must be determined for each patient and adjusted according to the pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.
The usual dosage range in adults is 0.5 mL (2.0 mcg) to 1 mL (4.0 mcg) daily, administered intravenously or subcutaneously, usually in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For patients who have been controlled on intranasal DDAVP and who must be switched to the injection form, either because of poor intranasal absorption or because of the need for surgery, the comparable antidiuretic dose of the injection is about one-tenth the intranasal dose.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic 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. (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)
Directions for use of One Point Cut (OPC) Ampules for DDAVP Injection (desmopressin acetate injection) :
- Use aseptic technique to clean ampule. Gently tap the top of the ampule to assist the flow of the solution from the upper portion of the ampule to the lower portion.
- Locate the blue dot on the upper portion of the ampule. Below this dot is a small score on the neck of the ampule. Hold the ampule with the blue dot facing away from you.
- Cover the vial with an appropriate wipe. Apply pressure to the top and bottom portions of the ampule to snap the ampule open away from you.
DDAVP Injection (desmopressin acetate injection) 4 mcg/mL is available as a sterile solution in cartons of ten 1 mL single-dose ampules (NDC 0075-2451-01) and in 10 mL multiple-dose vials (NDC 0075-2451-53), each containing 4.0 mcg DDAVP per mL.
Store refrigerated 2 to 8°C (36 to 46°F).
Keep out of the reach of children.
Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 Rev. July 2007. FDA Rev date: 10/26/2007This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/12/2008
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