Desmopressin Acetate

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. (2.1 ) 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 ) See Full Prescribing Information for instructions on reconstitution, preparation, and administration ( 2 ). 2.1 Pretreatment Testing and On-Treatment Monitoring Diabetes Insipidus 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. Hemophilia A 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. 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 Dosage Initiate fluid restriction during treatment with desmopressin acetate injection [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 , 8.5 )]. 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 1/10 th the 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 mL Monitor blood pressure and pulse during infusion. For Single-Dose Vial: Discard unused portion. 2.4 Switching Between Desmopressin Acetate Formulation Desmopressin 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.

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1 INDICATIONS AND USAGE 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.