Desmopressin

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. Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

Desmopressin acetate increases plasma levels of factor VIII activity in patients with hemophilia and von Willebrand’s disease Type I. The antidiuretic effects of desmopressin acetate are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water re-absorption in the kidney, and hence reducing urine production. Desmopressin acetate is a replacement hormone for antidiuretic hormone in the treatment of central diabetes insipidus. The change in structure of arginine vasopressin to desmopressin acetate resulted in increased duration of action and a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses were usually below threshold levels for effects on vascular or visceral smooth muscle.

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. 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. See Full Prescribing Information for instructions on reconstitution, preparation, and administration.

Desmopressin acetate injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate injection. Desmopressin acetate injection is contraindicated in patients with the following conditions due to an increased risk of hyponatremia: Moderate to severe renal impairment defined as a creatinine clearance below 50 mL/min. Hyponatremia or a history of hyponatremia, Use in Specific Populations ]. Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion. Polydipsia. Concomitant use with loop diuretics. Concomitant use with systemic or inhaled glucocorticoids.

Boxed warning (hyponatremia): Desmopressin acetate can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death. Desmopressin acetate is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids. Hypotension and Hypertension: May cause hypotension with compensatory increase in heart rate or hypertension. Monitor blood pressure during desmopressin acetate administration, especially in patients with heart disease. Increased Risk of Thrombosis in Patients with von Willebrand’s Disease Type IIB: Use of desmopressin acetate in patients with Type IIB von Willebrand’s disease may cause thrombosis due to platelet aggregation.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hyponatremia • Hypotension and Hypertension • Increased risk of thrombosis in patients with von Willebrand’s Disease Type IIB • Hypersensitivity reactions • Fluid retention The following adverse reactions have been identified during post-approval use of desmopressin acetate injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Drugs that increase risk of hyponatremia: Require more frequent serum sodium monitoring. Other vasoconstrictors: May require a reduction of the desmopressin acetate dosage.

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