Generic: DESMOPRESSIN ACETATE
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. ( 1.1 ) Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or...
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. ( 1.1 ) 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. ( 1.2 ) 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. ( 1.3 ) Limitations of Use Desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. ( 1.3 ) von Willebrand’s disease (severe Type I) - not indicated for the treatment of patients with severe Type I von Willebrand’s disease and when there is evidence of an abnormal molecular form of factor VIII antigen. ( 1.3 ) 1.1 Central Diabetes Insipidus Desmopressin acetate injection 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. Limitations of Use: Desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. 1.2 Hemophilia A Desmopressin acetate injection is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5% without factor VIII antibodies to: Maintain hemostasis during surgical procedures and postoperatively Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. 1.3 von Willebrand’s Disease (Type I) Desmopressin acetate injection is indicated for patients with mild to moderate von Willebrand’s disease (Type I) with factor VIII levels greater than 5% to: Maintain hemostasis during surgical procedures and postoperatively Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. Limitations of Use Desmopressin acetate is not indicated for the treatment of severe von Willebrand’s disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen [see Warnings and Precautions (5.2) ].
5 WARNINGS AND PRECAUTIONS 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. ( 5.2 ) 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. ( 5.3 ) Hypersensitivity Reaction...
5 WARNINGS AND PRECAUTIONS 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. ( 5.2 ) 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. ( 5.3 ) Hypersensitivity Reactions : Severe reactions have occurred. Monitor for reactions during administration and interrupt if reaction occurs. ( 5.4 ) Fluid Retention: Fluid retention can worsen underlying conditions that are susceptible to volume status. Not recommended in patients at risk for increased intracranial pressure or with a history of urinary retention. ( 5.5 ) 5.1 Hyponatremia Desmopressin acetate injection can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death [see Boxed Warning ]. Desmopressin acetate injection is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances [see Contraindications (4) , Drug Interactions (7) ]. Avoid concomitant treatments that also cause hyponatremia. Prior to starting or resuming desmopressin acetate injection, ensure that the serum sodium concentration is normal. Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration. Use of desmopressin acetate injection without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia. Monitor the serum sodium concentration within 1 week and approximately 1 month of initiating desmopressin acetate injection, and periodically thereafter [see Dosage and Administration (2.1) ]. Base the frequency of serum sodium monitoring on the patient’s risk of hyponatremia. Patients with conditions associated with fluid and electrolyte imbalance (i.e., cystic fibrosis, heart failure, and renal disorders), geriatric and pediatric patients, patients receiving concomitant treatments that also cause hyponatremia (i.e., tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide diuretics and chlorpropamide), and patients with habitual or psychogenic polydipsia who may drink excessive amounts of water, may be at increased risk of hyponatremia [see Contraindications (4) ]. If hyponatremia occurs, desmopressin acetate injection may need to be temporarily or permanently discontinued and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia. 5.2 Hypotension and Hypertension Desmopressin acetate may cause hypotension (with compensatory increase in heart rate) or hypertension. Monitor blood pressure during desmopressin acetate administration, particularly in patients with a history of coronary artery insufficiency and/or hypertensive cardiovascular disease [see Adverse Reactions (6) , Drug Interactions (7.2) ]. 5.3 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 result in platelet aggregation, thrombocytopenia, and possibly thrombosis. 5.4 Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis have been reported with intravenous and intranasal desmopressin acetate, including cases of fatal anaphylaxis with intravenous desmopressin acetate. Desmopressin acetate injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate injection [see Contraindications (4) ]. It is not known whether antibodies to desmopressin acetate injection are produced after repeated injections. Monitor patients for signs or symptoms of hypersensitivity reactions during administration, interrupt treatment should a reaction occur, and manage medically. Permanently discontinue for serious hypersensitivity reaction [see Adverse Reactions (6) ]. 5.5 Fluid Retention Desmopressin acetate injection can cause fluid retention, which can worsen underlying conditions that are susceptible to volume status. Patients with heart failure or uncontrolled hypertension may be at increased risk. Desmopressin acetate injection is not recommended in patients at risk for increased intracranial pressure or those with a history of urinary retention. Advise patients to limit fluid intake [see Patient Counseling Information (17) ].
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hyponatremia [see Contraindications , Warnings and Precautions (5.1) ] • Hypotension and Hypertension [see Warnings and Precautions (5.2) ] • Increased risk of thrombosis in patients with von Willebrand’s Disease Type IIB [see Warnings and Precautions (5.3) ] • Hypersensitivity reactions [see Warnings and Precautions (5.4) ] • Fluid retention [see Warnings and Precautions (5.5) ]...
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hyponatremia [see Contraindications , Warnings and Precautions (5.1) ] • Hypotension and Hypertension [see Warnings and Precautions (5.2) ] • Increased risk of thrombosis in patients with von Willebrand’s Disease Type IIB [see Warnings and Precautions (5.3) ] • Hypersensitivity reactions [see Warnings and Precautions (5.4) ] • Fluid retention [see Warnings and Precautions (5.5) ] 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. Cardiovascular: Hypertension, hypotension, tachycardia, thrombotic events, fluid retention Digestive: Nausea, abdominal cramps Immune: Hypersensitivity reactions Integumentary: Erythema, swelling, burning pain, facial flushing Laboratory: Hyponatremia Nervous: Headache, hyponatremic seizures Common adverse reactions are abdominal cramps, burning pain, erythema, facial flushing, fluid retention, headache, hypersensitivity reactions, hypertension, hyponatremia, hyponatremic seizures, hypotension, nausea, swelling, tachycardia, and thrombotic events. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Nordic Pharma, Inc. at 1-844-267-4641 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.