FDA

Desmopressin Acetate

Approved 19 Aug 2022InjectionInjectable

The FDA lists this product in 35 strengths and forms.

Boxed warningThe FDA label of this medicine carries a boxed warning, the strongest warning the FDA gives. Read it under warnings and precautions.

Indications

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 Willebr and's disease (Type I) - for patients with mild to moderate diseases 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 Injection 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 )

1.1Central 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 Injection is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus.

1.2Hemophilia 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 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.

At a glance

Brand name: Desmopressin Acetate
Route: Injection
Dosage form: Injectable
Applicant: DR Reddys
Status: Prescription
FDA approval: 19 Aug 2022
Application: ANDA215961-001

Indications

( 1.3 )

1.1Central Diabetes Insipidus Desmopressin Acetate

1.2Hemophilia A Desmopressin Acetate

Warnings and precautions

Hypotension and Hypertension: May cause hypotension with compensatory increase in heart rate or hypertension. Monitor blood pressure during Desmopressin Acetate Injection 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 Injection 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 )

5.1Hyponatremia 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.

5.2Hypotension and Hypertension Desmopressin Acetate

Injection may cause hypotension (with compensatory increase in heart rate) or hypertension. Monitor blood pressure during Desmopressin Acetate Injection administration, particularly in patients with a history of coronary artery insufficiency and/or hypertensive cardiovascular disease [see Adverse Reactions ( 6 ), Drug Interactions ( 7.2 )]

5.3Increased Risk of Thrombosis in Patients

with von Willebrand's Disease Type IIB Use of Desmopressin Acetate Injection in patients with Type IIB von Willebrand’s disease may result in platelet aggregation, thrombocytopenia, and possibly thrombosis.

5.4Hypersensitivity Reactions

Hypersensitivity reactions including anaphylaxis have been reported with intravenous and intranasal Desmopressin Acetate Injection, including cases of fatal anaphylaxis with intravenous Desmopressin Acetate Injection. 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 )].

5.5Fluid 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 )].

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Prolonged experience with Desmopressin Acetate Injection in pregnant women over several decades, based on the available published literature and case reports, have not identified a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In addition, in vitro studies with human placenta demonstrate poor placental transfer of desmopressin. No adverse developmental outcomes were observed in animal reproductive and developmental studies following administration of desmopressin acetate during organogenesis to pregnant rats and rabbits, at doses 130- and 110- times, respectively, the recommended dose of 18 mcg for a 60 kg patient, based on body surface area (mg/m 2 ).

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease Associated Maternal and Embryo-fetal Risk: Pregnant women with Hemophilia A or von Willebrand’s disease may be at an increased risk for bleeding diatheses and hemorrhagic events at delivery.

An affected newborn may also be at risk of bleeding diatheses. Data Animal Data In a developmental toxicity study in rats, desmopressin acetate was administered intravenously at doses of 9.68, 48.4, or 241 mcg/kg/day during the period of organogenesis (gestations days 7 to 17). Laparohysterectomy for fetal examinations were conducted on gestation day 20 for twenty females in each group; the remaining 10 females were allowed to litter in order to determine any postnatal effects that might be attributable to pre-natal treatment.

No effects were seen on maternal and fetal survival, growth and morphology or post-natal offspring survival, growth, development, behavior and reproductive performance up to 241 mcg/kg/day (130 times the 18mcg dose received by a 60 kg patient based on body surface area). In an embryo-fetal development study and a pre- and postnatal development study in rabbits, desmopressin acetate was administered subcutaneously at doses of 2, 20 or 200 mcg/kg/day (embryo-fetal development) and 0.1, 1 or 10 mcg/kg/day (pre- and postnatal development) during the period of organogenesis (gestation days 6 to 18).

No effects on maternal and fetal survival or morphology were observed in both studies at doses of up to 200 mcg/kg/day (215x the 18 mcg dose received by a 60 kg patient based on body surface area) nor were there effects in the pre- and postnatal development study on parturition, postnatal survival, growth, development or behavior, up to the highest dose tested of 10 mcg/kg/day (11 times the 18 mcg dose received by a 60 kg patient, based on body surface area).

Desmopressin Acetate

Indications

1.1Central Diabetes Insipidus Desmopressin Acetate

1.2Hemophilia A Desmopressin Acetate

At a glance

Two medicines in one question?

Desmopressin Acetate

Indications

1.1Central Diabetes Insipidus Desmopressin Acetate

1.2Hemophilia A Desmopressin Acetate

At a glance

Two medicines in one question?

Contraindications

Warnings and precautions

5.1Hyponatremia Desmopressin Acetate

5.2Hypotension and Hypertension Desmopressin Acetate

5.3Increased Risk of Thrombosis in Patients

5.4Hypersensitivity Reactions

5.5Fluid Retention Desmopressin Acetate

Interactions

7.1Other

7.2Other Vasoconstrictors Desmopressin Acetate

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Strengths and forms

Official product information