⛔ FDA Black Box Warning
WARNING: HYPONATREMIA Desmopressin acetate can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death [see Warnings and Precautions (5.1) ]. 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 [see Contraindications (4) and Warnings and Precautions (5.1) ]. Ensure the serum sodium concentration is normal before starting or resuming desmopressin acetate. Measure serum sodium within 7 days and approximately 1 month after initiating therapy, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ]. If hyponatremia occurs, desmopressin acetate may need to be temporarily or permanently discontinued [see Warnings and Precautions (5.1) ]. WARNING: HYPONATREMIA See full prescribing information for complete boxed warning. Desmopressin acetate can cause hyponatremia, which may be life-threatening if severe. ( 5.1 ) 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. ( 4 , 5.1 ) Ensure serum sodium concentration is normal before starting or resuming desmopressin acetate. Measure serum sodium within 1 week and approximately 1 month after starting therapy and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia. ( 2.1 , 5.1 ) If hyponatremia occurs, interrupt or discontinue desmopressin acetate. ( 5.1 )
Contraindications
4 CONTRAINDICATIONS Desmopressin acetate injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate injection [see Warnings and Precautions (5.4) , Adverse Reactions (6) , Description (11) ]. 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 [see Use in Specific Populations (8.5 , 8.6) and Clinical Pharmacology (12.3) ]. Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ], Use in Specific Populations (8.4 , 8.5) ]. Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Warnings and Precautions (5.1) ]. Polydipsia [see Warnings and Precautions (5.1) ]. Concomitant use with loop diuretics [see Boxed Warning ]. Concomitant use with systemic or inhaled glucocorticoids [see Boxed Warning ]. During illnesses that can cause fluid or electrolyte imbalance, such as gastroenteritis, salt-wasting nephropathies, or systemic infection [see Boxed Warning ]. Desmopressin acetate injection is contraindicated in patients with the following conditions because fluid retention increases the risk of worsening the underlying condition: Heart failure Uncontrolled hypertension Known hypersensitivity to desmopressin acetate or to any of the components ( 4 ) Moderate to severe renal impairment defined as a creatinine clearance below 50 mL/min ( 4 ) Hyponatremia or a history of hyponatremia ( 4 ) Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion ( 4 ) Polydipsia ( 4 ) Concomitant use with loop diuretics or systemic or inhaled glucocorticoids ( 4 ) During illnesses that can cause fluid or electrolyte imbalance ( 4 ) Heart failure or uncontrolled hypertension ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy 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 2-4% and 15-20%, 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 18 mcg dose re