Desmopressin Acetate Oral Solution

Contraindications

4 CONTRAINDICATIONS DESMODA is contraindicated in patients with: •Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1)]. •Hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA.Reactions have included anaphylaxis [see Warnings and Precautions (5.3)]. •Moderate to severe renal impairment (defined as creatinine clearance (CLcr) less than 50 mL/min)[see Use in Specific Populations (8.6)]. • Hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA. (4) • Patients with moderate to severe renal impairment defined as creatinine clearance below 50 mL/min. (4) • Patients with hyponatremia or a history of hyponatremia. (4)

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Available data on the use of desmopressin acetate during pregnancy over decades of use have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated central diabetes insipidus during pregnancy (see Clinical Considerations). In vitro studies with human placenta demonstrate poor placental transfer of desmopressin. No adverse developmental outcomes were observed in animal reproduction studies with administration of desmopressin during organogenesis to pregnant rats and rabbits at doses approximately <1 to 38 times, respectively, the maximum recommended human dose based on body surface areas (mg/m2) (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. 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 There are risks associated with untreated central diabetes insipidus during pregnancy such as dehydration, preterm birth and oligohydramnios. Pregnant patients with diabetes insipidus should be monitored for electrolyte imbalance, maternal hypotension, and low amniotic fluid levels. 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 m