Desmopressin (nasal)

Other Drugs that may Increase Risk of Hyponatremia: Monitor serum sodium more frequently. ( 7.1 ) Other Vasoconstrictors: May require a reduction of the STIMATE dosage. ( 7.2 )

7.1 Other Drugs that may Increase Risk of Hyponatremia The concomitant administration of STIMATE with other drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine, and carbamazepine) requires more frequent serum sodium monitoring [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6 )] .

7.2 Other Vasoconstrictors Desmopressin acetate can elevate blood pressure. Use of large doses of STIMATE with other vasoconstrictors may require a reduction of the STIMATE dosage [ see Warnings and Precautions ( 5.2 ) ] .

8.1 Pregnancy Risk Summary Available data on the use of desmopressin 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 hemophilia A and von Willebrand’s disease 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 and 38 times, respectively, the maximum recommended human dose based on body surface area (mg/m 2 ) (see Data). The background risk of major birth defects and miscarriage for the indicated population are 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 Pregnant women with Hemophilia A or von Willebrand’s disease may be at an increased risk for bleeding diatheses and hemorrhagic events at delivery. A newborn born to a mother with Hemophilia A or von Willebrand disease may also be at risk for bleeding diatheses. Data Animal Data Desmopressin acetate at up to 50 ng/kg/day was given by subcutaneous injection to pregnant rats, from gestation day 1 to 20 during the period of early embryonic development and organogenesis without teratogenic effects.

Desmopressin acetate at up to 10 mcg/kg/day was given to pregnant rabbits by subcutaneous injection from gestation day 6 to 18 during fetal organogenesis without teratogenic effects. These doses of desmopressin acetate represent approximately <1 times (rat) and 38 times (rabbit) the maximum recommended human dose based on body surface area (mg/m 2 ).