DESMODA (desmopressin acetate)

Following a single oral administration of DESMODA in healthy subjects at 0.6 mg, mean maximum concentration (SD) is 82 (33) pg/mL, and mean total systemic exposure (SD) is 314 (138) (hrs∙pg/mL).

AbsorptionDesmopressin absolute oral bioavailability is 0.16%. Desmopressin area under the plasma drug concentration time curve (AUC) is reduced by 95% following administration of the oral solution compared to the intranasal formulation. Effect of Food DESMODA Cmax was decreased 72% and the AUC was decr...

The effectiveness of DESMODA was supported by dose response studies of desmopressin acetate tablets in patients with diabetes insipidus. These studies demonstrated that oral doses of 0.025 mg to 0.4 mg of desmopressin acetate tablets produced clinically significant antidiuretic effects. In patients treated with desmopressin acetate tablets, doses of 0.1 mg to 0.2 mg produced optimal antidiuretic effects lasting up to eight hours [see Clinical Pharmacology (12.2)].

The following serious adverse reactions are described below and elsewhere in the labeling:

• Hyponatremia [see Warnings and Precautions (5.1)]
• Fluid Retention [see Warnings and Precautions (5.2)]
• Hypersensitivity [see Warnings and Precautions (5.3)]
• Risk of Benzyl Alcohol Toxicity in Neonates [see Warnings and Precautions (5.4)] The following adverse reactions associated with the use of desmopressin acetate were identified in clinical studies or postmarketing reports. Because some of these rea...

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 Spe...

5.1 Hyponatremia Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. Cases of hyponatremia have been reported from postmarketing experience in patients treated with desmopressin acetate. Unless properly diagnosed and treated hyponatremia can be fatal. Observe all patients receiving DESMODA for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium,...

7 DRUG INTERACTIONS 7.1 Other Drugs that may Increase Risk of Hyponatremia Concomitant administration of DESMODA 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, thiazide diuretics, NSAIDs, lamotrigine, sulfonylureas, particularly chlorpropamide, oxybut...