DESMODA

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE DESMODA is indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use • DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus. DESMODA is a vasopressin analog indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use • DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus. Dosage and administration 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage for Central Diabetes Insipidus • Instruct patients about appropriate fluid restriction during DESMODA treatment due to risk of hyponatremia [see Warnings and Precautions (5.1)]. • Individualize the dosage of DESMODA for each patient and adjust the dosage according to the diurnal pattern of response. Estimate patient response by adequate duration of sleep and water turnover. • Recommended starting dosage of DESMODA for adults and pediatric patients is 0.05 mg orally twice daily. • Titrate the daily dosage as needed to obtain an adequate antidiuretic response. • Administer DESMODA on an empty stomach, at least 1 hour prior to or 2 hours after food. • Administer DESMODA using an oral syringe provided by the pharmacy. • Monitor response by measuring urine volume and osmolarity. Monitoring measurements of plasma osmolarity may also be useful. 2.2 Switching Patients with Central Diabetes Insipidus to DESMODA From Desmopressin Acetate Nasal Spray • For patients with central diabetes insipidus switching to DESMODA from desmopressin acetate nasal spray, wait twelve hours after the last dose. • Monitor patients closely during the initial dose titration period. Instruct patients about appropriate fluid restriction during DESMODA treatment due to risk of hyponatremia. (2.1) • Recommended starting dosage for adults and pediatric patients is 0.05 mg twice. (2.1) • Titrate the daily dosage as needed to obtain an adequate antidiuretic response. (2.1) • Take DESMODA on an empty stomach, at least 1 hour before or 2 hours after food. (2.1) • Monitor response by measuring urine volume and osmolarity. (2.1) • For patients with central diabetes insipidus switching to DESMODA from desmopressin acetate nasal spray, wait twelve hours after the last dose. Monitor patients closely during the initial dose titration period. (2.2) Warnings and cautions 5 WARNINGS AND PRECAUTIONS 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, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms due to an extreme decrease in serum sodium and plasma osmolality may include one or a combination of the following: seizure, coma and/or respiratory arrest. In order to decrease the risk of water intoxication with hyponatremia, fluid restriction is recommended. Careful fluid intake is particularly important in pediatric and geriatric patients because these patients are at greater risk of developing hyponatremia [see Use in Specific Populations (8.4, 8.5)]. More frequent monitoring of serum sodium levels is recommended in the following patients: those with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure, renal disorders, habitual or psychogenic polydipsia or those taking concomitant drugs that may cause hyponatremia [see Drug Interactions (7.1)]. Temporarily stop treatment with DESMODA during acute intercurrent illness characterized by fluid and/or electrolyte imbalance (e.g., systemic infections, fever, recurrent vomiting or diarrhea) or under conditions of extremely hot weather, vigorous exercise or other conditions associated with increased water intake. 5.2 Fluid Retention Desmopressin acetate can cause fluid retention, which can worsen underlying conditions that are susceptible to volume status. Closely monitor patients with heart failure or uncontrolled hypertension. DESMODA is not recommended in patients at risk for increased intracranial pressure or those with a history of urinary retention. 5.3 Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis have been reported with intravenous and nasal administration of desmopressin acetate, including cases of fatal anaphylaxis with intravenous desmopressin acetate [see Adverse Rea