Desmopressin Acetate Oral Solution

Prescription

Brand names: DESMODA

Dosage Form

Liquid/Solution

Route

ORAL

Manufacturer

Eton Pharmaceuticals, Inc.

About This Medication

11 DESCRIPTION DESMODA oral solution contains active moiety desmopressin, an analog of natural pituitary hormone 8-arginine vasopressin (antidiuretic hormone), in the form of acetate salt. The chemical name of desmopressin acetate is 1-desamino-8-D-arginine vasopressin acetate. Desmopressin acetate has a molecular weight of 1129.30 g/mol, an empirical formula of C 46 H 64 N 14 O 12 S 2 ·C 2 H 4 O 2 , and structural formula: Desmopressin acetate is white amorphous powder and is soluble in water. DESMODA oral solution: Each mL contains 0.05 mg of desmopressin acetate (equivalent to 0.047 mg of desmopressin free base) as active ingredient. The inactive ingredients include benzoic acid and sodium benzoate as buffering agents and antimicrobial agents, and purified water. The pH of the oral solution is 4.8 to 5.2. Desmoda Structural Formula

Active Ingredients

Ingredient	Strength
Desmopressin Acetate	-

Indications & 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.

How It Works

12.1 Mechanism of Action Desmopressin acetate’s primary pharmacodynamic action involves its binding to vasopressin 2 (V2) receptors. V2 receptors are primarily located in the distal convoluted tubule and collecting ducts of the nephron in the kidneys. These receptors play a crucial role in regulating water reabsorption and urine concentration. By influencing the permeability of the renal tubules, V2 receptors help maintain the body’s water balance and overall homeostasis.

Dosage & 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)

Side Effects Overview

6 ADVERSE REACTIONS 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 reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders: hypertension Gastrointestinal disorders: nausea, vomiting, diarrhea, constipation, abdominal cramps General disorders: headache, malaise, drug ineffective, edema, fatigue Hepatobiliary disorders: transient increases in AST (1.5 times the upper limit of normal) Immune system disorders: severe allergic reactions, anaphylaxis has occurred with other formulations of desmopressin Metabolism and nutrition: dehydration, hyponatremia, water intoxication with hyponatremia Nervous system disorders: hyponatremic convulsions, hyponatremic convulsions associated with concomitant use of the following medications: oxybutynin and imipramine [see Drug Interactions (7.1)], asthenia, coma, disturbance in attention, psychomotor hyperactivity, dizziness, somnolence, depressed level of consciousness, falls. Psychiatric disorders: confusional state, abnormal behavior, emotional disorder, depression, hallucination, insomnia Renal and urinary disorders: bladder and urethral symptoms, including urinary retention, urine flow decreased, dysuria Skin and subcutaneous tissue disorders: rash, dermatitis allergic, sweating, flushing, urticaria Respiratory, thoracic and mediastinal disorders: dyspnea, epistaxis In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of desmopressin acetate oral therapy, transient increases in AST (SGOT) no higher than 1.5 times the upper limit of normal were occasionally observed. Elevated AST (SGOT) returned to the normal range despite the continued use of desmopressin acetate oral therapy. Most common adverse reactions include: headache, dizziness, nausea, abdominal pain, hypertension, and diarrhea. (6) To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnings & Precautions

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 Reactions (6)]. DESMODA is contraindicated in patients with a history of hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA [see Contraindications (4)]. If signs or symptoms of hypersensitivity reactions occur, discontinue DESMODA and initiate appropriate supportive care. 5.4 Risk of Benzyl Alcohol Toxicity in Neonates DESMODA contains 2.74 mg/mL of benzoic acid, a metabolite of benzyl alcohol. Serious adverse reactions of metabolic acidosis, including fatalities, have been reported in low-birth-weight neonates (less than 2,500 grams) and preterm neonates (gestational age less than 34 weeks) who received benzyl alcohol-containing drugs intravenously. The relationship between systemic levels of benzoic acid and toxicity is not well-characterized [see Use in Specific Populations (8.4)]. Use DESMODA with caution in low-birth-weight neonates or preterm neonates and monitor for signs and symptoms of metabolic acidosis. • Hyponatremia: Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. Fluid restriction is recommended. (5.1) • Fluid Retention: Desmopressin acetate may cause fluid retention. Use with caution in 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. (5.2) • Hypersensitivity: Severe reactions have occurred. Monitor for reactions during administration and interrupt if reaction occurs. (5.3)

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)

Pharmacokinetics

12.3 Pharmacokinetics 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). Absorption Desmopressin 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 decreased 64% following administration of 0.6 mg DESMODA with a high-fat meal (1000 calories, 50% fat). Distribution DESMODA mean apparent (oral) volume of distribution (SD) is 11717 (5086) L. Elimination Desmopressin is mainly excreted in the urine. Desmopressin estimated elimination half-life is 3.6 hours. DESMODA mean apparent (oral) clearance (SD) is 2264 (940) L/hr. Specific Populations Renal Impairment A pharmacokinetic study was conducted in subjects with normal renal function and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects each group) with a single dose of 2 mcg desmopressin acetate intravenous injection. The geometric mean terminal half-life was 2.8 hours in subjects with normal renal function, and 4, 6.6, and 8.7 hours in patients with mild, moderate, and severe renal impairment, respectively. In patients with mild, moderate and severe renal impairment, mean desmopressin AUC was 1.5-fold, 2.4-fold and 3.6-fold higher, respectively, compared to that of subjects with normal renal function.

Frequently Asked Questions

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.

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. • …

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 …

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 …

Desmopressin Acetate Oral Solution is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Desmopressin Acetate Oral Solution drug label (National Library of Medicine)
• openFDA — Desmopressin Acetate Oral Solution label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 2738083 (NLM Normalized Drug Names)
• NDC Directory — Desmopressin Acetate Oral Solution (FDA National Drug Code)

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Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication.

Data sources: DailyMed (NLM), openFDA, MFDS