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Important Safety Information Full Prescribing Information

This information is intended for US healthcare professionals

Patient Profiles

Hypervolemic Hyponatremia Secondary to Congestive Heart Failure (CHF)

78-year-old female was admitted to the hospital with hypervolemic hyponatremia secondary to CHF. The patient had been seen in the ED with a chief complaint of lethargy and shortness of breath.

Physical exam

Cardiac: increased jugular venous pressure, soft systolic murmur, bilateral rales, R>L pitting edema in extremities
Abdominal: no evidence of ascites
Neurological: confused, agitated, and irritable, with no focal neurological deficits
Vital signs: body weight 49.6 kg, BP 112/66, pulse 87 bpm
EKG: normal sinus rhythm, left-lead voltage change
Chest x-ray: a right pleural effusion with atelectasis and infiltrates

Medical history

Congestive heart failure (CHF)

Medications and tests

Spironolactone (aldosterone antagonist): 25 mg qd po
Furosemide (loop diuretic): 40 mg qam po
Metoprolol (beta-adrenergic–blocking agent): 50 mg bid po
Digoxin (positive inotrope): 0.25 mg qam po

Admission Laboratory Values
Serum [Na⁺] (normal: 135-145 mEq/L)	119 mEq/L
Serum [K⁺] (normal: 4.0-4.7 mEq/L)	3.9 mEq/L
Cl (normal: 96-106 mEq/L)	90 mEq/L
CO₂ (normal: 20-29 mmol/L)	31 mmol/L
BUN (normal: 10-20 mg/dL)	12 mg/dL
Creatinine (normal: 0.6-1.2 mg/dL)	0.6 mg/dL
Glucose (normal: ≤100 mg/dL)	101 mg/dL
CPK (normal: 40-170 IU/L)	26 IU/L
Hemoglobin (normal: 12-16 mg/dL)	9.9 mg/dL
Hematocrit (%) (normal: 37-47)	29.9
Serum osmolality	259 mOsm/kg
Urine osmolality	260 mOsm/kg
Urine sodium	49 mEq/L
Urine potassium	37 mEq/L
Digoxin level (normal: 0.5-2.0 ng/mL)	Within normal limits

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How Common Is Hyponatremia?

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Vaprisol Provides Proven Efficacy

Learn more about how Vaprisol raises serum [Na⁺] in a prompt but controlled fashion.

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Indication

Vaprisol is indicated for the treatment of euvolemic and hypervolemic hyponatremia in hospitalized patients
Vaprisol is not indicated for the treatment of congestive heart failure. It should only be used for the treatment of hyponatremia in patients with underlying heart failure when the expected benefit of raising serum sodium outweighs the increased risk of adverse events

Important Safety Information

Vaprisol is contraindicated in patients with hypovolemic hyponatremia. In addition, coadministration of Vaprisol with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated
Serum sodium, volume, and neurological status must be monitored frequently because Vaprisol potentially can cause overly rapid correction of sodium leading to serious sequelae
The use of Vaprisol in patients with hepatic impairment (including ascites, cirrhosis, or portal hypertension) or renal impairment has not been systematically evaluated. Use caution when administering Vaprisol to these patients
The most common adverse reactions reported were infusion site reactions (incidence of 73% and 63% for 20 mg/day and 40 mg/day, respectively) which were also the most common type of adverse reaction leading to discontinuation of Vaprisol. Discontinuations from treatment due to infusion site reactions were more common among Vaprisol-treated patients (3%) than among placebo-treated patients (0%). Other common adverse reactions were headaches (8%, 10%), hypokalemia (22%, 10%), orthostatic hypotension (14%, 6%), and pyrexia (11%, 5%) for Vaprisol 20 mg/day and 40 mg/day, respectively