VAPRISOL pivotal trials included patients with euvolemic and hypervolemic hyponatremia from a variety of underlying causes. We’ve provided the case study scenarios below to help you better understand when and how to use VAPRISOL in your patients.
Geriatric Patient With Euvolemic Hyponatremia
The patient is an 82-year-old white male admitted to the hospital from a nursing home with 2 to 3 days of increasing confusion and a cough.
Heart Failure Patient With Hypervolemic Hyponatremia
A 75-year-old woman was admitted to the hospital with hyponatremia secondary to acute decompensated congestive heart failure (CHF) of several days’ onset, primarily attributed to medication noncompliance.
Liver Cancer Patient With Hypervolemic Hyponatremia
The patient is a 69-year-old white female admitted to the hospital for evaluation of dyspnea and right-sided pleural effusion. At admission, the patient was mildly hyponatremic.
Lung Cancer Patient With Euvolemic Hyponatremia
A 69-year-old white male with SIADH related to small cell lung carcinoma was referred to the nephrology service for evaluation of hyponatremia.
Mild Renal Insufficiency With Euvolemic Hyponatremia
The patient is a 70-year-old Hispanic male with a long medical history who was brought to his physician by family members after they noted increasing fatigue, restlessness, and gait abnormalities.
Preoperative Euvolemic Hyponatremia in a Burn Patient
A 42-year-old white male was admitted to the Burn Unit with 15% Total Body Surface Area (TBSA) deep-partial thickness burns to his upper and lower extremities resulting from misuse of an accelerant.
Indication: VAPRISOL is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia.
Important Limitations: VAPRISOL has not been shown to be effective for the treatment of the signs and symptoms of heart failure and is not approved for this indication. It has not been established that raising serum sodium with VAPRISOL provides a symptomatic benefit to patients.
IMPORTANT SAFETY INFORMATION
VAPRISOL is contraindicated in patients with hypovolemic hyponatremia. The coadministration of VAPRISOL with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated. In addition, no benefit can be expected in patients unable to make urine.
WARNINGS & PRECAUTIONS
Hyponatremia associated with heart failure: Safety data on the use of VAPRISOL in these patients are limited. Consider other treatment options.
Overly rapid correction of serum sodium: Monitor serum sodium, volume and neurologic status and if the patient develops an undesirably rapid rate of rise of serum, VAPRISOL should be discontinued. If serum sodium concentration continues to rise, VAPRISOL should not be resumed. Serious neurologic sequelae, including osmotic demyelination syndrome, can result from over rapid correction of serum sodium. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction should be used.
Hypovolemia or Hypotension: For patients who develop hypovolemia or hypotension while receiving VAPRISOL, VAPRISOL should be discontinued, and volume status and vital signs should be monitored.
Infusion site reactions: Serious reactions have occurred. Administer through large veins and change infusion site every 24 hours.
The most common adverse reactions (incidence ≥10%) reported in clinical trials were infusion site reactions (including phlebitis), pyrexia, hypokalemia, headache and orthostatic hypotension.
Potent CYP3A inhibitors may increase the exposure of conivaptan and are contraindicated. Generally avoid CYP3A substrates. Exposure to coadministered digoxin may be increased and digoxin levels should be monitored.
USE IN SPECIAL POPULATIONS
Use in Patients with Hepatic Impairment
In patients with moderate to severe hepatic impairment, initiate VAPRISOL with a loading dose of 10 mg over 30 minutes followed by 10 mg/day as a continuous infusion for 2 to 4 days. If no rise in serum sodium, VAPRISOL may be titrated upward to 20 mg/day.