IMPORTANT SAFETY INFORMATION | FULL PRESCRIBING INFORMATION
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
CONTRAINDICATIONS
Vaprisol is contraindicated in patients with hypovolemic hyponatremia. Coadministration of Vaprisol with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated. In addition, in patients unable to make urine, no benefit can be expected. Solutions containing dextrose are contraindicated in patients with known allergy to corn or corn products.
WARNINGS & PRECAUTIONS
Hypervolemic hyponatremia associated with heart failure: Safety data on 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. 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.
Infusion site reactions: Serious reactions have occurred. Administer through large veins and change infusion site every 24 hours.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥10%) reported in clinical trials were infusion site reactions (including phlebitis), pyrexia, hypokalemia, headache and orthostatic hypotension.
DRUG INTERACTIONS
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.
SPECIAL POPULATIONS
Pregnancy: Based on animal data, Vaprisol may cause fetal harm.
Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother.
Pediatric Use: Safety and effectiveness in pediatric patients has not been studied.
Severe renal impairment: Vaprisol is not recommended.
REFERENCE: 1. Vaprisol Prescribing Information. Astellas Pharma US, Inc.
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