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Dosing and Administration
Accurate premixed IV formulation
- VAPRISOL does not require dilution and has a well-defined daily dose (10 mg, 20 mg, and 40 mg)1
Convenient administration
- Use in hospitalized patients only
- Therapy should begin with a loading dose of VAPRISOL 20 mg IV administered over 30 minutes, followed by a 20-mgcontinuous IV infusion administered over 24 hours1
- Therapy should be administered through large veins and infusion site changed every 24 hours to minimize the risk of vascular irritation1
- VAPRISOL should be administered for an additional 1 to 3 days as a continuous IV infusion of 20 mg/day; the total duration of VAPRISOL (after loading dose) should not exceed 4 days1
- May be titrated up to a maximum dose of 40 mg/day if serum sodium concentration is not rising at the desired rate1
- Serum sodium concentration, volume status, and neurological status must be carefully monitored
- Discontinue VAPRISOL in patients whose serum sodium concentration rises undesirably rapidly; if serum sodium concentration continues to rise, VAPRISOL administration should not be resumed
- Packaged in single-use, ready-to-use containers – can be stored in drug-dispensing units1
- 30-month shelf life1
- Maintain at room temperature and protect from light until ready for use
- The flexible container is for single use only – any unused portion should be discarded
- VAPRISOL has been shown to be incompatible with both Lactated Ringer’s Injection and furosemide injection when these products are mixed in the same container; therefore, do not combine VAPRISOL with these products in the same intravenous line or container
Specific populations (hepatic impairment)1,2
In patients with moderate to severe hepatic impairment, initiate VAPRISOL with a loading dose of 10 mg over 30 minutes followed by a continuous infusion of 10 mg over 24 hours for 2 to a maximum of 4 days. If serum sodium is not rising at the desired rate, VAPRISOL may be titrated upward to 20 mg over 24 hours.
REFERENCES: 1. Vaprisol® [Package Insert] Cumberland Pharmaceuticals Inc. Nashville, TN 2016 2. Marbury T, Fox J, Kaelin B, Pavliv L. Pharmacokinetics of conivaptan use in patients with severe hepatic impairment. Drug Des Devel Ther. 2017 Feb 13;11:373-382
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. 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.
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.
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.
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