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Safety Profile
Accurate premixed IV formulation
- Most common adverse reactions (incidence ≥ 10%) are infusion site reactions (including phlebitis), pyrexia, hypokalemia, headache and orthostatic hypotension.
- In clinical studies of VAPRISOL, the adverse event profile in elderly patients was similar to that seen in the general population1
- In clinical studies of IV VAPRISOL, 89% (20 mg/day regimen) and 60% (40 mg/day regimen) of participants were at least 65 years of age and 60% (20 mg/day regimen) and 40% (40 mg/day regimen) were at least 75 years of age
| Most Common Adverse Events With VAPRISOL* |
% Placebo [n=69] |
% VAPRISOL 20 mg [n=37] |
% VAPRISOL 40 mg [n=315] |
| Headache | 3 | 8 | 10 |
| Hypokalemia | 3 | 22 | 10 |
| Infusion site phlebitis | 1 | 51 | 32 |
| Infusion site reaction | 0 | 22 | 19 |
| Orthostatic hypotension | .0 | 14 | 6 |
| Pyrexia | 0 | 11 | 5 |
*Incidence ≥10% and higher than placebo.
REFERENCE: 1. Vaprisol® [Package Insert] Cumberland Pharmaceuticals Inc. Nashville, TN 2016
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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