NASHVILLE, Tenn. (Thursday, March 23, 2017) – Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) today announced the publication of an open label multicenter study adding to the growing body of literature supporting the efficacy and use of Vaprisol® (conivaptan) Injection. The study, published in Drug Design, Development and Therapy, demonstrated that Vaprisol was well tolerated in hyponatremic patients with severe hepatic impairment.
Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. Vaprisol is used to treat hyponatremia, which is commonly seen in a variety of critical care conditions, and is often found in those with liver cirrhosis or severe liver impairment. Cirrhosis is the 12th leading cause of death in the United States, with a mortality rate of 9.7 per 100,000 persons.
This study, published in March 2017, concluded that – for hyponatremic patients suffering from severe hepatic impairment – Vaprisol dosing should be reduced by 50%. Treatment is recommended to be initiated with a loading dose of 10 mg given intravenously >30 minutes, followed by infusions of 10 mg per day for 2 – 4 days. If serum sodium is not increasing at the desired rate, Vaprisol may be titrated up to 20 mg per day.
A.J. Kazimi, CEO – Cumberland Pharmaceuticals Inc. said “With reported incidences of hyponatremia in hospitalized cirrhosis patients being greater than 50%, the opportunity to treat hyponatremic patients inflicted with various degrees of hepatic impairment is high. There is much information and experience supporting the use of Vaprisol as a safe and well-tolerated treatment, and these study results support Cumberland’s mission to provide effective treatment options that help address the unmet medical needs.”
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.