Samsca Disease Interactions

Tolvaptan can cause serious and potentially fatal liver injury. Patients with symptoms that indicate liver injury such as fatigue, anorexia, right upper abdominal pain, dark urine or jaundice should discontinue treatment right away. Therapy duration should be limited to 30 days. The use of tolvaptan should be avoided in patients with underlying liver disease, including cirrhosis, because the ability to recover from liver injury may be impaired.

There are no clinical trials of tolvaptan in patients with CrCl < 10 mL/min, and because drug effects on serum sodium levels are likely lost at very low levels of renal function, use in these patients is not recommended. Additionally, no benefit can be expected in anuric patients, so the use of tolvaptan is contraindicated in these patients.

Osmotic demyelination syndrome is a risk associated with overly rapid correction of hyponatremia (> 12 mEq/L/24 hours). This syndrome can result in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizure, coma or death. Patients with advanced liver disease, alcoholism or severe malnutrition are at increased risk and require slower rates of correction. Serum sodium concentration and neurological status should be monitored appropriately during treatment administration. Vasopressin antagonists should be initiated and re- initiated in patients only in hospital settings were sodium levels can be monitored closely.