Samsca

Drug -  Samsca (tolvaptan) [Otsuka Pharmaceutical]

July 2011

FDA approved indication

Samsca is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).

Important limitations

• Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with Samsca
• It has not been established that Samsca provides a symptomatic benefit to patients

Criteria

• Patient has significant hypervolemic and euvolemic hyponatremia AND
• The patient's serum sodium <125 mEq/L or less-marked hyponatremia that is symptomatic and has resisted correction with fluid restriction AND
• Samsca is initiated in a place that has access to serum sodium monitoring AND
• The patient can respond appropriately to thirst

Questions?

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