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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