National PBM Monograph Template



Tolvaptan (Samsca®)

National Drug Monograph

June 2011

VA Pharmacy Benefits Management Services,

Medical Advisory Panel, and VISN Pharmacist Executives

The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. These documents will be updated when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current.

Executive Summary:

Tolvaptan is the first U.S. Food and Drug Administration (FDA) approved orally administered selective vasopressin V2-receptor antagonist for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium 12mEq/L at 24 hours post-first dose. No incidences of either event were reported for placebo.

Tolvaptan is contraindicated in patients who are hypovolemic due to the risk of dehydration. Furthermore, patients cannot be fluid restricted during the first 24 hours of tolvaptan therapy.

Tolvaptan is a CYP 3A substrate and therefore cannot be used with strong CYP 3A inhibitors. Use with moderate CYP 3A inhibitors should be avoided and use with CYP 3A inducers may require tolvaptan dose adjustments. Tolvaptan is also a P-gp substrate and may require decreased doses when taken with a p-glycoprotein (P-gp) inhibitor.

Most other clinical studies investigated the use of tolvaptan 30 mg daily for the treatment of heart failure, which did not show efficacy for various outcomes, including long-term mortality. The majority of data came from these studies and, therefore, overall evidence and safety data for the treatment of (1) marked and/or symptomatic hyponatremia, (2) diseases other than heart failure that may cause hyponatremia and (3) use of doses greater than 30 mg is limited.

Introduction1,2

The purposes of this monograph are to (1) evaluate the available evidence of safety, tolerability, efficacy, cost, and other pharmaceutical issues that would be relevant to evaluating tolvaptan for possible addition to the VA National Formulary; (2) define its role in therapy; and (3) identify parameters for its rational use in the VA.

Tolvaptan is the first U.S. FDA approved orally administered selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia. Clinically significant hyponatremia is defined as (1) serum sodium ................
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