Tolvaptan is a restricted formulary drug with ordering limited to nephrology and cardiology providers.  

The Jynarque® brand product is not routinely stocked by sites due to the Tolvaptan for ADPKD REMS program.   The goal of the Tolvaptan for ADPKD shared system REMS is to mitigate the risk of serious and potentially fatal livery injury, and includes health care provider, patient, pharmacy and wholesaler-distributor requirements for dispensing.

• • The Tolvaptan for ADPKD Shared System REMS applies to tolvaptan products indicated for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). This REMS does not apply to tolvaptan products that are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure and syndrome of inappropriate antidiuretic hormone.
  • See Legacy Health REMS Requirements for detail.

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