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FDA Approves SAMSCA(TM) (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia
Date:5/21/2009

sense or appropriately respond to thirst, hypovolemic hyponatremia, concomitant use of strong CYP 3A inhibitors, anuric patients

  • Too Rapid Correction of Serum Sodium Can Cause Serious Neurologic Sequelae - During initiation and after titration monitor patients to assess serum sodium concentrations and neurologic status. Subjects with SIADH or very low baseline serum sodium concentrations may be at greater risk for too-rapid correction of serum sodium. In patients receiving SAMSCA who develop too rapid a rise in serum sodium, discontinue or interrupt treatment with SAMSCA and consider administration of hypotonic fluid. Fluid restriction during the first 24 hours with SAMSCA may increase the likelihood of overly-rapid correction of serum sodium, and should generally be avoided.

  • Gastrointestinal Bleeding in Patients with Cirrhosis - Used only when the need to treat outweighs this risk

  • Dehydration and Hypovolemia - In patients who develop medically significant signs or symptoms of hypovolemia, discontinuation is recommended. Dehydration and hypovolemia can occur, especially in potentially volume-depleted patients receiving diuretics or those who are fluid restricted.
  • Co-administration with Hypertonic Saline - Not recommended
  • Other Drugs Affecting Exposure to SAMSCA -
    • CYP 3A Inhibitors - Do not use with strong inhibitors of CYP 3A; avoid concomitant use with moderate CYP 3A inhibitors
    • CYP 3A Inducers - Avoid concomitant use with CYP 3A inducers. If co-administered, the dose of SAMSCA may need to be increased
    • P-gp Inhibitors - The dose of SAMSCA may have to be reduced if co-administered with P-gp inhibitors


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SOURCE Otsuka Pharmaceutical Co., Ltd.; Otsuka America Pharmaceutical, Inc.; Otsuka Pharmaceutical Development & Commercialization, Inc.
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