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Samsca PMS in ADPKD Patients

This is a Post-Marketing Surveillance study of Samsca® tablets in actual use in cases to slow the progression of cyst development and renal insufficiency in accordance with Korean regulations on Risk Management Plan(RMP) and New Drug Re-examination. This survey is a post-marketing, prospective, single-arm, all-cases survey conducted on approved indication, usage, dosage.

Intervention:

Drug: Tolvaptan (other name: Samsca)

Inclusion criteria:

  • 18 years and older patients with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.
  • Patients who need to be prescribed by Investigators who got registered in Risk Management Plan.
  • Patients who have agreed and signed on conditions specified in Risk Management Plan.

Exclusion criteria:

  • Patients with known or suspected hypersensitivity to tolvaptan or chemically related structures such as benzazepines (benzazapril or mirtazapine) or to any ingredient of the drug
  • Patients requiring urgent intervention to raise serum sodium acutely.
  • Inability of the patient to sense or appropriately respond to thirst.
  • Hypovolemic hyponatremia
  • Concomitant use of strong CYP3A inhibitors
  • Anuric patients
  • Volume depletion patients
  • Hypernatremia patients
  • Women who are pregnant or possibly pregnant and lactation
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
  • Patients who are applicable to permanent discontinuation criteria prior to initiation of Samsca® Tablets

 Contact Information:

Hyo-Won Jeong

jhw0159@otsuka.co.kr