Tolvaptan (Jynarque®)

SELF ADMINISTRATION

Indications for Prior Authorization:

  • Indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)

Patients must meet the following criteria for the indication(s) above:

  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with a nephrologist, AND
  • Patient has rapidly-progressing ADPKD (e.g. reduced or declining renal function, high or increasing total kidney volume [height adjusted]), AND
  • Patient does not have Stage 5 chronic kidney disease (CKD) [GFR <15mL/min/1.73 m2 or receiving dialysis], AND
  • Will not be used with Samsca™, AND
  • Patient does not have a contraindication to therapy:
    • History, signs or symptoms of significant liver impairment or injury. This contraindication does not apply to uncomplicated polycystic liver disease
    • Concomitant use with strong CYP 3A inhibitors
    • Uncorrected abnormal blood sodium concentrations
    • Unable to sense or respond to thirst
    • Hypovolemia
    • Hypersensitivity (e.g. anaphylaxis, rash) to Tolvaptan or any component of Tolvaptan
    • Uncorrected urinary outflow obstruction
    • Anuria

Dosing:

  • Initial dose: 60 mg (total daily dose)
    • 45 mg (1st dose taken upon waking)
    • 15 mg taken 8 hours later
  • Titration step: 90 mg (total daily dose)
    • 60 mg (1st dose)
    • 30 mg taken 8 hours later
  • Target dose: 120 mg (total daily dose)
    • 90 mg (1st dose)
    • 30 mg taken 8 hours later
  • Concomitant use with moderate CYP 3A inhibitors: reduce dose of Jynarque

Approval:

  • 1 year

Last review date: May 28, 2019