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What is ADPKD?

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a hereditary & progressive disease characterized by gradual enlargement of cysts in both kidneys leading to renal insufficiency, or reduction in kidney function, ultimately leading to End-Stage Renal Disease (ESRD).

What is JINARC® RMP?

  • The Jinarc® RMP (Risk Management Program) is a safety monitoring program designed to manage the risk of drug-induced liver injury associated with using Tolvaptan in Autosomal Dominant Polycystic Kidney Disease (ADPKD).
  • All Tolvaptan (Jinarc®) prescribers and patients must comply with the risk management program (RMP) with baseline and regular liver function test monitoring during treatment.

References:
Tolvaptan (Jinarc®) [Package Insert]. Tokushima, Japan; OPC; December. 2022
Jdiaa SS, Mustafa RA, Yu ASL. Treatment of Autosomal-Dominant Polycystic Kidney Disease. Am J Kidney Dis. Published online October 16, 2024. doi:10.1053/j.ajkd.2024.08.008
Torres VE, Chapman AB, Devuyst O, et al. Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease.New England Journal of Medicine. 2012;367(25):2407-2418. doi:10.1056/nejmoa1205511
Torres VE,Chapman AB, Devuyst O, et al. Tolvaptan in Later-Stage autosomal dominant polycystic kidney disease. New England Journal of Medicine. 2017;377(20):1930-1942. doi:10.1056/nejmoa1710030
Watkins PB, Lewis JH, Kaplowitz N, et al. Clinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database. Drug Safety. 2015;38(11):1103-1113. doi:10.1007/s40264-015-0327-3

FOR PRESCRIBERS

To prescribe JINARC®, healthcare providers need to follow these steps:

  1. Complete the one-time safety prescribing certification (8 questions only, can be retaken).

    Tolvaptan (Jinarc®) Safety Prescribing Certification

  2. Counsel patients and conduct baseline liver testing before enrolling them in the RMP, then write the prescription.
  3. Continuously monitor patients, conduct liver function testing at 2 weeks and 4 weeks after treatment initiation, monthly for 2-18 months, and every 3 months thereafter.

FOR PATIENTS

Once prescribed, patients can call the ADPKD hotline to inquire and enroll in the mandatory safety monitoring program (Jinarc® RMP)

Requirements:

  1. Updated Tolvaptan (Jinarc®) prescription*
  2. Updated Liver Function Test (LFT) results*
    1. ✓ SGPT/ALT
    2. ✓ SGOT/AST
    3. ✓ Bilirubin

*must be updated (dated within the last 30 days)