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What is the importance of JINARC® RMP?

The JINARC® RMP aims to reduce the risk of severe and potentially fatal liver injury associated with the use of JINARC®.

This is done by:

  • Educating healthcare providers about:
    • The risks of using Tolvaptan (Jinarc®).
    • The importance of baseline & periodic monitoring.
    • The need to counsel patients on the risks of using Tolvaptan (Jinarc®).
  • Ensuring they follow the monitoring requirements.
  • Informing patients about the risks and monitoring requirements.

How to become a certified prescriber of Tolvaptan (Jinarc®)?

  1. Review the educational materials

    2. ✓ Prescribing Information

    ▶ ◀

    ✓ Prescribing Guide

    ▶ ◀

  2. Take the Jinarc® Safety Prescribing Certification. Will confirm your certification through your registered e-mail address.

    3. ▶ ◀

How do I enroll a patient in the JINARC® RMP?

  1. Counsel the patient on the risks and monitoring requirements using the Patient Guide.

    2. ▶ ◀

  2. Order and evaluate liver function test (LFT) before the first prescription.
  3. After reviewing patient’s LFT, inform the patient to contact the ADPKD hotline..

GLOBE: 0917-801-5689

SMART: 0998-841-3379 (w/ Viber)

EMAIL: otsukapap@globoasiatico.com

Once a patient is on Tolvaptan (JINARC®), how often should I monitor them?

  1. Order and review liver laboratory tests (liver transaminases and total bilirubin) at specific time points after treatment initiation, as follows:

Reference:
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

How should I report liver adverse events?

  • To report adverse events, adverse drug reactions or patient safety concerns, healthcare providers must notify the OPPI-Pharmacovigilance and collect the following information:

Description of event

Patient information

Otsuka product involved e.g. Tolvaptan (JINARC®)

Primary reporter contact information

OPPI-Pharmacovigilance:

✓Email: oppi-pv@otsuka.com.ph

✓Mobile: +63999 8869 910

✓Phone: +632 8844 9266, +632 8888 6774

✓Fax: +632 8811 2279

Full prescribing information available from Tolvaptan (Jinarc®) Package insert
Full prescribing information available from Tolvaptan (Jinarc®) Package insert
Tolvaptan (Jinarc®) [Package Insert]. Tokushima, Japan; OPC; December. 2022.