Your doctor will need to monitor your liver health while you are taking JYNARQUE® (tolvaptan)

You and your doctor will need to join a safety program to reduce your risk of liver injury

JYNARQUE can cause serious and potentially fatal liver injury.

The JYNARQUE Risk Evaluation and Mitigation Strategy (REMS) Program was set up to help reduce this risk for people taking JYNARQUE.

  • In clinical trials, about 5% of people taking JYNARQUE and 1% of people taking placebo experienced signs of liver injuries
    • In time, after JYNARQUE was stopped, there was no longer any sign of liver injury

To reduce your risk of liver injury while taking JYNARQUE, it is required that you have a blood test before you start JYNARQUE, then 2 weeks and 4 weeks after you start

After that, for the first 18 months of treatment with JYNARQUE, you will need to have a blood test every month. When that is done, you will only need to have a blood test every 3 months to be able to continue on JYNARQUE.

 

blood test start taking JYNARQUE before starting JYNARQUE blood test day 14 2 weeks after starting JYNARQUE day 0 blood test day 28 4 weeks after starting JYNARQUE blood test months 2—18 at the end of every month blood test months 21 and on at the end of every 3-month period
Layer 1 blood test before starting JYNARQUE day 14 blood test 2 weeks after starting JYNARQUE start taking JYNARQUE day 0 day 28 blood test 4 weeks after starting JYNARQUE months 2—18 at the end of every month blood test months 21 and on at the end of every 3-month period blood test

 

You should stop taking JYNARQUE and contact your doctor right away if you get any of the following symptoms:

  • Feeling tired
  • Fever
  • Loss of appetite
  • Rash
  • Nausea
  • Itching
  • Right upper stomach (abdomen) pain or tenderness
  • Yellowing of the skin and white part of the eye (jaundice)
  • Vomiting
  • Dark urine