JYNARQUE Risks & REMS

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

JYNARQUE REMS Program

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:

5% of people taking JYNARQUE experienced signs of liver injury

1% of people taking placebo experienced signs of liver injury

After JYNARQUE was stopped, signs of liver injury typically reversed within 1 to 4 months

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. After the first 18 months, 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
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 call 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

Serious side effects

JYNARQUE may cause serious side effects

Take JYNARQUE twice a day, unless advised otherwise by your doctor.

Serious side effects may include:

  • Liver injuries. Learn more about liver injuries and the JYNARQUE REMS Safety Program here
  • Too much sodium in your blood (hypernatremia) and loss of too much body fluid (dehydration). In some cases, dehydration can lead to extreme loss of body fluid called hypovolemia. You should drink water when you are thirsty and throughout the day and night. Stop taking JYNARQUE and call your healthcare provider if you cannot drink enough water for any reason, such as not having access to water, or vomiting or diarrhea.
  • Tell your healthcare provider if you get any of the following symptoms:
    • dizziness
    • fainting
    • weight loss
    • a change in the way your heart beats
    • feeling confused or weak

Call your healthcare provider right away if you have any of the above symptoms.


Common side effects

Most common side effects to be ready for

These side effects may take some lifestyle adjustments

The most common side effects caused by JYNARQUE include excessive thirst and urination. These side effects are related to how JYNARQUE acts in the kidneys.

Why do these side effects happen?

Vasopressin works differently in normal kidney cells. There, it helps control the amount of water in your body. When vasopressin is blocked, your body holds on to less water, which could make you thirstier and give you the urge to urinate more.

About 2 in 3 people (64%) felt thirsty while taking JYNARQUE

Practical step:

Try taking a water bottle with you everywhere so you always have something to drink. Be sure to drink water to stay hydrated and not other drinks

About 3 in 4 people (70%) had increased urination, including needing to wake up from sleep to urinate, urinating greater amounts, and urinating more often during the day

Practical step:

Wherever you go, plan ahead by finding out where the restrooms are

Practical step:

Take your first JYNARQUE dose upon waking and the second dose exactly 8 hours later and you may be able to reduce the need to wake up to urinate

OTHER STEPS:

  • Start treatment on a day when you're not going to work
  • Reduce the amount of protein and sodium in your diet

In a clinical study of patients with CKD stages 2 to 4, most people adjusted to taking JYNARQUE and were able to continue treatment

For people who took JYNARQUE in clinical trials, the first 2 to 4 months were critical to seeing if they could adjust to side effects like thirst, frequent urination, and waking up to urinate.

Most people who made it past the first 5 weeks with JYNARQUE stayed with it for the duration.

In a clinical study of patients with CKD stages 1 to 3, nearly all patients who took JYNARQUE were able to keep taking it every day

  • 75% of patients who made it to 3 years with JYNARQUE said they could keep taking their current dose for as long as their doctor tells them to