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 created for your safety, to monitor your liver function through your scheduled blood tests.

In clinical trials:

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5% of people taking JYNARQUE experienced signs of liver injury

1% of people taking placebo experienced signs of liver injury

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

Scheduling your required blood tests

To reduce your risk of liver injury while taking JYNARQUE, you are required to have a blood test before starting treatment, and again 2 weeks and 4 weeks after you start.

  • After that, for the next 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 Schedule Start taking JYNARQUE Day 0 Blood test Month 21 and on At the end of every 3-month period Blood test Month 2-18 At the end of every month Blood test Day 28 4 weeks after starting JYNARQUE Blood test Day 14 2 weeks after starting JYNARQUE Baseline blood test Before starting JYNARQUE
Blood Test Schedule 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
  • Loss of appetite
  • Nausea
  • Right upper stomach (abdomen) pain or tenderness
  • Vomiting
  • Fever
  • Rash
  • Itching
  • Yellowing of the skin and white part of the eye (jaundice)
  • Dark urine

Serious side effects

Serious side effects of JYNARQUE® (tolvaptan): what to watch out for

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 of JYNARQUE: what to expect

Because of the way JYNARQUE works in the kidneys, it is common to experience excessive thirst and urination.

  • About 2 in 3 people (64%) felt thirsty while taking JYNARQUE
  • About 3 in 4 people (70%) had increased urination, including needing to wake up to urinate, urinating greater amounts, and urinating more often during the day

It may take some time to adjust to the most common side effects of JYNARQUE. Being patient with yourself and the adjustments in your lifestyle will help you stay focused on slowing the decline of your kidney function.

The three tips to help manage the most common side effects of JYNARQUE:

Bottled Water, Icon Created with Lunacy

Bring a bottle of water wherever you go, so you always have something to drink

Restroom, Icon Created with Lunacy

Find out where restrooms are located ahead of time

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Take your first dose of JYNARQUE as soon as you wake up, and your second dose exactly 8 hours later

OTHER STEPS:

  • Start treatment on a day when you're not going to work
  • Reduce the amount of protein and sodium in your diet
  • Talk to your family about your journey. From diagnosis to starting treatment with JYNARQUE, you can help lead your family to a greater level of understanding about ADPKD by helping them take the first step

Why do these side effects happen?

The most common side effects of JYNARQUE have to do with how it works to slow kidney function decline. It blocks the hormone vasopressin, which controls the amount of water in your body. Because of this, your body holds on to less water, which makes you need to urinate and drink water frequently.
See how JYNARQUE works.

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

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 CKD Stages 1 to 3 Patients Were Able to Keep Taking JYNARQUE
75% of CKD Stages 1 to 3 Patients Were Able to Keep Taking JYNARQUE
  • 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

As you begin treatment with JYNARQUE, remember that it is a long-term treatment and it can take time to see a difference.