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Proven to slow kidney function decline in adults who are at risk for rapidly progressing ADPKD

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How to Get Started with JYNARQUE® (tolvaptan), Hero
Video file
How to Get Started with JYNARQUE® (tolvaptan), Hero

How to Get started

How to get started on JYNARQUE® (tolvaptan)

If you have been identified as an appropriate candidate for JYNARQUE and are ready to get started, check out our 5-step plan for beginning treatment, which includes important information about starting on JYNARQUE.

STEP 1
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STEP 1

WORK WITH YOUR NEPHROLOGIST

Partnering with your nephrologist is important in helping to slow the progression of your disease. Establish this connection to work together to create a plan and set expectations while you’re on your treatment journey.

STEP 2
Syringe, Icon
STEP 2

GET LAB WORK TO MONITOR YOUR LIVER

Once you begin treatment, you and your nephrologist will be enrolled in a program that helps to keep you safe by reducing your risk of liver injury. The JYNARQUE Risk Evaluation and Mitigation Strategy (REMS) Program was set up for your safety because JYNARQUE can cause serious and potentially fatal liver injury. Work with your nephrologist’s office to enroll and continue monitoring your liver function throughout the course of treatment.

STEP 3
Medication, Icon
STEP 3

RECEIVE JYNARQUE THROUGH A SPECIALTY PHARMACY

JYNARQUE is available exclusively through 3 REMS-certified pharmacies. Unlike other medications that you may pick up at a traditional pharmacy, JYNARQUE is delivered to you by a Specialty Pharmacy.

STEP 4
Welcome Kit, Icon
STEP 4

GET YOUR WELCOME KIT

Once you receive your first prescription of JYNARQUE, you will receive all the supporting materials you’ll need to help manage your treatment, including a 32-oz water bottle, a patient brochure, and a tips and tricks card.

Download the brochure to learn more

STEP 5
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STEP 5

LEARN HOW TO TAKE JYNARQUE

JYNARQUE is a pill that’s taken orally, twice a day. The first dose is taken upon waking, and the second dose is taken 8 hours later.



ADPKD=autosomal dominant polycystic kidney disease.

JYNARQUE Interstitial

Are you starting or currently taking JYNARQUE but can't make it to your required labwork?

We will come to you.

Learn more

 

JYNARQUE Interstitial modal

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To help, we are offering a Home Collection Service available to all current, eligible patients taking JYNARQUE. A phlebotomist will be sent to your home to collect a blood sample for your REMS*-required blood work. The collection and processing will be free of charge to you.

 

If you are interested in this service, please reach out to your prescribing physician directly to get more details on this program or contact the Otsuka Patient Support Center at 1-855-242-7787 who are available from 9AM to 5PM EST.

*Risk Evaluation and Mitigation Strategy

Learn more

ISI Block Title

IMPORTANT SAFETY INFORMATION and INDICATION for JYNARQUE® (tolvaptan)

  • Serious liver problems. JYNARQUE can cause serious liver problems that can lead to the need for a liver transplant or can lead to death. Stop taking JYNARQUE and call your healthcare provider 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

It is important that you have a blood test before you start JYNARQUE to help reduce your risk of liver problems. Your healthcare provider will do a blood test to check your liver:

  • before you start taking JYNARQUE
  • at 2 weeks and 4 weeks after you start treatment with JYNARQUE
  • then monthly for 18 months during treatment with JYNARQUE
  • and every 3 months from then on

Because of the risk of serious liver problems, JYNARQUE is only available through a restricted distribution program called the JYNARQUE Risk Evaluation and Mitigation Strategy (REMS) Program.

Do not take JYNARQUE if you:

  • have a history of liver problems or have signs or symptoms of liver problems, excluding polycystic liver disease
  • cannot feel if you are thirsty or cannot replace fluids by drinking
  • have been told that the amount of sodium (salt) in your blood is too high or too low
  • are dehydrated
  • are allergic to tolvaptan or any of the ingredients in JYNARQUE
  • are unable to urinate

Tell your healthcare provider about all your medical conditions, including if you:

  • have a history of sodium (salt) levels that are too low
  • are pregnant or plan to become pregnant. It is not known if tolvaptan will harm your unborn baby. Tell your healthcare provider if you become pregnant or think that you may be pregnant
  • are breastfeeding or plan to breastfeed. It is not known if tolvaptan passes into your breast milk. Do not breastfeed during your treatment with JYNARQUE. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

  • Taking JYNARQUE with certain medicines could cause you to have too much tolvaptan in your blood. JYNARQUE should not be taken with certain medications. Your healthcare provider can tell you if it is safe to take JYNARQUE with other medicines
  • Do not start taking a new medicine without talking to your healthcare provider

JYNARQUE may cause serious side effects, including:

  • 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

What should you avoid while taking JYNARQUE?

Do not drink grapefruit juice during treatment with JYNARQUE. This could cause you to have too much tolvaptan in your blood.

The most common side effects of JYNARQUE are:

  • thirst and increased fluid intake
  • making large amounts of urine, urinating often, and urinating at night

These are not all the possible side effects of JYNARQUE. Talk to your healthcare provider about any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

If you have any questions about your health or medicines, talk to your healthcare professional.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1‑800‑438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

INDICATION:

What is JYNARQUE?

JYNARQUE is a prescription medicine used to slow kidney function decline in adults who are at risk for rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). It is not known if JYNARQUE is safe and effective in children.

Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.

COVID-19 UPDATE

With the COVID-19 situation constantly developing, your health is our top priority. We hope that you and your families are staying safe and healthy during this unprecedented time.

If you are currently taking JYNARQUE® (tolvaptan), we encourage you to stay in close contact with your healthcare professional team regarding regular appointments and treatment management plans.

At this time, there is no expected impact on medication supply.

During the current COVID-19 pandemic, the JYNARQUE® (tolvaptan) REMS Program requirements remain in effect, as the health of patients who use this product is our top priority. Ongoing blood monitoring required by the REMS Program is extremely important due to the potential risk of serious liver injury from treatment with JYNARQUE. For these lab requirements during COVID-19 pandemic, we are able to temporarily offer our Mobile Phlebotomy Collection Service at no-cost for all patients taking JYNARQUE who prefer to have the REMS required blood work collected at home.

In helping patients who have lost a job or health insurance coverage due to the COVID-19 pandemic and to get through these challenging times, we have extended our Patient Support Program to provide ‘no-cost’ access for patients in the U.S. who are taking JYNARQUE. Please call Otsuka Patient Support at 1-855-242-7787 for more information on both programs.

For help accessing JYNARQUE, go to www.otsukapatientsupport.com/jynarque or call Otsuka Patient Support at 1-855-242-7787. The nurses at Otsuka Patient Support can answer questions related to Product Accessibility, Reimbursement and connecting patients to local treatment sites in their community.

Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.

September 202010US20EBC0103

IMPORTANT SAFETY INFORMATION and INDICATION for JYNARQUE® (tolvaptan)
ISI Block Title

IMPORTANT SAFETY INFORMATION and INDICATION for JYNARQUE® (tolvaptan)

  • Serious liver problems. JYNARQUE can cause serious liver problems that can lead to the need for a liver transplant or can lead to death. Stop taking JYNARQUE and call your healthcare provider 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

It is important that you have a blood test before you start JYNARQUE to help reduce your risk of liver problems. Your healthcare provider will do a blood test to check your liver:

  • before you start taking JYNARQUE
  • at 2 weeks and 4 weeks after you start treatment with JYNARQUE
  • then monthly for 18 months during treatment with JYNARQUE
  • and every 3 months from then on

Because of the risk of serious liver problems, JYNARQUE is only available through a restricted distribution program called the JYNARQUE Risk Evaluation and Mitigation Strategy (REMS) Program.

Do not take JYNARQUE if you:

  • have a history of liver problems or have signs or symptoms of liver problems, excluding polycystic liver disease
  • cannot feel if you are thirsty or cannot replace fluids by drinking
  • have been told that the amount of sodium (salt) in your blood is too high or too low
  • are dehydrated
  • are allergic to tolvaptan or any of the ingredients in JYNARQUE
  • are unable to urinate

Tell your healthcare provider about all your medical conditions, including if you:

  • have a history of sodium (salt) levels that are too low
  • are pregnant or plan to become pregnant. It is not known if tolvaptan will harm your unborn baby. Tell your healthcare provider if you become pregnant or think that you may be pregnant
  • are breastfeeding or plan to breastfeed. It is not known if tolvaptan passes into your breast milk. Do not breastfeed during your treatment with JYNARQUE. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

  • Taking JYNARQUE with certain medicines could cause you to have too much tolvaptan in your blood. JYNARQUE should not be taken with certain medications. Your healthcare provider can tell you if it is safe to take JYNARQUE with other medicines
  • Do not start taking a new medicine without talking to your healthcare provider

JYNARQUE may cause serious side effects, including:

  • 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

What should you avoid while taking JYNARQUE?

Do not drink grapefruit juice during treatment with JYNARQUE. This could cause you to have too much tolvaptan in your blood.

The most common side effects of JYNARQUE are:

  • thirst and increased fluid intake
  • making large amounts of urine, urinating often, and urinating at night

These are not all the possible side effects of JYNARQUE. Talk to your healthcare provider about any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

If you have any questions about your health or medicines, talk to your healthcare professional.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1‑800‑438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

INDICATION:

What is JYNARQUE?

JYNARQUE is a prescription medicine used to slow kidney function decline in adults who are at risk for rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). It is not known if JYNARQUE is safe and effective in children.

Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.