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

A Hidden Diagnosis, Video Thumbnail
A Hidden Diagnosis, Video Thumbnail

Jim is living with rapidly progressing autosomal dominant polycystic kidney disease, or ADPKD, and taking JYNARQUE® (tolvaptan).

For a very long time, Jim didn’t know that his mother, let alone himself, had been diagnosed with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). When he did learn, he felt like he had missed out on time to take better care of his health and build a big support system. Now, Jim shares his story to inspire others to take charge of their ADPKD.

Please remember that none of the information discussed in this article should replace the conversations with your healthcare provider. Jim is sharing his own thoughts and experiences, so please keep that in mind as your thoughts and experiences may be different. 

Talk to your doctor to see if JYNARQUE is right for you. 

You learned about your ADPKD diagnosis a little differently than others with the condition do. What was that moment like?

Jim: When I was almost 30, my parents came to visit. While there, my mom said she needed to tell me something in private. My mom and dad pulled me into the garage, which we used for storage. We stood around boxes of belongings stacked to the ceiling, and my mom told me, “You have a kidney disease. I have it too. We just need to watch our blood pressure.” That’s how I found out my mom had ADPKD…and I did too.

How did your mom even know the both of you had ADPKD?

Jim: Not too long ago, I asked her. My mom said that the day after her diagnosis, she rushed my sister and me to the hospital to see if we had it; I was 10 and my sister was 7. When my mom heard I had ADPKD too, she was heartbroken; it ate her up for almost 20 years until she told me.

Do you know why you didn’t learn about your ADPKD until you were an adult?

Jim: I’m not sure why my mom waited so long to tell me I had ADPKD. Maybe she didn’t know how to tell me; maybe it was the guilt; or maybe it was this idea our family had that you needed to “appear” sick to “be” sick. When I think of my own kids, I can imagine how tough it is to tell your child they inherited ADPKD.

How do you think your life would have been impacted if you’d known about ADPKD earlier?

Jim: If I’d known about ADPKD earlier, I’d have made some different choices. I never really paid close attention to how I was treating my body. I always felt good and could do pretty much anything I put my mind to. If I wanted to roll off my couch and run a half marathon, I had the energy and ability to do it. So I never recognized any signs that something was wrong with my kidneys. There were times I was put on antibiotics because of blood in my urine, but I never kept my follow-up appointments with my doctors when I was through the antibiotics.

Jim got in shape

“My mom had been training for [surgery], and that’s why she kept herself in such great shape. It was the wake-up call I’d been waiting for.”

Did your attitude change once you learned you had ADPKD?

Jim: Because my parents had been so nonchalant about telling me my diagnosis, I did nothing because I figured it wasn’t that big of a deal. And over the next few years, ADPKD did not seem to impact me. So I kept gaining more weight and wasn’t always diligent about managing my blood pressure or keeping up with my nephrologist’s appointments. My body was working harder and harder each year, while my cysts were growing larger and larger.

What did convince you to take charge of your ADPKD?

Jim: Probably the first time ADPKD became real to me was when my mom told us she would need a kidney transplant. While my mom was in surgery, her childhood best friend said that my mom had been training for this, and that’s why she kept herself in such great shape. It was the wake-up call I’d been waiting for.

Shortly after my mom’s transplant, my nephrologist’s nurse told me I had to stop pushing off my appointments and start facing this disease. I started eating right and religiously exercising. I also started talking to my nephrologist more. That’s how I found out about JYNARQUE. My doctor thought it would be good for me since I had rapidly progressing ADPKD.

Jim is eating and living healthy

“I’m eating and living healthy and staying active, not just for me, but for my family.”

What was it like to get on treatment with JYNARQUE?

Jim: The welcome kit answered a lot of my questions on JYNARQUE, and my doctor did share with me that because JYNARQUE can cause serious and potentially fatal liver problems, I need to have regular blood tests to monitor my liver function. This is part of the JYNARQUE Risk Evaluation and Mitigation Strategy (REMS) program.

As far as side effects go, I’ve had the things like waking up at night and going to the restroom more frequently, and thirst, plenty of thirst. But for me, this is manageable. This is my own experience regarding side effects from taking JYNARQUE. Side effects are on a patient-by-patient basis.

What results have you seen after taking better care of your health?

Jim: In my case, everything has been favorable so far despite my side effects; my lab results have improved, probably from a combination of lifestyle changes and JYNARQUE helping to slow the decline of my kidney function. Please remember, this is just my experience. Others should talk to their healthcare provider to see if JYNARQUE is right for them.

Why is it important to you now to manage your ADPKD?

Jim: I’m eating and living healthy and staying active, not just for me, but for my family. I’m doing everything I can to take care of my health today so I can be there for them tomorrow. I hope others with ADPKD do the same, because they deserve to live their lives…and their family deserves to have them in theirs.

JYNARQUE Interstitial

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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

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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.