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

Looking at ADPKD Differently, Video Thumbnail
Looking at ADPKD Differently, Video Thumbnail

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

19 years old and newly diagnosed with autosomal dominant polycystic kidney disease (ADPKD), Bill feared his life was halfway over. The family members he’d known with ADPKD all died in their 40s and 50s, and in Bill’s mind, there was nothing he could do to change that outcome. So, for the next 15 years, Bill did the only thing he thought he could—he went about his life. It wasn’t until Bill’s first encounter with the ADPKD community that he realized: I can do something about my ADPKD. Today, he encourages others living with ADPKD to take action, because—now more than ever—there is hope. 

Please remember that none of the information discussed in this article should replace the conversations with your healthcare provider. Bill 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.

When did you first become aware of ADPKD in your family?

Bill: I grew up knowing that my grandfather had dropped dead at 44, that his father had died at 45, and that his father’s father had died at 43—all of unexplained heart attacks. A few years after my grandfather died, his older sister Marie slipped and broke her leg. In the hospital, the doctors told her stunned children that Marie was going to die. Her kidneys were shot. Marie’s renal failure was the first hint of what might be causing all of those early deaths. 

When my dad was in his mid-twenties, he found blood in his urine after a pickup basketball game. An x-ray showed cysts all over his kidneys. Now he knew what had almost certainly killed his father, his aunt, and many other family members.

Was there a moment when you realized you might inherit the disease?

Bill: When I was 14, my dad told me that there was a chance I would inherit his condition. I don’t think he knew what it was called. He told me that the chance was only one in four, but I should check someday. He was wrong about the odds, but that was the information he was given. As a freshman in college, I needed a physical in order to row crew. I asked the college clinic doctor to check to see if I may have the cystic disease my dad had mentioned. I don’t remember worrying about it. My dad said it was just a one-in-four chance, so I figured the odds were on my side. When I went back to the doctor a week later, though, he said, “Well…you’ve got it.”

What thoughts and emotions were going through your mind when you received this diagnosis?

Bill: I went numb. I walked back to my dorm room, locked the door. I didn’t call any friends or family members. I didn’t want to tell anyone. I stood looking out the window, watching people walking by. I wanted to be alone because I felt alone. All I could think was, These people walking by can expect a full life. Mine may be half over.

Bill wanted to help others with ADPKD

“We believed that we were opening the door to further research that could help other families like ours.”

It must’ve been difficult coming to terms with a progressive diagnosis, especially at a young age. How would you describe your outlook on living with ADPKD?

Bill: I couldn’t help but wonder if it made sense to pursue a long-term career or project, because I might not live to complete it. I couldn’t see a way to be happy again. Get married? Have children? I thought, “I don’t want to die early on a wife or any kids we may have, and certainly don’t want to leave fatherless kids to face the bleak, short future I’m facing.” I felt a sense of futility—of uselessness. Why bother? The doctors I spoke to knew very little about managing ADPKD, but they told me to stay in touch. Something might happen in the years ahead. At that point, it never occurred to me that I might help something happen.

What changed your perspective on managing ADPKD?

Bill: In 2002, I went to my first awareness and fundraising walk sponsored by a PKD support and advocacy organization. There I met, for the first time, people outside my family who also had ADPKD. I was speechless. ADPKD had felt like a dark cloud hanging over my family alone. All at once, I realized that there were events like this one, featuring families like mine, all over the country. I got involved in fundraising and awareness efforts. I wore a kidney costume to a black-tie gala.

The following year, my cousin Mike died suddenly of ADPKD complications. He was just 35—my age. Mike’s death shocked me. It scared and enraged me. I vowed to do whatever I could to help support research for this disease. I’m not a scientist or a celebrity. I’m not rich. Nonetheless—however small the effect of my efforts might be—I felt that I had to make them. Sitting still meant waiting for an early death.

ADPKD is being addressed

“I want to communicate to as many people as possible that we have a way of addressing this disease. So don’t wait! Don’t procrastinate.”

How did you take action? What steps did you take to support ADPKD research?

Bill: I’d heard about a promising experimental drug called tolvaptan and had seen photos of the kidneys of mice who’d been treated with it. I liked what I saw, so I started following tolvaptan’s development. Some years after Mike’s passing, I joined 19 other people to participate in one of the first human clinical trials of tolvaptan. We believed we were doing something important: helping with the development of a treatment option for ADPKD. We believed that we were opening the door to further research that could help other families like ours. Now that the FDA has approved tolvaptan as JYNARQUE, my nephrologist has prescribed JYNARQUE to treat my rapidly progressing ADPKD. JYNARQUE can cause serious and potentially fatal liver damage, so to be certain that the medicine is not affecting my liver enzymes, I have my blood drawn on a regular basis as part of the Risk Evaluation and Mitigation Strategy, or REMS, program for JYNARQUE.

JYNARQUE makes me crave water in a way I never used to do. I keep a glass of it near me at all times and am aware of nearby water sources when I travel. I’m also more aware of bathroom locations than I used to be, because all that water has to go somewhere. Remember, this is my experience, and other people’s experiences may be different.

What’s your outlook on ADPKD today, and how is it different from when you were first diagnosed?

Bill: Today I’m lucky to be very happily married. My wife and I have three lovely daughters. They know that their dad has a kidney disease called ADPKD. They’ve heard that it runs in the family. They know it has killed some relatives they never met, including my cousin when he was quite young. But they also see me smiling in that kidney costume each year when they join me at walks for PKD. Although they don’t know it yet, I’m walking in large part for them. I’m walking for Mike, too. And I’m walking for others living with ADPKD. I want to communicate to as many people as possible that we have a way of addressing this disease. So don’t wait! Don’t procrastinate. This is a better time for us than we’ve ever had before.

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.