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

It’s All Relative, Video Thumbnail
It’s All Relative, Video Thumbnail

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

Anthony grew up in what he describes as the quintessential middle-class household. He played ball with his dad, ate family dinners at the table, danced around the house with his siblings, and always said his prayers before bed. But behind closed doors, his family was quietly dealing with autosomal dominant polycystic kidney disease (ADPKD). Anthony’s father had been diagnosed with the condition, and later, Anthony would be too. After years of loss and learning, he decided to take control of his health by eating right and staying active. He believes in the power to transform your circumstances through faith and optimism.

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

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

How old were you when you were diagnosed, and what was that experience like for you?

Anthony: I was in the sixth grade when my pediatrician diagnosed me with ADPKD. My family had a history of the disease—something I hadn’t known at the time. We reviewed my family history and my pediatrician ordered a few tests to confirm the diagnosis. I remember that when he told us, my mom cried, but my father sat stoically in the seat beside her.

That’s quite young for a diagnosis of any kind. Did things change for you after that?

Anthony: Not much changed. I was still just a little kid with big dreams. I was mostly worried about other things, like making friends at school and getting good grades. There was also a lot of secrecy in our family surrounding the illness. It wasn’t really something we talked about. My grandmother died of ADPKD-related complications, which I didn’t know back then. I remember seeing her when she looked so sick—I was in high school by that point, but still didn’t know much about the effect ADPKD had on our family.

Did your family ever open up to you about ADPKD?

Anthony: Yes, but it took a while. I found out one day when my father passed out at work. My sister and I rushed to the hospital, where the doctors explained the situation. That was the first time I realized that he had ADPKD too. We also learned that he needed a transplant. Luckily, my uncle donated a kidney to him. To say it was a gift is an understatement. My uncle made the impossible happen—he gave us more time with our dad.

Anthony takes care of his body

“That’s something I want to make sure other young people living with ADPKD keep in mind—your body needs you to take control of your health sooner rather than later.”

That sounds like a lot to take in all at once. Can you tell me a little bit about what that discovery meant for you moving forward?

Anthony: Well, when I went to college, I didn’t think much about kidney disease. That is, until I started cramming for exams, staying up all night, eating poorly—doing all the things college kids do. I was also really homesick and felt down a lot, which led to me gaining weight. Now, knowing what I know, I would’ve hiked more, eaten healthier meals, spaced out my class schedule, gotten more sleep. That’s something I want to make sure other young people living with ADPKD keep in mind—your body needs you to take control of your health sooner rather than later. The sooner, the better.

It can be so easy to lose sight of your health when you’re focused on school. What were things like after college?

Anthony: I graduated in 2006 and began my career as a nationally touring musician. It was definitely a crazy chapter of my life, performing at concerts so often. Things were hectic—it’s easy to forget to focus on your health. Then things became even more difficult when my father died unexpectedly during a transplant surgery. He passed the week before my 27th birthday.

I’m so sorry for your loss—that must’ve been so difficult to live through. I appreciate you sharing that. Is it strange to navigate ADPKD without him?

Anthony: His death woke me up. It hit me hard—made me realize that it was time for a big change. At that point, I weighed 290 pounds, and being overweight isn’t helpful when you have kidney disease. So I started doing yoga and ultimate frisbee, biking, and walking. I did everything I could to stay active and eat better. I tried to let go of things that were stressing me out emotionally and decided to spend my time with people who were positive. I also started taking JYNARQUE a little later.

Anthony is optimistic about his ADPKD

“I have chosen to be optimistic about my condition, and I’ve also chosen to take action.”

What has your experience with JYNARQUE been like?

Anthony: When I first heard about JYNARQUE, my sister, who also has ADPKD, said that it was the first treatment of its kind, and that that’s a good thing, which made me feel hopeful. But at the time, my nephrologist had just told me that my kidneys would fail by age 60, so there was a lot going on in my mind. My dad died at age 59, so it was hard not to compare things.

But I knew I had to be strong. I started taking JYNARQUE as soon as it was available to me in 2018. JYNARQUE can cause serious liver problems that can lead to the need for a transplant or can lead to death. My doctor had also told me that because JYNARQUE can cause serious and potentially fatal liver problems, I would need regular blood work to monitor my liver function. He enrolled me in the JYNARQUE Risk Evaluation and Mitigation Strategy, or REMS program, to help me stay on track with my blood work. 

I’ve had a few side effects while taking JYNARQUE, most notably that I have to urinate very often. As a father of a newborn, that actually hasn’t been so bad because I’m awake at night to check on the baby.

Congratulations on becoming a father! How does it feel to take on that new role?

Anthony: I met my wife through a church group a little while back and she’s the love of my life. She’s a doctor, so when I told her I had ADPKD, she knew exactly what I was talking about, which was nice. My wife and I took the right steps to minimize the risk of passing ADPKD on to our children, too. We decided on in vitro fertilization so we wouldn’t have to worry.

I think my relationship with my father is a good example for me on my journey of fatherhood, because he and I had the same drive and really loved one another. I think each generation of my family has gotten better and better at communicating and holding one another accountable, which I intend to do with my children.

Do you have any message or thoughts about living with ADPKD or taking JYNARQUE that you’d like to share?

Anthony: I have chosen to be optimistic about my condition, and I’ve also chosen to take action. Eating healthy, staying fit, and just taking care of yourself is so important. I hope that anyone with ADPKD can improve their circumstances—but especially those who are younger. They really have a chance to make a difference for themselves and for their families. I know firsthand! Despite everything I’ve been through with this disease, I’d say that I’m still the same little kid with big dreams. But now more than ever, I’m optimistic that I’ll be able to keep chasing them.

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.