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

From Diagnosis to Treatment, Video Thumbnail
From Diagnosis to Treatment, Video Thumbnail

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

Nancy had a plan. After her sixth and youngest child left for college, she’d return to college and become a hospital chaplain. She’d always loved her career in nursing but felt she had so much more to learn and do. Then a mysterious pain in Nancy’s back led to a shocking diagnosis of autosomal dominant polycystic kidney disease (ADPKD). She felt her hopes and plans dissolving and, instead of going back to college, she started getting her affairs in order. But with support from her children and healthcare team, Nancy figured out new plans for her life with ADPKD—an approach filled with hope and courage.

Please remember that none of the information discussed in this article should replace the conversations with your healthcare provider. Nancy is sharing her 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 you first started experiencing back pain, what did you think was the cause?

Nancy: I didn’t think much of it at first. It was a dull, nagging pain that seemed to bother me most in the morning. As my mattress was more than 20 years old, I was sure that was the cause. Then one afternoon, the dull pain became a severe, throbbing pain. A week after that, I found it difficult to even get out of bed, so my nurse practitioner recommended an ultrasound to see what was going on. When the scans came back, she gently told me that the radiologist had seen multiple cysts on my kidneys and they suspected ADPKD.

You were shocked by the diagnosis. What did you know of ADPKD at the time?

Nancy: What little I knew about ADPKD came from being a nurse. It was a hereditary disease that typically causes cysts to form on each kidney and eventually leads to kidney failure, then transplant or dialysis. This was not part of my plan. I remembered that my older sister had kidney issues when she was a teenager and had died when she was just 60 years old.

How did you move forward after your ADPKD diagnosis?

Nancy: I met with a nephrologist and, still in shock, searched for words, comments, or questions. I had nothing. It didn’t help when my nephrologist said I’d probably be in kidney failure in five years—10 at the most—and the best thing I could do at this point was control my blood pressure. This was the absolute lowest part of my journey with ADPKD. In that one visit, my hopes and plans dissolved away.

After my appointment, I did some online research. The results were not promising. If there was no treatment for this condition, I wasn’t going to dwell on it. Nearly all of my kids were in college, and I was a nurse supervisor working 60-hour weeks. I didn’t have time for this. I put ADPKD on the back burner. I told myself that if there was no treatment, I had no reason to think about it. But I did have reasons—six of them.

Treatment for ADPKD gave Nancy comfort

“Now, knowing there’s a treatment for ADPKD—it’s huge. It changes your whole perspective.”

It must’ve been difficult telling your children about your ADPKD diagnosis. How did you approach that conversation?

Nancy: Though my own health concerns were upsetting, the guilt I felt about what may happen to their health was a burden. I had to remind myself that I didn’t cause this and there was nothing I could have done to prevent it. I had brought six amazing people into this world. They were launching their careers, marrying, and having their own families. With ADPKD’s hereditary impact, my diagnosis could potentially become their diagnosis. This was one of the most difficult conversations I’ve ever had. And of course, they had many questions. Their biggest concern was that I should not go through this alone. I was deeply humbled by their grace.

Where else did you turn for support?

Nancy: I prayed. I prayed a lot. And by God’s grace, a transformation began to take root. I realized that I should approach my diagnosis differently. Instead of focusing on an expiration date—paying off bills, downsizing my belongings, saving for my funeral—I started looking forward to life. Before I got out of bed in the morning, I prayed, and I was thankful for the coming day. I took time to treasure each moment. I compounded my savings into a down payment for a small home. And I decided I needed a different healthcare team—one that would share my new outlook on life. My new nurse practitioners, nephrologist, and OB/GYN specialist encouraged me to take better care of myself, engage in my future, and focus on my needs. I also joined patient advocacy walks. I learned more about how others were living with and managing their ADPKD. Through these walks, I discovered there was a clinical trial for a drug called tolvaptan, and I later learned I was eligible.

Nancy’s kids were screened for ADPKD

“My children also decided to take control of their futures and got screened for ADPKD.”

How did participating in this clinical trial affect your outlook on ADPKD?

Nancy: There’s good and bad in trying anything new, but this opportunity was worth it for me. I thought, This clinical trial could lead to a medication that could make a difference in my life, my children’s lives…and the lives of my grandchildren. When the trial ended and the drug was approved by the FDA, it was called JYNARQUE. My nephrologist prescribed JYNARQUE to treat my rapidly progressing ADPKD. We talked about the fact that JYNARQUE can cause serious liver problems. Because of this, I enrolled in the JYNARQUE Risk Evaluation and Mitigation Strategy, or REMS, program to get frequent blood tests to monitor for liver injury.

I do get tired a lot. It’s hard to say whether this is based on my age or the medication, but it is something my nephrologist and I are keeping an eye on. I also drink a lot of water and use the bathroom a lot. Please remember that this is my story, and your experience may be different. Now, knowing there’s a treatment for ADPKD—it’s huge. It changes your whole perspective.

What are your hopes for the future—not only for yourself, but also for your family?

Nancy: I’ve been given an opportunity to learn what is truly important in life. ADPKD is not my focus. Life is my focus. I’m thankful for the strength and courage I have been given to face my life one beautiful day at a time.

My children also decided to take control of their futures and got screened for ADPKD. As it turns out, three of them have been diagnosed. But so much has changed since my diagnosis. For them, ADPKD is in the early stages, and with continued research and development, I am hopeful for their futures, too.

JYNARQUE Interstitial

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

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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.