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

Opening up about a diagnosis, Video Thumbnail
Opening up about a diagnosis, Video Thumbnail

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

Family means everything to Will. His parents modeled positive life lessons for him growing up: to live the American dream, he must do well in school, work extremely hard, and do the best he can—no matter what he was doing. On the flip side, his family was stoic and did not discuss difficult topics. So when it came to facing autosomal dominant polycystic kidney disease (ADPKD), they never discussed managing it—or discussed ADPKD at all—which later put Will’s health in jeopardy. To do the right thing for himself and his family, he sought out the best way to manage his ADPKD.

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

How did you learn about your mom’s ADPKD diagnosis—and that you might have it as well?

Will: In 2004, my mom called all of her kids together and finally let us know that she had ADPKD. She recommended that we all get checked out. The first thing I did was discuss this bombshell with my wife, Judy, and then I saw my general practitioner, who ordered an ultrasound and declared I had “fatty kidneys.” That did not sit well with Judy or me, and we wanted a second opinion. We found a nephrologist that specialized in ADPKD patients. The second ultrasound told my new nephrologist everything she needed to know. At age 40, I was officially diagnosed with ADPKD.

Did you ever have any hint that you might have ADPKD?

Will: For several years, I went to the doctor’s office for my annual physical and usually had elevated blood pressure readings. The doctors and I always rationalized it away by saying it’s “White Coat Syndrome,” which is when nervousness elevates someone’s blood pressure during appointments.

To tell you the truth, my first emotion after hearing my diagnosis was relief at finding out what was causing my high blood pressure. It also explained why I had a contrast-enhanced kidney ultrasound done around age 11, and why my mom always had backaches and an unexplained hernia, took so many medications, and needed afternoon naps.

What were your next steps after getting your diagnosis?

Will: Even with all of this evidence in front of me, I convinced myself that I would be okay until I was 70 to 75. During this time, I found out that my uncle had started kidney dialysis at age 79, and my mom was 73 when she told us about her ADPKD. This felt like enough proof for me that I didn’t have to worry for another 30 to 35 years. I continued on with my life.

Doing nothing wasn’t an option for Will

“I did have too much to live for—doing nothing wasn’t an option.”

What prompted you to take ADPKD seriously?

Will: In 2017, my son, Patrick, and I agreed that after he graduated from high school in the spring of 2022, we would fulfill my lifelong dream to bike across the country—me on the bike, him driving the support vehicle. That gave me four years to get back into biking shape.

By the end of 2017, I’d logged over 2,000 miles—a good start. But halfway through 2018, I noticed I wasn’t making any progress on my biking goals. Something was really wrong. I was getting headaches, I was always tired and easily winded, and my back was hurting every day. By then, I was only two weeks out from my annual nephrology appointment. When I got to the doctor’s office, my blood pressure was out of control. For the first time, my doctor could feel my kidneys through my stomach. We found that in less than nine months my eGFR—a test that measures kidney function—had dropped drastically. My ADPKD was rapidly progressing, and I now had stage 3b kidney failure.

That sounds terrifying. What did you think when you got those results?

Will: No! This is too soon. In my mind, this was not supposed to happen for another 20 years. I was in denial. Why me? Did my kids also have ADPKD? They had a 50 percent chance. My options were to wait until my eGFR fell more to make a treatment decision; start taking JYNARQUE, a newly approved drug my nephrologist recommended; or do what my mother did, which was nothing.

Will discussed his ADPKD

“I also openly discuss ADPKD with family and friends. These discussions have shown me how many wonderful people there are in this world.”

How did you decide what to do next?

Will: My mom passed away from end-stage renal failure due to ADPKD on September 11, 2007. She had chosen not to go on kidney dialysis. It was a heart-wrenching day for me and my family. A few days before my mother passed away, her last words to me were, “If this happens to you, please do something like going on dialysis. You have too much to live for.” Those words have stayed with me all of these years, and I thought of them again when I realized my ADPKD was not going to go the way it did for my mom and uncle. I did have too much to live for—doing nothing wasn’t an option.

So together, my nephrologist and I decided I would start JYNARQUE to try something that might help slow the decline of my kidney function. After stabilizing my blood pressure with appropriate medications and being authorized by my health insurance company, I was finally able to start JYNARQUE at the end of April 2019. Because JYNARQUE can cause serious and potentially fatal liver problems, I have regular blood tests to monitor my liver function as part of the Risk Evaluation and Mitigation Strategy, or REMS, program. My hope is to slow the progression of my ADPKD and the decline in my kidney function as much as possible.

What else do you do to help manage ADPKD?

Will: I made some life-changing adjustments like improving my diet and surrounding myself with healthcare providers that know about ADPKD. I also have to drink more than five liters of water per day with JYNARQUE, which causes me to go to the bathroom a lot. I pay much closer attention to where the restrooms are and have a portable urine bottle in each car. Knock on wood—I have not needed to use the bottles yet. As part of this, I learned my limitations during biking (I need to drink even more water so as not to dehydrate). Because I wake up several times a night to go to the bathroom, I never get a full night’s sleep, so I catnap whenever I can during the day, too. I also openly discuss ADPKD with family and friends. These discussions have shown me how many wonderful people there are in this world.

What advice do you have to others living with ADPKD?

Will: Be who you are and live true to yourself. Figure out who and what is important to you and your family, then hug and love them each and every day. You have so much to live for.

eGFR=estimated glomerular filtration rate.

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.