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

Taking Action Early On, Video Thumbnail
Taking Action Early On, Video Thumbnail

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

Zack was diagnosed with autosomal dominant polycystic kidney disease (ADPKD) 25 years ago. For a long time, even with a family history of the condition, he never thought he would be impacted by ADPKD. A former officer in the U.S. Coast Guard and fairly accomplished triathlete, Zack saw himself as linked to strength, stamina, and perseverance. Being affected by ADPKD made him suddenly feel like a 1965 model pickup truck, as opposed to a high-performance machine. But after living with ADPKD for several years, Zack has learned the key to managing it—knowing your limits, assembling your support team, and investing in your future.

Please remember that none of the information discussed in this article should replace the conversations with your healthcare provider. Zack 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 have a family history of ADPKD. Before you were diagnosed, what did you understand about the condition?

Zack: Growing up, I knew my mom had some kind of medical condition. I saw her trying several medications to combat her symptoms. By the time I was in college, I knew that it was a hereditary polycystic kidney disease, so there was a chance I could have it as well.

How did your mom’s experience with ADPKD prepare you for managing it?

Zack: I took my cues for how to live with ADPKD from my mom. She focused on preserving and protecting her kidney function. Together, my parents adapted to the disease, but they never let ADPKD dramatically impact their active lifestyle. My mom is [82], with no kidney transplant, and isn’t on dialysis. I hope my future is similar. My aunt tried to ignore her ADPKD, and it cost her her life way too early.

Even though my intent was to follow my mom’s example, there were some ways I had to adapt to manage my own ADPKD.

Do you have an example of how you adapted?

Zack: Sure. The first lesson I learned was: know your limits.

As an Emergency Manager in the U.S. Coast Guard, I responded to the worst oil spill to ever occur in the Gulf of Mexico, the Deepwater Horizon oil spill off the coast of Louisiana. My job was to coordinate the planning efforts to stop the flow of oil and clean up what had already discharged. It was exhausting, stressful, and physically and emotionally draining work. I worked 16-hour days for four weeks straight. Finally, I was released just before the Fourth of July weekend. My wife and I were going to spend the weekend in San Antonio to celebrate and relax. However, on the drive over, a cyst in my kidney burst.

Zack assembled an ADPKD support team

“Assembling your support team is key to managing ADPKD.”

Oh my goodness! Had you ever experienced anything like that before?

Zack: I hadn’t, and having a kidney cyst burst is excruciatingly painful. My mom describes it as equivalent to “giving birth,” which makes me even more appreciative of her having me!

The pain caused me to go unconscious. Luckily, I was not driving. My wife took me to the hospital. There, I realized I was not invincible, I was not Captain America. I wasn’t courageous; I was careless. I ignored my ADPKD. It didn’t ignore me. It was a vicious, painful reminder that I had not been following my mom’s principles of preserving and protecting my kidneys. I had to reexamine my work–life balance and set new limits.

What helps you maintain those limits and keep managing ADPKD every day?

Zack: My wife really deserves all the credit for getting me to where I am today. I met her a little later in life, so ADPKD has been a part of our marriage from the get-go and, like my parents, we’ve managed it as a team. She researched nephrologists, insurance, pharmacies, formularies, treatment availability, copays, drug interactions, etc. She also puts up with me shamelessly drinking both our waters at restaurants—and then having the audacity to ask our waiter for refills!—and then at home having to pause movies so I can run and pee all the time! She is so patient, encouraging, supportive, and understanding.

My extended family is also a great resource and support network. Assembling your support team is key to managing ADPKD.

Zack planned his treatment

“When I talked with my current nephrologist about taking JYNARQUE, it was because I felt it could make a difference in my life years down the road.”

What do you do in terms of slowing down the progression of your ADPKD?

Zack: The silver lining of being diagnosed in my late 20s is that I was able to take early steps to manage my kidney function through lifestyle changes, diet, exercise, and medication. Those early steps also led to me finding out that I had rapidly progressing ADPKD years later because my nephrologist regularly monitored my eGFR, my kidney volume, and the size of my cysts through sonograms and MRIs. I invest in my future with ADPKD even now.

When I talked with my current nephrologist about taking JYNARQUE® (tolvaptan), it was because I felt it could make a difference in my life years down the road. By taking JYNARQUE now, I’m investing in my kidneys’ future because JYNARQUE has been shown to slow kidney function decline in adults with rapidly progressing ADPKD.

Before I started JYNARQUE, my doctor and I discussed that it can cause serious and potentially fatal liver problems. That’s why I have regular blood tests to monitor my liver function as part of the JYNARQUE Risk Evaluation and Mitigation Strategy, or REMS program, due to the risk of serious liver injury. My doctor also warned me that I would have to drink large quantities of water when taking JYNARQUE. I didn’t see that as a negative consequence. Now, having to use a bathroom because I’m drinking so much water sure is! But personally, I can handle it. I just have to be more deliberate and methodical in my plans and activities. Of course, that is my experience with JYNARQUE.

Someone should talk to their own healthcare provider to see if JYNARQUE is right for them.

Overall, how do you view your journey with ADPKD?

Zack: Living with ADPKD is challenging. Sometimes it’s a struggle. But you can manage. My life has evolved. Not dramatically, and some may say even for the better.

eGFR=estimated glomerular filtration rate; MRI=magnetic resonance imaging.

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

Learn more

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.