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

Taking New Measures, Video Thumbnail
Taking New Measures, Video Thumbnail

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

Liz looks at her life in terms of the message stamped on a car’s mirror. The one that says, “Objects in the mirror are closer than they appear.” She’s a medical sales representative with a large territory to cover and is in her car a lot. The phrase also seems particularly relevant in terms of her autosomal dominant polycystic kidney disease (ADPKD). For a long time, she tried to ignore it, but it was always in her rearview mirror, closer than it appeared—and creeping closer every day.

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

How did you learn you had ADPKD?

Liz: Growing up I always enjoyed spending time with my dad. At age 40, he became really sick and was diagnosed with renal failure. Immediately, he was put on dialysis and almost died multiple times before getting a kidney transplant several years later.

After my dad was found to be in renal failure, he was diagnosed with ADPKD. But at the time there wasn’t much known about the disease, and honestly, not much that could be done to treat it. They had me tested because they realized it was hereditary. Both my sister and I were found to have ADPKD. I was only 14 years old.

Seeing everything your dad went through must have had a big impact on you.

Liz: I thought my life would follow the same disease trajectory as my father’s. I thought by age 40 my kidneys would fail and life as I knew it would be different.

It sounds like ADPKD was really on your mind then.

Liz: In some ways it was, but I didn’t want to think about it actually progressing. For a while, I didn’t really think about my ADPKD, other than staying current with medical appointments. But the first time I started to see my lab numbers change, it was chilling. My GFR had declined as my levels of blood urea nitrogen, or BUN, and creatinine (a waste product made by muscle activity) had been steadily and slowly creeping in the wrong direction. I’d been telling myself, “I don’t have a lot of pain. My kidneys are only a little enlarged. I’m watching my diet and exercising…I’m okay.” But the lab numbers were starting to tell a different story.

Elizabeth started treatment with JYNARQUE

“I learned that starting treatment sooner rather than later might be a good thing because JYNARQUE is used to slow kidney function decline.”

Did you think about starting treatment to lower those numbers?

Liz: Since I’m a science nerd, I read a lot of medical journals, and, naturally, read a lot about ADPKD. For years, I had been following the research and clinical trials for a treatment called tolvaptan. When it was approved by the FDA and available commercially as JYNARQUE, I just wasn’t sure if it was for me or not. I didn’t think I was “sick enough” for JYNARQUE. I also didn’t like facing the possibility that my disease was rapidly progressing.

But you are on JYNARQUE now. What made you realize it was the right choice for you?

Liz: It wasn’t until I began to have some intermittent pain, as well as some enlargement in my kidney size, that I expressed concern to my nephrologist. That’s when we discussed JYNARQUE. I learned that starting treatment sooner rather than later might be a good thing because JYNARQUE is used to slow kidney function decline.

My nephrologist and I talked about the serious and potentially fatal liver injury JYNARQUE can cause—I definitely wanted more data on that. Learning about the JYNARQUE Risk Evaluation and Mitigation Strategy, or REMS program, actually helped me make my decision to start JYNARQUE. I liked knowing my labs were going to be tracked so my nephrologist and I could notice any signs of liver damage as early as possible.

Elizabeth managed JYNARQUE side effects

“I felt confident that I could take JYNARQUE and manage my side effects—even with my busy lifestyle.”

What made you want to stay on JYNARQUE? Did you have to manage any side effects?

Liz: I was nervous initially about how to manage traveling, working, and the large intake of water and numerous trips to the bathroom. I joined a social media support group and got a lot of helpful tips. I felt confident that I could take JYNARQUE and manage my side effects—even with my busy lifestyle.

I have learned not to pass up a rest stop or a clean coffee shop bathroom. It took a little getting used to, but it has been manageable for me.

What is the importance to you of doing everything you can to manage your ADPKD?

Liz: It feels good to know I’m doing all that I can to hopefully slow my kidney function decline. I admit it, I am very vain, and I want to keep this waistline that I work so hard for at the gym!

I am a wife, mother, sister, aunt, and dog lover, and those people that I love are the reason that I take this medication. I don’t want them to see my disease progress the same way as my dad’s. I want to change the course of my disease for myself—and for my son, who also has ADPKD.

I have a lot of fun left to be had and living left to do. Because I’ve chosen to be proactive about managing my ADPKD, I’m not so worried about what’s in the rearview mirror, but more focused on what’s on the road ahead.

GFR=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

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.