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

From Denial to Defiance, Video Thumbnail
From Denial to Defiance, Video Thumbnail

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

After an abdominal ultrasound in college, Deidre suddenly learned that not only did she have autosomal dominant polycystic kidney disease (ADPKD)—she had a family history of the condition, too. Without much information on ADPKD, Deidre did not take it seriously until her endocrinologist and then nephrologist stepped in and suggested she start treatment. Afterward, Deidre had the chance to meet others with ADPKD and learned what facing the condition could mean. Now she takes charge of her own health and wants others with ADPKD to know there is a supportive community for them out there.

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

It sounds like your ADPKD diagnosis came as something of a surprise. What was your moment of diagnosis like?

Deidre: It was! When I was in college, I struggled with several inexplicable recurrent health issues. The healthcare office at my college sent me for an abdominal ultrasound and that’s when they found them: my big, cyst-covered kidneys. I was told in a phone call that I had something called ADPKD and I would need to see a nephrologist. I didn’t know what that meant. I told my dad and his response was, “Your mother has that.”

My parents divorced when I was young, and I was never close to my mother. Her side of the family didn’t really exist in my world, so I didn’t know about the several relatives that had ADPKD. In my world, it was just me.

What was your initial understanding of ADPKD?

Deidre: When I met with a nephrologist, they explained what ADPKD was and sent me home with a small book. It was not in-depth. My takeaway was that all they could do was monitor the disease and eventually I would go on dialysis.

When I was switched to a different nephrologist in the practice, it only further reinforced that unconcerned feeling. That doctor was so nonchalant that it made it even easier for me not to worry. Basically, “keep an eye on your bloodwork and we’ll deal with this when things get bad” was the message I received.

Without much guidance on ADPKD, how did you face it?

Deidre: For a long time, I didn’t. I was eventually dropped from the nephrology practice for too many rescheduled appointments. I even thought I didn’t necessarily need a nephrologist, so I just saw my primary care provider to check my levels. I didn’t really talk about my ADPKD unless I was filling out medical history forms. If there wasn’t anything I could do about it, why even think about it? It was a low priority.

Deidre, JYNARQUE Patient

“I knew I needed to do something. Together with my doctor, I decided to start on JYNARQUE because it was the first approved treatment for adults at risk of rapidly progressing ADPKD.”

Were there any steps you eventually took to manage your ADPKD?

Deidre: Basically, my endocrinologist got me to a nephrologist because she knew I wasn’t doing anything about my ADPKD. That nephrologist introduced me to JYNARQUE at my very first appointment after reviewing my medical history and previous lab work. He felt that I would be a good candidate, as he explained that at that point, I had rapidly progressing ADPKD. Even though the treatment was new to the market, he was enthusiastic about it, as he had a patient who had success as part of the clinical trials.

Was there anything about JYNARQUE that appealed to you?

Deidre: At first, I was hesitant. Sure, JYNARQUE had been shown to slow kidney function decline, but with the possible side effects, I might have to urinate all the time. My doctor had also told me that because JYNARQUE can cause serious and potentially fatal liver problems, I would need regular bloodwork to monitor my liver function. He enrolled me in the JYNARQUE Risk Evaluation and Mitigation Strategy, or REMS, program to help me keep on track with my bloodwork. But still I wondered, Did I really need this? Were the side effects worth it?

As I was researching JYNARQUE, I also wondered more about ADPKD. I researched it online and almost fell over. I knew I needed to do something. Together with my doctor, I decided to start on JYNARQUE because it was the first approved treatment for adults at risk of rapidly progressing ADPKD. It was definitely a change for me. The drive to drink water was incredible and I was using the bathroom a lot, but soon I felt that my body adjusted. It’s shocking how much urine my bladder can hold now! I do have to plan a little more and make sure I have a water bottle at all times. I always know where the fill stations and bathrooms are. I even have a device to help me urinate outside easily because there are not always bathrooms available! Of course, this is my experience, and the experiences of others may be different.

The biggest thing for me is having a medication—something I can take for my rapidly progressing ADPKD now, rather than just keeping an eye on it.

Patient Ambassador Deidre, Headshot

“The biggest thing for me is having a medication—something I can take for my rapidly progressing ADPKD now, rather than just keeping an eye on it.”

Did anything else happen that changed your outlook on ADPKD?

Deidre: Several months after starting JYNARQUE, I had the opportunity to attend meetings where I met other people with ADPKD, which I had never done before. I heard the stories of some of their family members who had complications from dialysis, failed transplants, or died in their 40s or 50s. It was terrifying, but I also realized those stories were of the past. I was lucky. For the first time, I found strength and courage. I was taking the necessary steps to manage my condition. I was actually doing something.

How are you proactive about your ADPKD now?

Deidre: I make sure to drink lots of water and follow a plant-based diet. I subscribe to ADPKD newsletters and joined a couple of social media groups for the disease. The support groups are like a lifeline. It makes a world of difference to have support from someone who knows what you’re going through. I find I’ve also become more active in the groups and I’m excited to support others. I hope that I can open that door for someone else and let the ADPKD community in for them as well.

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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.