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

Empowered by a treatment option, Video Thumbnail
Empowered by a treatment option, Video Thumbnail

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

Autosomal dominant polycystic kidney disease (ADPKD) was always a force in Joseph’s family. It can be traced back to his paternal great-grandmother, affecting Joseph and many of his relatives. In Joseph’s family, the consequences of ADPKD included early death related to health complications, removal of kidneys, dialysis, and lots of transplants. Joseph saw his relatives respond to ADPKD in a variety of different ways, from ignoring it to an intense focus on diet and exercise. He chose to face ADPKD proactively and pursue treatment options. Joseph wants others with ADPKD to do what they can to take charge of their condition.

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

ADPKD plays a big part in your family history. How did you understand it as a kid?

Joseph: At some point growing up, my parents told my brother, sister, and me about this disease that my dad had that could also affect us. My younger brother found out that he had ADPKD in high school.

The reality in our family is that ADPKD means that somewhere around age 55, you may be put on a transplant list and receive a new kidney. If that isn’t possible, then you may face dialysis three times a week for the rest of your life.

What was it like to watch multiple family members get transplants or go on dialysis?

Joseph: Many of my family members, when it was their time, successfully received transplanted kidneys. They recovered quickly and went back to work and life feeling better. That was not what I saw in my dad’s life.

That sounds scary. What did your dad have to face with ADPKD?

Joseph: My dad had his first transplant in his mid-50s. Things went well at first and there was a lot of optimism. However, he had many complications and went on to have two more transplants in the next 10 years. Between the high points of the transplants, there was a lot of dialysis and several hospitalizations due to infections from the immunosuppression medications. In fact, my mom estimates that my dad has been hospitalized over 20 times (and still counting) in a little over a decade for complications directly related to his ADPKD and the transplants.

For several years now, his third donated kidney has been damaged and functioning at a reduced level, but it has been adequate to keep him going and active. He does know that if this one fails, his body won’t be able to handle another transplant.

When my dad had his first transplant, ADPKD became real for me in a way it never had before. I remember thinking, Oh man…that’s going to be me one day.

Joe and his father have ADPKD

“When my dad had his first transplant, ADPKD became real for me in a way it never had before. I remember thinking, Oh man…that’s going to be me one day.”

What was it like when you officially got your ADPKD diagnosis?

Joseph: I was around age 30 when my family doctor ordered a kidney ultrasound to see if I had ADPKD too. I remember where I was standing in my bedroom when he called to tell me that it showed cysts on my kidneys. It was real. I knew I would have to deal with the consequences of ADPKD like many others in my family.

What did you decide to do to help manage your ADPKD?

Joseph: A few years after my diagnosis, my cousin, who also has ADPKD, connected me with some people at a major research clinic who were doing some drug studies related to ADPKD. I went through some short-term studies with them and then began my first long-term study with tolvaptan, which was later approved by the FDA to slow kidney function decline in adults at risk of rapidly progressing ADPKD. It felt good to be a part of research that could benefit other people with ADPKD…and that I myself might benefit from the drug, too.

My nephrologist at the clinic and the other study coordinators were quick to share the importance of a healthy lifestyle. Through my many, many trips to the clinic, I learned the importance of exercising, watching my protein consumption, controlling my blood pressure, and staying at a healthy weight. I was pleased that all of these things plus tolvaptan would create an arsenal to help me in my fight to slow down kidney function decline.

Joe uses JYNARQUE to live his life and dreams

“My goal for my children is for them to see we’ve done everything we can about ADPKD, and it doesn’t have to stop them from living their lives or dreams.”

What made you decide to stick with tolvaptan as a treatment option?

Joseph: I began to wonder if tolvaptan—plus living a healthy lifestyle—could slow the decline in my kidney function, and I tried to imagine what kind of an impact that would have. After watching all of the ups and downs that my mom and dad have gone through with ADPKD, these thoughts seemed very attractive.

After the FDA approved tolvaptan as JYNARQUE, I continued with the medication and kept my nephrologist from the clinic. 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.

I have had to make adjustments while on JYNARQUE. I drink a lot of water every day. Wherever I go, I need to bring a full water bottle and keep my eye out for a bathroom. The swing between thirst and the pressure of a full bladder is constant. My kids have gotten used to that fact whenever we travel. They understand that Dad needs to stop to use the bathroom a lot, and they roll with it. Keep in mind, this is just my experience and others could be different.

You saw various ways of handling ADPKD growing up. How do you try to model life with this condition for your own family?

Joseph: My goal for my children is for them to see we’ve done everything we can about ADPKD, and it doesn’t have to stop them from living their lives or dreams. They know that I have some kind of disease, that I’m also doing everything I can to fight it, and I’m trying to help other people with ADPKD.

My family still travels, pursues the vocations we are passionate about, and lives life not because I have ADPKD, but in spite of it. I rest in the fact that I am doing everything I can to slow the decline of my kidney function. We don’t ignore ADPKD—we deal with it and move on with life. Hopefully, there will be lots more options for the generation to come, so that they don’t have to let ADPKD define who they are and what they can do.

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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.