info flag

 

COVID-19 Update >

 

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

Talking About Progression, Video Thumbnail
Talking About Progression, Video Thumbnail

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

Before Karen was diagnosed with autosomal dominant polycystic kidney disease (ADPKD) at the age of 42, she knew she possibly could have inherited kidney disease from her mother. Since the time Karen was a child, she watched her mother progress from weakness and fatigue to dialysis to the need for a new kidney. When Karen discovered she couldn’t donate her own kidney because of the family history of kidney disease, well, that was when she started to understand how this information could impact her future.

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

When did you first notice that you may have inherited your family’s kidney disease, let alone ADPKD?

Karen: I didn’t think I would get ADPKD. Three out of four of my cousins were diagnosed with it, but none of my siblings had it. I was active, healthy, and never had any of the symptoms that I watched my mother go through. Even on the day I felt a bulge in my abdomen, it never occurred to me that I might have anything wrong with my kidneys. I suspected I could have polycystic liver disease, or PLD (something else my mom had). I was hoping it was just my gallbladder. Who needs a gallbladder?

But my body did have a glitch. I went in for an ultrasound and discovered that not only did I have PLD, but also ADPKD. I knew I needed to learn as much as I could about both diseases as soon as possible.

What made you think about getting ahead of your ADPKD progression?

Karen: The thought of going through what my mother did was one I did not want to bear. At first, I relied a lot on my local doctors. I saw a local nephrologist, who looked at my ultrasounds and blood work and cheerfully said that I had nothing to worry about. He said that, aside from the cysts on my kidneys, I was asymptomatic. Based on the doctor’s reaction, I think he saw ADPKD as something that was diagnosed and treated after my kidneys no longer worked. I felt like there was nothing to do but wait—wait for my mother’s fate. I wasn’t okay with that. I wanted to learn more about both ADPKD and PLD.

Karen wants to treat her ADPKD

“The thought of going through what my mother did was one I did not want to bear.”

Watching your mother’s progression with ADPKD must be incredibly motivating when it comes to making your own medical decisions. 

Karen: In a way, it was. My mom’s story is very different than my own so far. I lost her due to complications of ADPKD when I was 33, nine years before I was diagnosed with the disease. My mom didn’t have the same level of care I have had—or an available treatment option. She went on dialysis at age 53. She received a transplant two years later, but her health continued to decline. After seven years, she had to go back on dialysis. She remained hopeful that she would receive another kidney.

One evening, the night before Thanksgiving, she went into the hospital for what was supposed to be a routine procedure. Because of the damage to her kidneys from ADPKD, she couldn’t process the pain medication that the hospital gave her and spent the last week of her life in an unresponsive state. That is an image I try to block from my mind as much as possible and a fate I wish to save myself from.

Learning from your mother’s experience, how did you go about taking control of your own ADPKD progression?

Karen: In the process of researching as much as I could on my diseases, I came across an online PLD forum that posted information about ADPKD. I learned about a Phase II clinical study for a treatment that showed evidence of slowing kidney function decline in adults with rapidly progressing ADPKD. I signed up for the study, feeling I didn’t have anything to lose and I could contribute to the research.

My doctor had 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.

Since taking JYNARQUE, I have experienced an increase in thirst. I have water with me at all times to keep myself hydrated. Drinking water has become my new normal, and of course, the more water I drink, the more I have to go to the bathroom, so I’ve also become a master and connoisseur of bathroom locations.

Karen wants to take care of her health

“Having ADPKD has strengthened my determination and willingness to take care of my health, to believe anything is possible, and to remember that hope can empower us.”

Having ADPKD can leave some people weary. How has ADPKD changed your outlook of the future?

Karen: I grew up to be a teacher and a performer. Teaching and performing magic are about engaging people and helping them feel that anything is possible. Maybe that is a reflection of who I really am. I want to feel important and believe that anything is possible. Like everyone, I want to have a purpose and hope that things can get better in the future.

My ADPKD experience has humbled me by helping me not take my life for granted, especially as I get older. I never had a bad outlook on life since being diagnosed, but I knew that I never wanted to have a hopeless fate. Having ADPKD has strengthened my determination and willingness to take care of my health, to believe anything is possible, and to remember that hope can empower us. Magic gives us hope that anything is possible, but science and our willingness to continually learn make that hope a reality.

JYNARQUE Interstitial

Are you starting or currently taking JYNARQUE but can't make it to your required labwork?

We will come to you.

Learn more

 

JYNARQUE Interstitial modal

X

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.