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

Hope for the Future, Video Thumbnail
Hope for the Future, Video Thumbnail

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

The evening Evelynn started to experience pain across her lower back, she simply thought it was from a cheerleading injury. After her diagnosis, Evelynn embarked on her treatment journey without any sign of slowing down. By sharing her story, Evelynn aims to inspire others living with autosomal dominant polycystic kidney disease (ADPKD) to look to the future and have hope—because it’s hope that has kept Evelynn moving forward.

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

You’ve always been an active person since your high school years. What was it like for you when you were first diagnosed with ADPKD?

Evelynn: When I was first diagnosed with ADPKD, I was 17 years old and living with my parents. I was running late to get to school and my only excuse was that I had the worst pain stretching across my lower back. I thought I had sustained an injury during cheerleading practice a couple of days before and planned to ride it out, but the pain was so bad that I was sent home from school. My mother made an appointment for me to see a pediatric nephrologist who diagnosed me with ADPKD and gave me information about what it is and who it affects.

Did anyone else in your family know they also had ADPKD?

Evelynn: When the pediatric nephrologist asked my mom about our family’s medical history, she told her about my uncle’s kidney problems. She said that in light of that, I most likely had autosomal dominant polycystic kidney disease. She also explained that because I may have it, one of my parents probably also have it. I remember my parents really keeping everything “hush-hush,” but my mom was ultimately diagnosed with ADPKD as well.

You were pretty young when you were diagnosed. How did this affect your thoughts and plans for your future?

Evelynn: At first, I wasn’t overly concerned about what ADPKD meant for my future. After I was diagnosed, I went on to graduate high school, then university, and I really never made a big deal out of having ADPKD. For the most part, I was okay…I had fewer infections, I took my antihypertensives, and I checked my blood pressure at home regularly. As I got older and started to take care of myself more, I understood the hereditary nature of ADPKD, so I don’t really plan for a family. 

JYNARQUE gave Evelynn hope

“There was less fear now because knowing that I had a treatment option to help slow my kidney function decline gave me hope.”

What convinced you to take charge of your ADPKD?

Evelynn: At the end of 2017, the constant, dull pain I’d been ignoring in my side started to worsen, and I asked my new primary care physician about it. Even though she knew I had ADPKD, she didn’t run any labs—she simply told me it was a muscle strain and gave me a referral for an x-ray of my back. It was at this time I decided to change up doctors and get myself a nephrologist. And I’m so glad I did, because when I sat down with my new nephrologist, we went over my history with ADPKD together. He said the pain that I was experiencing was because my ADPKD is the type that rapidly progresses. When I heard that, I knew I made the right choice.

What was it like to start treatment with JYNARQUE?

Evelynn: Once I finally started JYNARQUE, I got into the habit of always having water around and making frequent trips to the bathroom. My blood pressure also decreased, so my doctor adjusted my antihypertensives accordingly. At first, I lost weight because I couldn’t keep anything down. I worked with my doctor to manage that and eventually the nausea eased. My doctor also told me about how JYNARQUE can cause serious and potentially fatal liver problems. He enrolled me in the JYNARQUE Risk Evaluation and Mitigation Strategy, or REMS, program to help me keep on track with my routine bloodwork I would need to monitor my liver function. That was just my experience, and everyone’s may be different.

With my nephrologist’s okay, I got an MRI of my abdomen (I’d never had one before) so I could visualize what my kidneys looked like inside my body. There was less fear now because knowing that I had a treatment option to help slow my kidney function decline gave me hope. I was ready to see what the effects of ADPKD looked like in my body.

ADPKD changed Evelynn’s life

“I’m a pretty positive person, and I feel that the pain of ADPKD brought me to the wonderful specialists that I needed to help me change my life for the better.”

What gives you hope for the future of ADPKD?

Evelynn: Living with ADPKD used to make me believe I wasn’t going to live a very long life, based on the family history that we pieced together after both mom and I were diagnosed. But I’m a pretty positive person, and I feel that the pain of ADPKD brought me to the wonderful specialists that I needed to help me change my life for the better. I am encouraged by the medical advances and by current results related to my lifestyle and treatment. Who knows what the future will hold, but I wholeheartedly believe that with JYNARQUE, diet, exercise, controlled blood pressure, a good support system, and a positive outlook on life, I have the strength and tools to live my life with ADPKD. There are always going to be risks no matter what you do in life, but I’ve found hope with JYNARQUE.

MRI=magnetic resonance imaging.

JYNARQUE Interstitial

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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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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.