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177"guideline": ["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"],
178"adverseOutcome": "The most common side effects of JYNARQUE are: thirst and increased fluid intake and making large amounts of urine, urinating often, and urinating at night",
179"seriousAdverseOutcome": "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",
180"contraindication": ["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","Do not drink grapefruit juice during treatment with JYNARQUE. This could cause you to have too much tolvaptan in your blood."],
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205"breastfeedingWarning": "Tell your healthcare provider about all your medical conditions, including if you: 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",
206"warning": "Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.",
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211
212
213    <title>JYNARQUE Copay Assistance | JYNARQUE® (tolvaptan) tablets</title>
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616                          <div class="field--item"><p>Proven to slow kidney function decline in adults who are at risk for rapidly progressing ADPKD</p></div>
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664      <h1 class="copay-assistance"><span>Savings while</span> <span><strong>ON TREATMENT</strong></span></h1>
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702                        <div  class="field field--name-field-text field--type-text-long field--label-hidden">
703                          <div class="field--item"><h2>Eligible patients may pay<br class="d-lg-none"> as little as</h2>
704<div class="price-offer">
705    <span class="price"><sup>$</sup>0</span>
706    <span class="info">
707        <div><strong>per month*</strong></div>
708    </span>
709</div>
710<div class="subtext">No copay card necessary.</div></div>
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733                        <div  class="field field--name-field-text field--type-text-long field--label-hidden">
734                          <div class="field--item"><p class="mt-4">Since a REMS-certified Specialty Pharmacy will deliver JYNARQUE directly to your door, you do not need a copay card. Make sure to tell your Specialty Pharmacy that you are interested in having your copay support applied directly to lowering your out-of-pocket costs. Find a Specialty Pharmacy <a class="link-advanced" href="specialty-pharmacy.html">here</a>.</p><p class="mb-1 mb-md-0">Have a prescription but not insured or need help paying for your JYNARQUE? Learn about additional assistance <a class="link-advanced" href="https://www.otsukapatientassistance.com/check-eligibility" target="_blank">here</a>.</p></div>
735                      </div>
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747                        <div  class="field field--name-field-text field--type-text-long field--label-hidden">
748                          <div class="field--item"><p class="mt-2 mt-md-4">REMS=Risk Evaluation and Mitigation Strategy.</p>
749<p class="hanging-asterisk">*For eligible commercially insured patients who are prescribed JYNARQUE<sup>®</sup>. Benefits may apply to copays, co-insurance, and pharmacy deductibles. Maximum annual benefit and other restrictions apply. Click below for full terms and conditions.</p></div>
750                      </div>
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774                          <div class="field--item"><button type="button" data-toggle="modal" data-target="#savings-card-terms-and-conditions">See Savings Card Terms and Conditions</button>
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781        </button>
782        <h2>Eligibility Requirements</h2>
783      </div>
784      <div class="modal-body">
785        <p><strong>Patients may be eligible for the Commercial Copay Savings Program for JYNARQUE if:</strong></p>
786        <p>The patient is insured by commercial insurance and the prescription insurance coverage does not cover the full cost of the patient’s JYNARQUE prescription; AND</p>
787        <ol>
788            <li>The patient is not covered by a state or federal healthcare program, including but not limited to Medicare Part D, Medicaid (including Medicaid managed care), Medigap, Veterans Affairs (VA), or Department of Defense (DOD) or TRICARE programs; AND</li>
789            <li>The patient is 18 years of age or older; AND</li>
790            <li>The patient is a resident of the United States or Puerto Rico; AND</li>
791            <li>The patient has a prescription consistent with FDA-approved product labeling</li>
792        </ol> 
793        <h2>Commercial Copay Savings Program Terms & Conditions</h2>
794        <ol>
795            <li>Eligible patients who have an activated Member Number under the Commercial Copay Savings Program, together with a valid prescription for JYNARQUE, may pay as little as $0 per 28-day supply of JYNARQUE. Benefit amount is subject to (1) a monthly maximum based on typical insurance reimbursement rates, including maximum annual out-of-pocket limits established by the Affordability Care Act, and (2) a separate annual maximum benefit of the Affordable Care Act Maximum Out-of-pocket ($10,600 for 2026). These maximums are set and may be changed at Otsuka’s sole discretion. Maximum benefits and copay assistance redemption methods may vary as necessary to ensure compliance with these Terms and Conditions. Other restrictions may apply.</li>
796            <li>Offer not applicable to copays of $0 or less.</li>
797            <li>This offer is non-transferable, no substitutions are permissible, and this offer is intended solely for the patient’s benefit and cannot be combined with any other rebate/coupon, free trial, or other offer for the specified prescription (including any pharmacy benefit manager or insurer program that adjusts patients’ out-of-pocket costs for their drugs, such as through “maximizers” or “accumulators”).</li>
798            <li>Eligible patients must enroll in the Commercial Copay Savings Program, without the help of any insurer, pharmacy benefit manager, or agent to these entities. Pharmacy-assisted enrollment is permitted.</li>
799            <li>Patient agrees, if required by their insurer, to notify the insurer of their participation in the Co-pay Assistance Program.</li>
800            <li>Otsuka reserves the right to rescind, revoke, or amend this offer at any time without notice and for any reason, including to ensure that the offer is used solely for the patient’s benefit.</li>
801            <li><strong>The Commercial Copay Savings Program for JYNARQUE is not insurance and is not intended to substitute for insurance.</strong></li>
802            <li>No purchase necessary, other than of the prescription for JYNARQUE for which assistance is provided under the Copay Savings Program. AND</li>
803            <li>The Copay Savings Program is void where taxed, restricted, or prohibited by law or patient’s insurance plan.  Beginning May 13, 2025, patients residing in Massachusetts are prohibited from accessing or using the Copay Savings Program, per applicable state laws. Beginning August 13, 2025, patients residing in California are prohibited from accessing or using the Copay Savings Program, per applicable state laws. Notwithstanding the foregoing, patients residing in California may, in accordance with California law, continue to access and use the Copay Savings Program if (i) the applicable patient has completed any applicable step therapy or prior authorization requirements for JYNARQUE, as mandated by the patient’s health insurer, health care service plan, or other health coverage, or (ii) a generic alternative is not available through the patient’s insurance coverage at a lower cost tier.</li>
804        </ol>
805      </div>
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845			
846      <div class="isi-inline-inner-wrap"><div class="isi-content-block"><h3>IMPORTANT SAFETY INFORMATION and INDICATION for JYNARQUE<sup>®</sup> (tolvaptan)</h3><ul class="list-style-dash"><li><strong>Serious liver problems.</strong> 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:<ul><li>feeling tired</li><li>loss of appetite</li><li>nausea</li><li>right upper stomach (abdomen) pain or tenderness</li><li>vomiting</li><li>fever</li><li>rash</li><li>itching</li><li>yellowing of the skin and white part of the eye (jaundice)</li><li>dark urine</li></ul></li></ul><p><strong>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:</strong></p><ul><li><strong>before you start taking JYNARQUE</strong></li><li><strong>at 2 weeks and 4 weeks after you start treatment with JYNARQUE</strong></li><li><strong>then monthly for 18 months during treatment with JYNARQUE</strong></li><li><strong>and every 3 months from then on</strong></li></ul><p><strong>Because of the risk of serious liver problems, JYNARQUE is only available through a restricted distribution program called the Tolvaptan for ADPKD Shared System Risk Evaluation and Mitigation Strategy (REMS).</strong></p><p><strong>Do not take JYNARQUE if you:</strong></p><ul><li>have a history of liver problems or have signs or symptoms of liver problems, excluding polycystic liver disease</li><li>cannot feel if you are thirsty or cannot replace fluids by drinking</li><li>have been told that the amount of sodium (salt) in your blood is too high or too low</li><li>are dehydrated</li><li>are allergic to tolvaptan or any of the ingredients in JYNARQUE</li><li>are unable to urinate</li></ul><p><strong>Tell your healthcare provider about all your medical conditions, including if you:</strong></p><ul><li>have a history of sodium (salt) levels that are too low</li><li>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</li><li>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</li></ul><p><strong>Tell your healthcare provider about all the medicines you take,</strong> including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.</p><ul><li>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</li><li>Do not start taking a new medicine without talking to your healthcare provider</li></ul><p><strong>JYNARQUE may cause serious side effects, including:</strong></p><ul><li><strong>Too much sodium in your blood (hypernatremia) and loss of too much body fluid (dehydration).</strong> In some cases, dehydration can lead to extreme loss of body fluid called hypovolemia. You should drink 
846water 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:<ul><li>dizziness</li><li>fainting</li><li>weight loss</li><li>a change in the way your heart beats</li><li>feeling confused or weak</li></ul></li></ul><p><strong>What should you avoid while taking JYNARQUE?</strong></p><p>Do not drink grapefruit juice during treatment with JYNARQUE. This could cause you to have too much tolvaptan in your blood.</p><p>The <strong>most common side effects</strong> of JYNARQUE are:</p><ul><li>thirst and increased fluid intake</li><li>making large amounts of urine, urinating often, and urinating at night</li></ul><p>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.</p><p><strong>If you have any questions about your health or medicines, talk to your healthcare professional.</strong></p><p>To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1‑800‑438-9927 or FDA at 1-800-FDA-1088 (<a href="https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program">www.fda.gov/medwatch</a>).</p></div><div class="isi-content-block"><h3>INDICATION:</h3><p><strong>What is JYNARQUE?</strong></p><p>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.</p></div><p>Please read <a class="external-link-popup-disabled" href="https://www.otsuka-us.com/media/static/JYNARQUE-PI.pdf" aria-label="FULL PRESCRIBING INFORMATION, Download PDF">FULL PRESCRIBING INFORMATION</a>, including <strong>BOXED WARNING</strong>, and <a class="external-link-popup-disabled" href="https://www.otsuka-us.com/media/static/JYNARQUE-Medguide.pdf" aria-label="MEDICATION GUIDE, Download PDF">MEDICATION GUIDE</a>.</p>
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907      10US26EBC0002
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940  
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945                  <a href="https://www.facebook.com/JYNARQUE" target="_blank" class="facebook">Facebook</a>
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966
967
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969    <div id="block-covidpopupblock" class="block-content-covid-popup-block block-content-basic block block-block-content block-block-content70c8b744-13e7-4ccb-b65f-37b04443e87e block-covid-popup-block">
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978  
979                        <div  class="field field--name-body field--type-text-with-summary field--label-hidden">
980                          <div class="field--item"><h2>COVID-19 UPDATE</h2>
981
982<p>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.</p>
983
984<p>If you are currently taking JYNARQUE<sup>®</sup> (tolvaptan), we encourage you to stay in close contact with your healthcare professional team regarding regular appointments and treatment management plans.</p>
985
986<p>At this time, there is no expected impact on medication supply.</p>
987
988<p>During the current COVID-19 <span class="text-nowrap">pandemic, the JYNARQUE<sup>®</sup> (tolvaptan)</span> 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.</p>
989
990<p>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 <a class="cta_phone" href="tel:1-855-242-7787">1-855-242-7787</a> for more information on both programs.</p>
991
992<p>For help accessing JYNARQUE, go to <a class="cta_exit" href="https://www.otsukapatientsupport.com/jynarque" target="_blank">www.otsukapatientsupport.com/jynarque</a> or call Otsuka Patient Support at <a class="cta_phone" href="tel:1-855-242-7787">1-855-242-7787</a>. The nurses at Otsuka Patient Support can answer questions related to Product Accessibility, Reimbursement and connecting patients to local treatment sites in their community.</p>
993
994<p>Please read <a class="dummy external-link-popup-disabled" href="https://www.otsuka-u
994s.com/media/static/JYNARQUE-PI.pdf" target="_blank">FULL PRESCRIBING INFORMATION</a>, including <strong>BOXED WARNING</strong>, and <a class="dummy external-link-popup-disabled" href="https://www.otsuka-us.com/media/static/JYNARQUE-Medguide.pdf" target="_blank">MEDICATION GUIDE</a>.</p>
995
996<p class="covid-footnote"><span class="covid-prc-1">September&nbsp;2020</span><span class="covid-prc-2">10US20EBC0103</span></p>
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1023            <div class="drawer-title">IMPORTANT SAFETY INFORMATION and INDICATION for JYNARQUE<sup>®</sup> (tolvaptan)
1024</div>
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1033          <div class="isi-content-block"><h3>IMPORTANT SAFETY INFORMATION and INDICATION for JYNARQUE<sup>®</sup> (tolvaptan)</h3><ul class="list-style-dash"><li><strong>Serious liver problems.</strong> 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:<ul><li>feeling tired</li><li>loss of appetite</li><li>nausea</li><li>right upper stomach (abdomen) pain or tenderness</li><li>vomiting</li><li>fever</li><li>rash</li><li>itching</li><li>yellowing of the skin and white part of the eye (jaundice)</li><li>dark urine</li></ul></li></ul><p><strong>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:</strong></p><ul><li><strong>before you start taking JYNARQUE</strong></li><li><strong>at 2 weeks and 4 weeks after you start treatment with JYNARQUE</strong></li><li><strong>then monthly for 18 months during treatment with JYNARQUE</strong></li><li><strong>and every 3 months from then on</strong></li></ul><p><strong>Because of the risk of serious liver problems, JYNARQUE is only available through a restricted distribution program called the Tolvaptan for ADPKD Shared System Risk Evaluation and Mitigation Strategy (REMS).</strong></p><p><strong>Do not take JYNARQUE if you:</strong></p><ul><li>have a history of liver problems or have signs or symptoms of liver problems, excluding polycystic liver disease</li><li>cannot feel if you are thirsty or cannot replace fluids by drinking</li><li>have been told that the amount of sodium (salt) in your blood is too high or too low</li><li>are dehydrated</li><li>are allergic to tolvaptan or any of the ingredients in JYNARQUE</li><li>are unable to urinate</li></ul><p><strong>Tell your healthcare provider about all your medical conditions, including if you:</strong></p><ul><li>have a history of sodium (salt) levels that are too low</li><li>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</li><li>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</li></ul><p><strong>Tell your healthcare provider about all the medicines you take,</strong> including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.</p><ul><li>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</li><li>Do not start taking a new medicine without talking to your healthcare provider</li></ul><p><strong>JYNARQUE may cause serious side effects, including:</strong></p><ul><li><strong>Too much sodium in your blood (hypernatremia) and loss of too much body fluid (dehydration).</strong> In some cases, dehydration can lead to extreme loss of body fluid called hypovolemia. You should drink 
1033water 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:<ul><li>dizziness</li><li>fainting</li><li>weight loss</li><li>a change in the way your heart beats</li><li>feeling confused or weak</li></ul></li></ul><p><strong>What should you avoid while taking JYNARQUE?</strong></p><p>Do not drink grapefruit juice during treatment with JYNARQUE. This could cause you to have too much tolvaptan in your blood.</p><p>The <strong>most common side effects</strong> of JYNARQUE are:</p><ul><li>thirst and increased fluid intake</li><li>making large amounts of urine, urinating often, and urinating at night</li></ul><p>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.</p><p><strong>If you have any questions about your health or medicines, talk to your healthcare professional.</strong></p><p>To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1‑800‑438-9927 or FDA at 1-800-FDA-1088 (<a href="https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program">www.fda.gov/medwatch</a>).</p></div><div class="isi-content-block"><h3>INDICATION:</h3><p><strong>What is JYNARQUE?</strong></p><p>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.</p></div><p>Please read <a class="external-link-popup-disabled" href="https://www.otsuka-us.com/media/static/JYNARQUE-PI.pdf" aria-label="FULL PRESCRIBING INFORMATION, Download PDF">FULL PRESCRIBING INFORMATION</a>, including <strong>BOXED WARNING</strong>, and <a class="external-link-popup-disabled" href="https://www.otsuka-us.com/media/static/JYNARQUE-Medguide.pdf" aria-label="MEDICATION GUIDE, Download PDF">MEDICATION GUIDE</a>.</p>
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