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nav-item"> 456 <a href="#"><span>About JYNARQUE</span></a> 457 <ul class="menu nav"> 458 <li class="menu-item menu-item-1 nav-item"> 459 <a href="understanding-adpkd-progression.html" data-drupal-link-system-path="node/37481">Understanding ADPKD & Progression</a> 460 </li> 461 <li class="menu-item menu-item-2 nav-item"> 462 <a href="why-jynarque.html" data-drupal-link-system-path="node/6">Why JYNARQUE?</a> 463 </li> 464 <li class="menu-item menu-item-3 nav-item"> 465 <a href="how-jynarque-works.html" data-drupal-link-system-path="node/26">How JYNARQUE Works</a> 466 </li> 467 <li class="menu-item menu-item-4 nav-item"> 468 <a href="side-effects-rems.html" data-drupal-link-system-path="node/25741">JYNARQUE Side Effects and REMS</a> 469 </li> 470 <li class="menu-item menu-item-5 nav-item"> 471 <a href="is-jynarque-for-you.html" data-drupal-link-system-path="node/25746">See if JYNARQUE is Right for You</a> 472 </li> 473 </ul> 474 475 </li> 476 <li class="menu-item menu-item-2 menu-item--expanded nav-item"> 477 <a href="#"><span>Getting Started</span></a> 478 <ul class="menu nav"> 479 <li class="menu-item menu-item-1 nav-item"> 480 <a href="how-to-get-started.html" data-drupal-link-system-path="node/36">How to Get Started</a> 481 </li> 482 <li class="menu-item menu-item-2 nav-item"> 483 <a href="risks-and-rems.html" data-drupal-link-system-path="node/25736">REMS: Lab Work and Monitoring</a> 484 </li> 485 <li class="menu-item menu-item-3 nav-item"> 486 <a href="specialty-pharmacy.html" data-drupal-link-system-path="node/15816">Working With a Specialty Pharmacy</a> 487 </li> 488 <li class="menu-item menu-item-4 nav-item"> 489 <a href="how-to-take-jynarque.html" data-drupal-link-system-path="node/25726">How to Take JYNARQUE</a> 490 </li> 491 </ul> 492 493 </li> 494 <li class="menu-item menu-item-3 nav-item"> 495 <a href="tips-while-on-treatment.html" data-drupal-link-system-path="node/31">Tips While on Treatment</a> 496 </li> 497 <li class="menu-item menu-item-4 menu-item--expanded nav-item"> 498 <a href="#"><span>Resources</span></a> 499 <ul class="menu nav"> 500 <li class="menu-item menu-item-1 nav-item"> 501 <a href="online-resources.html" data-drupal-link-system-path="node/25831">Online Resources</a> 502 </li> 503 <li class="menu-item menu-item-2 nav-item"> 504 <a href="downloadable-resources.html" data-drupal-link-system-path="node/25721">Downloadable Resources</a> 505 </li> 506 </ul> 507 508 </li> 509 </ul> 510 511 512 513 </nav> 514 515 <a href="#" class="mobile-menu-open-btn" data-test='mobile-menu-toggle'>
516 <span>Mobile menu</span> 517 </a> 518 <a href="#" class="mobile-menu-close-btn"> 519 <span>Mobile menu</span> 520 </a> 521 </div> 522 523 </div> 524 </div> 525 </header> 526 527 <div id="mobile-menu" class="region--mobile-menu" data-analytics-position="header"> 528 <div class="container"> 529 <div class="region region-mobile-menu clearfix"> 530 <nav role="navigation" aria-labelledby="block-mainnavigation-menu" id="block-mainnavigation"> 531 532 <h2 class="visually-hidden" id="block-mainnavigation-menu">Main navigation</h2> 533 534 535 536 <ul data-block="block-mainnavigation" data-test="main-menu" class="menu menu-main nav"> 537 <li class="menu-item menu-item-1 menu-item--expanded nav-item"> 538 <a href="#"><span>About JYNARQUE</span></a> 539 <ul class="menu nav"> 540 <li class="menu-item menu-item-1 nav-item"> 541 <a href="understanding-adpkd-progression.html" data-drupal-link-system-path="node/37481">Understanding ADPKD & Progression</a> 542 </li> 543 <li class="menu-item menu-item-2 nav-item"> 544 <a href="why-jynarque.html" data-drupal-link-system-path="node/6">Why JYNARQUE?</a> 545 </li> 546 <li class="menu-item menu-item-3 nav-item"> 547 <a href="how-jynarque-works.html" data-drupal-link-system-path="node/26">How JYNARQUE Works</a> 548 </li> 549 <li class="menu-item menu-item-4 nav-item"> 550 <a href="side-effects-rems.html" data-drupal-link-system-path="node/25741">JYNARQUE Side Effects and REMS</a> 551 </li> 552 <li class="menu-item menu-item-5 nav-item"> 553 <a href="is-jynarque-for-you.html" data-drupal-link-system-path="node/25746">See if JYNARQUE is Right for You</a> 554 </li> 555 </ul> 556 557 </li> 558 <li class="menu-item menu-item-2 menu-item--expanded nav-item"> 559 <a href="#"><span>Getting Started</span></a> 560 <ul class="menu nav"> 561 <li class="menu-item menu-item-1 nav-item"> 562 <a href="how-to-get-started.html" data-drupal-link-system-path="node/36">How to Get Started</a> 563 </li> 564 <li class="menu-item menu-item-2 nav-item"> 565 <a href="risks-and-rems.html" data-drupal-link-system-path="node/25736">REMS: Lab Work and Monitoring</a> 566 </li> 567 <li class="menu-item menu-item-3 nav-item"> 568 <a href="specialty-pharmacy.html" data-drupal-link-system-path="node/15816">Working With a Specialty Pharmacy</a> 569 </li> 570 <li class="menu-item menu-item-4 nav-item"> 571 <a href="how-to-take-jynarque.html" data-drupal-link-system-path="node/25726">How to Take JYNARQUE</a> 572 </li> 573 </ul> 574 575 </li> 576 <li class="menu-item menu-item-3 nav-item"> 577 <a href="tips-while-on-treatment.html" data-drupal-link-system-path="node/31">Tips While on Treatment</a> 578 </li> 579 <li class="menu-item menu-item-4 menu-item--expanded nav-item"> 580 <a href="#"><span>Resources</span></a> 581 <ul class="menu nav"> 582 <li class="menu-item menu-item-1 nav-item"> 583 <a href="online-resources.html" data-drupal-link-system-path="node/25831">Online Resources</a> 584 </li> 585 <li class="menu-item menu-item-2 nav-item"> 586 <a href="downloadable-resources.html" data-drupal-link-system-path="node/25721">Downloadable Resources</a> 587 </li> 588 </ul> 589 590 </li> 591 </ul> 592 593 594 595 </nav> 596 597 </div> 598 599 </div> 600 </div> 601 <section aria-label="Header Information"> 602 <div id="header-info" class="region--header-info"> 603 <div class="container"> 604 <div class="region region-header-info clearfix"> 605 <div id="block-jynarque-hcc-2021-headertextdescription" class="block-content-header-text-description block-content-basic block block-block-content block-block-content855941ea-329b-4a19-bc10-2bd1df83da5c block-header-text-description"> 606 607 608 <div class="content"> 609 610 611 612 613 614 615 <div class="field field--name-body field--type-text-with-summary field--label-hidden"> 616 <div class="field--item"><p>Proven to slow kidney function decline in adults who are at risk for rapidly progressing ADPKD</p></div> 617 </div> 618 619 620 </div> 621 </div> 622 623 </div> 624 625 </div> 626 </div> 627 </section> 628 629 630 <main role="main" class="main-content" id="main-content"> 631 <div class="container"> 632 <div class="region region-highlighted clearfix"> 633 <div data-drupal-messages-fallback class="hidden"></div> 634 635 </div> 636 637 </div> 638 <div class="no-sidebar"> 639 <div class="region region-content clearfix">
640 <div id="block-jynarque-hcc-2021-content" class="block block-system block-system-main-block"> 641 642 643 <div class="content"> 644 645 646<article data-history-node-id="25731" about="/copay-assistance" class="node node-type-landing-page node--promoted node-view-mode-full"> 647 648 649 650 651 652 <div class="hero-section"> 653 654 655 </div> 656 657 <div class="node-content"> 658 659 660 661 662<div class="field field--name-field-formatted-title field--type-text-long field--label-hidden container" data-test='paragraph'> 663 <div class="field--item"> 664 <h1 class="copay-assistance"><span>Savings while</span> <span><strong>ON TREATMENT</strong></span></h1> 665 666 </div> 667 </div> 668 669 670 671 672 673 674 <div class="field field--name-field-paragraphs field--type-entity-reference-revisions field--label-hidden"> 675 <div class="field--item"> <div class="container clearfix paragraph paragraph--type--wrapper paragraph--view-mode--default mt-md-5" id="paragraph-856" data-test='paragraph'> 676 677 678 679 680 681 682 683 684 <div class="field field--name-field-paragraphs field--type-entity-reference-revisions field--label-hidden"> 685 <div class="field--item"> <div class="row clearfix paragraph paragraph--type--wrapper paragraph--view-mode--default ie11-flex-md-6" id="paragraph-851" > 686 687 688 689 690 691 692 693 694 <div class="field field--name-field-paragraphs field--type-entity-reference-revisions field--label-hidden"> 695 <div class="field--item"> <div class="col-md-6 blue-rectangle-block clearfix paragraph paragraph--type--text paragraph--view-mode--default" id="paragraph-831" > 696 697 698 699 700 701 702 <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> 711 </div> 712 713 714 </div> 715</div> 716 </div> 717 718 719 </div> 720</div> 721 </div> 722 723 724 </div> 725</div> 726 <div class="field--item"> <div class="container clearfix paragraph paragraph--type--text paragraph--view-mode--default" id="paragraph-861" data-test='paragraph'> 727 728 729 730 731 732 733 <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> 736 737 738 </div> 739</div> 740 <div class="field--item"> <div class="container footnote clearfix paragraph paragraph--type--text paragraph--view-mode--default" id="paragraph-866" data-test='paragraph'> 741 742 743 744 745 746 747 <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> 751 752 753 </div> 754</div> 755 <div class="field--item"> <div class="container clearfix paragraph paragraph--type--block paragraph--view-mode--default" id="paragraph-5746" data-test='paragraph'> 756 757 758 759 760 761 762 <div class="field field--name-field-block field--type-entity-reference field--label-hidden"> 763 <div class="field--item"><div id="block-jynarque-hcc-2021-savingscardtermsandconditions" class="block-content-savings-card-terms-and-conditions block-content-basic block block-block-content block-block-content948204b2-fc74-4e39-8fdf-feded6f16861 block-savings-card-terms-and-conditions"> 764 765 766 <div class="content"> 767 768 769 770 771 772 773 <div class="field field--name-body field--type-text-with-summary field--label-hidden"> 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> 775<div class="modal fade" id="savings-card-terms-and-conditions" tabindex="-1" aria-labelledby="exampleModalLabel" aria-hidden="true"> 776 <div class="modal-dialog"> 777 <div class="modal-content"> 778 <div class="modal-header"> 779 <button type="button" class="close" data-dismiss="modal" aria-label="Close">
780 <span class="visually-hidden" aria-hidden="true">Close</span> 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 patientâs 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 Otsukaâs 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 patientâs 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 patientsâ out-of-pocket costs for their drugs, such as through âmaximizersâ or âaccumulatorsâ).</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 patientâs 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 patientâs 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 patientâs health insurer, health care service plan, or other health coverage, or (ii) a generic alternative is not available through the patientâs insurance coverage at a lower cost tier.</li> 804 </ol> 805 </div> 806 </div> 807 </div> 808</div></div> 809 </div> 810 811 812 </div> 813 </div> 814</div> 815 </div> 816 817 818 </div> 819</div> 820 </div> 821 822 823 </div> 824 825</article> 826 827 </div> 828 </div> 829 830 </div> 831 832 </div> 833 <div class="isi-page-wrapper"> 834 <div class="container"> 835 <div class="region region-isi clearfix"> 836 837 838 839 <a id="isi-top" name="isi-top"></a> 840 <section id="inline-isi-wrapper" class="section isi-section" data-test="isi"> 841 842 <div class="isi isi-block"> 843 <div class="isi-inline-title-wrap"><span class="isi-block-title">ISI Block Title 844</span></div> 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 1â800â438-9927 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> 847</div> 848 </div> 849 850 </section> 851 852 </div> 853 854 </div> 855 </div> 856 </main> 857 858 </div> 859 860 861<footer id="section-footer" role="contentinfo"> 862 <div id="footer"> 863 <div class="container"> 864 <div class="row"> 865 <div class="col-12 col-lg-7 col-xl-8"> 866 <div class="logo-footer"> 867 <a href="https://www.otsuka-us.com/" target="_blank" data-test='navbar-branding' data-analytics-name="Otsuka Logo"> 868 <img src="sites/g/files/qhldwo12166/themes/site/themes/custom/jynarque_hcc_2021/assets/build/img/otsuka-logo.png" alt="Otsuka, Logo"> 869 </a> 870 </div> 871 <div class="footer-inline-items"> <div class="region region-footer-1 clearfix"> 872 <div id="block-otsukacopyright" class="block block-otsuka-prc-code block-otsuka-copyright"> 873 874 875 <div class="content" data-test='copyright'> 876 © 2026 Otsuka America Pharmaceutical, Inc. 877 </div> 878 </div> 879<div id="block-footerinlinetext" class="block-content-footer-inline-text block-content-basic block block-block-content block-block-content7f8acdb7-b4f7-4e3a-b947-0371f92fc130 block-footer-inline-text"> 880 881 882 <div class="content"> 883 884 885 886 887 888 889 <div class="field field--name-body field--type-text-with-summary field--label-hidden"> 890 <div class="field--item"><p>All rights reserved.</p></div> 891 </div> 892 893 894 </div> 895 </div> 896<div id="block-jynarque-hcc-2021-prcdate" class="block block-otsuka-prc-code block-prc-code-date"> 897 898 899 <div class="content" data-test='prc-date'> 900 May 2026 901 </div> 902 </div> 903<div id="block-jynarque-hcc-2021-prccode" class="block block-otsuka-prc-code block-prc-code"> 904 905 906 <div class="content" data-test='prc-code'> 907 10US26EBC0002 908 </div> 909 </div> 910 911 </div> 912</div> 913 </div> 914 <div class="col-12 col-lg-5 col-xl-4"> 915 <div class="region region-footer-2 clearfix"> 916 <nav role="navigation" aria-labelledby="block-jynarque-hcc-2021-footer-menu" id="block-jynarque-hcc-2021-footer"> 917 918 <h2 class="visually-hidden" id="block-jynarque-hcc-2021-footer-menu">Footer menu</h2> 919 920 921 922 <ul data-block="block-jynarque-hcc-2021-footer" data-test="footer-menu" class="menu menu-footer nav"> 923 <li class="menu-item menu-item-1 nav-item">
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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 2020</span><span class="covid-prc-2">10US20EBC0103</span></p> 997</div> 998 </div> 999 1000 1001 </div> 1002 </div> 1003 1004 </div> 1005 1006 1007 </div> 1008 1009 1010 1011 1012 1013 1014 1015 1016 1017<section id="drawer-isi" class="isi-tray jsIsiContainer isi-drawer-collapsed" aria-label="ISI"> 1018 1019 <!--<div id="isi-drawer-wrapper" class="isi-drawer-collapsed">--> 1020 1021 <div class="isi-header"> 1022 <div class="isi-header-wrap"> 1023 <div class="drawer-title">IMPORTANT SAFETY INFORMATION and INDICATION for JYNARQUE<sup>®</sup> (tolvaptan) 1024</div> 1025 <button class="isi-btn jsIsiMinimize" data-oapigtmcategory="Button Clicks" data-oapigtmaction="ISI" data-oapigtmlabel="More +"><span class="jsSwapText jsSwapTextExpand">More +</span><span class="jsSwapText jsSwapTextCollapse hide">Less -</span><span class="isi-btn-icon"></span></button> 1026 </div> 1027 </div> 1028 1029 <div class="isi isi-block isi-drawer-content isi-content-wrap"> 1030 <div class="jcf-scrollable jcf-container mCustomScrollbar"> 1031 <div class="isi-drawer-content-heading">ISI Block Title 1032</div> 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 1â800â438-9927 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> 1034 1035 </div> 1036 </div> 1037 1038 <!--</div>--><!--/#isi-drawer-wrapper--> 1039 1040</section> 1041<style> 1042 1043 .isi-tray { 1044 left: 0%; 1045 width: 100%; 1046 } 1047 .isi-drawer-expanded { 1048 height: 100px; 1049 } 1050 .isi-drawer-collapsed { 1051 height: 40px; 1052 } 1053 1054 .isi-tray.isi-drawer-expanded .isi-content-wrap, 1055 .isi-tray.isi-drawer-expanded .isi-content-wrap>div { 1056 height: calc(50vh - 220px); 1057 } 1058 @media all and (min-width: 768px) { 1059 .isi-tray.isi-drawer-expanded .isi-content-wrap, 1060 .isi-tray.isi-drawer-expanded .isi-content-wrap>div { 1061 height: calc(50vh - 60px); 1062 } 1063 } 1064</style> 1065 1066 1067
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