Treatment Resources: Tools and Guides for Prescribing JYNARQUE

REMS Enrollment (Prescriber)

Prescribers enroll and certify in the Tolvaptan for ADPKD Shared System REMS. The enrollment process takes just minutes*

REMS Portal Guide

Step-by-step instructions on how to use the REMS Portal

JYNARQUE Overview Brochure

This resource includes information about ADPKD, assessing ADPKD progression, and data from the JYNARQUE clinical trials

JYNARQUE Prescription Process Checklist

Use this checklist as a reminder of the forms needed to prescribe patients JYNARQUE

*Individual times may vary.

REMS Patient Guide

Comprehensive guide outlining the Tolvaptan for ADPKD Shared System REMS and enrollment requirements for patients


REMS Patient Status Form

Use the form to help document hepatic monitoring for all patients treated with JYNARQUE

REMS Patient Enrollment

Prepare the Patient Enrollment Form for your patient to sign by completing the HCP section first, either online at www.TolvaptanADPKDSharedREMS.com or by downloading a paper copy that can be submitted by fax

JYNARQUE is exclusively available through 3 REMS-certified pharmacies:

The specialty pharmacies can:

  • Mail medication directly to patients
  • Offer clinical and educational support by nurses and pharmacists
  • Provide lab tests and refill reminders
  • Coordinate with patients and prescribers

Prescription Referral Form

E-prescribe or fax a completed Prescription Referral Form to one of the REMS-certified specialty pharmacies

VA Prescription Ordering Form

The VA uses a custom prescription form due to their specific process. Fax the completed VA Prescription Form to Walgreens

Otsuka Patient Support Program 
Consent Form (Patient)

Obtain your patient's signature on this form so that they may enroll in the Otsuka Patient Support Program. Otsuka Patient Support Service is offered by Otsuka to help patients throughout their treatment with JYNARQUE. Completed paper forms should be sent with the Prescription Referral Form to the preferred REMS-certified specialty pharmacy

ADPKD Risk Factor Checklist

This tool helps patients recognize the risk factors for rapid progression and prepare for their next nephrologist appointment


Patient Community Support Brochure

This brochure introduces patients to the ADPKD Peer Mentor and the ADPKD Peer Conversations programs, where they can connect with others in the ADPKD community

Hear from real patients about their experiences with ADPKD

Patients and their caregivers can hear from the first generation at risk of rapidly progressing ADPKD with a treatment to call their own. Watch their videos and read their stories for a closer look into their experiences with ADPKD and their treatment journeys.

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Copay Savings Program

Otsuka is committed to helping your patients get access to JYNARQUE

Eligible patients may pay as little as $0 per month for JYNARQUE

Since a REMS-certified specialty pharmacy will deliver JYNARQUE directly to your patient's door, they will not need a copay card. Instead, they can tell their specialty pharmacy that they are interested in having their copay support applied directly to lowering their out-of-pocket costs.

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Letter of Medical Necessity

A letter that can help support your case for prescribing JYNARQUE to your appropriate patients

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Eligibility Requirements

Patients may be eligible for the Commercial Copay Savings Program for JYNARQUE if:

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

  1. 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
  2. The patient is 18 years of age or older; AND
  3. The patient is a resident of the United States or Puerto Rico; AND
  4. The patient has a prescription consistent with FDA-approved product labeling

Commercial Copay Savings Program Terms & Conditions:

  1. 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 ($9,200 for 2025). 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.
  2. Offer not applicable to copays of $0 or less.
  3. 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”).
  4. 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.
  5. Patient agrees, if required by their insurer, to notify the insurer of their participation in the Co-pay Assistance Program.
  6. 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.
  7. The Commercial Copay Savings Program for JYNARQUE is not insurance and is not intended to substitute for insurance.
  8. No purchase necessary, other than of the prescription for JYNARQUE for which assistance is provided under the Copay Savings Program. And
  9. 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.

INDICATION and IMPORTANT SAFETY INFORMATION

JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

WARNING: RISK OF SERIOUS LIVER INJURY

WARNING: RISK OF SERIOUS LIVER INJURY

  • JYNARQUE® (tolvaptan) can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported
  • Measure transaminases (ALT, AST) and bilirubin before initiating treatment, at 2 weeks and 4 weeks after initiation, then monthly for the first 18 months and every 3 months thereafter. Prompt action in response to laboratory abnormalities, signs, or symptoms indicative of hepatic injury can mitigate, but not eliminate, the risk of serious hepatotoxicity
  • Because of the risks of serious liver injury, JYNARQUE is available only through a Risk Evaluation and Mitigation Strategy program called the Tolvaptan for ADPKD Shared System REMS

CONTRAINDICATIONS:

  • History, signs or symptoms of significant liver impairment or injury. This contraindication does not apply to uncomplicated polycystic liver disease
  • Taking strong CYP3A inhibitors
  • With uncorrected abnormal blood sodium concentrations
  • Unable to sense or respond to thirst
  • Hypovolemia
  • Hypersensitivity (e.g., anaphylaxis, rash) to JYNARQUE or any component of the product
  • Uncorrected urinary outflow obstruction
  • Anuria

Serious Liver Injury: JYNARQUE can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported in the post-marketing ADPKD experience. Discontinuation in response to laboratory abnormalities or signs or symptoms of liver injury (such as fatigue, anorexia, nausea, right upper abdominal discomfort, vomiting, fever, rash, pruritus, icterus, dark urine or jaundice) can reduce the risk of severe hepatotoxicity. To reduce the risk of significant or irreversible liver injury, assess ALT, AST and bilirubin prior to initiating JYNARQUE, at 2 weeks and 4 weeks after initiation, then monthly for 18 months and every 3 months thereafter.

Hypernatremia, Dehydration and Hypovolemia: JYNARQUE therapy increases free water clearance which can lead to dehydration, hypovolemia and hypernatremia. Instruct patients to drink water when thirsty, and throughout the day and night if awake. Monitor for weight loss, tachycardia and hypotension because they may signal dehydration. Ensure abnormalities in sodium concentrations are corrected before initiating therapy. If serum sodium increases above normal or the patient becomes hypovolemic or dehydrated and fluid intake cannot be increased, suspend JYNARQUE until serum sodium, hydration status and volume status parameters are within the normal range.

Inhibitors of CYP3A: Concomitant use of JYNARQUE with drugs that are moderate or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, indinavir/ritonavir, ritonavir, and conivaptan) increases tolvaptan exposure. Use with strong CYP3A inhibitors is contraindicated; dose reduction of JYNARQUE is recommended for patients taking moderate CYP3A inhibitors. Patients should avoid grapefruit juice beverages while taking JYNARQUE.

Adverse Reactions: Most common observed adverse reactions with JYNARQUE (incidence >10% and at least twice that for placebo) were thirst, polyuria, nocturia, pollakiuria and polydipsia.

Other Drug Interactions:

  • Strong CYP3A Inducers: Co-administration with strong CYP3A inducers reduces exposure to JYNARQUE. Avoid concomitant use of JYNARQUE with strong CYP3A inducers
  • V2-Receptor Agonist: Tolvaptan interferes with the V2-agonist activity of desmopressin (dDAVP). Avoid concomitant use of JYNARQUE with a V2-agonist

Pregnancy and Lactation: Based on animal data, JYNARQUE may cause fetal harm. In general, JYNARQUE should be discontinued during pregnancy. Advise women not to breastfeed during treatment with JYNARQUE.

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).

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.