Treatment resources

JYNARQUE Risk Evaluation and Mitigation Strategy (REMS) Program Enrollment (Prescriber)

Prescribers enroll and certify in the JYNARQUE REMS Program. The enrollment process takes just minutes*

GET CERTIFIED AT
JYNARQUEREMS.COM

JYNARQUE REMS Quick Reference Guide

Step-by-step instructions on how to use the REMS Portal as well as an overview of the latest REMS enhancements

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JYNARQUE Prescription Process Checklist

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

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JYNARQUE Overview Brochure

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

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*Individual times may vary.

REMS Patient Guide

Comprehensive guide outlining the JYNARQUE REMS Program and enrollment requirements for patients


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JYNARQUE REMS Program Patient Status Form

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

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JYNARQUE REMS Program Patient Enrollment

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

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Enroll online

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

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VA Prescription Ordering Form

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

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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

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JYNARQUE Patient Tracker

Keep track of the liver function monitoring tests and Patient Status Forms required by the JYNARQUE REMS Program

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ADPKD Risk Factor Checklist

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


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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

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Real JYNARQUE Patient

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 pay as little as $10 per month for JYNARQUE*

83% of patients with commercial insurance have coverage, and 94% of all patients pay $10 or less per month for JYNARQUE, regardless of coverage type.1,2 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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*Assumes one 28-day supply prescription per month. If more than one prescription is filled in a calendar month, you may pay more than $10 in that month. Offer is not transferable. Patients are not eligible if they are under 18 years of age or are covered in whole or in part by any state program or federal healthcare program, including, but not limited to, Medicare or Medicaid (including Medicaid managed care), Medigap, VA, DOD, or TRICARE. Patients must have a prescription consistent with FDA-approved product labeling for JYNARQUE. Only valid in US and Puerto Rico. Offer void where prohibited by law, taxed, or restricted. Other restrictions may apply. This program is not health insurance. Otsuka America Pharmaceutical, Inc. has the right to rescind, revoke, or amend this program at any time without notice. Your participation in this program confirms that this offer is consistent with your insurance coverage and that you will report the value received if required by your insurance provider. When you use this program, you are certifying that you understand and comply with the program rules, terms, and conditions. The information provided in this communication is provided for informational purposes and does not guarantee coverage or payment (partial or full). Actual benefits are determined by each plan’s administrator in accordance with its respective policy and procedures. Providers should consult with their payers for all relevant coverage, coding, and reimbursement requirements. It is the sole responsibility of the provider to ensure the accuracy of all claims used in seeking reimbursement. Nothing herein may be construed as an endorsement, approval, recommendation, representation, or warranty of any kind by any plan or insurer referenced. This communication is solely the responsibility of Otsuka America Pharmaceutical, Inc. This resource is not intended as legal advice or a substitute for a provider’s independent professional judgment.

  1. Managed Markets Insight & Technology, LLC: Analytics website as of June 21, 2022. Commercial lives exclude Health Insurance Exchanges Program (HIX) data.
  2. Managed Markets Insight & Technology, LLC: Analytics website as of July 24, 2023. Commercial lives exclude Health Insurance Exchanges Program (HIX) data.

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 JYNARQUE REMS Program

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.