Patient counseling is a cornerstone of treatment
with JYNARQUE

Help your patients know what they can expect throughout their treatment journey

As part of patient counseling, review the JYNARQUE Medication Guide with every patient.

Working closely with your patients and setting expectations can help motivate them to stay on track throughout treatment. Practical tips for diet and lifestyle management, based on feedback from your peers, can help patients prepare for their experience with JYNARQUE.

Inside the conversation: Talking to patients about JYNARQUE

Talking to Patients About JYNARQUE®, Video

Here are some helpful counseling tips from other healthcare professionals that could benefit your patients:

Water bottle icon

Prior to starting treatment, consider advising your patients to increase their normal water intake. Suggest carrying a water bottle at work, in the car, and during physical activities.

Dietary counseling with salt and protein icon

Offering dietary counselling may help patients tolerate the aquaretic side effects of JYNARQUE.1-3

Decreasing a patient’s protein and sodium intake may help reduce urine volume when taking JYNARQUE.1-3

Get a helpful guide to discussing aquaretic side effects with patients here.

8-hour interval icon with arrow

Counsel patients to take the first dose of JYNARQUE upon waking and the second dose exactly 8 hours later to reduce the need to wake up to urinate. Set alarms or reminders for each dose of JYNARQUE.

Calendar with test tube icon

Encourage patients to set a recurring calendar event for lab testing and other appointments.

Medical cross with speech bubble icon

Your patients can connect with a Peer Mentor and watch real stories about living with rapidly progressing ADPKD and taking JYNARQUE. Learn more

Connect your patients with someone in their shoes

Connect your patients Connect your patients

The ADPKD Peer Mentor Program is an easy way for patients to talk with someone else living with ADPKD who knows what they are going through. Your patients can speak one-on-one with a Peer Mentor over the phone or video call to get the personal support they’re looking for.

  • Everyday life with ADPKD
  • Communication with family and friends
  • Treatment with JYNARQUE
  • JYNARQUE patient support services

To register or for more information about the ADPKD Peer Mentor Program, call 855-415-7459 or visit www.jynarque.com/adpkd-peer-mentor-program.

JYNARQUE copay support

Eligible commercially insured patients pay as little as $10 per month for JYNARQUE.*

*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.

See if JYNARQUE could help change the course of progression for your patients with ADPKD

SEE HOW

  1. Chebib FT, Perrone RD, Chapman AB, et al. A practical guide for treatment of rapidly progressive ADPKD with tolvaptan. J Am Soc Nephrol. 2018;29(10):2458-2470.
  2. Kramers BJ, van Gastel MDA, Boertien WE, Meijer E, Gansevoort RT. Determinants of urine volume in ADPKD patients using the vasopressin V2 receptor antagonist tolvaptan. Am J Kidney Dis. 2019;73(3):354-362.
  3. Côté G, Asselin-Thompstone L, Mac-Way F, et al. Sodium and urea excretion as determinants of urine output in autosomal dominant polycystic kidney disease patients on V2 receptor antagonists: impact of dietary intervention. Int Urol Nephrol. 2020;52(2):343-349.
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Patient Counseling: Setting expectations for treatment with JYNARQUE

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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.