Patient counseling is a cornerstone of treatment
with JYNARQUE® (tolvaptan)

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.

Starting and
continuing treatment

Help your patients start and continue JYNARQUE using counseling tips provided by your peers

Your patients may have questions before starting treatment with JYNARQUE. Setting expectations can help motivate your patients to stay on track throughout treatment.

Dr. Gerard J. Tepedino

“If the patient is invested in the decision to start treatment from the beginning, I find it is more likely that they will be able to stay motivated throughout the course of treatment.”

Dr Gerard J Tepedino, PRINE Health Medical Group, PLLC, Manhasset, NY

Dr Tepedino is a paid consultant of Otsuka America Pharmaceutical, Inc.

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HCP Counseling Guide for Patients

This material highlights peer provided tips to help patients start and stay motivated on JYNARQUE

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Tips for starting your patients on JYNARQUE

  • Prior to starting treatment, consider advising your patients to increase their normal water intake
  • Recommend that your patients start JYNARQUE on a weekend, or when they are not at work1
  • Take into account patients’ individual lifestyles and daily activities when assessing the dosing and titration of JYNARQUE1
  • The tone you use to present treatment information really matters to your patients and will affect how they view their treatment

Some patients may have concerns about how much water they will need to drink and how frequently they may have to urinate

You could mention that the onset of aquaretic adverse events (AAEs) are related to the mechanism of action of JYNARQUE:

  • JYNARQUE targets vasopressin, a hormone that maintains the volume of water in the fluid space surrounding the cells; people with ADPKD have too much vasopressin, causing kidney cysts to grow
  • JYNARQUE works by selectively inhibiting the binding of vasopressin at the V2-receptor in the kidney

Offering dietary counseling may help patients tolerate the
aquaretic side effects of JYNARQUE1-3

It is important to set expectations with your patients and offer them practical tips for managing AAEs throughout the course of treatment

  • Reducing sodium and protein intake may help reduce urine volume1-3
  • Suggest carrying a water bottle everywhere to stay hydrated, and avoiding drinks with high sugar content
  • Advise patients to plan ahead to find the restrooms near where they will be
  • Remind your patients that taking the first JYNARQUE dose upon waking and the second dose exactly 8 hours later may be able to reduce the need to wake up to urinate1

Helpful reminders for patients

  • Suggest using the restroom before meetings, movies, travel, and social events
  • Suggest that patients set alarms or reminders for each dose of JYNARQUE
  • Encourage patients to set a recurring calendar event for lab testing and other appointments
  • Mobile restroom finder apps can help patients locate restrooms while away from home
  • Sharing experiences with their family, friends, and healthcare team can help patients feel more comfortable with treatment; being open about their condition may be helpful in managing the emotional impact

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

Otsuka is committed to making JYNARQUE available and affordable

Pay as little as $10 a month for JYNARQUE® (tolvaptan) Eligible commercially insured patients pay as little as $10 per month for JYNARQUE*

*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. 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.

Patient Experience Liaisons (PEL)

A PEL is a patient support representative who can speak directly to your patient or caregiver to review treatment access steps, provide helpful resources, and answer questions about insurance.

Otsuka Connect Rx: Organize and monitor JYNARQUE treatment for your patients

Otsuka patient support has collaborated with Medocity to create a digital care platform that can help HCPs, patients, and caregivers communicate, track treatment, assist with refills and fulfill REMS requirements.

  • Access to patient status form due dates and more
  • Specialty pharmacy and prescription status
  • Instantly share your patients’ lab results
  • Easily connect with your patients who opt in

Your patients can find more helpful resources at: JYNARQUE.com >

  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.
Hear from
real patients

Hear from the first generation of patients at risk of rapidly progressing autosomal dominant polycystic kidney disease (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.

To see more treatment experiences from real patients taking JYNARQUE, visit JYNARQUE.com/patient-stories.

Patients were compensated for their time.
ADPKD=autosomal dominant polycystic kidney disease.

Connect patients
to resources

Connect patients with an online ADPKD community

Your patients can sign up for helpful texts and emails or speak one-on-one to a Peer Mentor about a variety of topics.
Peer Mentors are real patients living with ADPKD and taking JYNARQUE.

ADPKD patient community

Topics include:

  • Everyday life with ADPKD
  • ADPKD symptoms
  • Communication with family and friends
  • ADPKD, treatment, and the workplace
  • Treatment with JYNARQUE
  • Side effects of JYNARQUE
  • Risk Evaluation and Mitigation Strategy (REMS)
    Safety Program
  • 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.

ADPKD=autosomal dominant polycystic kidney disease.

Watch Video, Icon

Hear from a peer about setting expectations for patients

VIEW VIDEO
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.

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INDICATION and IMPORTANT SAFETY INFORMATION
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.