Additional Resources for JYNARQUE® (tolvaptan)

Downloadable HCP Resources

ADDITIONAL RESOURCES

1. Downloadable HCP Resources

Otsuka Patient Support, Icon

Patient Case Library

Understand the risk factors associated with rapidly progressing ADPKD

Patient cases are fictional.

JYNARQUE® (tolvaptan) Overview Brochure, Icon

JYNARQUE Overview Brochure

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

JYNARQUE® (tolvaptan) Kidney, Icon

Imaging Order Form

Request kidney imaging for patients with this form

JYNARQUE® (tolvaptan) Overview Brochure, Icon

ADPKD Imaging Brochure

This material contains information on ADPKD, rapid disease progression, imaging techniques, and how to order/calculate total kidney volume.

JYNARQUE Patient Resources

2. JYNARQUE Patient Resources

To learn more about available resources for patients, including lifestyle tips, a JYNARQUE dosing chart, and the JYNARQUE patient brochure, visit www.jynarque.com

Talk to your patients about the Peer Mentoring Program

Patients and their caregivers can speak with a Peer Mentor to hear their story about living with rapidly progressing ADPKD and their experience taking JYNARQUE.

Patients can call 855-415-7459 to register

Clinical Reprints

3. Clinical Reprints

REPRISE Trial: Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease

New England Journal of Medicine 2017. Torres, et al.

A registrational, phase 3 trial to investigate the efficacy and safety of tolvaptan in the treatment of patients with late stage CKD 2 to early stage 4, with the use of monthly hepatic safety monitoring. The primary end point was the change in eGFR over the 1-year trial period from pretreatment baseline to posttreatment follow-up

TEMPO 3:4 Trial: Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease

New England Journal of Medicine 2012. Torres, et al.

A registrational, phase 3 trial to investigate the efficacy of tolvaptan in the treatment of autosomal dominant polycystic kidney disease in adult patients with CKD stages 1-3. The primary end point was the annual rate of change in total kidney volume

A Practical Guide for Treatment of Rapidly Progressive ADPKD With Tolvaptan.

Journal of American Society of Nephrology 2018. Chebib, et al.

In this review, authors provide practical guidance on initiating and managing patients treated with JYNARQUE.

Tolerability of Aquaretic-Related Symptoms Following Tolvaptan for Autosomal Dominant Polycystic Kidney Disease: Results From TEMPO 3:4.

Kidney International Reports 2017. Devuyst, et al.

A post-hoc analysis of TEMPO 3:4 and TEMPO 4:4 to characterize the impact of tolvaptan-related aquaretic adverse events (AAEs) on a subject's decision to discontinue from the trial, and to identify characteristics of ADPKD patients who were at an increased risk for AAEs

Determinants of Urine Volume in ADPKD Patients Using the Vasopressin V2 Receptor Antagonist Tolvaptan.

American Journal of Kidney Diseases 2019. Kramers, et al.

In a study (N=27), reviewers assessed determinants of urine volume in patients with ADPKD using vasopressin V2 receptor antagonists (V2RAs) to help develop strategies to improve V2RA tolerability 

Sodium and urea excretion as determinants of urine output in autosomal dominant polycystic kidney disease patients on V2 receptor antagonists: impact of dietary intervention.

Springer Nature B.V. 2020. Cote, et al.

In a retrospective analysis (N=30), the goal was to identify the contribution of sodium and urea excretion rate to daily urine output, and to evaluate the effectiveness of dietary counseling

Additional Resources

4. Additional Resources

Disease Progression

Learn about the methods and importance of imaging kidneys in patients with ADPKD

FDA Guidance

In 2016, the FDA provided a recommendation for the use of total kidney volume (TKV) as a prognostic enrichment biomarker to select patients with ADPKD at a high risk of progressive decline in renal function for inclusion in interventional clinical trials1

Medscape

Learn more about ADPKD at Medscape, a leading online destination for physicians and healthcare professionals worldwide

ADPKD
=autosomal dominant polycystic kidney disease.
CKD
=chronic kidney disease.
INDICATION and IMPORTANT SAFETY INFORMATION for JYNARQUE® (tolvaptan)

INDICATION:

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

IMPORTANT SAFETY INFORMATION:

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
  • OATP1B1/3 and OAT3 Transporter Substrates: Patients who take JYNARQUE should avoid concomitant use with OATP1B1/B3 and OAT3 substrates (e.g., statins, bosentan, glyburide, nateglinide, repaglinide, methotrexate, furosemide), as the plasma concentrations of these substrates may be increased.
  • BCRP Transporter Substrates: Tolvaptan is an inhibitor of BCRP. Patients who take JYNARQUE, should avoid concomitant use with BCRP substrates (e.g., rosuvastatin)
  • 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 for JYNARQUE® (tolvaptan)
INDICATION and IMPORTANT SAFETY INFORMATION for JYNARQUE (tolvaptan)

INDICATION:

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

IMPORTANT SAFETY INFORMATION:

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
  • OATP1B1/3 and OAT3 Transporter Substrates: Patients who take JYNARQUE should avoid concomitant use with OATP1B1/B3 and OAT3 substrates (e.g., statins, bosentan, glyburide, nateglinide, repaglinide, methotrexate, furosemide), as the plasma concentrations of these substrates may be increased.
  • BCRP Transporter Substrates: Tolvaptan is an inhibitor of BCRP. Patients who take JYNARQUE, should avoid concomitant use with BCRP substrates (e.g., rosuvastatin)
  • 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.