Identify appropriate patients
for JYNARQUE® (tolvaptan)

Select a patient to see how clinical and imaging markers can indicate the risk of rapid progression
Rapidly declining eGFR
Tim, Patient
Tim, 31
Stage 2 CKD
TKV greater than expected for his age
Multiple risk factors
Patient images and patient cases are fictional.

Physical Findings and Labs:

Age:
31
Height:
5’11”
Weight:
180 lbs
BMI:
25

BP: 107/73 mm/Hg, controlled on an ARB therapy

Creatinine: 1.4 mg/dL

Current eGFR: 67 mL/min/1.73 m2
— eGFR: 70 mL/min/1.73 m2 1 year ago

htTKV: 583 mL/m

Mayo Imaging Classification: 1C (high risk)

 

Click here for TKV Calculation

Medical history:
  • Diagnosed with ADPKD as a young adult when an ultrasound showed innumerable, bilateral cysts
  • Kidney stones
Family History:
  • Father, uncle, and brother diagnosed with ADPKD
  • Father developed ESKD at age 54
  • Uncle received a kidney transplant at age 50

Tim, 31 — Stage 2 CKD

Stage 2 CKD Patient Tim

Tim works from home as a sales manager for a technology company. Lately, he’s been taking online classes to learn to play drums.

Mayo Classification of 1C (high risk) and TKV greater than expected for his age point to a risk of rapidly progressing ADPKD4

Assessing ADPKD progression and treatment considerationAssessing ADPKD progression and treatment consideration
  • Even though Tim had a relatively stable eGFR, his family history of early ESKD led his nephrologist to scan his kidneys for a TKV measurement
  • His nephrologist knew that CRISP data show that a one-time measurement of TKV can help assess the rate of progression and predict the rate of future kidney function decline5*
  • Given the Mayo Imaging Classification of 1C, Tim’s nephrologist determined he was at high risk for rapidly progressing ADPKD4
  • After further assessment, Tim’s nephrologist determined he was an appropriate patient and recommended he start treatment with JYNARQUE® (tolvaptan)
Starting JYNARQUE

Starting JYNARQUE

  • Tim’s nephrologist explained the benefits and risks associated with treatment, including the risk of serious liver injury, discussed the requirements of the REMS program, and reviewed the medication guide prior to starting treatment
  • Concerned with his family history and risk of rapidly progressing ADPKD, Tim chose to go on JYNARQUE after his nephrologist explained that it has the ability to slow the progression of ADPKD
    • 48% of the patients in the TEMPO 3:4 clinical trial had CKD Stage 2, like Tim
  • Tim’s nephrologist advised him to take JYNARQUE twice daily, the first dose upon waking and the second dose 8 hours later
    • He explained that JYNARQUE may cause aquaretic side effects and advised to drink more water to avoid thirst and dehydration
  • Tim had additional questions about the risk of serious liver injury and his nephrologist reviewed the incidence of liver injury observed during the clinical trials
    • Incidence of serious liver injury: 0.2% (3/1487) of JYNARQUE patients experienced serious hepatocellular injury (elevations of hepatic transaminases of at least 3 times ULN combined with elevated bilirubin at least 2 times the ULN) in a 3-year placebo-controlled trial and its open-label extension (in which patients’ liver tests were monitored every 4 months) compared to none of the placebo-treated patients
    • Incidence of liver injury: 4.9% (80/1637) of JYNARQUE patients experienced ALT elevations >3 times the ULN at an increased frequency within the first 18 months after initiating treatment compared to 1.1% (13/1166) of patients taking placebo in the two double-blind, placebo-controlled trials. ALT elevations usually resolved within 1 to 4 months after discontinuing treatment
  • Based on Tim’s commercial insurance coverage, his specialty pharmacy determined he was eligible for $10/month copay support†

ARB=angiotensin II receptor blockers; ADPKD=autosomal dominant polycystic kidney disease; ALT=alanine transaminase; BMI=body mass index; BP=blood pressure; CKD=chronic kidney disease; CRISP=Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease; eGFR=estimated glomerular filtration rate; ESKD=end-stage kidney disease; htTKV=height-adjusted total kidney volume; NIH=National Institutes of Health; REMS=Risk Evaluation and Mitigation Strategy; TEMPO=Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes; TKV=total kidney volume; ULN=upper limit of normal.

*CRISP is an NIH-funded, 14-year observational study (N=241) of adult ADPKD patients. The primary goal was to determine the extent to which TKV forecasts the development of renal insufficiency in ADPKD.5,6

†Assumes one 28-day supply prescription per month. If more than one prescription is filled in a calendar month, patients may pay more than $10 in that month. Other terms and conditions may apply.

Additional resources for you and your patients

Access Resources

  1. Gansevoort RT, Arici M, Benzing T, et al. Recommendations for the use of tolvaptan in autosomal dominant polycystic kidney disease: a position statement on behalf of the ERA-EDTA Working Groups on Inherited Kidney Disorders and European Renal Best Practice. Nephrol Dial Transplant. 2016;31(3):337-348. 
  2. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Intern Suppl. 2013;3(1):1-150.
  3. Torres VE, Chapman AB, Devuyst O, et al; for the REPRISE Trial Investigators. Tolvaptan in later-stage autosomal dominant polycystic kidney disease. N Engl J Med. 2017;377(20):1930-1942. 
  4. Irazabal MV, Rangel LJ, Bergstralh EJ, et al. Imaging classification of autosomal dominant polycystic kidney disease: a simple model for selecting patients for clinical trials. J Am Soc Nephrol. 2015;26(1):160-172.
  5. Yu ASL, Shen C, Landsittel DP, et al; for the Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP). Long-term trajectory of kidney function in autosomal-dominant polycystic kidney disease. Kidney Int. 2019;95(5):1253-1261.
  6. Chapman AB, Guay-Woodford LM, Grantham JJ, et al. Renal structure in early autosomal-dominant polycystic kidney disease (ADPKD): The Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) cohort. Kidney Int. 2003;64(3):1035-1045.
  7. Magistroni R, Corsi C, Martí T, Torra R. A review of the imaging techniques for measuring kidney and cyst volume in establishing autosomal dominant polycystic kidney disease progression. Am J Nephrol. 2018;48:67-78. 
  8. Chapman AB, Bost JE, Torres VE, et al. Kidney volume and functional outcomes in autosomal dominant polycystic kidney disease. Clin J Am Soc Nephrol. 2012;7(3):479-486.
  9. Bhutani H, Smith V, Rahbari-Oskoui F, et al; for the CRISP Investigators. A comparison of ultrasound and magnetic resonance imaging shows that kidney length predicts chronic kidney disease in autosomal dominant polycystic kidney disease. Kidney Int. 2015;88(1):146-151. 
  10. 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.
  11. 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.
  12. 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.
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.