Identify appropriate patients
for JYNARQUE

Select a patient to see how clinical and imaging markers can indicate the risk of rapid progression
Bob, Patient
Bob, 53
Stage 3A CKD
Rapidly declining eGFR
TKV greater than expected for his age
Multiple risk factors
Cyst-related flank pain
Patient images and patient cases are fictional.

Physical Findings and Labs:

Age:
53
Height:
5’9”
Weight:
150 lbs
BMI:
22

BP: 125/77 mm/Hg, controlled on an ACE-inhibitor

Creatinine:  1.6 mg/dL

Current eGFR: 48 mL/min/1.73 m2  
— eGFR: 51 mL/min/1.73 m2 1 year ago
— eGFR: 63 mL/min/1.73 m2 5 years ago

Medical history:
  • Diagnosed with ADPKD in his mid-30s when an ultrasound showed innumerable, bilateral cysts
  • Abdominal pain
  • Hematuria
  • Liver cysts
Family History:
  • Mother developed ESKD in her early 70s. She is currently on dialysis and Bob takes her to and from her appointments

Bob, 53Stage 3A CKD

Stage 3A CKD Patient Bob

Bob is physically active and eats well. He is a woodworking enthusiast who spends his free time with his wife, Susan, and their dog, Daisy. 

His rapidly declining eGFR is evidence of rapidly progressing ADPKD1,2

  • Bob believed his ADPKD was progressing at a slow and steady (but unknown) rate throughout life, and because of this, he hasn’t always been consistent with his doctor visits, occasionally missing his yearly appointments
  • At his last appointment, his nephrologist noticed a decrease
in eGFR of 3 mL/min/1.73 m2 over a 1-year period
  • Based on an eGFR decline of ≥3 mL/min/1.73 m2 over a year for the past few years, Bob’s nephrologist noted the evidence of rapidly progressing ADPKD1,2,*
  • After assessing the evidence of rapid progression, his nephrologist determined Bob was an appropriate patient and recommended he start treatment with JYNARQUE
  • Bob’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 rate of progression, Bob chose to go on JYNARQUE after his nephrologist explained that it has the ability to slow kidney function decline3
  • Bob’s nephrologist explained that JYNARQUE may cause aquaretic side effects and advised him to drink more water to avoid thirst and dehydration.
  • In addition, the office staff told Bob about the Peer Mentor Program, where he could speak with a peer living with rapidly progressing ADPKD about their experience taking JYNARQUE
  • Based on Bob’s commercial insurance coverage, his specialty pharmacy determined he was eligible for $10/month copay support

ACE=angiotensin-converting enzyme; ADPKD=autosomal dominant polycystic kidney disease; BMI=body mass index; BP=blood pressure; CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; ESKD=end-stage kidney disease; REMS=Risk Evaluation and Mitigation Strategy; REPRISE=Replicating Evidence of Preserved Renal Function: An Investigation of Tolvaptan Safety and Efficacy.

*Rapid disease progression is defined as reliable eGFR decline ≥3.0 mL/min/1.73 m2 per year over a period of ≥4 years with no other confounding cause than ADPKD and indexed for age: 18-39 years: any eGFR; 40-44 years: eGFR <90 mL/min/1.73 m2; 45-49 years: eGFR <75 mL/min/1.73 m2; 50-55 years: eGFR <60 mL/min/1.73 m2.2

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.

  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. Müller RU, Messchendorp AL, Birn H. An update on the use of tolvaptan for autosomal dominant polycystic kidney disease: consensus statement on behalf of the ERA Working Group on Inherited Kidney Disorders, the European Rare Kidney Disease Reference Network and Polycystic Kidney Disease International. Nephrol Dial Transplant. 2022;37(5):825-839.
  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.