Patient profiles

Select a patient to see how clinical and imaging markers can indicate risk of rapid progression

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*Patient images and patient cases are fictional.

Caroline, CKD Stage 2
Caroline, CKD Stage 2

Caroline*

CKD stage 2

Caroline is a 42-year-old female who is seeking answers for her abdominal pain. An initial ultrasound reveals that her kidneys are enlarged with numerous cysts. A subsequent eGFR indicates she has CKD stage 2.

CLINICAL AND IMAGING MARKERS

Identifying certain risk factors associated with rapidly progressing ADPKD can start to give you a better understanding of a patient’s disease.

Family history

  • Mother diagnosed with CKD stage 3A in her mid-30s and is now on dialysis awaiting a kidney transplant
  • Grandfather on dialysis

History of symptoms

  • Gross hematuria: Yes
  • Abdominal/flank pain: Yes
  • Kidney stones: No
  • Urinary tract infection: No
  • Kidney cyst infections: No

Vitals

  • Height: 5’ 4”
  • Weight: 170 lbs
  • BMI: 29 kg/m2
  • Blood pressure: 124/76 mm Hg

Clinical findings

  • eGFR: 60.5 mL/min/1.73 m2
  • CKD stage: stage 2
  • htTKV: 618 mL/m
  • US kidney length: 17.9 cm

CAROLINE HAS AT LEAST 2 RISK FACTORS FOR RAPID PROGRESSION

Urologic events before age 351

She has a history of gross hematuria and abdominal/flank pain related to cysts. Consult medical history to confirm if either event occurred before age 35.

Click here to see risk factors associated with rapid disease progression.

Ultrasound kidney length >16.5 cm in patients <45 years old2,3

In the CRISP study that included ADPKD patients <45 years of age with CKD stage 1 or 2,* a kidney length of >16.5 cm is an indicator of rapidly progressing ADPKD.

Click here to see how imaging modalities can help assess kidney size to identify patients at risk of rapid progression.

Click expand to see more
VISUALIZE CAROLINE’S ADPKD DISEASE PROGRESSION

Imaging the kidneys to determine TKV can help assess the risk of rapid progression, and can predict changes in the rate of decline in kidney function.4-7

Based on risk factors associated with rapidly progressing ADPKD it could be important to order an MRI or CT scan to evaluate TKV and see the extent of Caroline’s disease.4

This is not intended to be a diagnostic tool. Simulated kidney is intended to show modeled progression based on this hypothetical patient profile. ADPKD progression modeling is calculated based on the Mayo Clinic Imaging Classification of ADPKD, and is for demonstration purposes only.5Click here to see ADPKD Imaging Classification Class 1C: High risk for eGFR decline; 3.0-4.5% estimated yearly increase in kidney growth5,8

Mayo Clinic Imaging Classification of ADPKD4,5,8

Plotting htTKV and age predicts the change in eGFR over time in patients with typical ADPKD5

Caroline on Imaging Classification Chart
Republished with permission of the American Society of Nephrology from imaging classification autosomal dominant polycystic kidney disease: a simple model for selecting patients of clinical trials. J Am Soc Nephrol. 2015;26(I):160-172.

Class 1C: High risk for eGFR decline 3.0%-4.5% estimated yearly increase in kidney growth5,8

Click expand to see more
Jackson, CKD Stage 2
Jackson, CKD Stage 2

Jackson*

CKD stage 2

Jackson is a 31-year-old male. His family history of ADPKD, along with some urological symptoms, have prompted him to get screened. An eGFR indicates he has CKD stage 2.

CLINICAL AND IMAGING MARKERS

Identifying certain risk factors associated with rapidly progressing ADPKD can start to give you a better understanding of a patient’s disease.

Family history

  • Father diagnosed with ADPKD in late-20s with CKD stage 2
  • Aunt reached ESKD at age 57

History of symptoms

  • Gross hematuria: Yes
  • Abdominal/flank pain: Yes
  • Kidney stones: No
  • Urinary tract infection: No
  • Kidney cyst infections: No

Vitals

  • Height: 5’ 7”
  • Weight: 147 lbs
  • BMI: 23 kg/m2
  • Blood pressure: 150/99 mm Hg

Clinical findings

  • eGFR: 79 mL/min/1.73 m2
  • CKD stage: stage 2
  • htTKV: 588 mL/m
  • US kidney length: 15.8 cm

JACKSON HAS SEVERAL RISK FACTORS OF RAPID PROGRESSION

Male gender9,10

Hypertension before age 351,10

He has presented with hypertension and is under the age of 35.

Urologic events before age 351

He has presented with gross hematuria and abdominal/flank pain related to cysts.

Family history of ESKD by age 582

Has an aunt who reached ESKD at age 57.

Click here to see risk factors associated with rapid disease progression.

Ultrasound kidney length >16.5 cm in patients <45 years old2,3

In the CRISP study that included ADPKD patients <45 years of age with CKD stage 1 or 2,* a kidney length of >16.5 cm is an indicator of rapidly progressing ADPKD.

Click here to see how imaging modalities can help assess kidney size to identify patients at risk of rapid progression.

Click expand to see more
VISUALIZE JACKSON’S ADPKD DISEASE PROGRESSION

Imaging the kidneys to determine TKV can help assess the risk of rapid progression, and can predict changes in the rate of decline in kidney function.4-7

Based on risk factors associated with rapidly progressing ADPKD it could be important to order an MRI or CT scan to evaluate TKV and see the extent of Jackson’s disease.4

This is not intended to be a diagnostic tool. Simulated kidney is intended to show modeled progression based on this hypothetical patient profile. ADPKD progression modeling is calculated based on the Mayo Clinic Imaging Classification of ADPKD, and is for demonstration purposes only.5Click here to see ADPKD Imaging Classification Class 1D: High risk for eGFR decline; 4.5%-6.0% estimated yearly increase in kidney growth5,8

Mayo Clinic Imaging Classification of ADPKD4,5,8

Plotting htTKV and age predicts the change in eGFR over time in patients with typical ADPKD5

Jackson on Imaging Classification Chart
Republished with permission of the American Society of Nephrology from imaging classification autosomal dominant polycystic kidney disease: a simple model for selecting patients of clinical trials. J Am Soc Nephrol. 2015;26(I):160-172.

Class 1D: High risk for eGFR decline 4.5%-6.0% estimated yearly increase in kidney growth5,8

Click expand to see more
Peter, CKD Stage 3A
Peter, CKD Stage 3A

Peter*

CKD stage 3A

Peter is a 49-year-old male. Early onset hypertension and a family history of ADPKD prompted Peter's physician to refer him to a nephrologist. An ultrasound confirmed a diagnosis of ADPKD.

CLINICAL AND IMAGING MARKERS

Identifying certain risk factors associated with rapidly progressing ADPKD can start to give you a better understanding of a patient’s disease.

Family history

  • Mother diagnosed with ADPKD in mid-30s with CKD stage 3A and started dialysis at age 45

History of symptoms

  • Hematuria: Yes
  • Abdominal/flank pain: Yes
  • Kidney stones: No
  • Urinary tract infection: No
  • Liver cysts: Yes
  • Kidney cyst infections: Yes

ADPKD diagnosis

  • 13 years ago, Peter’s PCP was concerned about Peter’s early onset hypertension and family history of ADPKD
  • Peter was referred to a nephrologist who used an ultrasound to confirm diagnosis of ADPKD

Vitals

  • Height: 5’ 8”
  • Weight: 165 lbs
  • BMI: 25 kg/m2
  • Blood pressure: 128/85 mm Hg (managed with antihypertensive therapy)

Clinical findings

  • CKD stage: stage 3A
  • Hypertension (presented with a blood pressure of 153/95 mm Hg)
  • Serum creatinine: 1.5 mg/dL
  • htTKV: 2641.2 mL/m
  • eGFR: 54 mL/min/1.73 m2 (5.2 mL/min/1.73 m2 decline in 12 months)

PETER HAS SEVERAL RISK FACTORS OF RAPID PROGRESSION

Family history of ESKD by age 582

Mother reached ESKD at age 45.

Click here to see risk factors associated with rapid disease progression.

eGFR decline2

An eGFR decline ≥5 mL/min/1.73 m2 within 1 year is a risk factor associated with rapidly progressing ADPKD.

Click expand to see more
VISUALIZE PETER’S ADPKD DISEASE PROGRESSION

Imaging the kidneys to determine TKV can help assess the risk of rapid progression, and can predict changes in the rate of decline in kidney function.4-7

Based on risk factors associated with rapidly progressing ADPKD it could be important to order an MRI or CT scan to evaluate TKV and see the extent of Peter’s disease.4

This is not intended to be a diagnostic tool. Simulated kidney is intended to show modeled progression based on this hypothetical patient profile. ADPKD progression modeling is calculated based on the Mayo Clinic Imaging Classification of ADPKD, and is for demonstration purposes only.5Click here to see ADPKD Imaging Classification Class 1E: High risk for eGFR decline; >6% estimated yearly increase in kidney growth5,8

Mayo Clinic Imaging Classification of ADPKD4,5,8

Plotting htTKV and age predicts the change in eGFR over time in patients with typical ADPKD5

Peter on Imaging Classification Chart
Republished with permission of the American Society of Nephrology from imaging classification autosomal dominant polycystic kidney disease: a simple model for selecting patients of clinical trials. J Am Soc Nephrol. 2015;26(I):160-172.

Class 1E: High risk for eGFR decline >6% estimated yearly increase in kidney growth5,8

Click expand to see more
ADPKD
=autosomal dominant polycystic kidney disease.
BMI
=body mass index.
CKD
=chronic kidney disease.
CRISP
=Consortium for Radiologic Imaging Studies in
Polycystic Kidney Disease.
CT
=computed tomography.
eGFR
=estimated glomerular filtration rate.
ESKD
=end-stage kidney disease.
htTKV
=height-adjusted total kidney volume.
MRI
=magnetic resonance imaging.
TKV
=total kidney volume.
*Average baseline eGFR of 98 mL/min/1.73m2.
 
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.