What is Jynarque, and how does it work?
Jynarque is a prescription medicine used to slow kidney function decline in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
It is not known if Jynarque is safe and effective in children.
What are the side effects of Jynarque?
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 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 restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the Jynarque REMS Program.
Jynarque can cause serious side effects, including:
- Serious liver problems. Jynarque can cause serious liver problems that can lead to the need for a liver transplant or can lead
to death. Stop taking Jynarque and call your healthcare provider right away if you get any of the following symptoms:
- feeling tired
- loss of appetite
- nausea
- right upper stomach (abdomen) pain or tenderness
- vomiting
- fever
- rash
- itching
- yellowing of the skin and white part of the eye (jaundice)
- dark urine
To help reduce your risk of liver problems, your healthcare provider will do a blood test to check your liver:
- before you start taking Jynarque
- at 2 weeks and 4 weeks after you start treatment with Jynarque
- then monthly for 18 months during treatment with Jynarque
- and every 3 months from then on
It is important to stay under the care of your healthcare provider during treatment with Jynarque.
Because of the risk of serious liver problems Jynarque is only available through a restricted distribution program called the Jynarque Risk Evaluation and Mitigation Strategy (REMS) Program.
- Before you start treatment with Jynarque, you must enroll in the Jynarque REMS Program. Talk to your healthcare provider about how to enroll in the program.
- Jynarque can only be dispensed by a certified pharmacy that participates in the Jynarque REMS Program. Your healthcare provider can give you information on how to find a certified pharmacy.
Jynarque may cause serious side effects, including:
- Too much sodium in your blood (hypernatremia) and loss of too much body fluid (dehydration). In some cases, dehydration
can lead to extreme loss of body fluid called hypovolemia. You should drink water when you are thirsty and throughout the
day and night. Stop taking Jynarque and call your healthcare provider if you cannot drink enough water for any reason, such
as not having access to water, or vomiting or diarrhea. Tell your healthcare provider if you get any of the following symptoms:
- dizziness
- fainting
- weight loss
- a change in the way your heart beats
- feel confused or weak
The most common side effects of Jynarque include:
- thirst and drinking more fluid than normal
- making large amounts of urine, urinating often and urinating at night
These are not all the possible side effects of Jynarque.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Jynarque?
Recommended Dosage
- The initial dosage for Jynarque is a total of 60 mg taken orally per day.
- This dosage includes taking 45 mg on waking and then taking 15 mg 8 hours later.
- The dosage may be increased to 60 mg plus 30 mg, then to 90 mg plus 30 mg per day, if tolerated with at least weekly intervals between titrations.
- Patients may also decrease the dosage based on tolerability.
- Patients should drink enough water to avoid thirst or dehydration.
Monitoring
To mitigate the risk of significant or irreversible liver injury, perform blood testing for ALT, AST and bilirubin prior to initiation of Jynarque, at 2 and 4 weeks after initiation, monthly for 18 months and every 3 months thereafter. Monitor for concurrent symptoms that may indicate liver injury.
Missed Doses
If a dose of Jynarque is not taken at the scheduled time, take the next dose at its scheduled time.
Co-Administration With CYP 3A Inhibitors
CYP 3A Inhibitors
Concomitant use of strong CYP 3A inhibitors is contraindicated.
In patients taking concomitant moderate CYP 3A inhibitors, reduce the dose of Jynarque per Table 1. Consider further reductions if patients cannot tolerate the reduced dose. Interrupt Jynarque temporarily for short term therapy with moderate CYP 3A inhibitors if the recommended reduced doses are not available.
Table 1: Dose adjustment for patients taking moderate CYP 3A inhibitors
Standard Morning and Afternoon Dose (mg) | Dose (mg) with Moderate CYP 3A Inhibitors |
90 mg and 30 mg | 45 mg and 15 mg |
60 mg and 30 mg | 30 mg and 15 mg |
45 mg and 15 mg | 15 mg and 15 mg |

QUESTION
The only purpose of the kidneys is to filter blood. See AnswerWhat drugs interact with Jynarque?
CYP 3A Inhibitors And Inducers
CYP 3A Inhibitors
- Tolvaptan's AUC was 5.4 times as large and Cmax was 3.5 times as large after co-administration of tolvaptan and 200 mg ketoconazole.
- Larger doses of the strong CYP 3A inhibitor would be expected to produce larger increases in tolvaptan exposure. Concomitant use of tolvaptan with strong CYP 3A inhibitors is contraindicated.
- Dose reduction of Jynarque is recommended for patients while taking moderate CYP 3A inhibitors.
- Patients should avoid grapefruit juice beverages while taking Jynarque.
Strong CYP 3A Inducers
- Co-administration of Jynarque with strong CYP 3A inducers reduces exposure to Jynarque.
- Avoid concomitant use of Jynarque with strong CYP 3A inducers.
OATP1B1/3 And OAT3 Transporter Substrates
- The oxobutyric acid metabolite of tolvaptan is an inhibitor of OATP1B1/B3 and OAT3 in vitro.
- 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
- As a V2-receptor antagonist, tolvaptan will interfere with the V2-agonist activity of desmopressin (dDAVP).
- Avoid concomitant use of Jynarque with a V2-agonist.
Is Jynarque safe to use while pregnant or breastfeeding?
- Available data with Jynarque use in pregnant women are insufficient to determine if there is a drug associated risk of adverse developmental outcomes.
- There are no data on the presence of tolvaptan in human milk, the effects on the breastfed infant, or the effects on milk production.
- Because of the potential for serious adverse reactions, including liver toxicity, electrolyte abnormalities (e.g., hypernatremia), hypotension, and volume depletion in breastfed infants, women should not breastfeed during treatment with Jynarque.
Summary
Jynarque is a prescription medicine used to slow kidney function decline in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Serious side effects of Jynarque include serious liver problems, too much sodium in your blood (hypernatremia), and loss of too much body fluid (dehydration).
Multimedia: Slideshows, Images & Quizzes
-
Ways to Keep Your Kidneys Healthy
You might know that more than a drink or two a day is bad for your health. But in some cases, any alcohol at all may not be a...
-
Kidney Stones: Symptoms, Causes, and Treatment
What causes kidney stones? Where is kidney stone pain located on your body? Learn the symptoms and signs of kidney stone pain....
-
Kidney Disease Quiz: Test Your Medical IQ
Kidney disease is common. Take this kidney disease quiz to test your knowledge and learn the symptoms, causes and types of kidney...
-
Picture of Kidney Stone Crystal
Kidney stones are made of salts and minerals in the urine that stick together, creating small "pebbles" formed within the kidney...
-
Picture of Kidney Stone Diagnosis
The diagnosis of kidney stones is suspected by the typical pattern of symptoms when other possible causes of the abdominal or...
-
Picture of Kidney Stone
A stone in the kidney (or lower down in the urinary tract). See a picture of Kidney Stone and learn more about the health topic.
-
Picture of Kidneys
The kidneys are a pair of organs located in the back of the abdomen. See a picture of the Kidneys and learn more about the health...
Related Disease Conditions
-
Kidney (Renal) Failure
Kidney failure can occur from an acute event or a chronic condition or disease. Prerenal kidney failure is caused by blood loss, dehydration, or medication. Some of the renal causes of kidney failure include sepsis, medications, rhabdomyolysis, multiple myeloma, and acute glomerulonephritis. Post renal causes of kidney failure include bladder obstruction, prostate problems, tumors, or kidney stones.Treatment options included diet, medications, or dialysis.
-
Kidney Pain
Kidney pain has a variety of causes and symptoms. Infection, injury, trauma, bleeding disorders, kidney stones, and less common conditions may lead to kidney pain. Symptoms associated with kidney pain may include fever, vomiting, nausea, flank pain, and painful urination. Treatment of kidney pain depends on the cause of the pain.
-
Kidney Stones (Nephrolithiasis)
Kidney stones are solid masses of crystalline material that form in the kidneys. Symptoms and signs of kidney stones can include pain, nausea, vomiting, and even fever and chills. Kidney stones are diagnosed via CT scans and specialized X-rays. Treatment of kidney stones involves drinking lots of fluids and taking over-the-counter pain medications to medical intervention including prescription medications, lithotripsy, and sometimes even surgery.
-
Kidney Infection (Pyelonephritis)
Kidney infection (pyelonephritis) usually is caused by E. coli and other bacteria that have spread from the bladder from a UTI (urinary tract infection), poor hygiene, sexual intercourse, pregnancy, catheter, cystoscope exam, surgery, kidney stones, or prostate enlargement. Symptoms of kidney infection include back pain, frequent urination, pain during urination, fever, and or pus or blood in the urine. Kidney infection can be cured with antibiotic treatment. Cranberry juice may prevent UTIs, but that hasn’t been proven in all research studies.
-
Kidney Infection in Adults
Second Source article from Government
-
Kidney Failure
Second Source article from Government
-
Hypertension-Related Kidney Disease
Second Source WebMD Medical Reference
-
Hypertension-Induced Chronic Kidney Disease
Hypertension-induced chronic kidney disease (CKD) is a long-standing kidney condition that develops over time due to persistent or uncontrolled high blood pressure (hypertension).
-
Kidney Pain vs. Back Pain
The signs and symptoms of kidney pain and back pain depend upon the underlying cause. Doctors may use blood tests, X-rays, CT, and/or MRI to diagnose kidney pain and back pain. Treatment may include rest, ice, stretching, muscle strengthening, and pain-relieving medications.
-
Signs of a Kidney Disease
Most of the signs of kidney diseases are unnoticed, ignored, or appear very late in the disease. Over 37 million American adults have kidney diseases, and most are not aware of it.
-
Is Kidney Cancer Curable?
Kidney cancer is an uncontrolled division of cells (cancer) that begins in the kidney. How curable is a particular cancer depends on its stage, its cell type, and the stage at which it is diagnosed.
Treatment & Diagnosis
- Kidney Disease FAQs
- Kidney Infections During Pregnancy
- Polycystic Kidney Disease Gene Isolated
- Kidney Stones and Calcium
- What Are Risk Factors for Diabetic Kidney Disease?
- Does Kidney Transplant or Chronic Dialysis Offer Longer Survival?
- Side Effects of Zyloprim (Allopurinol) for Kidney Damage Prevention
- How Are Kidney Stones Diagnosed?
- Kidney Stone Causes
- Lacerated Kidney Symptoms, Treatment, and Recovery Time
- What Are the Symptoms and Signs of Kidney Stones?
- Kidney Stone Treatment
- Blood Pressure Elevation Established as Risk for Kidney Failure
Medications & Supplements

Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.