Jinarc: Uses, Side Effects and Dosage

Serious warnings and precautions box

What JINARC is used for:

JINARC is used in adults (18 years of age and older) to treat autosomal dominant polycystic kidney disease (ADPKD). ADPKD is a genetic disorder that causes the growth of multiple cysts (sacs filled with fluid) in the kidneys. This can damage the way the kidneys work and may lead to kidney failure.

JINARC should only be prescribed by a healthcare professional experienced in identifying and treating ADPKD.

Before starting this medication: Your healthcare professional will carefully discuss if JINARC is right for you. Once you and your healthcare professional have agreed that JINARC is suitable for you, your healthcare professional will ask that you sign a patient-prescriber agreement form (PPAF), stating that you understand the benefits and risks of treatment and that you agree to take blood tests as prescribed by your healthcare professional to start and remain on treatment. For more information on JINARC controlled hepatic safety monitoring and distribution (HSMD) programme, please call 1-844-254-6272.

How JINARC works:

JINARC belongs to a group of medicines known as “vasopressin V₂-receptor antagonists”. It works by blocking the effects of a hormone called vasopressin, which promotes cyst growth in the kidneys in patients with ADPKD. By blocking the effects of the hormone, JINARC reduces the growth of the cysts in the kidneys and slows the decline of kidney function. This helps protect the kidneys from damage and failure.

The ingredients in JINARC are:

Medicinal ingredient(s): Tolvaptan.

Non-medicinal ingredients: Corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted

hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and FD&C Blue No. 2 Aluminum Lake (as a colorant).

JINARC comes in the following dosage form(s):

Tablets: 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg of tolvaptan.

Do not use JINARC if:

• you have taken tolvaptan and been asked to permanently discontinue tolvaptan in the past.
• you are allergic to tolvaptan, benzazepine, benzazepine derivatives (e.g., benazepril, conivaptan, fenoldopam mesylate, or mirtazapine), or any of the other ingredients in JINARC.
• you can not replace fluids by drinking, do not have access to fluids, or you can not feel if you are thirsty.
• you have high sodium (salt) levels in your blood (hypernatremia).
• you have a condition associated with a low blood volume (hypovolemia).
• you have liver problems. The presence of liver cysts should not stop the treatment of JINARC.
• you are pregnant or plan to become pregnant. It is not known if JINARC will harm your unborn baby.
• you are breastfeeding or plan to breastfeed. It is not known if JINARC passes into your breast milk. You and your healthcare professional should decide if you will take JINARC or breastfeed. You must not do both.
• you have a condition where the kidneys are not able to make any urine (anuria). JINARC will not help your condition.

• you take any of the following medicines, as these can cause you to have too much JINARC in your blood:

  • antifungals, used to treat fungal infections (e.g., ketoconazole and itraconazole);
  • antibiotics, used to treat bacterial infections (e.g., clarithromycin and telithromycin);
  • anti-HIV medicines, used to treat HIV (e.g., ritonavir, indinavir, nelfinavir, and saquinavir);
  • antidepressants, used to treat depression (e.g., nefazodone).

• you have one of the following rare genetic conditions:

  • galactose intolerance,
  • Lapp lactase deficiency,
  • glucose-galactose malabsorption.

Lactose is a non-medicinal ingredient in JINARC.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JINARC. Talk about any health conditions or problems you may have, including if you:

• have difficulty urinating or have an enlarged prostate.
• are approaching kidney failure.
• are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• have low sodium levels in your blood.
• have high potassium levels in your blood.
• have high levels of uric acid in your blood or gout.

Other warnings you should know about:

Pregnancy: If you are a women that can become pregnant, you must used effective birth control measures before and during your treatment with JINARC. Ask your healthcare professional if you are unsure.

Driving and using machines: JINARC can cause dizziness, weakness, and fainting. Before you drive or do tasks that require special attention, wait until you know how you respond to JINARC.

Testing and check-ups: Your healthcare professional will monitor your health and do certain tests before and during your treatment with JINARC. These tests can include monitoring the levels of uric acid, potassium, sodium, fluid, concentration of your urine, and liver function.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with JINARC:

• antibiotics, used to treat bacterial infections (e.g., rifampicin, clarithromycin, erythromycin, rifampin, and telithromycin).
• antifungals, used to treat fungal infections (e.g., ketoconazole, fluconazole, and itraconazole).
• anti-HIV medicines, used to treat HIV infection (e.g., ritonavir, indinavir, nelfinavir, and saquinavir).
• antidepressants, used to treat depression (e.g., nefazodone and St. John’s Wort).
• lovastatin, used to lower the amount of cholesterol in the blood.
• digoxin, used to treat heart failure and certain heartbeat problems.
• vasopressin drugs, used to control bleeding (e.g., desmopressin).
• antihypertensive agents, used to treat high blood pressure (e.g., diuretics such as furosemide and hydrochlorothiazide).
• verapamil, used to treat high blood pressure, chest pain, and irregular heartbeats.
• carbamazepine, used to prevent epilepsy or seizures.
• quinidine, used to treat or prevent irregular heartbeats.
• cyclosporine, used to prevent organ rejection during transplants.
• hypertonic saline solutions, mixtures that contain a high concentration of salt.
• drugs that increase serum sodium concentrations.
• drugs known to increase the amount of potassium in the blood (e.g., spironolactone).
• grapefruit juice.

If you are unsure, ask your healthcare professional.

How to take JINARC:

• Always take JINARC exactly as prescribed by your healthcare professional. Check with your healthcare professional if you are not sure.

• You can take JINARC with or without food.

• While taking JINARC you will produce more urine, urinate more frequently, and/or urinate at night. If this causes you concern, consult your healthcare professional. This side-effect should become less pronounced with time.
• To prevent becoming dehydrated, have water available to drink at all times while taking JINARC. Unless your healthcare professional tells you otherwise, drink plenty of water during the day and one or two glasses before going to bed. Call your healthcare professional, if you suffer from vomiting, diarrhea, or any other condition that might cause you to become dehydrated while taking JINARC.
• Do not drink grapefruit juice or eat grapefruit during your treatment with JINARC. This may cause unwanted side effects.

Usual dose:

Your healthcare professional will decide the right dose and frequency of JINARC for you. This may depend on your health, if you take other medications, and how you respond to JINARC. The usual daily dose (a combination of two tablets) that your healthcare professional may prescribe include:

• one 45 mg tablet and one 15 mg tablet, for a total dose of 60 mg per day, or
• one 60 mg tablet and one 30 mg tablet, for a total dose of 90 mg per day, or
• one 90 mg tablet and one 30 mg tablet, for a total dose of 120 mg per day.

The tablet of the higher dose (45 mg, 60 mg, or 90 mg) should be taken in the morning upon waking up, and the tablet of the lower dose (15 mg or 30 mg) should be taken 8 hours later.

Overdose:

Missed dose:

If you miss or forget to take a dose of JINARC, skip the missed dose and take your next dose at the regularly scheduled time and prescribed level. Do not take a double dose to make up for the missed dose.

Possible side effects from using JINARC:

These are not all the possible side effects you may have when taking JINARC. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• thirst;
• increased amount of urine;
• increased frequency of urination during the day and at night;
• headache;
• constipation, diarrhea, dry mouth, indigestion, decreased appetite;
• fatigue, weakness, dizziness;
• trouble sleeping;
• muscle spasms;
• rash, itching;
• abdominal pain.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

Storage:

Store JINARC between 15^oC to 30^oC.

Keep out of reach and sight of children.

If you want more information about JINARC:

• Talk to your healthcare professional.
• Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.otsukacanada.com); or by calling 1-877-341-9245.

Imported / distributed by: Otsuka Canada Pharmaceutical Inc.

Date of Authorization: 2026-08-12

JINARC is a trademark of Otsuka Pharmaceutical Co., Ltd., used under licence by Otsuka Canada Pharmaceutical Inc.