Tolvaptan (kidney disease)

Tolvaptan (Jynarque) may cause liver damage, sometimes serious enough to require liver transplantation or to cause death. Tell your doctor if you have or ever had liver problems, including hepatitis. Your doctor may tell you not to take tolvaptan (Jynarque). Your doctor will order laboratory tests regularly before and during your treatment to see if tolvaptan (Jynarque) is affecting your liver. Your doctor may tell you that you should not receive this medication if the tests show that you have liver problems. If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, extreme tiredness, unusual bleeding or bruising, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, dark-colored urine, rash, itching, or flu-like symptoms.

Because of the risks with this medication, tolvaptan (Jynarque) is available only through a special restricted distribution program. A program called the Jynarque Risk Evaluation and Mitigation Strategies (REMS) has been set up to decrease the risks of taking tolvaptan (Jynarque). Your doctor and your pharmacist must be registered with the Jynarque REMS program. Ask your doctor for more information about this program and how you will receive your medication. Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to check your body’s response to tolvaptan (Jynarque).

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with tolvaptan (Jynarque) and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risk of taking tolvaptan (Jynarque).

🔔 Why is this medication prescribed?

Tolvaptan (Jynarque) is used to slow the worsening of kidney function in certain patients with autosomal dominant polycystic kidney disease (ADPKD; a certain type of inherited kidney disease). Tolvaptan (Jynarque) is in a class of medications called vasopressin V2 receptor antagonists. It works by increasing the amount of water released from the body as urine and decreases the growth of cysts in the kidneys. Removing fluid from the body and slowing the growth of cysts helps to slow the worsening of kidney function.

Tolvaptan is also available as a tablet (Samsca) to treat low blood levels of sodium in people who have heart failure or certain other conditions. This monograph only gives information about tolvaptan tablets (Jynarque) to slow the worsening of kidney function in patients with ADPKD. If you are using this medication to treat low levels of sodium in the blood, read the monograph entitled tolvaptan (low blood sodium).

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🔔 How should this medicine be used?

Tolvaptan (Jynarque) comes as a tablet to take by mouth. It is usually taken twice a day, one tablet in the morning and one tablet 8 hours later, with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tolvaptan (Jynarque) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of tolvaptan (Jynarque) and gradually increase your dose.

Your doctor may need to decrease your dose if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment.

🔔 Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.