Jinarc - Tolvaptan

What is Jinarc-Tolvaptan and what is it used for?

Jinarc is a medicine used in adults with autosomal dominant polycystic kidney. It is an inherited disease characterized by the growth of numerous fluid-filled cysts in the kidneys, which end up compromising kidney function and can cause kidney failure. Jinarc is intended for use in patients with normal or moderately reduced kidney function at the start of treatment with Jinarc and with rapidly progressing disease. Jinarc contains the active substance tolvaptan.

How is Jinarc -Tolvaptan used?

Jinarc can only be obtained with a prescription and treatment should be initiated and monitored under the supervision of physicians experienced in the management of autosomal dominant polycystic kidney and aware of the risks of Jinarc therapy. Jinarc is available as tablets (15, 30, 45, 60 and 90 mg) and should be administered twice a day in two different doses. The starting dose should be 45 mg in the morning and 15 mg in the evening (45 + 15 mg), to be subsequently increased to 60 + 30 mg or 90 + 30 mg, depending on tolerability. The morning dose should be taken at least 30 minutes before breakfast, while the evening dose can be taken with or without food. Doses may need to be reduced in patients treated with other medicines. Patients should drink plenty of water during treatment.

For more information, see the package leaflet.

How does Jinarc-Tolvaptan work?

The active substance in Jinarc, tolvaptan, is a vasopressin V2 receptor antagonist: it works by blocking the kidney receptors to which the hormone vasopressin binds. Vasopressin regulates the level of water and sodium in the body. In autosomal dominant polycystic kidney, kidney cells are thought to not respond normally to vasopressin, causing fluid-filled cysts to form.By blocking vasopressin receptors in the kidneys, Jinarc can slow cyst formation.

What benefit has Jinarc-Tolvaptan shown during the studies?

In a main study involving 1,445 adults with rapidly progressing autosomal dominant polycystic kidney but with normal or moderately reduced kidney function, Jinarc was shown to be effective in slowing cyst formation. In the study, Jinarc was compared with placebo (a dummy treatment) and the main measure of effectiveness was the change in kidney size after three years of treatment (a way of measuring the enlargement caused by cyst formation). Overall kidney size increased by 18.8% in placebo-treated patients while in Jinarc-treated patients the increase was 9.6%. Treatment effects were greatest during the first year.

What is the risk associated with Jinarc-Tolvaptan?

The most common side effects with Jinarc (which may affect more than 2 in 10 people) are thirst, polyuria (increased urine output), nocturia (need to urinate at night) and pollakiuria (increased need to urinate during the day) . Jinarc has been associated with an increase in certain liver enzymes in the blood (a sign of possible liver problems). For the full list of side effects reported with Jinarc, see the package leaflet. Jinarc must not be used in patients with elevated liver enzymes in the blood or with signs or symptoms of liver injury. Blood tests should be performed to check function the patient's liver before starting treatment with Jinarc and then repeat them every month for 18 months and then every three months thereafter. Monitoring in patients for symptoms of liver damage (such as loss of appetite, nausea and vomiting, itching, fatigue) is also recommended. and pain in the right upper abdominal area) during treatment Jinarc must not be used in patients with hypovolaemia (decreased fluid in the body) and in patients unable to feel or respond to thirst. It must not be used in patients with hypernatremia (increased sodium levels in the blood) and in pregnant and breastfeeding women. For the full list of restrictions, see the package leaflet.

Why has Jinarc -Tolvaptan been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Jinarc's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted the unmet need for treatment for Autosomal dominant polycystic kidney and considered that Jinarc is effective in slowing cyst formation and possibly deterioration of renal function in patients with the disease, although further long-term data are expected. Regarding safety, the most common side effects are manageable, the committee identified hepatotoxicity as the most important risk associated with the use of Jinarc, which was addressed by implementing various measures to minimize the risks (see below).

What measures are being taken to ensure the safe and effective use of Jinarc-Tolvaptan?

A risk management plan has been developed to ensure that Jinarc is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Jinarc, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Jinarc will provide patients and doctors who will use the medicine with information on the risk of hepatotoxicity and the importance of avoiding pregnancy during treatment.The company will also carry out a study to further investigate the safety of the medicine, including the risk of hepatotoxicity, a study on the long-term efficacy of the medicine and an efficacy study in patients with severely reduced kidney function. Further information can be found in the summary of the risk management plan.

More information about Jinarc -Tolvaptan

On 27 May 2015, the European Commission issued a "Marketing Authorization" for Jinarc, valid throughout the European Union. For more information on Jinarc therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 05-2015.

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