Jinarc 90mg+30mg Tablet

Jinarc 90mg+30mg Tablet contains tolvaptan, manufactured by Otsuka, supplied as a split-dose combination pack providing a 90mg morning tablet and a 30mg afternoon tablet. It is used to slow the progression of kidney cyst growth and kidney function decline in adults with autosomal dominant polycystic kidney disease (ADPKD), and must only be prescribed and monitored by a nephrology (kidney) specialist.

Tolvaptan is a vasopressin V2-receptor antagonist. It blocks the action of antidiuretic hormone (vasopressin) on the kidneys, which reduces cyclic AMP signalling inside kidney cells that is believed to drive cyst growth in ADPKD, and produces an aquaretic effect – increased excretion of free water (without proportionate loss of electrolytes) – which is why adequate fluid intake is essential throughout treatment.

Tolvaptan selectively blocks the vasopressin V2 receptor in the kidney’s collecting ducts, reducing intracellular cyclic AMP levels. In ADPKD, excessive cyclic AMP signalling is believed to drive cyst cell proliferation and fluid secretion into cysts; by blocking this pathway, tolvaptan is thought to slow cyst growth and the decline in kidney function. The same receptor blockade also produces a marked aquaretic (water-excreting) effect, increasing urine output.

Take the 90mg tablet from Jinarc 90mg+30mg Tablet immediately upon waking, at least 30 minutes before breakfast, and take the 30mg tablet about 8 hours later. Drink water as directed throughout the day, and be prepared for increased urination (including at night) as an expected effect of treatment – do not restrict fluids to reduce this effect, as this can cause dehydration.

Jinarc 90mg+30mg Tablet is taken as a split daily dose – 90mg on waking, followed by 30mg about 8 hours later – as one part of a titration schedule that your nephrology specialist will individualise and adjust based on your tolerability and liver function test results. Never change your dose or schedule without your specialist’s instruction.

Use this product before the expiry date stated on the packaging. Do not use the medicine if the expiry date has passed.

Store below 30°C in a dry place, away from direct sunlight and out of reach of children.

• Increased thirst and dry mouth
• Increased urination (polyuria), including at night (nocturia)
• Fatigue
• Dizziness
• Serious: signs of liver injury (unexplained fatigue, loss of appetite, nausea, right upper abdominal pain, dark urine, or yellowing of the skin/eyes) require immediate medical attention and prompt liver function testing

• Known hypersensitivity to tolvaptan or any ingredient in this product
• Significant liver impairment, or elevated liver enzymes with symptoms suggestive of liver injury
• Inability to sense or respond to thirst
• Hypovolaemia (low blood volume/dehydration)
• Concomitant use with strong CYP3A4 inhibitors (e.g. ketoconazole, certain HIV protease inhibitors) due to markedly increased tolvaptan levels
• Pregnancy and breastfeeding

• Strong and moderate CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, grapefruit juice) can significantly increase tolvaptan blood levels and increase side-effect risk
• CYP3A4 inducers (e.g. rifampicin, certain anti-seizure medicines) can reduce tolvaptan’s effectiveness
• Other medicines that raise blood sodium, or diuretics, may add to tolvaptan’s fluid and electrolyte effects and require closer monitoring
• Inform your nephrology specialist of all other medicines and supplements you take, given the significant CYP3A4-related interaction potential

• Drink water regularly throughout the day, including before bed, to offset increased fluid loss – never restrict fluids to reduce urination
• Attend all scheduled liver function blood tests – regular monitoring is mandatory for the duration of treatment
• Take the morning dose immediately on waking and the afternoon dose about 8 hours later, exactly as scheduled
• Report unexplained fatigue, loss of appetite, nausea, dark urine, or yellowing of skin/eyes to your specialist immediately
• This medicine is prescribed and monitored only by a nephrology specialist – do not obtain or continue it outside that specialist supervision