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Jynarque 90mg/30mg Tablet
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Indications & Clinical Uses
- Jynarque 90 mg/30 mg tablets contain tolvaptan, a selective vasopressin V2-receptor antagonist.
- Jynarque is approved in the United States to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
- The identical medicine is sold in the European Union and United Kingdom as Jinarc.
- Jynarque is taken as a split daily dose: the larger tablet on waking, at least 30 minutes before breakfast, and the smaller tablet eight hours later.
- The 90 mg/30 mg pack is the target dose; 45 mg/15 mg and 60 mg/30 mg packs are used while titrating upwards.
- Jynarque must NOT be confused with Samsca, which is tolvaptan for low blood sodium, uses different doses and carries a completely different warning about correcting sodium too quickly; the two are never interchangeable.
- Treatment is started and supervised by a kidney specialist under a restricted programme.
Side Effects
- Jynarque carries a BOXED WARNING that tolvaptan can cause serious and potentially fatal liver injury, and that acute liver failure requiring liver transplantation has been reported; because of this it is available only through the Tolvaptan for ADPKD Shared System REMS.
- Because Jynarque makes the kidneys excrete water, the commonest effects relate to fluid: increased urination in about 70 percent of people, thirst in about 64 percent, night-time urination, excessive drinking, dry mouth in about 16 percent and tiredness in about 14 percent.
- Headache, dizziness, diarrhoea and dehydration are also reported, and liver enzymes may rise.
- Get urgent medical advice for yellowing of the skin or eyes, dark urine, pain in the upper right abdomen, persistent nausea or vomiting, unusual tiredness, loss of appetite, itching or fever.
- Keep water within reach, including overnight.
Precautions & Warnings
- Liver blood tests are required before starting Jynarque, at 2 weeks and 4 weeks after starting, then monthly for 18 months and at least every 3 months thereafter; treatment is interrupted or stopped if enzymes or bilirubin reach the label limits.
- Jynarque is dispensed only through the Tolvaptan for ADPKD Shared System REMS, with certified prescribers, enrolled patients and certified pharmacies.
- You must be able to sense thirst and drink enough water, especially at night, or you can become dangerously dehydrated.
- Jynarque is contraindicated in people with a history of significant liver injury caused by tolvaptan, with strong CYP3A inhibitors, in those unable to sense or respond to thirst, in uncorrected abnormal blood sodium, in hypovolaemia, in anuria, and in known hypersensitivity.
- Sodium and kidney function are monitored.
- Dizziness and tiredness may affect driving.
- Store the tablets at 20 to 25 degrees Celsius, with excursions permitted between 15 and 30 degrees.
Avoid Interactions
- Blood levels of Jynarque are raised sharply by CYP3A inhibitors.
- Strong inhibitors such as ketoconazole, itraconazole, clarithromycin, telithromycin and lopinavir/ritonavir are contraindicated, and moderate inhibitors including fluconazole, erythromycin, verapamil and diltiazem require a reduced dose.
- Grapefruit juice also increases exposure and must be avoided.
- The effect of Jynarque is greatly reduced by strong CYP3A inducers: rifampicin cuts tolvaptan exposure by roughly 85 percent, and phenytoin, carbamazepine, phenobarbital, rifabutin and St John's wort have a similar effect, so combined use is best avoided.
- Do not use Jynarque with desmopressin or other vasopressin V2-receptor agonists, and take care with other diuretics and with hypertonic saline because of the risk of dehydration and rapid sodium change.
- Medicines that raise potassium, such as ACE inhibitors, angiotensin receptor blockers and potassium supplements, need monitoring.
- Tell your healthcare provider about every medicine, herbal remedy and supplement.
References
Frequently Asked Questions
Jynarque (tolvaptan) slows the decline in kidney function in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease. It does not cure the condition or remove existing cysts. The same medicine is sold as Jinarc in Europe and the United Kingdom.
Jynarque (tolvaptan) is taken as two split doses daily. Take the 90 mg tablet on waking, at least 30 minutes before breakfast, and the 30 mg tablet eight hours later. Doses can be taken with or without food. Drink enough water to replace the extra urine, including at night.
Jynarque (tolvaptan) mainly causes increased urination in about 70 percent of people, thirst in about 64 percent, night-time urination, dry mouth and tiredness. The most serious risk is liver injury: Jynarque has a boxed warning for serious and potentially fatal liver damage, including liver failure needing a transplant.
Avoid grapefruit juice and strong CYP3A inhibitors such as ketoconazole, itraconazole, clarithromycin and ritonavir, which are contraindicated with Jynarque (tolvaptan). Rifampicin, carbamazepine, phenytoin and St John's wort make it much less effective. Do not use desmopressin, and do not let yourself become dehydrated.
Liver tests are done before starting Jynarque (tolvaptan), at 2 and 4 weeks, then monthly for 18 months and at least every 3 months after that. Sodium and kidney function are also checked. A REMS programme enforces this monitoring through certified prescribers and pharmacies in the United States.
No. Both contain tolvaptan, but Jynarque treats polycystic kidney disease while Samsca treats low blood sodium, using different doses and a different key warning about correcting sodium too fast. They are never interchangeable. Jynarque is sold as Jinarc in Europe.
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