TM Owner Kyowa Kirin
Nourianz 40mg Tablet
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Indications & Clinical Uses
- Nourianz 40 mg tablets contain istradefylline, an adenosine A2A receptor antagonist used as add-on therapy to levodopa/carbidopa in adults with Parkinson's disease who have "off" episodes, periods when symptoms return between levodopa doses.
- It is not a stand-alone treatment and is always given together with a levodopa-containing medicine.
- Nourianz was first approved in the United States in 2019 by Kyowa Kirin; it is not authorised in the European Union.
- The same molecule is sold in Japan, where Kyowa Kirin markets it as Nouriast for the same use.
- Nourianz comes as 20 mg and 40 mg film-coated tablets taken once daily by mouth; this product is the 40 mg strength.
- It is prescribed by a neurologist or movement-disorder specialist for use at home.
Side Effects
- The most common side effect of Nourianz is dyskinesia, uncontrolled involuntary movements, which affected 15% to 17% of people on the 40 mg dose in trials compared with 8% on placebo; it is usually managed by adjusting the levodopa dose rather than stopping Nourianz.
- Other common effects include dizziness, constipation, nausea, insomnia, and hallucinations.
- Hallucinations and other psychotic-like symptoms can occur and should be reported to the prescriber promptly, since a dose reduction or stopping treatment may be needed.
- Nourianz does not carry a boxed warning.
- Seek urgent medical attention for severe confusion, new or worsening hallucinations, fainting, or signs of a serious allergic reaction such as swelling of the face or throat or difficulty breathing.
- Tell your healthcare provider about any new or worsening involuntary movements at each visit.
Precautions & Warnings
- Before starting Nourianz, tell your healthcare provider about any liver disease, current or planned pregnancy, or history of psychiatric illness, and list all other Parkinson's medicines you take.
- Nourianz is not recommended during pregnancy because animal studies showed harm to the fetus at clinically relevant exposures; discuss contraception if pregnancy is possible.
- In moderate liver impairment the maximum dose is 20 mg once daily, and Nourianz should be avoided in severe liver impairment; no dose adjustment is specified for kidney problems, but these should still be reported.
- Nourianz can cause new or worsening hallucinations, confusion, impulsive urges, or unusual behaviour; tell your healthcare provider if these occur.
- Dyskinesia and dizziness can affect your ability to drive or operate machinery, so use caution until you know how the tablets affect you.
Avoid Interactions
- Nourianz is broken down by the CYP3A4 liver enzyme, so strong CYP3A4 inhibitors such as ketoconazole, clarithromycin, and ritonavir raise istradefylline levels; if used together, the maximum Nourianz dose is lowered to 20 mg once daily.
- Strong CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St John's Wort lower istradefylline levels and reduce its effect, so they should be avoided with Nourianz.
- There is no specific grapefruit warning on the label, but grapefruit juice can also raise CYP3A4-metabolised drug levels and is best avoided.
- Alcohol may add to dizziness and dyskinesia.
- Tell your healthcare provider and pharmacist about every prescription medicine, over-the-counter medicine, herbal product, and supplement you take, since your Parkinson's regimen may need adjusting.
References
Frequently Asked Questions
Nourianz (istradefylline) is an add-on tablet for adults with Parkinson's disease who have "off" episodes on levodopa/carbidopa. It is always taken alongside levodopa, never alone, and it helps reduce the time each day when Parkinson's symptoms return between levodopa doses.
Nourianz is a tablet taken by mouth once daily, with or without food, usually starting at 20 mg and increased to a maximum of 40 mg if needed. It is used together with your regular levodopa/carbidopa dose, not as a substitute for it.
The most common side effect is dyskinesia (involuntary movements), affecting up to 17% of users, along with dizziness, constipation, nausea, and insomnia. Hallucinations and unusual behaviour can occur and need prompt reporting to your prescriber; Nourianz has no boxed warning.
Avoid strong CYP3A4 inhibitors like ketoconazole or clarithromycin, which raise Nourianz levels, and strong inducers like rifampin or St John's Wort, which make it less effective. Grapefruit juice and alcohol may increase side effects. Tell your prescriber about all medicines you take.
Take a missed Nourianz dose as soon as you remember that day; skip it if it is almost time for the next dose. Do not take two doses together. Missing doses can worsen "off" episodes, so keep dosing as regular as possible.
Nourianz is not recommended during pregnancy because animal studies showed fetal harm at doses used in people. Discuss effective contraception with your healthcare provider if pregnancy is possible, and tell them right away if you become pregnant while taking Nourianz.
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