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NOURIANZ: Safety supported by clinical trial experience in over seven hundred patients1,2

The safety of NOURIANZ was evaluated in randomized, multicenter, double-blind, placebo-controlled trials with 734 patients1

The trials included patients with Parkinson's disease (PD) taking a stable dose of levodopa/carbidopa (Studies 1, 2, 3, and 4) or levodopa/benserazide (Studies 3 and 4) with or without other medications for PD.1 Studies were 12-week studies of 734 patients (NOURIANZ
20 mg [n=356], NOURIANZ 40 mg [n=378]).1

Select patient baseline characteristics2:

  • Mean age: 65 years (range: 33 to 84 years)
  • 50% male, 50% female
  • 67% Asian, 32% white
Clinical
trials1
  • Safety trials, N=734

NOURIANZ: Safety and tolerability

Incidence of adverse reactions ≥2% in either dose of NOURIANZ and greater than placebo2

NOURIANZ Adverse Reaction Table

aIncludes hallucinations (visual, olfactory, somatic, and auditory).

Treatment-emergent adverse reactions of special interest1

NOURIANZ Common Treatment Emergent Adverse Event Table
  • aIncludes fractures and injuries.
  • bIncludes hallucination, illusion, auditory, olfactory, somatic, visual, and mixed hallucination.
  • cIncludes sleep disorder, irregular sleep phase, poor quality sleep, rapid eye movements, and sleep abnormal.
  • dIncludes agranulocytosis, granulocytopenia, leukopenia, neutropenia, neutrophil count decreased, neutrophil percentage decreased, pancytopenia, and white blood cell count decreased.
Discontinuation rates compared to placebo

In clinical trials, discontinuation rates for NOURIANZ were comparable to placebo2

  • 5% discontinuation rate with placebo2
  • 5% discontinuation rate with NOURIANZ 20 mg2
  • 6% discontinuation rate with NOURIANZ 40 mg2

Low rates of discontinuation due to dyskinesia2

  • One percent of patients treated with either NOURIANZ 20 mg or 40 mg discontinued treatment because of dyskinesia,
    compared to no patients on placebo2

Incidence of adverse reactions with NOURIANZ was similar across age groups.1

 
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Indication

NOURIANZ (istradefylline) is an adenosine receptor antagonist indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes.

Important Safety Information

Warnings and Precautions

Dyskinesia: NOURIANZ in combination with levodopa may cause dyskinesia or exacerbate pre-existing dyskinesia. In clinical trials, 1% of patients treated with either NOURIANZ 20 mg or 40 mg discontinued treatment because of dyskinesia, compared to 0% for placebo.

Hallucinations / Psychotic Behavior: Because of the potential risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with NOURIANZ. Consider dosage reduction or discontinuation if a patient develops hallucinations or psychotic behaviors while taking NOURIANZ.

Impulse Control / Compulsive Behaviors: Patients treated with NOURIANZ and one or more medication(s) for the treatment of Parkinson’s disease (including levodopa) may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, and the inability to control these urges. In clinical trials, 1 patient treated with NOURIANZ 40 mg was reported to have impulse control disorder, compared to no patient on NOURIANZ 20 mg or placebo.

Drug Interactions

The maximum recommended dosage in patients taking strong CYP3A4 inhibitors is 20 mg once daily. Avoid use of NOURIANZ with strong CYP3A4 inducers.

Specific Populations

Pregnancy: Based on animal data, may cause fetal harm.

Hepatic impairment: The maximum recommended dosage of NOURIANZ in patients with moderate hepatic impairment is 20 mg once daily. Avoid use in patients with severe hepatic impairment.

Adverse Reactions

The most common adverse reactions with an incidence ≥5% and occurring more frequently than with placebo were dyskinesia (15%, 17%, and 8%), dizziness (3%, 6%, and 4%), constipation (5%, 6%, and 3%), nausea (4%, 6%, and 5%), hallucination (2%, 6%, and 3%), and insomnia (1%, 6%, and 4%) for NOURIANZ 20 mg, 40 mg, and placebo, respectively.

You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for NOURIANZ.

Reference: 1. NOURIANZ [package insert]. Kyowa Kirin, Inc., Bedminster, NJ, USA.

References: 1. Hickey P, Stacy M. Available and emerging treatments for Parkinson’s disease: a review. Drug Des Devel Ther. 2011;5:241-254. 2. The voice of the patient: Parkinson’s disease. Silver Spring, MD: US Food and Drug Administration; April 2016. https://www.fda.gov/media/124392/download. Accessed June 11, 2019. 3. Parkinson’s Foundation. Statistics. https://parkinson.org/Understanding-Parkinsons/Statistics. Accessed May 5, 2019. 4. Stocchi F, Antonini A, Barone P, et al. Early DEtection of wEaring off in Parkinson disease: the DEEP study. Parkinsonism Relat Disord. 2014;20(2):204-211. 5. NOURIANZ [package insert]. Kyowa Kirin, Inc., Bedminster, NJ, USA.

References: 1. NOURIANZ [package insert]. Kyowa Kirin, Inc., Bedminster, NJ, USA. 2. Kalia LV, Brotchie JM, Fox SH. Novel nondopaminergic targets for motor features of Parkinson's disease: review of recent trials. Mov Disord. 2013;28(2):131-144. 3. Morelli M, Di Paolo T, Wardas J, Calon F, Xiao D, Schwarzschild MA. Role of adenosine A2A receptors in parkinsonian motor impairment and L-DOPA-induced motor complications. Prog Neurobiol. 2007;83(5):293-309. 4. Mishina M, Ishiwata K, Naganawa M, et al. Adenosine A2A receptors measured with [11C]TMSX PET in the striata of Parkinson's disease patients. PLoS One. 2011;6(2):e17338. doi:10.1371/journal.pone.0017338. 5. Varani K, Vincenzi F, Tosi A, et al. A2A adenosine receptor overexpression and functionality, as well as TNF-α levels, correlate with motor symptoms in Parkinson’s disease. FASEB J. 2010;24(2):587-598. doi:10.1096/fj.09-141044. 6. Brooks DJ. Dopamine agonists: their role in the treatment of Parkinson’s disease [editorial]. J Neurol Neurosurg Psychiatry. 2000;68(6):685-689. 7. Brichta L, Greengard P, Flajolet M. Advances in the pharmacological treatment of Parkinson’s disease: targeting neurotransmitter systems. Trends Neurosci. 2013;36(9):543-554. 8. Ishibashi K, Miura Y, Wagatsuma K, Toyohara J, Ishiwata K, Ishii K. Occupancy of adenosine A2A receptors by istradefylline in patients with Parkinson’s disease using 11C-preladenant PET. Neuropharmacology. 2018;143:106-112. 9. Ossola B, Schendzielorz N, Chen SH, et al. Amantadine protects dopamine neurons by a dual action: reducing activation of microglia and inducing expression of GDNF in astroglia. Neuropharmacology. 2011;61(4):574-582. 10. Kaakkola S, Wurtman RJ. Effects of COMT inhibitors on striatal dopamine metabolism: a microdialysis study. Brain Res. 1992;587(2):241-249. 11. Kong P, Zhang B, Lei P, et al. Neuroprotection of MAO-B inhibitor and dopamine agonist in Parkinson disease. Int J Clin Exp Med. 2015;8(1):431-439. 12. GOCOVRI® (amantadine) [Prescribing Information]. Emeryville, CA: Adamas Pharma LLC; 2017. 13. Gerlach M, Double K, Arzberger T, Leblhuber F, Tatschner T, Riederer P. Dopamine receptor agonists in current clinical use: comparative dopamine receptor binding profiles defined in the human striatum. J Neural Transm (Vienna). 2003;110(10):1119-1127. 14. Rubí B, Maechler P. Minireview: new roles for peripheral dopamine on metabolic control and tumor growth: let's seek the balance. Endocrinology. 2010;151(12):5570-5581. doi:10.1210/en.2010-0745. 15. Jenner P. Istradefylline, a novel adenosine A2A receptor antagonist, for the treatment of Parkinson's disease. Expert Opin Investig Drugs. 2005;14(6):729-738.

References: 1. NOURIANZ [package insert]. Kyowa Kirin, Inc., Bedminster, NJ, USA. 2. Data on file. Kyowa Kirin Pharmaceutical Development, Inc., Princeton, NJ.

References: 1. Data on file. Kyowa Kirin Pharmaceutical Development, Inc., Princeton, NJ. 2. NOURIANZ [package insert]. Kyowa Kirin, Inc., Bedminster, NJ, USA.

Reference: 1. NOURIANZ [package insert]. Kyowa Kirin, Inc., Bedminster, NJ, USA.