NOURIANZ Film-coated tablet (2020)

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Kyowa Kirin, Inc.

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1. Indications and Usage

NOURIANZ is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinsons disease (PD) experiencing off episodes.

2. Dosage and Administration

2.1 Dosing Information The recommended dosage of NOURIANZ is 20 mg administered orally once daily. The dosage may be increased to a maximum of 40 mg once daily, based on individual need and tolerability. ...

3. Dosage Forms and Strengths

20 mg tablets: Peach-colored, pillow-shaped, film-coated tablets with 20 debossed on one side. 40 mg tablets: Peach-colored, almond-shaped, film-coated tablets with 40 debossed on one side.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Dyskinesia NOURIANZ in combination with levodopa may cause dyskinesia or exacerbate pre-existing dyskinesia. In controlled clinical trials (Studies 1, 2, 3, and 4) [see Clinical Studies (14)] ...

6. Adverse Reactions

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Dyskinesia [see Warnings and Precautions (5.1)] Hallucinations/Psychotic ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Immunogenicity

The following adverse reaction has been identified during post approval use of istradefylline outside of the United States. Because these reactions are reported voluntarily from a population of uncertain ...

7. Drug Interactions

7.1 Effect of Other Drugs on NOURIANZ Strong CYP3A4 Inhibitors Coadministration of NOURIANZ with a strong CYP3A4 inhibitor (ketoconazole) increased istradefylline AUCinf by 2.5-fold [see ...

8. Use in Specific Populations

8.8 Tobacco Smokers Tobacco smoking decreased NOURIANZ steady-state systemic exposures by 38% to 54% [see Clinical Pharmacology (12.3)], which may decrease efficacy. Therefore, the recommended ...

8.1. Pregnancy

Risk Summary There are no adequate data on the developmental risk associated with the use of NOURIANZ in pregnant women. In animal studies (see Data), oral administration of istradefylline during ...

8.2. Lactation

Risk Summary There are no data on the presence of istradefylline in human milk, the effects of istradefylline on the breastfed infant, or the effects of istradefylline on milk production. Istradefylline ...

8.3. Females and Males of Reproductive Potential

Contraception Use of NOURIANZ during pregnancy is not recommended. Women of childbearing potential should be advised to use contraception during treatment with NOURIANZ [see Use in Specific Populations ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

No adjustment of NOURIANZ dosage is recommended on the basis of age. Of the total number of PD patients who received NOURIANZ in clinical trials, 53% were ≥65 years and 13% were ≥75 years of age. No overall ...

8.6. Renal Impairment

No adjustment of NOURIANZ dosage is needed in patients with mild renal impairment (estimated creatinine clearance (CrCL) by Cockcroft-Gault equation: 60-89 mL/min), moderate renal impairment (CrCL 30-59 ...

8.7. Hepatic Impairment

No adjustment of NOURIANZ dosage is needed in patients with mild hepatic impairment (Child-Pugh Class A). In patients with moderate hepatic impairment (Child-Pugh B), the steady-state exposures (AUC ...

10. Overdosage

10.1 Human Experience There is limited clinical experience regarding human overdosage with NOURIANZ. In clinical trials, one patient took 6 tablets (120 mg, 3 times the maximum recommended dosage) of istradefylline ...

11. Description

NOURIANZ contains istradefylline, an adenosine receptor antagonist, which has a xanthine derivative structure. The chemical name is (E)8(3,4-dimethoxystyryl)-1,3-diethyl-7-methyl-3,7-dihydro-1 ...

12.1. Mechanism of Action

The precise mechanism by which istradefylline exerts its therapeutic effect in Parkinson disease is unknown. In in vitro studies and in in vivo animal studies, istradefylline was demonstrated ...

12.2. Pharmacodynamics

Cardiac Electrophysiology The effect of NOURIANZ (40 mg or 160 mg [4 times the maximum recommended dosage] once daily for 14 days) on the QTc interval was evaluated in a randomized, placebo and moxifloxacin-controlled, ...

12.3. Pharmacokinetics

Istradefylline exhibits dose-proportional pharmacokinetics after multiple oral doses from 20 mg to 80 mg (2 times the maximum recommended dosage). Steady-state was reached within 2 weeks of once-daily ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In lifetime oral carcinogenicity studies, there was no evidence of carcinogenicity in mouse (0, 25, 125, or 250 mg/kg) or rat (0, 30, 100, or 320 mg/kg). Plasma exposures (AUC) at the highest ...

13.2. Animal Toxicology and/or Pharmacology

Oral administration of istradefylline (0, 30, 100, or 320 mg/kg/day) to rats for two years resulted in an increase in the incidence and severity of vascular mineralization in the brain (including in the ...

14. Clinical Studies

The efficacy of NOURIANZ for the adjunctive treatment to levodopa/carbidopa in patients with Parkinsons disease experiencing off episodes was shown in four randomized, multicenter, double-blind, 12-week, ...

16.1. How Supplied

NOURIANZ (istradefylline) tablets are available as: 20 mg Tablets: Peach-colored, pillow-shaped, film-coated tablets with 20 debossed on one side. Bottle of 90: NDC 42747-602-90 40 mg Tablets: ...

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Dyskinesia Advise patients that NOURIANZ may cause dyskinesia or exacerbate pre-existing dyskinesia [see Warnings ...