国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
istradefylline (UNII: 2GZ0LIK7T4) (istradefylline - UNII:2GZ0LIK7T4)
Kyowa Kirin, Inc.
ORAL
PRESCRIPTION DRUG
NOURIANZ is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes. None. 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 pregnancy resulted in teratogenicity (increased incidences of fetal structural abnormalities, embryofetal and offspring mortality and growth deficits) at clinically relevant exposures and in the absence of maternal toxicity. The teratogenic effects of istradefylline in pregnant rabbits were substantially greater when administered in combination with levodopa/carbidopa than when administered alone. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respe
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: Peach-colored, almond-shaped, film-coated tablets with "40" debossed on one side. Bottle of 90: NDC 42747-604-90 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].
New Drug Application
NOURIANZ- ISTRADEFYLLINE TABLET, FILM COATED KYOWA KIRIN, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NOURIANZ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NOURIANZ. NOURIANZ (ISTRADEFYLLINE) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2019 INDICATIONS AND USAGE NOURIANZ is an adenosine receptor antagonist indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes (1). DOSAGE AND ADMINISTRATION The recommended dosage is 20 mg orally once daily. The dosage may be increased to a maximum of 40 mg once daily (2.1). May be taken with or without food (2.1). Patients with hepatic impairment: Maximum recommended dosage with moderate hepatic impairment is 20 mg once daily; use of NOURIANZ in patients with severe hepatic impairment should be avoided (2.4, 8.7). Patients who smoke 20 or more cigarettes per day (or the equivalent of another tobacco product): Recommended dosage is 40 mg once daily (2.5, 8.8). DOSAGE FORMS AND STRENGTHS Tablets: 20 mg and 40 mg (3). CONTRAINDICATIONS None (4). WARNINGS AND PRECAUTIONS Dyskinesia: Monitor patients for dyskinesia or exacerbation of existing dyskinesia (5.1). Hallucinations / Psychotic Behavior: Consider dosage reduction or stopping NOURIANZ if occurs (5.2). Impulse Control / Compulsive Behaviors: Consider dosage reduction or stopping NOURIANZ if occurs (5.3). ADVERSE REACTIONS The most common adverse reactions (at least 5% and more frequent than placebo) were dyskinesia, dizziness, constipation, nausea, hallucination, and insomnia (6.1). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT KYOWA KIRIN INC. AT 1-844-768-3544 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Strong CYP3A4 inhibitors: Recommended maximum dosage with concomitant use is 20 mg once daily (2.2, 7.1). Strong CYP3A4 inducers: Avoid use (2.3, 7.1). USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 完全なドキュメントを読む