NOURIANZ- istradefylline tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

istradefylline (UNII: 2GZ0LIK7T4) (istradefylline - UNII:2GZ0LIK7T4)

Dostupno od:

Kyowa Kirin, Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

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].

Status autorizacije:

New Drug Application

Svojstava lijeka

NOURIANZ- ISTRADEFYLLINE TABLET, FILM COATED
KYOWA KIRIN, INC.
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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 (