NOURIANZ

NOURIANZ- istradefylline tablet, film coated
Kyowa Kirin, Inc.

1 INDICATIONS AND USAGE

NOURIANZ is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s 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. Initial dose titration is not required.

NOURIANZ can be taken with or without food [see Clinical Pharmacology (12.3)].

2.2 Dosage Adjustment with Strong CYP 3A4 Inhibitors

The maximum recommended dosage of NOURIANZ with concomitant use of strong CYP3A4 inhibitors is 20 mg once daily [see Drug Interactions (7.1)].

2.3 Dosing with Strong CYP 3A4 Inducers

Avoid use of NOURIANZ with strong CYP3A4 inducers [see Drug Interactions (7.1)].

2.4 Dosage Adjustment in Patients with Hepatic Impairment

The maximum recommended dosage of NOURIANZ in patients with moderate hepatic impairment (Child-Pugh B) is 20 mg once daily. Closely monitor patients with moderate hepatic impairment for adverse reactions when on NOURIANZ treatment [see Adverse Reactions (6.1)]. Avoid use of NOURIANZ in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.7)].

2.5 Dosage Adjustment for Tobacco Smokers

The recommended dosage of NOURIANZ in patients who use tobacco in amounts of 20 or more cigarettes per day (or the equivalent of another tobacco product) is 40 mg once daily [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

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)], the incidence of dyskinesia was 15% for NOURIANZ 20 mg, 17% for NOURIANZ 40 mg, and 8% for placebo, in combination with levodopa. One percent of patients treated with either NOURIANZ 20 mg or 40 mg discontinued treatment because of dyskinesia, compared to 0% for placebo.

5.2 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.

In controlled clinical trials (Studies 1, 2, 3, and 4) [see Clinical Studies (14)], the incidence of hallucinations was 2% for NOURIANZ 20 mg, 6% for NOURIANZ 40 mg, and 3% for placebo. In patients treated with NOURIANZ 40 mg, 1% discontinued because of hallucinations, compared to 0% for placebo and 0% for patients treated with NOURIANZ 20 mg. The incidence of “abnormal thinking and behavior” (paranoid ideation, delusions, confusion, mania, disorientation, aggressive behavior, agitation, or delirium) reported as an adverse reaction was 1% for NOURIANZ 20 mg, 2% for NOURIANZ 40 mg, and 1% for placebo.

5.3 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 controlled clinical trials (Studies 1, 2, 3 and 4) [see Clinical Studies (14)], one patient treated with NOURIANZ 40 mg was reported to have impulse control disorder, compared to no patient on placebo or NOURIANZ 20 mg.

In some postmarketing cases, these urges were reported to have stopped when the dose was reduced, or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with NOURIANZ. Consider dose reduction or discontinuation if a patient develops such urges while taking NOURIANZ [see Adverse Reactions (6.2)].

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

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 drug and may not reflect the rates observed in practice.

The safety of NOURIANZ was evaluated in 734 patients with Parkinson’s disease (PD) taking a stable dose of levodopa and a DOPA decarboxylase inhibitor, with or without other PD medications, in four randomized, multicenter, double-blind, placebo-controlled trials 12 weeks in duration (Studies 1, 2, 3 and 4) [see Clinical Studies (14)]. Of the patient population exposed to NOURIANZ, 50% were male, 32% White, 67% Asian, and the mean age was 65 years (range: 33 to 84 years). Of these patients, 356 received NOURIANZ 20 mg and 378 received NOURIANZ 40 mg.

Adverse Reactions Leading to Discontinuation of Treatment

The incidence of patients discontinuing for any adverse reaction was 5% for NOURIANZ 20 mg, 6% for NOURIANZ 40 mg, and 5% for placebo. The most frequently reported adverse reaction causing study discontinuation was dyskinesia [see Warnings and Precautions (5.1)].

Common Adverse Reactions in Pooled Placebo-Controlled Trials

Table 1 shows adverse reactions with a frequency of at least 2% in patients treated with NOURIANZ 20 mg or 40 mg once daily. The most common adverse reactions in which the frequency for NOURIANZ was at least 5%, and greater than the incidence on placebo, were dyskinesia, dizziness, constipation, nausea, hallucination, and insomnia.

Table 1: Adverse Reactions with an Incidence of at Least 2% in Patients Treated with NOURIANZ, and Greater than on Placebo, in Pooled Studies 1, 2, 3, and 4
Adverse Reactions NOURIANZ 20 mg/day (N=356) % NOURIANZ 40 mg/day (N=378) % Placebo N=426 (%)
*
Includes hallucinations, hallucinations visual, hallucinations olfactory, hallucinations somatic, hallucinations auditory.
Nervous system disorders
Dyskinesia 15 17 8
Dizziness 3 6 4
Gastrointestinal disorders
Constipation 5 6 3
Nausea 4 6 5
Diarrhea 1 2 1
Psychiatric disorders
Hallucination * 2 6 3
Insomnia 1 6 4
Metabolism and nutrition disorders
Decreased appetite 1 3 1
Investigations
Blood alkaline phosphatase increased 1 2 1
Blood glucose increased 1 2 0
Blood urea increased 1 2 0
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation 1 2 0
Skin and subcutaneous tissue disorders
Rash 1 2 1

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