Nourianz

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. Common side effects of Nourianz include:

• involuntary muscle movements,
• dizziness,
• constipation,
• nausea,
• hallucinations, and
• insomnia

The recommended dosage of Nourianz is 20 mg orally once daily. The dosage may be increased to a maximum of 40 mg once daily. Nourianz may interact with itraconazole, ketoconazole, clarithromycin, carbamazepine, rifampin, phenytoin, St. John's wort, midazolam, atorvastatin, and digoxin. Nourianz is not recommended for use during pregnancy; it may harm a fetus. Women of childbearing potential are advised to use contraception during treatment with Nourianz. It is unknown if Nourianz passes into breast milk or how it would affect a nursing infant. Consult your doctor before breastfeeding.

Our Nourianz (istradefylline) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Nourianz Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• uncontrolled or involuntary muscle movements;
• unusual thoughts or behavior;
• confusion, hallucinations; or
• risk-taking behavior, being impulsive.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common side effects may include:

• involuntary muscle movements;
• hallucinations;
• dizziness;
• nausea, constipation; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nourianz (Istradefylline Tablets)

 

Nourianz Professional Information

SIDE EFFECTS

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

• Dyskinesia [see WARNINGS AND PRECAUTIONS]
• Hallucinations / Psychotic Behavior [see WARNINGS AND PRECAUTIONS]
• Impulse Control / Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]

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]. 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].

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 (%)
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
Hallucination1	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
1 Includes hallucinations, hallucinations visual, hallucinations olfactory, hallucinations somatic, hallucinations auditory.

Postmarketing Experience

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 size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: increased libido.

Read the entire FDA prescribing information for Nourianz (Istradefylline Tablets)