Istradefylline

What is Istradefylline?

Istradefylline (NOURIANZ) is an adenosine receptor antagonist used with levodopa and carbidopa to treat adults with Parkinson's disease (PD).

What are the uses of this medicine?

• This medicine is used with levodopa and carbidopa to treat adults with Parkinson's disease (PD) who are having "off" episodes.

How does this medicine work?

• The 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 to be an adenosine A2A receptor antagonist.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Coadministration of NOURIANZ with a strong CYP3A4 inhibitor (e.g., itraconazole, ketoconazole, clarithromycin) increased istradefylline AUCinf by 2.5-fold. Recommended maximum dosage with concomitant use is 20 mg once daily.
• It is recommended to avoid use of NOURIANZ with strong CYP3A4 inducers (e.g., carbamazepine, rifampin, phenytoin, St. John's wort).

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage

• 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.

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.

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.

Administration

• Take NOURIANZ exactly as your healthcare provider tells you to.
• Take NOURIANZ one time each day.
• You can take NOURIANZ with or without food.
• If you take too much NOURIANZ, call your health care provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 20 mg and 40 mg

This medicine is available in fallowing brand namesː

• NOURIANZ

What side effects can this medication cause?

The most common side effects of this medicine include:

• uncontrolled movements (dyskinesia)
• dizziness
• constipation
• nausea
• hallucinations
• problems sleeping (insomnia)

NOURIANZ may cause serious side effects, including:

• uncontrolled sudden movements (dyskinesia). Uncontrolled sudden movements is one of the most common side effects
• hallucinations and other symptoms of psychosis
• unusual urges (impulse control or compulsive behaviors)

What special precautions should I follow?

• Monitor patients for dyskinesia or exacerbation of existing dyskinesia.
• Consider dosage reduction or stopping NOURIANZ if hallucinations / psychotic Behavior occurs.
• Consider dosage reduction or stopping NOURIANZ if impulse Control / compulsive Behaviors occurs.

What to do in case of emergency/overdose?

The symptoms of overdosage may include:

• hallucinations
• agitation
• worsening dyskinesia

Management for overdosage

• There are no known specific antidotes for NOURIANZ nor any specific treatment for istradefylline overdose.
• If an overdose occurs, NOURIANZ treatment should be discontinued and supportive treatment should be administered as clinically indicated.
• Consider the long terminal half-life of istradefylline (about 83 hours) and the possibility of multiple drug involvement.
• Consult a Certified Poison Control Center for up-to-date guidance and advice.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of NOURIANZ in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: istradefylline
• Inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, hypromellose, polyethylene glycol 3350, titanium dioxide, triacetin, iron oxide red, iron oxide yellow, and carnauba wax.

Who manufactures and distributes this medicine?

• Manufactured by: Kyowa Kirin Inc., Bedminster, NJ 07921 U.S.

NOURIANZ is a registered trademark of Kyowa Kirin Inc.

What should I know about storage and disposal of this medication?

• 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).

• Dailymed label info on Istradefylline
• FDA Istradefylline

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