An “off” episode is a time when a patient’s medications for Parkinson's disease (PD) are not working well, causing a return in PD symptoms, such as a tremor and difficulty walking.

In clinical trials, adult patients with Parkinson's disease (PD) who took NOURIANZ with levodopa, with or without other PD medications, had less “off” time. See NOURIANZ clinical trial results.

NOURIANZ may cause serious side effects,
including:

• uncontrolled sudden movements (dyskinesia). Uncontrolled sudden movements is one of the most common side effects. NOURIANZ may cause uncontrolled sudden movements or make such movements you already have worse or more frequent. Tell your healthcare provider if this happens
• hallucinations and other symptoms of psychosis. NOURIANZ can cause abnormal thinking and behavior including:
  • being overly suspicious or feeling people want to harm you (paranoid ideation)
  • believing things that are not real (delusions)
  • seeing or hearing things that are not real (hallucinations)
  • confusion
  • increased activity or talking (mania)
  • disorientation
  • aggressive behavior
  • agitation
  • delirium (decreased awareness of things around you)

If you have hallucinations or any other abnormal thinking or behavior, talk with your healthcare provider.

• unusual urges (impulse control or compulsive behaviors). Some people taking NOURIANZ get urges to behave in a way unusual for them. Examples of this are unusual urges to gamble, increased sexual urges, strong urges to spend money, binge eating, and the inability to control these urges. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider

The most common side effects of NOURIANZ include uncontrolled movements (dyskinesia), dizziness, constipation, nausea, hallucinations, and problems sleeping (insomnia).

These are not all the possible side effects of NOURIANZ.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088, or at www.fda.gov/safety.

Before you take NOURIANZ, tell your healthcare provider about all your medical conditions, including if you:

• have a history of abnormal movement (dyskinesia)
• have reduced liver function
• smoke cigarettes
• are pregnant or plan to become pregnant. NOURIANZ may harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if NOURIANZ passes into breast milk.
  You and your healthcare provider should decide if you will take NOURIANZ or breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NOURIANZ and other medicines may affect each other causing side effects. NOURIANZ may affect the way other medicines work, and other medicines may affect how NOURIANZ works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

• 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 healthcare provider or go to the nearest hospital emergency room right away

The active ingredient in NOURIANZ is istradefylline. The inactive ingredients are 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.

If your doctor has prescribed NOURIANZ and you need help with the out-of-pocket cost, the Kyowa Kirin Cares program may be able to help.

Eligible commercially insured patients may pay as little as $20 for a 1-month supply of NOURIANZ. For full program eligibility requirements, terms, conditions, and limitations, click here.

Kyowa Kirin Cares also provides information, support, and other resources to eligible patients. For more information about Kyowa Kirin Cares, click here.

If you need help paying for NOURIANZ, the Kyowa Kirin Cares program may be able to help you get the information and resources you need to start and stay with NOURIANZ.

Visit Kyowa Kirin Cares for more information, including full eligibility requirements, terms, and conditions.