Istradefylline (is-tra-DEF-i-lin)

Used with carbidopa/levidopa to treat Parkinson's disease in patients who are having "off" episodes.

Brand Name(s):

Nourianz

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how istradefylline works. Tell your doctor if you are using atorvastatin, carbamazepine, clarithromycin, digoxin, itraconazole, ketoconazole, midazolam, phenytoin, rifampin, or St John's wort.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or a history of dyskinesia (trouble controlling movements) or mental illness. Tell your doctor if you smoke.
• This medicine may cause the following problems:
  • Dyskinesia
  • Unusual changes in thoughts or behavior, including the urge to gamble or an increased sex drive
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Compulsive behavior or intense urges you cannot control
• Jerky muscle movement you cannot control (often in your face, tongue, or jaw)
• Unusual behavior, mood changes, seeing or hearing things that are not there, or thoughts of hurting yourself

If you notice these less serious side effects, talk with your doctor:

• Constipation, nausea
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088