Nourianz 20mg Tablets
It is used to treat Parkinson's disease.
Drug Class
Adjunctive treatment for Parkinson's disease
Pharmacologic Class
Adenosine A2A receptor antagonist
Pregnancy Category
Not available
FDA Approved
Aug 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nourianz is a medication used along with levodopa/carbidopa to help reduce 'off' times (periods when your Parkinson's symptoms return or worsen) in people with Parkinson's disease.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions precisely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions precisely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take Nourianz exactly as prescribed by your doctor, usually once daily.
- It can be taken with or without food.
- Do not stop taking Nourianz suddenly without talking to your doctor.
- Be aware of potential side effects like dyskinesia (uncontrolled movements), hallucinations, or changes in behavior.
- Avoid alcohol or other sedating medications, as Nourianz can cause drowsiness or sudden sleep onset.
- Use caution when driving or operating machinery until you know how Nourianz affects you.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg orally once daily, may increase to 40 mg once daily based on efficacy and tolerability.
Dose Range:
20 - 40 mg
Condition-Specific Dosing:
Initial Dose:
20 mg once daily
Titration:
May increase to 40 mg once daily after 2-4 weeks if needed and tolerated.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
Not studied; use with caution.
Dialysis:
Not studied; use with caution.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
Not recommended (increased exposure observed).
Severe:
Not recommended (not studied).
Pharmacology
Mechanism of Action
Istradefylline is a selective adenosine A2A receptor antagonist. The precise mechanism by which istradefylline exerts its therapeutic effects in Parkinson's disease is unknown, but it is thought to involve antagonism of adenosine A2A receptors in the striatum, which modulates the indirect pathway of the basal ganglia, thereby improving motor function.
Pharmacokinetics
Absorption:
Bioavailability:
Not formally determined, but well absorbed.
Tmax:
1-2 hours
FoodEffect:
High-fat meal delays Tmax by approximately 1 hour and decreases Cmax by approximately 20%, but AUC is not significantly affected.
Distribution:
Vd:
Approximately 1000 L
ProteinBinding:
>99%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 18-30 hours
Clearance:
Not available
ExcretionRoute:
Primarily urine (75-85%) and feces (15-25%)
Unchanged:
<1% in urine
Pharmacodynamics
OnsetOfAction:
Not precisely defined for chronic therapy, but clinical trials showed reduction in 'off' time within weeks.
PeakEffect:
Not precisely defined for chronic therapy.
DurationOfAction:
Once daily dosing suggests sustained effect over 24 hours.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening trouble controlling body movements
New or worsening mental, mood, or behavior changes
Hallucinations (seeing or hearing things that are not there)
Feeling confused
Strong, uncontrollable urges (such as eating, gambling, sex, or spending money)
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Constipation
Upset stomach
Trouble sleeping
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening trouble controlling body movements
New or worsening mental, mood, or behavior changes
Hallucinations (seeing or hearing things that are not there)
Feeling confused
Strong, uncontrollable urges (such as eating, gambling, sex, or spending money)
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Constipation
Upset stomach
Trouble sleeping
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- New or worsening uncontrolled movements (dyskinesia)
- Seeing or hearing things that are not real (hallucinations)
- Unusual thoughts or behaviors (e.g., paranoia, delusions)
- New or increased urges to gamble, increased sexual urges, compulsive shopping, or binge eating
- Excessive daytime sleepiness or suddenly falling asleep
- Severe dizziness or fainting spells
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A history of mental health or behavioral problems, as this may impact your treatment.
Existing liver disease, as this may affect how your body processes the medication.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this drug and should not be taken concurrently.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may be relevant to your treatment. Therefore, it is vital to discuss all of your medications and health issues with your doctor and pharmacist to ensure safe treatment. Before starting, stopping, or modifying the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A history of mental health or behavioral problems, as this may impact your treatment.
Existing liver disease, as this may affect how your body processes the medication.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this drug and should not be taken concurrently.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may be relevant to your treatment. Therefore, it is vital to discuss all of your medications and health issues with your doctor and pharmacist to ensure safe treatment. Before starting, stopping, or modifying the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you use tobacco products, such as smoking, you should discuss this with your doctor, as your dosage may need to be adjusted if you start or stop using these products.
This medication can pose a risk to an unborn baby. If you are of childbearing potential, it is crucial to use effective birth control methods while taking this drug to prevent pregnancy. If you become pregnant, notify your doctor immediately. Additionally, if you are breastfeeding, you should consult your doctor to discuss the potential risks to your baby and determine the best course of action.
This medication can pose a risk to an unborn baby. If you are of childbearing potential, it is crucial to use effective birth control methods while taking this drug to prevent pregnancy. If you become pregnant, notify your doctor immediately. Additionally, if you are breastfeeding, you should consult your doctor to discuss the potential risks to your baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Exaggerated known side effects such as dyskinesia
- Hallucinations
- Somnolence
- Dizziness
What to Do:
There is no specific antidote for istradefylline overdose. Treatment should be supportive and symptomatic. Contact a poison control center or emergency services immediately (e.g., call 911 or 1-800-222-1222).
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir): Increase istradefylline exposure. Consider reducing istradefylline dose to 20 mg/day.
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Decrease istradefylline exposure. Avoid coadministration.
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil): May increase istradefylline exposure. Monitor for adverse reactions.
- Moderate CYP3A4 inducers (e.g., efavirenz, bosentan): May decrease istradefylline exposure. Monitor for reduced efficacy.
Monitoring
Baseline Monitoring
Motor symptoms (dyskinesia)
Rationale: To establish baseline severity and monitor for worsening or new onset dyskinesia.
Timing: Prior to initiation
Psychiatric history (hallucinations, psychosis, impulse control disorders)
Rationale: To identify predisposition and monitor for new or worsening psychiatric symptoms.
Timing: Prior to initiation
Routine Monitoring
Dyskinesia
Frequency: Regularly during treatment, especially after dose adjustments
Target: Minimize severity
Action Threshold: If severe or bothersome, consider reducing istradefylline dose or levodopa dose.
Hallucinations/Psychotic behavior
Frequency: Regularly during treatment
Target: Absence or minimal
Action Threshold: If new or worsening, consider dose reduction or discontinuation.
Impulse control disorders (e.g., pathological gambling, hypersexuality, binge eating, compulsive shopping)
Frequency: Regularly during treatment
Target: Absence
Action Threshold: If new or worsening, consider dose reduction or discontinuation.
Orthostatic hypotension symptoms (dizziness, lightheadedness)
Frequency: Regularly during treatment
Target: Absence or minimal
Action Threshold: If symptomatic, consider dose reduction or other interventions.
Symptom Monitoring
- New or worsening dyskinesia
- Hallucinations (visual, auditory)
- Delusions
- Paranoia
- Confusion
- Impulsive or compulsive behaviors (e.g., gambling, hypersexuality, compulsive shopping, binge eating)
- Dizziness
- Lightheadedness
- Somnolence/sleep attacks
Special Patient Groups
Pregnancy
Limited human data on istradefylline use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. In animal reproduction studies, oral administration of istradefylline to pregnant rats and rabbits during organogenesis resulted in developmental toxicity (e.g., skeletal abnormalities, reduced fetal weight) at doses associated with maternal toxicity.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity based on animal data; human data lacking.
Second Trimester:
Potential for developmental toxicity based on animal data; human data lacking.
Third Trimester:
Potential for developmental toxicity based on animal data; human data lacking.
Lactation
It is not known whether istradefylline is excreted in human milk. Istradefylline and its metabolites were excreted in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Nourianz and any potential adverse effects on the breastfed infant from Nourianz or from the underlying maternal condition.
Infant Risk:
Unknown; potential for adverse effects based on animal data.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects (≥65 years) and younger subjects. No dosage adjustment is necessary based on age alone.
Clinical Information
Clinical Pearls
- Nourianz is an adjunctive therapy to levodopa/carbidopa, not a monotherapy for Parkinson's disease.
- Dyskinesia is a common side effect, and may require adjustment of either Nourianz or levodopa dose.
- Patients should be monitored for psychiatric adverse reactions, including hallucinations, delusions, and impulse control disorders.
- Caution patients about the risk of somnolence and sudden onset of sleep, and advise them to avoid driving or operating heavy machinery if affected.
- Avoid coadministration with strong CYP3A4 inducers due to significantly decreased istradefylline exposure.
Alternative Therapies
- Dopamine agonists (e.g., pramipexole, ropinirole, rotigotine)
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
- COMT inhibitors (e.g., entacapone, opicapone, tolcapone)
- Amantadine (for dyskinesia or 'off' time)
- Other non-dopaminergic agents (e.g., pimavanserin for Parkinson's disease psychosis)
Cost & Coverage
Average Cost:
$1000 - $1500+ per 30 tablets
Insurance Coverage:
Tier 3 or higher (Specialty Drug)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.