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Frequently Asked Questions

What is RYTARY?

RYTARY (pronounced: rye-TAR-ee) is an extended-release capsule formulation of
carbidopa and levodopa for the treatment of Parkinson’s disease.
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RYTARY is formulated in a 1:4 carbidopa to levodopa ratio. Each capsule contains both
immediate-release and extended-release beads.
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Initial peak with extended release

RYTARY provides both initial and extended levodopa plasma concentrations after a single
dose. Following an initial peak at about 1 hour, plasma concentrations are maintained for
about 4 to 5 hours before declining.
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How is RYTARY thought to work?

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Levodopa is a metabolic precursor of dopamine that crosses the blood-brain barrier and is
presumably converted to dopamine in the brain. This is thought to be the mechanism whereby
levodopa relieves symptoms of Parkinson’s disease. Carbidopa inhibits the metabolism of
peripheral levodopa, making more levodopa available for delivery to the brain.
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What is the bioavailability of RYTARY?

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At equivalent doses, the bioavailability of levodopa from RYTARY was approximately
70% relative to immediate-release carbidopa-levodopa.
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Based on RYTARY pharmacokinetic characteristics, the dosages of other
carbidopa-levodopa products are not interchangeable with dosages of RYTARY. You
cannot convert on a 1-to-1 basis.
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Who can take RYTARY?

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RYTARY is indicated for the treatment of Parkinson’s disease, post-encephalitic
parkinsonism and parkinsonism that may follow carbon monoxide intoxication or
manganese intoxication.

Levodopa-naïve patients with Parkinson’s disease
RYTARY was studied in patients with Parkinson’s disease who were levodopa-naïve and
classified as Hoehn and Yahr Stages I-III.
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Patients classified as Hoehn and Yahr Stages I-III range in severity from “minimal or no
functional impairment” to “mild to moderate disability.”
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Patients experiencing “off” time
RYTARY was also studied in patients with Parkinson’s disease who were experiencing
“off” time and classified as Hoehn and Yahr Stages I-IV.
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Patients classified as Hoehn and Yahr Stages I-IV range in severity from “minimal or no
functional impairment” to “severely disabled.”
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Are there patients for whom RYTARY is contraindicated?

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RYTARY is contraindicated in patients who are currently taking or have recently (within
2 weeks) taken a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and
tranylcypromine). Hypertension can occur if these drugs are used concurrently.
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For more information, please see the Full Prescribing Information and Important Safety Information.

What are the Warnings and Precautions for RYTARY?

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May cause falling asleep during activities of daily living.
Avoid sudden discontinuation or rapid dose reduction to reduce the risk of
withdrawal-emergent hyperpyrexia and confusion.
Cardiovascular events: Monitor patients with a history of cardiovascular disease.
Hallucinations/psychosis may occur.
Impulse control disorders: Consider dose reduction or stopping RYTARY if this occurs.
May cause or exacerbate dyskinesia: Consider dose reduction.
May increase the possibility of upper gastrointestinal hemorrhage in patients with a history of
peptic ulcer.
May cause increased intraocular pressure in patients with glaucoma.
Parkinson’s disease patients have a higher risk of developing melanoma. Perform periodic
skin examinations to monitor for melanoma.

What are most common adverse reactions associated
with RYTARY?

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The most common adverse reactions in clinical trials of patients with:

Early Parkinson’s disease: (occurring in at least 5% of RYTARY-treated patients and at a
higher rate than placebo) nausea, dizziness, headache, insomnia, abnormal dreams, dry
mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension.

Advanced Parkinson’s disease: (occurring in at least 5% of RYTARY-treated patients and
at a higher rate than oral immediate-release carbidopa-levodopa) nausea and headache.

For more information, please see the Full Prescribing Information and Important Safety
Information
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What are the RYTARY dosage strengths?

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RYTARY is a fixed-dose combination product of carbidopa and levodopa in a 1:4 ratio.
RYTARY is available in 4 strengths
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RYTARY 23.75 mg / 95 mg, containing 23.75 mg of carbidopa and 95 mg of levodopa.
RYTARY 36.25 mg / 145 mg, containing 36.25 mg of carbidopa and 145 mg of levodopa.
RYTARY 48.75 mg / 195 mg, containing 48.75 mg of carbidopa and 195 mg of levodopa.
RYTARY 61.25 mg / 245 mg, containing 61.25 mg carbidopa and 245 mg of levodopa.

How is RYTARY dosed?

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For levodopa-naïve patients, the recommended starting dose of RYTARY is 23.75 mg of
carbidopa and 95 mg of levodopa (23.75 mg / 95 mg) 3 times daily for the first 3 days; this
may be increased to 36.25 mg / 145 mg 3 times daily on Day 4 of treatment, if needed.
Click here for more information on starting patients on RYTARY.
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To convert patients from immediate-release carbidopa-levodopa to RYTARY, click here to
see the recommended dosing conversion guidelines.

How should RYTARY be taken?

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Instruct your patients:

RYTARY should not be chewed, divided, or crushed.
Swallow RYTARY whole with or without food.
A high-fat, high-calorie meal may delay the absorption of levodopa by about 2 hours.
-For this reason, patients should consider taking the first dose of the day about 1 to
2 hours prior to eating.
A high-protein meal may reduce the absorption of levodopa.
Administration option: RYTARY can be sprinkled on applesauce
Do not chew, divide or crush RYTARY capsules. For patients who have difficulty swallowing intact capsules, administer RYTARY by carefully twisting apart both halves of the capsule. Sprinkle the entire contents of both halves of the capsule on a small amount of applesauce (1 to 2 tablespoons) and consume the mixture immediately. Do not store the drug/food mixture for future use.

What are the Drug Interactions with RYTARY?

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Iron salts and dopamine D2 antagonists including metoclopramide: May reduce the
effectiveness of RYTARY.
Selective MAO-B inhibitors: May be associated with orthostatic hypotension.
RYTARY Efficacy Results
View the clinical trial results now. LEARN MORE
Review RYTARY
Interactive Dosing Charts
to start your patients
on RYTARY TRY IT NOW

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

RYTARY is contraindicated in patients who are currently taking or have recently (within 2 weeks) taken a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine). Hypertension can occur if these drugs are used concurrently.

WARNINGS AND PRECAUTIONS

Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with levodopa (a component of RYTARY) have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events have been reported more than 1 year after initiation of treatment. Before initiating treatment with RYTARY, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with RYTARY, such as concomitant sedating medications or the presence of a sleep disorder. Prescribers should consider discontinuing RYTARY in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating). If a decision is made to continue RYTARY, patients should be advised not to drive and to avoid other potentially dangerous activities that might result in harm if the patients become somnolent.

Withdrawal-Emergent Hyperpyrexia and Confusion: A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction of, withdrawal of, or changes in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction in patients taking RYTARY. If the decision is made to discontinue RYTARY, the dose should be tapered to reduce the risk of hyperpyrexia and confusion.

Cardiovascular Ischemic Events: Cardiovascular ischemic events have occurred in patients taking RYTARY. In patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias, cardiac function should be monitored in an intensive cardiac care facility during the period of initial dosage adjustment.

Hallucinations/Psychosis: There is an increased risk for hallucinations and psychosis in patients taking RYTARY. Hallucinations present shortly after the initiation of therapy and may be responsive to dose reduction in levodopa. Hallucinations may be accompanied by confusion, insomnia, and excessive dreaming. Abnormal thinking and behavior may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium. Because of the risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with RYTARY. In addition, medications that antagonize the effects of dopamine used to treat psychosis may exacerbate the symptoms of Parkinson’s disease and may decrease the effectiveness of RYTARY.

Because of the risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with RYTARY. In addition, medications that antagonize the effects of dopamine used to treat psychosis may exacerbate the symptoms of Parkinson’s disease and may decrease the effectiveness of RYTARY.

Impulse Control/Compulsive Behaviors: Case reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including RYTARY, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson’s disease. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with RYTARY. Consider a dose reduction or stopping the medication if a patient develops such urges while taking RYTARY.

Dyskinesia: RYTARY can cause dyskinesias that may require a dosage reduction of RYTARY or other medications used for the treatment of Parkinson’s disease.

Peptic Ulcer Disease: Treatment with RYTARY may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.

Glaucoma: RYTARY may cause increased intraocular pressure in patients with glaucoma. Monitor intraocular pressure in patients with glaucoma after starting RYTARY.

Melanoma: Patients with Parkinson’s disease have a higher risk of developing melanoma than the general population. Patients and providers are advised to monitor for melanoma frequently and on a regular basis when using RYTARY.

ADVERSE REACTIONS:

Clinical Trials Experience:

  • Early Parkinson’s Disease: Most common adverse reactions (incidence ≥ 5 % and greater than placebo) are nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension.
  • Advanced Parkinson’s Disease: Most common adverse reactions (incidence ≥ 5 % and greater than oral immediate-release carbidopa-levodopa) are nausea and headache.

Postmarketing Experience: Reported adverse reactions identified during post approval use of RYTARY include suicide attempt and ideation. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to RYTARY exposure.

DRUG INTERACTIONS:

Monitor patients taking selective MAO-B inhibitors and RYTARY. The combination may be associated with orthostatic hypotension. Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide), isoniazid, and iron salts or multivitamins containing iron salts may reduce the effectiveness of RYTARY. Monitor patients for worsening Parkinson’s symptoms.

USE IN SPECIFIC POPULATIONS:

Pregnancy and nursing mothers: RYTARY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when RYTARY is administered to a nursing woman.

Pediatrics: Safety and efficacy in pediatric populations have not been established.

OVERDOSAGE:

The acute symptoms of levodopa/dopa decarboxylase inhibitor overdosage can be expected to arise from dopaminergic overstimulation. Doses of a few grams may result in CNS disturbances, with an increasing likelihood of cardiovascular disturbance (e.g., hypotension, tachycardia) and more severe psychiatric problems at higher doses.

GENERAL DOSING AND ADMINISTRATION INFORMATION:

See Full Prescribing Information for instructions for starting levodopa-naïve patients on RYTARY and converting patients from immediate-release carbidopa and levodopa to RYTARY (Table 1). The dosages of other carbidopa and levodopa products are not interchangeable on a 1:1 basis with the dosages of RYTARY.

RYTARY should not be chewed, divided, or crushed. Swallow RYTARY whole with or without food. A high-fat, high-calorie meal may delay the absorption of levodopa by about 2 hours.

For patients who have difficulty swallowing capsules, administer RYTARY by carefully twisting apart both halves of the capsule. Sprinkle the entire contents of both halves of the capsule on a small amount of applesauce (1 to 2 tablespoons) and consume the mixture immediately. Do not store the drug/food mixture for future use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS contact Impax Laboratories, Inc. at 1-877-994-6729.

Please see Full Prescribing Information.

INDICATION

RYTARY is a combination of carbidopa and levodopa indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

References:

1. RYTARY [package insert]. Hayward, CA: Impax Laboratories, Inc.; 2016.
2. Pahwa R, Lyons KE, Hauser RA, et al; APEX-PD Investigators. Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson’s disease.
Parkinsonism Relat Disord. 2014;20(2):142-148.