Frequently Asked Questions

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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.1
RYTARY is formulated in a 1:4 carbidopa to levodopa ratio. Each capsule contains both immediate-release
and extended-release beads.2
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.1
How is RYTARY thought to work?
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.1
What is the bioavailability of RYTARY?
• At equivalent doses, the bioavailability of levodopa from RYTARY was approximately 70% relative to
immediate-release carbidopa-levodopa.1
• 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.1
Who can take RYTARY?
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.1
• Patients classified as Hoehn and Yahr Stages I-III range in severity from “minimal or no functional
impairment” to “mild to moderate disability.”1
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.1
• Patients classified as Hoehn and Yahr Stages I-IV range in severity from “minimal or no functional
impairment” to “severely disabled.”1
Are there patients for whom RYTARY is contraindicated?
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.1
Please see additional Important Safety Information throughout and the Full Prescribing Information at www.RYTARYhcp.com.
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What are the most common adverse reactions associated with RYTARY?1
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.
Please see additional Important Safety Information throughout and the Full Prescribing Information at
www.RYTARYhcp.com.
What are the RYTARY dosage strengths?
RYTARY is a fixed-dose combination product of carbidopa and levodopa in a 1:4 ratio. RYTARY is
available in 4 strengths:1
• 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?
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. See Full Prescribing Information for
more information on starting patients on RYTARY.1
To convert patients from immediate-release carbidopa-levodopa to RYTARY, see the dosing conversion
recommendations and the Full Prescribing Information at www.RYTARYhcp.com.
How should RYTARY be taken?1
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
• For patients who have difficulty swallowing intact capsules, administer RYTARY by carefully
opening the capsule, sprinkling the entire contents on 1 to 2 tablespoons of applesauce, and
consuming immediately.
• Do not store the drug/food mixture for future use.
Please see additional Important Safety Information throughout and the Full Prescribing Information at www.RYTARYhcp.com.
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What are the Warnings and Precautions for RYTARY?1
• 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 the Drug Interactions?1
• Iron salts and dopamine D2 antagonists including metoclopramide: May reduce the effectiveness
of RYTARY.
• Selective MAO-B inhibitors: May be associated with orthostatic hypotension.
INDICATION
RYTARY is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and
parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
IMPORTANT SAFETY INFORMATION
• 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.
• 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, etc.). 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.
Please see additional Important Safety Information throughout and the Full Prescribing Information at www.RYTARYhcp.com.
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IMPORTANT SAFETY INFORMATION, continued
• 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, 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 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.
• 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.
• 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.
• RYTARY can cause dyskinesias that may require a dosage reduction of RYTARY or other medications
used for the treatment of Parkinson’s disease.
• Treatment with RYTARY may increase the possibility of upper gastrointestinal hemorrhage in patients
with a history of peptic ulcer and may cause increased intraocular pressure in patients with glaucoma.
• 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.
• 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.
Please see additional Important Safety Information throughout and the Full Prescribing Information at www.RYTARYhcp.com.
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IMPORTANT SAFETY INFORMATION, continued
Overdosage
• The acute symptoms of levodopa/dopa decarboxylase inhibitor overdosage can be expected to arise
from dopaminergic overstimulation (cardiovascular and central nervous system disturbances).
Drug Interactions:
• Monitor patients taking selective MAO-B inhibitors and carbidopa-levodopa. The combination may be
associated with orthostatic hypotension. RYTARY should be co-administered cautiously with: dopamine
D2 antagonists (metoclopramide), isoniazid, and iron salts.
Dosing Information:
• Dosages of RYTARY are not interchangeable with other carbidopa-levodopa products. The starting
dose for levodopa-naïve patients is 23.75 mg / 95 mg three times daily; may increase to 36.25 mg /
145 mg three times daily on the fourth day of treatment. See Full Prescribing Information for instructions
for starting patients on RYTARY and converting patients from immediate-release carbidopa and
levodopa to RYTARY.
• Doses and dosing intervals may be adjusted depending upon individual therapeutic response and
adverse reactions. Maintain patients on the lowest dosage required to achieve symptomatic control and
minimize adverse reactions such as dyskinesia and nausea.
• RYTARY should not be chewed, divided, or crushed.
• The maximum recommended daily dose of RYTARY is 612.5 / 2450 mg.
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.
References:
1. RYTARY [package insert]. Hayward, CA: Impax Laboratories, Inc.; 2015. 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.
©2015 Impax Pharmaceuticals, a division of Impax Laboratories, Inc. All rights reserved.
RYTARY is a trademark of Impax Laboratories, Inc. PP-PAT-RYT-US-0018 04/15
Please see additional Important Safety Information throughout and the Full Prescribing Information at www.RYTARYhcp.com.
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