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RYTARY Is an Extended-Release Treatment for Parkinson’s Disease

RYTARY is an extended-release
carbidopa and levodopa capsule
approved by the US Food and Drug
Administration (FDA) in 2015.

Capsule Icon

The combination of carbidopa and
levodopa is one of the most commonly
used therapies
for treating Parkinson's
disease symptoms.1

Carbidopa2

  • Is used in combination with levodopa.
  • Decreases the body's conversion of levodopa
    so more can reach the brain.

Levodopa3

  • Nerve cells convert levodopa into dopamine to
    replenish the brain's supply.

RYTARY is for early, moderate,
and advanced
Parkinson's disease.

“OFF” Time, “ON” Time, and Dyskinesia

Medication “Off” Time Icon

“OFF” time

is when your medication
isn’t working and you have
to cope with your
symptoms. You might feel
stiff, move slowly, or not
be able to get around so

easily because your
symptoms are getting in
the way.

Medication “On” Time Icon

“ON” time

is when your symptoms
are less apparent and you
can go about your day.
You feel more mobile and
flexible and are able to
move around.

“On” Time Without Troublesome Dyskinesia Icon

Dyskinesia

is a form of involuntary
movement. Sometimes
your dyskinesia may not
bother you. However,
there is also troublesome
dyskinesia
, defined as
uncontrollable movements
that get in the way of your
daily activities.
4

How might RYTARY help?

In Clinical Studies of RYTARY5:

Patients with early Parkinson’s
disease
who took RYTARY

experienced a significant improvement
in their ability to move and perform
activities during the day.
*

Patients with advanced Parkinson’s
disease
who took RYTARY

experienced significantly less “off” time,
with more “on” time without troublesome
dyskinesia (uncontrollable movements)
during the day.

* In a clinical study of patients with early Parkinson’s disease, based on a scale that measures activities of daily living and ability to move (called the Unified
Parkinson’s Disease Rating Scale or UPDRS).
In a clinical study measuring “OFF” time during waking hours.

Why wait?
Ask your doctor today if RYTARY is right for you.

IMPORTANT SAFETY INFORMATION

Do not take RYTARY with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors because taking these two drugs within two weeks of each other can result in high blood pressure.

Taking RYTARY may result in falling asleep while engaged in normal activities, even without warning and as late as one year after starting to take RYTARY. Other sedating medicines and alcohol taken together with RYTARY may have additional sedative effects. Tell your healthcare provider if you have any kind of sleep disorder or are experiencing drowsiness or sleepiness.

Some side effects of taking RYTARY including sleepiness and dizziness may affect your ability to drive or operate machinery. Do not drive a car, operate a machine, or do anything that requires you to be alert until you know how RYTARY affects you.

Talk to your healthcare provider before you lower the dose or stop taking RYTARY, as this may result in serious side effects. Call your healthcare provider immediately if you develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness.

Make sure to tell your healthcare provider if you have any heart conditions, especially if you have had a heart attack or experience irregular heartbeat. Some people with a history of or risk factors for heart disease have experienced heart problems while taking RYTARY.

Some patients taking RYTARY can experience hallucinations (unreal visions, sounds, or sensations) or abnormal thoughts and behaviors (such as excessive suspicion, believing things that are not real, confusion, agitation, aggressive behavior, and disorganized thinking). If you have hallucinations or abnormal thoughts or behaviors, talk with your healthcare provider.

Some patients taking certain medicines to treat Parkinson’s disease have intense urges to gamble, increased sexual urges, other intense urges, and the inability to control those urges. If you or your family members notice that you are developing unusual urges or behaviors, talk to your healthcare provider.

Tell your healthcare provider if abnormal involuntary movements appear or get worse during treatment with RYTARY.

Tell your healthcare provider if you have ever had an ulcer, because RYTARY may increase your chances of having bleeding in your stomach.

Tell your healthcare provider if you have glaucoma, because RYTARY may increase the pressure in your eyes.

Parkinson’s disease patients are at an increased risk of developing melanoma, a form of skin cancer. See your healthcare provider for regular skin examinations when taking RYTARY.

The most common side effects that may occur with RYTARY include nausea, dizziness, headache, sleeplessness, abnormal dreams, dry mouth, abnormal involuntary movements, anxiety, constipation, vomiting, and low blood pressure upon rising. Rise slowly after sitting or lying down for a prolonged period.

In post marketing use, some patients taking RYTARY have experienced suicidal thoughts or have attempted suicide. A causal relationship has not been established. Tell your healthcare provider if you have thoughts of suicide or have attempted suicide.

Tell your healthcare provider if you have any side effects while taking RYTARY. He or she can make adjustments that may reduce these effects.

Notify your healthcare provider if you become pregnant or intend to become pregnant during therapy or if you intend to breast-feed or are breast-feeding an infant.

Make sure you tell your healthcare provider about all of the prescription and non-prescription medications you take, including supplements, and especially those for Parkinson’s disease, heart disease, blood pressure, abnormal thoughts, tuberculosis, and sleep problems, and supplements containing iron. Do not take other carbidopa-levodopa preparations with RYTARY without consulting your healthcare provider.

Be sure to take your medicine as instructed. You may take RYTARY with or without food; however, taking RYTARY with food may decrease or delay its effect. For this reason consider taking the first dose of the day about 1 to 2 hours before eating. Swallow RYTARY whole; do not chew, divide, or crush. If you have difficulty swallowing the capsule, twist apart both halves and sprinkle the entire contents of both halves of the capsule on a small amount of applesauce (1 to 2 tablespoons). Consume the mixture immediately. Do not store the drug/food mixture for future use.

Note: The above information for patients being treated with RYTARY is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

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 read the Full Prescribing Information. For more information, go to RYTARY.com and/or talk to your healthcare provider.

INDICATION

RYTARY is a prescription medication that contains a combination of carbidopa and levodopa for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease resulting from carbon monoxide or manganese poisoning.

References:

1.Olanow CW, Stern MB, Sethi K. The scientific and clinical basis for the treatment of Parkinson disease. Neurology. 2009;72(21)(suppl 4):S1-S136.
2.Parkinson’s disease—frequently asked questions. What is carbidopa? NIH Senior Health. http://nihseniorhealth.gov/parkinsonsdisease/faq/faq16.html. Accessed
January 25, 2017.
3.Parkinson’s disease—frequently asked questions. What is levodopa? NIH Senior Health. http://nihseniorhealth.gov/parkinsonsdisease/faq/faq13.html. Accessed
January 25, 2017.
4.Hauser RA, Friedlander J, Zesiewicz TA, et al. A home diary to assess functional status in patients with Parkinson’s disease with motor fluctuations and dyskinesia.
Clin Neuropharmacol. 2000;23(2):75-81.
5.RYTARY [package insert]. Hayward, CA: Impax Laboratories, Inc.; 2016.