1. No category

Together, you and your doctor
have chosen RYTARY
LOOK
INSIDE FOR
SAVINGS
An Extended-Release
Treatment for
Parkinson’s Disease
Important Safety Information
Do not take RYTARY with an antidepressant
medication class known as nonselective
monoamine oxidase (MAO) inhibitors because
high blood pressure can result.
Please see additional Important Safety
Information throughout, complete Important
Safety Information on pages 12-14, and
Full Prescribing Information at RYTARY.com.
48.75 mg / 195 mg • 61.25 mg / 245 mg
Welcome to RYTARY
(carbidopa and levodopa)
extended-release capsules
If you’re living with Parkinson’s disease, you want to live
in the moment, not in your symptoms.
Now, an extended-release prescription therapy called RYTARY
(rye-TAR-ee) may help. With RYTARY, you may be able to spend
less time focusing on your “off” time and more time getting back
to your daily activities and the people you love.
R Y TA R Y I S F O R
Imagine time when
the focus is on you,
not on your symptoms
E AR LY
M OD E R ATE
AD VAN CE D
PAR K IN SON ’S D ISE ASE
Important Safety Information
Important Safety Information
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. Central nervous system depressants 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.
2
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.
Please see additional Important
Safety Information throughout,
complete Important Safety
Information on pages 12-14,
and Full Prescribing Information
at RYTARY.com.
48.75 mg / 195 mg • 61.25 mg / 245 mg
3
What is RYTARY?1
In clinical studies of RYTARY 1
An extended-release treatment for Parkinson’s disease.
•  Patients with early Parkinson’s disease who took RYTARY
experienced a significant improvement in their ability to move
and perform activities during the day.*
...
z
...
FDA
approved
...
Combination
treatment
...
...
Extended
release
•  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 to measure activities of daily living and ability to move (called the
Unified Parkinson’s Disease Rating Scale or UPDRS).1
†
In a clinical study measuring “off” time during waking hours.1
*
Capsule
DURING T H E DAY
•  RYTARY is an extended-release carbidopa and levodopa
capsule approved by the US Food and Drug Administration
(FDA) in 2015.
•  The combination of carbidopa and levodopa is one of the
most commonly used therapies for treating Parkinson’s
disease symptoms.2
Less “OFF”
Time
More “ON”
Time
Without
Troublesome
Dyskinesia
Important Safety Information
Important Safety Information
Do not quickly lower or change your dose or suddenly stop taking
RYTARY without talking to your healthcare provider as this may
result in developing serious side effects. Call your healthcare
provider immediately if you develop withdrawal symptoms such
as fever, confusion, or severe muscle stiffness.
4
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
taking RYTARY have experienced heart
problems while taking RYTARY.
Please see additional Important
Safety Information throughout,
complete Important Safety
Information on pages 12-14,
and Full Prescribing Information
at RYTARY.com.
48.75 mg / 195 mg • 61.25 mg / 245 mg
5
Two ways to take RYTARY 1
When taking RYTARY with food1
1. Swallow the capsule whole
•  Do not chew, divide, or crush RYTARY.
•  Know that a high-fat, high-calorie meal before you take RYTARY
can delay the absorption of RYTARY by about 2 hours. For this
reason, consideration should be given to taking the first dose of
the day about 1 to 2 hours before eating.
2. Sprinkle onto applesauce
•  Foods rich in protein or amino acids may decrease the absorption
of RYTARY.
•  You can take RYTARY with or without food.
You can take your RYTARY dose by sprinkling it onto a small
amount (1-2 tablespoons) of applesauce.
•  Gently open the RYTARY capsule by holding the ends of the
capsule and twisting it open.
•  Then sprinkle the entire contents of the RYTARY capsule onto
approximately 1-2 tablespoons of applesauce.
•  Eat the applesauce and the entire contents of RYTARY immediately.
1-2 TBS
Important Safety Information
Y O U C A N TAKE RY TARY WI T H APPLES AUC E
Important Safety Information
Patients taking RYTARY can also 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.
6
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.
Please see additional Important
Safety Information throughout,
complete Important Safety
Information on pages 12-14,
and Full Prescribing Information
at RYTARY.com.
48.75 mg / 195 mg • 61.25 mg / 245 mg
7
Learn more about RYTARY 1
•  You will start taking RYTARY 3 times a day. Your doctor will
determine the right dose of RYTARY for you to take.
THE STARTING DOSE IS 3x A DAY
•  Because of the way RYTARY is formulated, the dose of levodopa
in RYTARY may be higher than what you have received before.
Important information you need
to know about RYTARY 1
•  Always follow the recommendations of your doctor or
healthcare provider.
•  Do not quickly lower your dose or suddenly stop taking RYTARY
without first talking to your healthcare provider. Certain serious
side effects may occur when stopping or reducing levodopa.
You may develop fever, confusion, or severe muscle stiffness.1
•  Store RYTARY at 77°F (25°C).
•  Tell your doctor about any side effects you experience.
What happens to RYTARY after you take it?1
After you swallow the capsule, the medication is released from the
capsule and is absorbed into your body. The medication stays in
your body for about 4 to 5 hours.
RYTARY
is swallowed.
RYTARY
is released.
RYTARY
is still available
in the body.
Important Safety Information
Tell your healthcare provider if abnormal involuntary movements
appear or get worse during treatment with RYTARY.
8
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 additional Important
Safety Information throughout,
complete Important Safety
Information on pages 12-14,
and Full Prescribing Information
at RYTARY.com.
48.75 mg / 195 mg • 61.25 mg / 245 mg
9
Goals to aim for when you live
with Parkinson’s disease2
Know the difference between
your “off” time and “on” time
Depending on your stage of Parkinson’s disease, you may
be experiencing “off” time and “on” time.
1
Maintaining current activity level 2
“OFF” TIME is when your medication isn’t working and you
2
Experiencing more “on” time
by decreasing “off” time
“ON” TIME is when your symptoms are less apparent and
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.3
you can go about your day. You feel more mobile and flexible
and are able to move around.3
DYSKINESIA is a form of involuntary movement. Sometimes
3
Being able to move and
perform daily tasks1
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.3
FOCUS ON THE DAILY GOAL: Experience less
4
Maintaining relationships
with family and friends
“off” time each day and more “on” time without troublesome
dyskinesia (uncontrollable movements).
Important Safety Information
Tell your healthcare provider if you have
glaucoma, because RYTARY
may increase the pressure in your eyes.
Important Safety Information
Tell your healthcare provider if you have ever had an ulcer, because
RYTARY may increase your chances of having bleeding in your stomach.
10
Please see additional Important
Safety Information throughout,
complete Important Safety
Information on pages 12-14,
and Full Prescribing Information
at RYTARY.com.
48.75 mg / 195 mg • 61.25 mg / 245 mg
11
Important Safety Information
INDICATION
RYTARY (rye-TAR-ee) is a prescription medication that contains
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.
IMPORTANT SAFETY INFORMATION—for patients
Do not take RYTARY with an antidepressant medication class
known as nonselective monoamine oxidase (MAO) inhibitors
because high blood pressure can result.
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. Central nervous system
depressants 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.
Do not quickly lower or change your dose or suddenly stop
taking RYTARY without talking to your healthcare provider as this
may result in developing 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 taking RYTARY
have experienced heart problems while taking RYTARY.
12
Patients taking RYTARY can also 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.
Tell your healthcare provider if
you have any side effects while
taking RYTARY. He or she can
make adjustments that may
reduce those effects.
48.75 mg / 195 mg • 61.25 mg / 245 mg
13
Important Safety Information, cont.
Notify your healthcare provider if you become pregnant or intend
to become pregnant during therapy or if you intend to breastfeed or are breast-feeding an infant.
Facts about Parkinson’s disease
1M
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.
PEOPLE
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 may be carefully opened and
the entire contents sprinkled on a small amount of applesauce
(1 to 2 tablespoons) and taken immediately.
60s
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. Please read the Full Prescribing Information and
talk to your healthcare provider for more information concerning
your treatment if you have questions, or go to RYTARY.com.
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.
LE ARN MORE AT RY TARY.COM
14
YOUR
Approximately 1 million people in the
US have Parkinson’s disease.4
Most people with Parkinson’s
disease are diagnosed while
in their 60s.2
1967
In the early 1960s, levodopa was first
introduced as a medication. Yet, it
wasn’t until 1967 that doctors started
using it regularly with patients.5
1817
Parkinson’s disease is named for the
English physician Dr. James Parkinson.
He wrote an essay about the condition
back in 1817. To honor his birthday,
April 11 is World Parkinson’s Day.6
Please see additional Important
Safety Information throughout,
complete Important Safety
Information on pages 12-14,
and Full Prescribing Information
at RYTARY.com.
48.75 mg / 195 mg • 61.25 mg / 245 mg
15
Living with Parkinson’s disease
Exercising body and mind
Each year in the United States, around 60,000 people learn that
they have Parkinson’s disease.4 While hearing this news is never
easy, you can take steps in the right direction. Start by making
positive lifestyle changes, learn as much as you can about your
medication, and stay optimistic.
Patients with Parkinson’s disease who exercise do better than
those patients who don’t.8 So if you have a favorite exercise or
activity that you enjoy, stick with it.
For the body9:
•  Walking.
Three areas that can help:
•  Yoga/tai chi.
•  Marching to music while swinging your arms.
•  Aerobics or dance class.
•  Video sports games and balance activities—
involve your grandkids.
•  Be sure to tailor the exercise to your abilities, and talk
to your doctor before starting any exercise plan.
Eating Well
Body & Mind
Family/Caregivers
Eating well
Good nutrition is important at any age. With Parkinson’s, there
are a few goals to keep in mind:
•  Eat a balanced diet. Ask your doctor or talk to a nutritionist
if you need help.7
•  Fiber can be helpful.
•  Drink enough water.
•  Tell your doctor about all medications you take, including
vitamins or supplements.
16
For the mind9:
•  Jigsaw or crossword puzzles.
•  Board games or card games.
•  Sudoku or other memory games.
Important Safety Information
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.
Please see additional Important
Safety Information throughout,
complete Important Safety
Information on pages 12-14,
and Full Prescribing Information
at RYTARY.com.
48.75 mg / 195 mg • 61.25 mg / 245 mg
17
Involving your family and caregivers
Tips for caregivers10
Taking care of your health is a team effort. This includes you,
your doctor, your family, and any other friends or caregivers who
may support you. Good communication can help you stay on
top of your condition. Be sure to tell your family and caregivers
as much as you can about how you are feeling so that they can
support you as much as possible.
Talk Openly
Learn More
Find Support
1. Respect the journey. Even though you might have an idea
of what a loved one is going through, only he or she can
understand the journey. Be respectful.
2. T
alk openly. It’s important to communicate with each other
about your feelings on both sides.
3. D
on’t let this disease take over. Your loved one may have
a disease, but he or she is not “the” disease. While this is a
challenge, don’t forget who your loved one is.
4. Learn more. Educate yourself as much as you can about
Parkinson’s disease. You don’t need to learn it all at once.
Take your time.
5. Find a support group. Seek help from friends, family, and
other caregivers. Plus, you can give back and support others.
6. T
ake care of yourself. Spend time relaxing and choosing
enjoyable activities, and make time for you.
Important Safety Information
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.
18
Please see additional Important
Safety Information throughout,
complete Important Safety
Information on pages 12-14,
and Full Prescribing Information
at RYTARY.com.
48.75 mg / 195 mg • 61.25 mg / 245 mg
19
More resources
American Parkinson Disease Association
1.800.223.2732
apdaparkinson.org
National Parkinson Foundation
1.800.473.4636
parkinson.org
The Michael J. Fox Foundation for Parkinson’s Research
1.800.708.7644
michaeljfox.org
Parkinson’s Disease Foundation
1.800.457.6676
pdf.org
Two options to help you pay
for your RYTARY prescription
If you need help paying for your prescription, there are several
options available.
FO R T H OSE W I T H PR I VAT E I NSU R A N C E
Get the RYTARY Co-Pay Savings Card for help in paying for
your RYTARY prescription. Whether your doctor has prescribed
one strength of RYTARY or two, you may be able to save. See the
RYTARY Co-pay Savings Card brochure for terms, conditions, and
eligibility criteria.
FO R T H OSE W I T H LI T T LE O R N O I NSU R A N C E
References: 1. RYTARY [package insert]. Hayward, CA: Impax Laboratories, Inc.;
2015. 2. Olanow CW, Stern MB, Sethi K. The scientific and clinical basis for the
treatment of Parkinson disease. Neurology. 2009;72(suppl 4):S1-S136. 3. 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. 4. Parkinson’s disease overview. National
Parkinson Foundation website. http://www.parkinson.org/parkinson-s-disease.aspx.
Accessed August 10, 2014. 5. Tolosa E, Marti MJ, Valldeoriola F, Molineuvo JL.
History of levodopa and dopamine agonists in Parkinson’s disease treatment.
Neurology. 1998;50(6 suppl 6):S2-S10, S44-S48. 6. Dr James Parkinson. Parkinson’s
UK website. http://www.parkinsons.org.uk/content/dr-james-parkinson.
Accessed August 10, 2014. 7. Traviss K. Nutrition and Parkinson’s disease: what
matters most? Parkinson’s Disease Foundation website. http://www.pdf.org/
en/winter06_07_Nutrition_and_Parkinson. Accessed August 10, 2014. 8. Golbe LI,
Mark MH, Sage JI. Parkinson’s Disease Handbook. New Brunswick, NJ: The
American Parkinson’s Disease Association, Inc; 2010:21-31. 9. Exercise and
physical therapy. Parkinson’s Disease Clinic and Research Center at UCSF website.
http://pdcenter.neurology.ucsf.edu/patients-guide/exercise-and-physical-therapy.
Accessed August 10, 2014. 10. The PD partnership: tips for people with PD and
their care partners. Parkinson’s Disease Foundation website. www.pdf.org/pdf/
fs_pd_partnership_08.pdf. Accessed August 10, 2014.
20
Through the RYTARY Patient Assistance Program, people with
limited income or no insurance may be eligible for extra financial
assistance. Call 1-877-764-9021 to learn more.
Important Safety Information
Tell your healthcare provider if you have
any side effects while taking RYTARY.
He or she can make adjustments that
may reduce those effects.
Please see additional Important
Safety Information throughout,
complete Important Safety
Information on pages 12-14,
and Full Prescribing Information
at RYTARY.com.
48.75 mg / 195 mg • 61.25 mg / 245 mg
21
The MyRYTARY™ Patient Resources
Program is here to support you
The MyRYTARY ™ Patient Resources Program is here to support
you and your caregivers with helpful tools and resources.
Symptom Tracker
Help your doctor manage your symptoms.
Take notes of any changes you notice when
you start taking RYTARY.
Taking RYTARY Reminders
Keep this booklet of reminders of how to take
your RYTARY dose.
RYTARY Co-Pay Savings Card
Rx
•  Pay no more than $25 on your RYTARY
prescription with private insurance.*
•  No additional costs if you’re prescribed
a second dosage strength.*
RYTARY.com website
Visit RYTARY.com for more information about your
treatment and living with Parkinson’s disease.
*
p to $100 maximum benefit. See terms, conditions, and eligibility
U
criteria inside the RYTARY Co-Pay Savings Card brochure.
Important Safety Information
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.
22
E V ERY MOMENT COUNT S
Please see additional Important
Safety Information throughout,
complete Important Safety
Information on pages 12-14,
and Full Prescribing Information
at RYTARY.com.
48.75 mg / 195 mg • 61.25 mg / 245 mg
23
Your time matters.
Make the most of it.
V ISIT RYTARY.C O M
Important Safety Information
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.
RYTARY and MyRYTARY are trademarks of Impax Laboratories, Inc.
©2015 Impax Pharmaceuticals, a division of Impax Laboratories, Inc.
All rights reserved. PP-PAT-RYT-US-0015 04/15
48.75 mg / 195 mg • 61.25 mg / 245 mg