Stimuli 9 - Bubbles_W1wContext_110510

Drug Approved by FDA: 2005
Last Revised: May 2009

Rheutopia [Roo-TOH-pee-ah] (also known as arixalate)
Uses
• Rheumatoid arthritis in adults. Rheutopia
reduces painful and swollen joints, slows joint
damage, and improves mobility and
the ability to do physical activities.
• Polyarticular juvenile rheumatoid arthritis in
children at least 4 years old who did not have
good results from other medicines. Rheutopia
reduces pain, improves mobility, and decreases
the number of painful joints.
• Ankylosing spondylitis. Rheutopia reduces back
pain, swelling, and improves mobility.
• Plaque psoriasis in adults who may benefit
from taking medicine or receiving phototherapy
(using ultraviolet light). Rheutopia improves or
clears up areas of skin with psoriasis.

Important Warning: Serious Infections
• Rheutopia affects the immune system.
It can lower your ability to fight infections.
Do not use Rheutopia if you have an active
infection.
• People taking Rheutopia have gotten
serious infections including tuberculosis (TB)
and infections caused by viruses, fungi, or
bacteria. Some people have died from
these infections.

Tell Your Doctor
Before using Rheutopia, tell your doctor if you:
• have an infection, are being treated for an
infection, or think you have an infection (such as
a cold, flu or skin infection).
• have TB or have been near someone who has
TB. You may be tested and treated for TB.
• have any nervous system or heart problems.
• have lived in or traveled to other countries.
There is more risk for getting TB or other
infections in certain countries.
• have been recently been vaccinated or are
scheduled to receive a vaccination (including a
flu shot). You should not get a vaccination while
taking Rheutopia.
• are taking the medicine Kineret (anakinra). The
risk of serious infections increases when used
with Rheutopia.

Call Your Doctor
Stop using Rheutopia and tell your doctor right
away if you develop:
• Fever, cough, flu-like symptoms, skin infection
(red, warm, painful skin or open sores). These
can be symptoms of a serious infection.
• Numbness, tingling, weakness, vision problems,
or dizziness. Symptoms of nervous system
diseases, like multiple sclerosis, may develop or
get worse.
• Chills, swollen lymph nodes, night sweats, fever,
or weight loss. You may have a higher chance
of getting lymph node cancer.
• Bruising, bleeding, and pale skin. Your body
may not make enough blood cells to fight
infection or to help stop bleeding.
• Shortness of breath, swelling of ankles or feet,
or sudden weight gain. These are symptoms of
heart failure that may develop or get worse.
• Chest discomfort or pain, shortness of breath,
joint pain or a rash on your cheeks or arms.
These may be symptoms of an immune reaction
with lupus-like syndrome.

Common Side Effects
• Redness, rash, swelling, itching or bruising
where the shot was given.
• Headache
• Runny nose
Call your doctor for medical advice about side
effects. You may report side effects to FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.

Directions for Use
• Rheutopia is an injection (shot). Do not use
Rheutopia until your doctor has shown you how
to give a shot.
• Store Rheutopia in the refrigerator. Do not
shake or freeze.
• If you forget to take a dose, take it as soon as
you remember. Take your next dose at your
regularly scheduled time.
• Your doctor will tell you how often to use
Rheutopia. Do not use Rheutopia more often
than prescribed.

Draft Prototype 2A_Warnings

Drug Approved by FDA: 2005
Last Revised: May 2009

Rheutopia [Roo-TOH-pee-ah] (also known as arixalate)
Uses
• R heumatoid arthritis in adults. Rheutopia reduces
painful and swollen joints, slows joint damage,
and improves mobility and the ability to do
physical activities.
• Polyarticular juvenile rheumatoid arthritis in
children at least 4 years old who did not have
good results from other medicines. Rheutopia
reduces pain, improves mobility, and decreases
the number of painful joints.
• Ankylosing spondylitis. Rheutopia reduces
back pain, swelling, and improves mobility.
• Plaque psoriasis in adults who may benefit
from taking medicine or receiving phototherapy
(using ultraviolet light). Rheutopia improves or
clears up areas of skin with psoriasis.
Important Warning: Serious Infections
• R heutopia affects the immune system.
It can lower your ability to fight infections.
Do not use Rheutopia if you have an active
infection.
• People taking Rheutopia have gotten serious
infections including tuberculosis (TB) and
infections caused by viruses, fungi, or bacteria.
Some people have died from these infections.

Tell Your Doctor
Before using Rheutopia, tell your doctor if you:
• have an infection, are being treated for an
infection, or think you have an infection
(such as a cold, flu or skin infection).
• have TB or have been near someone who has TB.
You may be tested and treated for TB.
• have any nervous system or heart problems.
• have lived in or traveled to other countries.
There is more risk for getting TB or other
infections in certain countries.
• have been recently been vaccinated or are
scheduled to receive a vaccination (including a
flu shot). You should not get a vaccination while
taking Rheutopia.
• are taking the medicine Kineret (anakinra).
The risk of serious infections increased when
used with Rheutopia.

Call Your Doctor
Stop using Rheutopia and tell your doctor right
away if you develop:
• Fever, cough, flu-like symptoms, skin infection
(red, warm, painful skin or open sores). These
can be symptoms of a serious infection.
• Numbness, tingling, weakness, vision problems,
or dizziness. Symptoms of nervous system
diseases, like multiple sclerosis, may develop or
get worse.
• Chills, swollen lymph nodes, night sweats, fever,
or weight loss. You may have a higher chance of
getting lymph node cancer.
• Bruising, bleeding, and pale skin. Your body may
not make enough blood cells to fight infection or
to help stop bleeding.
• Shortness of breath, swelling of ankles or feet, or
sudden weight gain. These are symptoms of heart
failure that may develop or get worse.
• Chest discomfort or pain, shortness of breath,
joint pain or a rash on your cheeks or arms.
These may be symptoms of an immune reaction
with lupus-like syndrome.

Common Side Effects
• Redness, rash, swelling, itching or bruising where
the shot was given.
• Headache
• Runny nose
Call your doctor for medical advice about side
effects. You may report side effects to FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Directions for Use
• R heutopia is an injection (shot). Do not use
Rheutopia until your doctor has shown you how
to give a shot.
• Store Rheutopia in the refrigerator. Do not shake
or freeze.
• If you forget to take a dose, take it as soon as
you remember. Take your next dose at your
regularly scheduled time.
• Your doctor will tell you how often to use
Rheutopia. Do not use Rheutopia more often
than prescribed.
Draft Prototype 2B_Warnings