Stimuli 8 - Bubbles_W1NOcontext_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.

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).
• Numbness, tingling, weakness, vision
problems, or dizziness.
• Chills, swollen lymph nodes, night sweats,
fever, or weight loss.
• Bruising, bleeding, and pale skin.
• Shortness of breath, swelling of ankles or
feet, or sudden weight gain.
• Chest discomfort or pain, shortness of
breath, joint pain or a rash on your cheeks or
arms.

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.

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.

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.
• have any nervous system or heart problems.
• have lived in or traveled to other countries.
• have been recently been vaccinated or are
scheduled to receive a vaccination (including
a flu shot).
• are taking the medicine Kineret (anakinra).

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.
• have any nervous system or heart problems.
• have lived in or traveled to other countries.
• have been recently been vaccinated or are
scheduled to receive a vaccination (including
a flu shot).
• are taking the medicine Kineret (anakinra).

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).
• Numbness, tingling, weakness, vision problems,
or dizziness.
• Chills, swollen lymph nodes, night sweats, fever,
or weight loss.
• Bruising, bleeding, and pale skin.
• Shortness of breath, swelling of ankles or feet, or
sudden weight gain.
• Chest discomfort or pain, shortness of breath,
joint pain or a rash on your cheeks or arms.

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