Stimuli 5 - OTC_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 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.

Stop using Rheutopia and call your doctor right away if you develop:
• Fever, cough, flu-like symptoms, skin infection
•B
 ruising, bleeding, and pale skin. Your body
(red, warm, painful skin or open sores). These
may not make enough blood cells to fight
can be symptoms of a serious infection.
infection or to help stop bleeding.
• Numbness, tingling, weakness, vision problems,
•S
 hortness of breath, swelling of ankles or feet,
or dizziness. Symptoms of nervous system
or sudden weight gain. These are symptoms
diseases, like multiple sclerosis, may develop or
of heart failure that may develop or get worse.
get worse.
•C
 hest discomfort or pain, shortness of breath,
• Chills, swollen lymph nodes, night sweats, fever,
joint pain or a rash on your cheeks or arms.
or weight loss. You may have a higher chance of
These may be symptoms of an immune
getting lymph node cancer.
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 3A_Warnings

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 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.

Stop using Rheutopia and call your doctor right away if you develop:
• Fever, cough, flu-like symptoms, skin infection (red, • Bruising, bleeding, and pale skin. Your body may
warm, painful skin or open sores). These can be
not make enough blood cells to fight infection or
symptoms of a serious infection.
to help stop bleeding.
• Numbness, tingling, weakness, vision problems, or • Shortness of breath, swelling of ankles or feet, or
dizziness. Symptoms of nervous system diseases,
sudden weight gain. These are symptoms of heart
like multiple sclerosis, may develop or get worse.
failure that may develop or get worse.
• Chills, swollen lymph nodes, night sweats, fever,
• Chest discomfort or pain, shortness of breath,
or weight loss. You may have a higher chance of
joint pain or a rash on your cheeks or arms.
getting lymph node cancer.
These may be symptoms of an immune reaction
with lupus-like syndrome.
Common side effects
•R
 edness, rash, swelling, itching or bruising where the shot was given.
•H
 eadache
•R
 unny 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 3B_Warnings