Stimuli 6 - Bubbles_D1NOcontext_110510

Drug Approved by FDA: 2005
Last Revised: May 2009

Rheutopia [Roo-TOH-pee-ah] (also known as arixalate)
Uses

Tell Your Doctor

• Rheumatoid arthritis in adults. Rheutopia
reduces painful and swollen joints, slows joint
damage, and improves mobility and
the ability to do physical activities.

Before using Rheutopia, tell your doctor if you:

• 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.

• 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
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.

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.

Draft Prototype 2A_Directions

Drug Approved by FDA: 2005
Last Revised: May 2009

Rheutopia [Roo-TOH-pee-ah] (also known as arixalate)

Uses

Tell Your Doctor

• R heumatoid arthritis in adults. Rheutopia
reduces painful and swollen joints, slows joint
damage, and improves mobility and the ability
to do physical activities.

Before using Rheutopia, tell your doctor if you:

• Polyarticular juvenile rheumatoid arthritis
(JRA) in people older than 4 years of age who
did not have good results from other medicines.
Rheutopia reduces pain, improves mobility, and
decreases the number of painful joints.

• have TB or have been near someone who has TB.

• 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.

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.

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.

• have an infection, are being treated for an infection,
or think you have an infection (such as a cold, flu
or skin infection).
• 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.

Draft Prototype 2B_Directions