Stimuli 2 - OTC_D1NOcontext_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.
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.
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 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 recently been vaccinated or are
scheduled to receive a vaccination
(including a flu shot).
• are taking the medicine Kineret (anakinra).

Stop use and call your doctor right away if you develop
• Fever, cough, flu-like symptoms, a 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 3A_Directions

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.

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.
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 if you

• have lived in or traveled to other countries.
• have an infection, are being treated for an
infection, or think you have an infection (such
• h ave recently been vaccinated or are
as a cold, flu or skin infection).
scheduled to receive a vaccination (including
• have TB or have been near someone who has TB. a flu shot).
• are taking the medicine Kineret (anakinra).
• have any nervous system or heart problems.

Stop use and call your doctor right away if you develop

• Fever, cough, flu-like symptoms, a skin infection • Bruising, bleeding, and pale skin.
(red, warm, painful skin or open sores).
• Shortness

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

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 3B_Directions