STELARA™ is a prescription medicine approved to treat adults 18 years and older with moderate or severe psoriasis that involves large areas
or many areas of their body, who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light
alone or with pills).
IMPORTANT SAFETY INFORMATION
STELARA'
is
a
prescription medicine that affects your immune
system. STELARA" can increase your chance of having serious
side effects including:
Serious Infections
STELARA" may lower your ability to fight infections and may
increase your risk of infections. While taking STELARAT some
people have serious infections, which may require hospitalization,
including tuberculosis (TB)r and infections caused by bacteria,
fungi, or viruses.
* Your doctor should check you for TB before starting
STELARA1
' and watch you closely for signs and symptoms of
TB during treatment with STELARAT
* If your doctor feels that you are at risk for TB, you may be
treated for TB before and during treatment with STELARAT
You should not start taking STELARA" if you have any kind of
infection unless your doctor says it is okay.
Before starting STELARA." tell vour doctor if you think you have
an infection or have symptoms of an infection such as:
* fever, sweats, or chills
* muscle aches
* cough
* shortness of breath
* blood in your phlegm
* weight loss
* warm, red, or painful skin or sores on your body
* diarrhea or stomach pain
* burning when you urinate or urinate more often than normal
* fee! very tired
* are being treated for an infection
* get a lot of infections or have infections that keep coming back
* have TB, or have been in close contact with someone
who hasTB
After starting STELARAT call vour doctor right away if you have
any symptoms of an infection (see above}.
STELAR AIM
can make you more likely to get infections or make
an infection that you have worse. People who have a genetic
problem where the body does not make any of the proteins
interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher
risk for certain serious infections that can spread throughout
the body and cause death. It is not known if people who take
STELARA™ will get any of these infections because of the effects
of STELARA"' on these proteins.
Cancer
STELARA" may decrease the activity of your immune system
and increase your risk for certain types of cancer. Tell your
doctor if you have ever had any type of cancer.
Reversible posterior leukoencephalopathy syndrome (RPLS)
RPLS is a rare condition that affects the brain and can cause
death. The cause of RPLS is not known.
If
RPLS is found early
and treated, most people recover. Tell your doctor right away if
you have any new or worsening medical problems including:
headache, seizures, confusion, and vision problems.
Before receiving STELARAT tell your doctor if you:
* have any of the conditions or symptoms listed above for
serious infections, cancer, or RPLS.
* have recently received or are scheduled to receive an
immunization (vaccine). People who take STELARA" should
not receive live vaccines. Tell your doctor if anyone in your
house needs a vaccine. The viruses used in some types of
vaccines can spread to people with a weakened immune
system, and can cause serious problems.
You should not
receive the BCG vaccine during the one year before taking
STELARA™ or one year after you stop taking STELARAT
Non-live vaccinations received while taking STELARA"
may not fully protect you from disease.
* receive phototherapy for your psoriasis.
* have any other medical conditions.
* are pregnant or plan to become pregnant. It is not known if
STELARA"' will harm your unborn baby. You and your doctor
should decide if you will take STELARAT
* are breast-feeding or plan to breast-feed. It is thought that
STELARA" passes Into your breast milk. You should not
breast-feed while taking STELARA" without first talking
to your doctor.
Tell your doctor about all the medicines you take,
including
prescription and non-prescription medicines, vitamins, and
herbal supplements. Especially tell your doctor if you take:
* other medicines that affect your immune system
* certain medicines that can affect how your liver
breaks down other medicines
Common side effects of STELARA™ include:
upper
respiratory infections, headache, and firedness.
These are not all of the side effects with STELARAT
Tell your doctor about any side effect that bothers you
or does not go away. Ask your doctor or pharmacist for
more information.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www,fda.gov/medwatch
or call 1-800-FDA-1088.
Please read accompanying Medication Guide for STELARA™
and discuss any questions you have with your doctor.
©
Centocor Ortho Biotech Inc. 2010 07/10 25US09039B
