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What should I tell my doctor before receiving STELARA'“?
Before receiving STELARA?” tell your doctor if you:
• have any of the conditions or symptoms listed in the
section “What is the most important information I should
know about STELARA™?”
• have recently received or are scheduled to receive an
immunization (vaccine). People who take STELARA1
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 STELARA™
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
STELARA1
'' will harm your unborn baby. You and your doctor
should decide if you will take STELARA™
• are breast-feeding or plan to breast-feed. It is thought
that STELARA“1
passes into your breast milk. You should
not breast-feed while taking STELARA™ without first
talking with 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.
Ask your doctor or pharmacist if you are not sure if your
medicine is one that is listed above.
Know the medicines you take. Keep a list of them to show
your doctor and pharmacist when you get a new medicine.
How will I receive STELARA™?
• STELARA"
is given by injection under the skin
(subcutaneous injection).
• STELARA “’ should only be given by a healthcare provider as
directed by your doctor.
• Your doctor will decide the right dose of STELARA'“1
for you
and how often you should receive it.
• Be sure to keep all of your scheduled follow-up
appointments.
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What should I avoid while receiving STELARA™?
You should not receive a live vaccine while taking STELARA.“’
See “What should I tell my doctor before taking STELARA “1?'1
What are the possible side effects of STELARA™?
STELARA
can increase your chances of having serious
side effects. See “What is the most important information I
should know about STELARA™?”
Common side effects of STELARA™ include:
• upper respiratory infections
• headache
• tiredness
These are not all of the possible side effects of STELARA?'1
Tell your doctor about any side effect that bothers you or that
does not go away. For more information, ask your doctor or
pharmacist.
Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088
or to Centocor Ortho Biotech Inc. at 1-800-457-6399.
General information about STELARA™
Medicines are sometimes prescribed for purposes other than
those listed in a Medication Guide.
This Medication Guide summarizes the most important
information about STELARA™ If you would like more
information, talk with your doctor. You can ask your doctor
or pharmacist for information about STELARA™ that was
written for healthcare professionals.
What are the ingredients in STELARA1“?
Active ingredient: ustekinumab
Inactive ingredients: L-histidine, L-histidine monohydrochloride
monohydrate, polysorbate 80, and sucrose.
Prefilled Syringe Manufactured by: Centocor Ortho Biotech Inc.,
Horsham, PA 19044, License No. 1821 at Baxter Pharmaceutical
Solutions, Bloomington, IN 47403
Vial Manufactured by: Centocor Ortho Biotech Inc,,
Horsham, PA 19044, License No. 1821 at Cilag AG,
Schaffhausen, Switzerland
Revised December 2009
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
U.S. License No. 1821
© Centocor Ortho Biotech Inc. 2010
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