IMPORTANT SAFETY INFORMATION
After starting YESINTEK, call your healthcare provider right away if you have any symptoms of
an infection (see above). These may be signs of infections such as chest infections, or skin infections or
shingles that could have serious complications. YESINTEK 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. These
infections can spread throughout the body and cause death. People who take YESINTEK may also be more likely to
get these infections.
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Cancers: YESINTEK may decrease the activity of your immune system and increase your risk for
certain types of cancer. Tell your healthcare provider if you have ever had any type of cancer. Some people
who are receiving ustekinumab products and have risk factors for skin cancer developed certain types of skin
cancers. During your treatment with YESINTEK, tell your healthcare provider if you have any new skin growths.
Serious Allergic Reactions: Serious allergic reactions including death can occur with YESINTEK.
Stop using YESINTEK and get medical help right away if you have any symptoms of a serious allergic reaction,
such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, trouble breathing,
or skin rash.
Posterior Reversible Encephalopathy Syndrome (PRES):
PRES is a rare condition that affects the brain and can cause death. Tell your healthcare provider right away if
you have any symptoms of PRES during treatment with YESINTEK, including headache, seizures, confusion, and
vision problems.
Lung Inflammation: Cases of lung inflammation have happened in some people who receive
ustekinumab and may be serious. These lung problems may need to be treated in a hospital. Tell your healthcare
provider right away if you develop shortness of breath or a cough that doesn’t go away during treatment with
YESINTEK.
Common side effects of YESINTEK include: nasal congestion, sore throat, and runny nose, redness
at the injection site, upper respiratory infections, vaginal yeast infections, fever, urinary tract infections,
headache, sinus infection, tiredness, bronchitis, itching, diarrhea, nausea and vomiting, stomach pain,
influenza and joint pain. These are not all of the possible side effects with YESINTEK. Tell your doctor for
medical advice about side effects.
Before you receive YESINTEK, tell your doctor about all of your
medical conditions, including if you:
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have any of the conditions or symptoms listed above for serious
infections, cancers, or PRES.
-
ever had an allergic reaction to ustekinumab or any of its ingredients. Ask your healthcare provider if you
are not sure.
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have recently received or are scheduled to receive an immunization (vaccine). People who take YESINTEK should
not receive live vaccines. Tell your healthcare provider if anyone in your house needs a live vaccine. The
viruses used in some types of live 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
receiving YESINTEK or one year after you stop receiving
YESINTEK.
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have any new or changing lesions within psoriasis areas or on normal
skin.
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are receiving or have received allergy shots, especially for serious
allergic reactions. Allergy shots may not work as well for you during
treatment with YESINTEK. YESINTEK may also increase your risk of
having an allergic reaction to an allergy shot.
- receive or have received phototherapy for your psoriasis.
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are pregnant or plan to become pregnant. It is not known if YESINTEK can harm your unborn baby. You and your
healthcare provider should decide if you will receive YESINTEK.
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are breastfeeding or plan to breastfeed. YESINTEK can pass into your
breast milk.
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talk to your healthcare provider about the best way to feed your baby if you receive YESINTEK.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines
you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should YESINTEK be used:
- Use YESINTEK exactly as your healthcare provider tells you to. The healthcare provider will determine the
right dose of YESINTEK, the amount for each injection, and how often it should be given. Be sure to keep all
scheduled follow up appointments.
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Adults with Crohn’s disease and ulcerative colitis will receive the first dose of YESINTEK through a vein in
the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour to
receive the full dose of medicine. YESINTEK will be received as an injection under the skin (subcutaneous
injection) 8 weeks after the first dose of YESINTEK, as described below.
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Adults and children 6 years of age and older with plaque psoriasis or psoriatic arthritis will receive
YESINTEK as an injection under the skin as described below.
Injecting YESINTEK under your skin:
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YESINTEK is intended for use under the guidance and supervision of your healthcare provider.
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In children, it is recommended that YESINTEK be administered by a healthcare provider. If your healthcare
provider decides that you or a caregiver may give your injections of YESINTEK at home, you should receive
training on the right way to prepare and inject YESINTEK. Do not try to inject YESINTEK until you have been
shown how to inject YESINTEK by a healthcare provider.
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YESINTEK can be injected under the skin in your upper arms, buttocks, upper legs (thighs) or stomach area
(abdomen).
- Do not give an injection in an area of the skin that is tender, bruised, red or hard.
-
Use a different injection site each time you use YESINTEK.
If you inject more YESINTEK than prescribed, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest emergency room right away.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit
https://www.fda.gov/medwatch
or call 1-800-FDA-1088.