• adults and children 6 years and older with moderate or severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
• adults and children 6 years and older with active psoriatic arthritis.
• adults 18 years and older with moderately to severely active Crohn's disease.
• adults 18 years and older with moderately to severely active ulcerative colitis.

It is not known if STELARA is safe and effective in children less than 6 years of age.

Before you receive STELARA, tell your doctor about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section " What is the most important information I should know about STELARA?"
• ever had an allergic reaction to STELARA. Ask your doctor if you are not sure.
• are allergic to latex. The needle cover on the prefilled syringe contains latex.
• 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 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 STELARA or one year after you stop receiving STELARA.
• have any new or changing lesions within psoriasis areas or on normal skin.
• are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with STELARA. STELARA may also increase your risk of having an allergic reaction to an allergy shot.
• receive or have received phototherapy for your psoriasis.
• are pregnant or plan to become pregnant. It is not known if STELARA can harm your unborn baby. You and your doctor should decide if you will receive STELARA. See " What should I avoid while using STELARA?"
• received STELARA while you were pregnant. It is important that you tell your baby's healthcare provider before any vaccinations are given to your baby.
• are breastfeeding or plan to breastfeed. STELARA can pass into your breast milk
• Talk to your doctor about the best way to feed your baby if you receive STELARA.

Tell your doctor 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 doctor and pharmacist when you get a new medicine.

• Use STELARA exactly as your doctor tells you to.
• The needle cover on the STELARA prefilled syringe contains latex. Do not handle the needle cover if you are sensitive to latex.
• Adults with Crohn's disease and ulcerative colitis will receive the first dose of STELARA 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. You will then receive STELARA as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of STELARA, as described below.
• Adults with psoriasis or psoriatic arthritis, and children 6 years and older with psoriasis or psoriatic arthritis will receive STELARA as an injection under the skin (subcutaneous injection) as described below.
• Injecting STELARA under your skin
  • STELARA is intended for use under the guidance and supervision of your doctor. In children 6 years and older, it is recommended that STELARA be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA at home, you should receive training on the right way to prepare and inject STELARA. Your doctor will determine the right dose of STELARA for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA yourself until you or your caregiver have been shown how to inject STELARA by your doctor or nurse.
  • Inject STELARA under the skin (subcutaneous injection) 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 STELARA.
  • If you inject more STELARA than prescribed, call your doctor right away.
  • Be sure to keep all of your scheduled follow-up appointments.

Read the detailed Instructions for Use at the end of this Medication Guide for instructions about how to prepare and inject a dose of STELARA, and how to properly throw away (dispose of) used needles and syringes. The syringe, needle and vial must never be re-used. After the rubber stopper is punctured, STELARA can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused portion of STELARA.

What should I avoid while using STELARA?

You should not receive a live vaccine while taking STELARA. See " Before you receive STELARA, tell your doctor about all of your medical conditions, including if you:"

• Store STELARA vials and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C).
• Store STELARA vials standing up straight.
• Store STELARA in the original carton to protect it from light until time to use it.
• Do not freeze STELARA.
• Do not shake STELARA.

If needed, individual STELARA prefilled syringes may also be stored at room temperature up to 30°C (86ºF) for a maximum single period of up to 30 days in the original carton to protect from light. Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space provided. Once a syringe has been stored at room temperature, it should not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature storage. Do not use STELARA after the expiration date on the carton or on the prefilled syringe.

Keep STELARA and all medicines out of the reach of children.