Before you receive Ustekinumab, 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 Ustekinumab?"
• ever had an allergic reaction to Ustekinumab. 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 Ustekinumab 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 Ustekinumab or one year after you stop receiving Ustekinumab.
• 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 Ustekinumab. Ustekinumab 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 Ustekinumab can harm your unborn baby. You and your doctor should decide if you will receive Ustekinumab. See " What should I avoid while using Ustekinumab?"
• received Ustekinumab 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. Ustekinumab can pass into your breast milk.
• Talk to your doctor about the best way to feed your baby if you receive Ustekinumab

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 Ustekinumab exactly as your doctor tells you to.
• The needle cover on the Ustekinumab 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 Ustekinumab 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 Ustekinumab as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of Ustekinumab, as described below.
• Adults with psoriasis or psoriatic arthritis, and children 6 years and older with psoriasis or psoriatic arthritis will receive Ustekinumab as an injection under the skin (subcutaneous injection) as described below.
• Injecting Ustekinumab under your skin
  • Ustekinumab is intended for use under the guidance and supervision of your doctor. In children 6 years and older, it is recommended that Ustekinumab be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of Ustekinumab at home, you should receive training on the right way to prepare and inject Ustekinumab. Your doctor will determine the right dose of Ustekinumab for you, the amount for each injection, and how often you should receive it. Do not try to inject Ustekinumab yourself until you or your caregiver have been shown how to inject Ustekinumab by your doctor or nurse.
  • Inject Ustekinumab 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 Ustekinumab.
  • If you inject more Ustekinumab 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 Ustekinumab, 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, Ustekinumab can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused portion of Ustekinumab.

What should I avoid while using Ustekinumab?

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

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

If needed, individual Ustekinumab 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 Ustekinumab after the expiration date on the carton or on the prefilled syringe.

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