• are being treated for an infection or have any open cuts.
• get a lot of infections or have infections that keep coming back.
• have TB, or have been in close contact with someone with TB.
  After starting STEQEYMA, 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. STEQEYMA 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 STEQEYMA may also be more likely to get these infections.
• Cancers. STEQEYMA may decrease the activity of your immune system and increase your risk for certain types of cancers. 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 have developed certain types of skin cancers. During your treatment with STEQEYMA, tell your healthcare provider if you develop any new skin growths.

• adults and children 6 years of age and older with moderate to severe plaque 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 of age and older with active psoriatic arthritis.
• adults with moderately to severely active Crohn's disease.
• adults with moderately to severely active ulcerative colitis.

Who should not use STEQEYMA?
Do not use STEQEYMA if you are allergic to ustekinumab products or any of the ingredients in STEQEYMA. See the end of this Medication Guide for a complete list of ingredients in STEQEYMA.

Before you use or receive STEQEYMA, tell your healthcare provider 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 STEQEYMA?"
• ever had an allergic reaction to ustekinumab products. Ask your healthcare provider if you are not sure.
• have recently received or are scheduled to receive an immunization (vaccine). People who are being treated with STEQEYMA should avoid receiving 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 avoid receiving the BCG vaccine during the one year before receiving STEQEYMA or one year after you stop receiving STEQEYMA.
• 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 STEQEYMA. STEQEYMA 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 STEQEYMA can harm your unborn baby. You and your healthcare provider should decide if you will receive STEQEYMA.
• are breastfeeding or plan to breastfeed. STEQEYMA can pass into your breast milk.
• Talk to your healthcare provider about the best way to feed your baby if you receive STEQEYMA.

• Use STEQEYMA exactly as the healthcare provider tells you to. The healthcare provider will determine the right dose of STEQEYMA, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow-up appointments.
• Adults with Crohn's disease and ulcerative colitis will receive the first dose of STEQEYMA 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. STEQEYMA will then be received as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of STEQEYMA, as described below.
• Adults and children 6 years of age and older with plaque psoriasis or psoriatic arthritis will receive STEQEYMA as an injection under the skin as described below.
• Injecting STEQEYMA under the skin
  • STEQEYMA is intended for use under the guidance and supervision of a healthcare provider.
  • In children, it is recommended that STEQEYMA be administered by a healthcare provider. If a healthcare provider decides that you or a caregiver may give the injections of STEQEYMA at home, you or a caregiver should receive training on the right way to prepare and inject STEQEYMA.
  • Do not try to inject STEQEYMA until you have been shown how to inject STEQEYMA by a healthcare provider.
  • STEQEYMA can be injected under the skin in the 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 STEQEYMA.
• If you inject too much STEQEYMA, call the healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest emergency room right away.

• Store STEQEYMA vials and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C).
• Store STEQEYMA vials standing up straight (upright).
• Store STEQEYMA in the original carton to protect it from light until time to use it.
• Do not freeze STEQEYMA.
• Do not shake STEQEYMA.
• If needed, individual STEQEYMA prefilled syringes may also be stored at room temperature up to 77ºF (25°C) for a maximum single period of up to 31 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.
• You may return the prefilled syringe to the refrigerator 1 time only during the 31-day period at room temperature or at the end of the 31-day period at room temperature.
• Throw away (discard) the prefilled syringe if not used within 31 days at room temperature storage and you did not return it to the refrigerator.
• If needed, individual STEQEYMA vials may also be stored at room temperature up to 86ºF (30°C) for a maximum single period of up to 15 days in the original carton to protect from light.
• Record the date when the vial is first removed from the refrigerator on the carton in the space provided.
• After a vial has been stored at room temperature, do not return it to the refrigerator.
• Throw away (discard) the vial if not used within 15 days at room temperature storage.
• Do not use STEQEYMA after the expiration date on the carton or on the vial or the prefilled syringe.