WARNINGS
What is the most important information I should know about STELARA?
STELARA is a medicine that affects your immune system. STELARA can increase your risk of having serious side effects, including:
Serious infections. STELARA may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections during treatment with STELARA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.
Your healthcare provider should check you for TB before starting STELARA.
If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with STELARA and during treatment with STELARA.
Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with STELARA.
You should not start STELARA if you have any kind of infection unless your healthcare provider says it is okay.
Before starting STELARA, tell your healthcare provider if you:
think you have an infection or have symptoms of an infection such as:
fever, sweat, or chills
weight loss
muscle aches
warm, red, or painful skin or sores on your body
cough
diarrhea or stomach pain
shortness of breath
burning when you urinate or urinate more often than normal
blood in phlegm
feel very tired
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 STELARA, 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. STELARA 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 STELARA may also be more likely to get these infections.
• Cancers. STELARA 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 STELARA and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with STELARA, tell your healthcare provider if you develop any new skin growths.
USES
STELARA is a prescription medicine used to treat:
• 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.
It is not known if STELARA is safe and effective in children with Crohn’s disease or ulcerative colitis or in children less than 6 years of age with plaque psoriasis or psoriatic arthritis.
HOW TO USE
How should I use STELARA?
Use STELARA exactly as the healthcare provider tells you to. The healthcare provider will determine the right dose of STELARA, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow-up appointments.
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. STELARA will then be received as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of STELARA, as described below.
Adults and children 6 years of age and older with plaque psoriasis or psoriatic arthritis will receive STELARA as an injection under the skin as described below.
Injecting STELARA under the skin
STELARA is intended for use under the guidance and supervision of a healthcare provider.
In children, it is recommended that STELARA be administered by a healthcare provider. If a healthcare provider decides that you or a caregiver may give the injections of STELARA at home, you or a caregiver should receive training on the right way to prepare and inject STELARA.
Do not try to inject STELARA until you have been shown how to inject STELARA by a healthcare provider.
STELARA 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 STELARA.
• If you inject too much STELARA, call the healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest emergency room right away.
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, syringes, and vials. 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 are the possible side effects of STELARA?
STELARA may cause serious side effects, including:
• See “What is the most important information I should know about STELARA?”
• Serious allergic reactions. Serious allergic reactions can occur with STELARA. Stop using STELARA and get medical help right away if you get any of the following symptoms of a serious allergic reaction:
feeling faint chest tightness
swelling of your face, eyelids, tongue, or throat
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 get any symptoms of PRES during treatment with STELARA, including:
headache
confusion
seizures
vision problems
• Lung inflammation. Cases of lung inflammation have happened in some people who receive STELARA, 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 STELARA.
The most common side effects of STELARA 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
• joint pain
These are not all of the possible side effects of STELARA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Janssen Biotech, Inc. at 1-800-526-7736.
General information about the safe and effective use of STELARA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use STELARA for a condition for which it was not prescribed. Do not give STELARA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about STELARA that was written for health professionals.
What are the ingredients in STELARA?
Active ingredient: ustekinumab
Inactive ingredients: Single-dose prefilled syringe and single-dose vial for subcutaneous use contain L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, and sucrose. Single-dose vial for intravenous infusion contains EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 80, and sucrose.
OVERDOSE
If you inject too much STELARA, call the healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest emergency room right away.
MISSED DOSE
Please call the healthcare provider for more information.
STORAGE
How should I store STELARA?
• Store STELARA vials and prefilled syringes in a refrigerator between 36-degree F to 46-degree F (2 -degree C to 8-degree C).
• Store STELARA vials standing up straight (upright).
• 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 86-degree F (30-degree C) 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.
• After a prefilled syringe has been stored at room temperature, do not return it to the refrigerator.
• Throw away (discard) the prefilled syringe if it is 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.
NOTES
Medication Guide: revision date 06/2025
Prescribing Information: revision date 06/2025
1. ) Concomitant Therapies
In trials in subjects with plaque psoriasis the safety of STELARA in combination with immunosuppressive agents or phototherapy has not been evaluated. In trials in subjects with psoriatic arthritis, concomitant MTX use did not appear to influence the safety or efficacy of STELARA. In trials in subjects with Crohn’s disease (CD-1 and CD-2) and ulcerative colitis (UC-1), immunomodulators (6-MP, AZA, MTX) were used concomitantly in approximately 30% of subjects and corticosteroids were used concomitantly in approximately 40% and 50% of Crohn’s disease and ulcerative colitis subjects, respectively. Use of these concomitant therapies did not appear to influence the overall safety or efficacy of STELARA.
2.) CYP450 Substrates
The formation of CYP450 enzymes can be suppressed by increased levels of certain cytokines (e.g., IL-1, IL-6, TNFα, IFN) during chronic inflammation. Thus, use of STELARA, an antagonist of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of STELARA in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and adjust the individual dosage of the CYP substrate as needed. See the prescribing information of specific CYP substrates. A CYP-mediated drug interaction effect was not observed in subjects with Crohn’s disease.
3.) Allergen Immunotherapy
STELARA has not been evaluated in patients who have undergone allergy immunotherapy. STELARA may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis
Before you use or receive STELARA, 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 STELARA?”
• ever had an allergic reaction to STELARA. Ask your healthcare provider 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 are being treated with STELARA 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 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 healthcare provider should decide if you will receive STELARA.
• are breastfeeding or plan to breastfeed. STELARA can pass into your breast milk.
• Talk to your healthcare provider about the best way to feed your baby if you receive STELARA.
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.
