Important Safety Information

Thank You For Requesting The STELARA® Information Kit

You can now access your Information Kit electronically, and learn about what's possible with STELARA®.

You will also receive an e-mail within the next 24 hours that contains a link to your E-kit. Click on the link to build and read your E-kit at your convenience.

To ensure you receive timely information about STELARA® and plaque psoriasis, please add to your e-mail address book. In the meantime, explore our website to learn more about STELARA® and start taking advantage of all the resources available to you.


STELARA® is a prescription medicine approved to treat adults 18 years and older with moderate or severe plaque psoriasis that involves large areas or many areas of their body, who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). LEARN MORE >

STELARA® is a prescription medicine approved to treat adults 18 years and older with active psoriatic arthritis, either alone or with methotrexate.

STELARA® is a 45 mg or 90 mg injection given under the skin by a healthcare provider or self-injected as directed by your doctor.


STELARA® is a prescription medicineA drug that is only available with written instructions from a healthcare professional to a pharmacist. that affects your immune system. STELARA® can increase your chance of having serious side effects including:

Serious Infections

STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB)An infectious disease, most commonly of the lungs, resulting in coughing, fever, chest pain, and weight loss., and infections caused by bacteria, fungi, or virusesGerms that grow within the body and cause a disease..

  • Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®.
  • If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®.
You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.

Before starting STELARA, tell your doctor if you think you have an infection or have symptoms of an infection such as:
  • fever, sweats, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in your phlegm
  • weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal
  • feel very tired
  • are being treated for an infection
  • get a lot of infections or have infections that keep coming back
  • have TB, or have been in close contact with someone who has TB
  • After starting STELARA, call your doctor right away if you have any symptoms of an infection (see above).

    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)Proteins that increase the growth and function of white blood cells, which are found in your immune system. and interleukin 23 (IL-23)Proteins that increase the growth and function of white blood cells, which are found in your immune system. are at a higher risk for certain serious infections that can spread throughout the body and cause death. It is not known if people who take STELARA® will get any of these infections because of the effects of STELARA® on these proteins.


    STELARA® may decrease the activity of your immune systemA system inside the body that protects against germs and infections. and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.

    Reversible posterior leukoencephalopathy syndrome (RPLS)

    RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.

    Serious Allergic Reactions

    Serious allergic reactions can occur. Get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, trouble breathing, throat or chest tightness, or skin rash.

    Before receiving STELARA®, tell your doctor if you:
    • have any of the conditions or symptoms listed above for serious infections, cancers, or RPLS
    • ever had an allergic reaction to STELARA® or any of its ingredients. 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 immunizationAn injection that provides protection against diseases. (vaccine). People who take STELARA® should not receive live vaccinesA vaccine made with living organisms.. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccineAn injection that protects against tuberculosis. during the one year before taking STELARA® or one year after you stop taking 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
    • receive or have received phototherapy for your psoriasis
    • have any other medical conditions
    • are pregnant or plan to become pregnant. It is not known if STELARA® will harm your unborn baby. You and your doctor should decide if you will take STELARA®
    • are breast-feeding or plan to breast-feed. It is thought that STELARA® passes into your breast milk. You should not breast-feed while taking STELARA® without first talking to your doctor.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplementsNatural substances, made from herbs, that are used for medical reasons..Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

    When prescribed STELARA®:
    • Use STELARA® exactly as prescribed by your doctor
    • 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®. Do not try to inject STELARA® yourself until you or your caregiver has been shown how to inject STELARA® by your doctor or nurse.

    Common side effects of STELARA® include: upper respiratory infectionsA bodily infection that affects the nose, throat, and larynx (voice box)., headache, tiredness, joint pain and nausea.These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

    Please read the Full Prescribing Information, including the Medication Guide for STELARA®, and discuss any questions you have with your doctor.

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