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).

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 as directed by your doctor at weeks 0, 4, and every 12 weeks thereafter. It is administered by a healthcare provider or self-injected only after proper training.

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.

Cancers

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:

When prescribed STELARA:

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch 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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