Stelara™ (ustekinumab) Injection

MEDICATION GUIDE STELARA™
(stel ar' a) (ustekinumab) Injection

Stelara™ introduction

Read this Medication Guide before you start taking STELARA™ and each time before you get an injection. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment with STELARA™.

What is the most important information I should know about STELARA™?

STELARA™ is a medicine that affects your immune system. STELARA™ can increase your chances 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 while taking STELARA™, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.

  • Your doctor should check you for TB before starting STELARA™.
  • If your doctor 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 doctor should watch you closely for signs and symptoms of TB 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) and interleukin 23 (IL-23) are at a higher risk for certain serious infections. These infections 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 in your body.

Cancers:

STELARA™ may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your doctor if you have ever had any type of cancer.

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:

What is STELARA™?

STELARA™ is a prescription medicine used to treat adults 18 years and older with moderate or severe 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).



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