Stelara (ustekinumab Injection) FAQ (cont.)

STELARA™ may improve your psoriasis but may also lower the ability of your immune system to fight infections. This may also increase your risk for certain types of cancer.

It is not known if STELARA™ is safe and effective in children.

It is not known if taking STELARA™ for more than 2 years is safe and effective.

What should I tell my doctor before receiving STELARA™?

Before receiving STELARA™, tell your doctor if you:

  • have any of the conditions or symptoms listed in the section “What is the most important information I should know about STELARA™?”
  • have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA™ should not receive live vaccines. 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 vaccine during the one year before taking STELARA™ or one year after you stop taking STELARA™.
  • receive phototherapy for your psoriasis.
  • have any other medical conditions.
  • are pregnant or planning 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 with your doctor.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • other medicines that affect your immune system.
  • certain medicines that can affect how your liver breaks down other medicines.

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How will I receive STELARA™?

  • STELARA™ is given by injection under the skin (subcutaneous injection).
  • STELARA™ should only be given by a healthcare provider as directed by your doctor.
  • Your doctor will decide the right dose of STELARA™ for you and how often you should receive it.
  • Be sure to keep all of your scheduled follow-up appointments.

What should I avoid while receiving STELARA™?

You should not receive a live vaccine while taking STELARA™. See “What should I tell my doctor before taking STELARA™?”

What are the possible side effects of STELARA™?

STELARA™ can increase your chances of having serious side effects. See “What is the most important information I should know about STELARA™?”

Common side effects of STELARA™ include:

  • upper respiratory infections
  • headache
  • tiredness

These are not all of the possible side effects of STELARA™. Tell your doctor about any side effect that bothers you or that does not go away. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about STELARA™

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

This Medication Guide summarizes the most important information about STELARA™. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about STELARA™ that was written for healthcare professionals. For more information, go to or call 1-800-457-6399.

What are the ingredients in STELARA™?

Active ingredient: ustekinumab

Inactive ingredients: sucrose, L-histidine, and polysorbate 80.

Manufactured by Cilag AG, Schaffhausen, Switzerland for Centocor Ortho Biotech Inc. Horsham, PA 19044

Revised September 2009

This Medication Guide has been approved by the U.S. Food and Drug Administration.

U.S. License No. 1821

© Centocor Ortho Biotech Inc. 2009

SOURCE: FDA; "MEDICATION GUIDE STELARATM (stel ar' a) (ustekinumab) Injection."

Last Editorial Review: 12/3/2009 12:35:45 PM