STELARA- ustekinumab injection, solution
Janssen Biotech, Inc.
STELARA® (stel ar' a)
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 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.
You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.
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.
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. 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 doctor if you develop 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:
What is STELARA®?
STELARA® is a prescription medicine used to treat adults 18 years and older with:
STELARA® may improve your psoriasis and psoriatic arthritis 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.
Who should not take STELARA®?
Do not take STELARA® if you are allergic to ustekinumab or any of the ingredients in STELARA®. See the end of this Medication Guide for a complete list of ingredients in STELARA®.
Before you receive STELARA®, tell your doctor if you:
Tell your doctor 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 doctor and pharmacist when you get a new medicine.
How should I use STELARA®?
What should I avoid while using STELARA®?
You should not receive a live vaccine while taking STELARA®. See "What should I tell my doctor before receiving STELARA®?"
What are the possible side effects of STELARA®?
STELARA® may cause serious side effects, including:
Common side effects of STELARA® include:
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.
You may also report side effects to Janssen Biotech, Inc. at 1-800-JANSSEN (1-800-526-7736).
How do I store STELARA®?
Keep STELARA® and all medicines out of the reach of children.
General information about 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.
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 health professionals.
What are the ingredients in STELARA®?
Active ingredient: ustekinumab
Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, and sucrose.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Prefilled Syringe Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Baxter Pharmaceutical Solutions, Bloomington, IN 47403 and at Cilag AG, Schaffhausen, Switzerland
Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Cilag AG, Schaffhausen, Switzerland
© Janssen Biotech, Inc. 2012