AUTIONS (5.5)].
Inform patients the needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex [see DOSAGE AND ADMINISTRATION (2.4)]
Immunizations
Inform patients that STELARA® can interfere with the usual response to immunizations and that they should avoid live vaccines [see WARNINGS AND PRECAUTIONS (5.7)].
Pregnancy Registry
Inform patients that there is a pregnancy registry to monitor fetal outcomes of pregnant women exposed to STELARA® [see USE IN SPECIFIC POPULATIONS (8.1)].
Administration
Instruct patients to follow sharps disposal recommendations, as described in the Instructions for Use.
SPL UNCLASSIFIED SECTION
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
© 2012, 2016 Janssen Biotech, Inc.
MEDICATION GUIDE
This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 11 2016
MEDICATION GUIDE
STELARA (stel ar' a)
(ustekinumab)
injection, for subcutaneous or intravenous use
What is the most important information I should know about STELARA?
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.
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, sweat, or chills
muscle aches
cough
shortness of breath
blood in 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 with 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. People who take STELARA may also be more likely to get these infections.
Cancers:
STELARA may decrease the ac |
