Important Safety Information
STELARA® (ustekinumab) is a prescription medicine that affects your immune system. Before starting STELARA®, you should tell your doctor if you think you have an infection, are being treated for an infection, are receptive to infections, have tuberculosis (TB) or been in close contact with someone with TB, or have symptoms of an infection, including:
- Fever, sweats, or chills
- Muscle aches
- Shortness of breath
- Blood in phlegm
- Weight loss
- Warm, red, or painful skin or sores on your body
- Diarrhea or stomach pain
- Burning sensation when you urinate
- Urinating more often than normal
What is the most important information I should know about STELARA®?
STELARA® may lower your ability to fight infections and increase your risk of contracting them. While taking the medication, some people have serious complications, which may require hospitalization — including TB and infections caused by bacteria, fungi, or viruses.
Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment. If your doctor feels that you are at risk for TB, you may be treated for it before and during treatment with STELARA®. You should avoid taking the medication if you have an infection unless your doctor says that it is okay.
Before receiving STELARA®, tell your doctor about all of your medical conditions, including if you:
- Ever had an allergic reaction to STELARA® or any of its ingredients
- Are allergic to latex
- Have recently received or are scheduled to receive an immunization (vaccine) — as the viruses used in some types of live vaccines can spread to people with weakened immune systems and cause serious problems
- Have received the BCG vaccine during the one year before receiving or one year after you stop receiving STELARA®
- Have any new or changing lesions within psoriasis areas or on normal skin
- Are receiving or have received allergy shots, especially for serious allergic reactions
- Receive or have received phototherapy for your psoriasis
- Are pregnant or plan to become pregnant
STELARA® Side Effects
Since STELARA® can make you more likely to get infections or worsen an existing infection, you should call your doctor right away if you have any symptoms. If you’re someone with a genetic problem where the body does not make any of the proteins interleukin 12 (IL‐12) and interleukin 23 (IL‐23), you’re at a higher risk for certain serious infections that can spread throughout the body and cause death. Taking STELARA® may also increase your risk of getting these infections. Other common side effects may include:
- Upper respiratory infections
- Tiredness in psoriasis patients
- Joint pain and nausea in psoriatic arthritis patients
- Redness at the injection site
- Vaginal yeast infections
- Urinary tract infections
- Vomiting in Crohn’s disease patients
STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while taking the medication. 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 headaches, seizures, confusion, and vision problems.
Serious Allergic Reactions
Serious allergic reactions may occur. If they do, you should stop using STELARA® and get medical help right away. Common symptoms of a serious allergic reaction include feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.
Cases of lung inflammation have happened in some people who receive STELARA®, and the result can be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment.
Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting MedWatch: The FDA Safety Information and Adverse Event Reporting Program, or by calling 1-800-FDA-1088.
Females Who Can Become Pregnant
It is not known if STELARA® can harm your unborn baby. You and your doctor should decide if you should receive the medication. It is thought that STELARA® passes into your breast milk, so you should talk to your doctor before breastfeeding or if you’re considering breastfeeding in the future. Talk to your doctor about the best way to feed your baby if you receive STELARA®.
Tell your doctor about all the medicines you take — including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Keep a list of your medications to show your doctor and pharmacist when you get a new medicine. Use STELARA® exactly as your doctor prescribes as the medication is intended for use under the guidance and supervision of your doctor.
In children 12 years and older, it is recommended that a healthcare provider administers STELARA®. If your doctor decides that you or a caregiver may give your injections of STELARA® at home, you should receive training immediately to prepare.
Your doctor will determine the right dose of STELARA® for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA® yourself until you or your caregiver have been trained.