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STELARA® is a prescription medicine approved to treat adults 18 years and older with moderate or severe plaque 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).
STELARA® is a 45 mg or 90 mg injection given under the skin as directed by your doctor at weeks 0, 4, and every 12 weeks thereafter. It is administered by a healthcare provider or self-injected after proper training.
STELARA® is a prescription medicineA drug that is only available with written instructions from a healthcare professional to a pharmacist. that affects your immune system. STELARA® can increase your chance of having serious side effects including:
STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB),An infectious disease, most commonly of the lungs, resulting in coughing, fever, chest pain, and weight loss and infections caused by bacteria, fungi, or virusesGerms that grow within the body and cause a disease.
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:
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)Proteins that increase the growth and function of white blood cells, which are found in your immune system and interleukin 23 (IL-23)Proteins that increase the growth and function of white blood cells, which are found in your immune system are at a higher risk for certain serious infections that 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.
STELARA® may decrease the activity of your immune systemA system inside the body that protects against germs and infections and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.
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: headache, seizures, confusion, and vision problems.
Serious allergic reactions can occur. Get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, trouble breathing, throat or chest tightness, or skin rash.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplementsNatural substances, made from herbs, that are used for medical reasons.. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
When prescribed STELARA®:
Common side effects of STELARA® include: upper respiratory infectionsA bodily infection that affects the nose, throat, and larynx (voice box), headache, and tiredness.
These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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