Uses of Stelara:

• It is used to treat plaque psoriasis.
• It is used to treat psoriatic arthritis.
• It is used to treat Crohn's disease.
• It is used to treat ulcerative colitis.

What do I need to tell my doctor BEFORE I take Stelara?

• If you are allergic to Stelara (ustekinumab subcutaneous injection); any part of Stelara (ustekinumab subcutaneous injection); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have had the BCG vaccine in the past year.
• If you have an infection.
• If you have active TB (tuberculosis).

This is not a list of all drugs or health problems that interact with Stelara (ustekinumab subcutaneous injection).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Stelara (ustekinumab subcutaneous injection) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Stelara?

• Tell all of your health care providers that you take Stelara (ustekinumab subcutaneous injection). This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• The chance of cancer is higher after using Stelara (ustekinumab subcutaneous injection). Talk with the doctor.
• Have your skin checked. Tell your doctor if you have any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• Talk with your doctor before getting any vaccines while you take Stelara (ustekinumab subcutaneous injection) and after you stop taking it. Vaccine use with Stelara (ustekinumab subcutaneous injection) may either raise the chance of an infection or make the vaccine not work as well. Talk with your doctor.
• You will need a TB (tuberculosis) test before starting Stelara (ustekinumab subcutaneous injection).
• If your weight changes, talk with your doctor. The dose of Stelara (ustekinumab subcutaneous injection) may need to be changed.
• If you are 60 or older, use Stelara (ustekinumab subcutaneous injection) with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Stelara) best taken?

Use Stelara (ustekinumab subcutaneous injection) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin in the upper arm, thigh, buttocks, or stomach area.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Wash your hands before and after use.
• Move the site where you give the shot with each shot.
• This product may contain small white particles. Do not use if the solution is cloudy, leaking, or has large lumps, flakes, or other particles.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not shake.
• Each prefilled syringe or vial is for one use only. Throw away any part left over after the dose is given.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Warm, red, or painful skin or sores on the body.
• Shortness of breath.
• Flushing.
• Very bad dizziness or passing out.
• A skin lump or growth.
• Vaginal itching or discharge.
• A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with Stelara (ustekinumab subcutaneous injection). Call your doctor right away if you have signs like feeling confused, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache.
• Pneumonia has happened during use of Stelara (ustekinumab subcutaneous injection). Sometimes this has been serious, and people have needed to go to the hospital. Tell your doctor if you have cough, fever, chest pain, shortness of breath, or trouble breathing.

What are some other side effects of Stelara?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Headache.
• Upset stomach or throwing up.
• Stomach pain or diarrhea.
• Nose or throat irritation.
• Signs of a common cold.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Stelara?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Stelara (ustekinumab subcutaneous injection) is refilled. If you have any questions about Stelara (ustekinumab subcutaneous injection), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• What causes Plaque Psoriasis?
• What food should I avoid while on Stelara?
• Stelara and the Covid Vaccine: What should I know?
• Does Stelara cause hair loss?
• Does Stelara treat ulcerative colitis?
• Is Stelara an immunosuppressant?
• Is Stelara a biologic?

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