Generic Name: ustekinumab (US-te-KIN-ue-mab)
Brand Name: Stelara

Stelara is used for:

Treating certain patients with moderate to severe plaque psoriasis. It is also used to treat active psoriatic arthritis alone or with methotrexate. It may also be used for other conditions as determined by your doctor.

Stelara is a monoclonal antibody. It works by blocking certain substances in the body that affect inflammation and the body's immune system.

Do NOT use Stelara if:

  • you are allergic to any ingredient in Stelara
  • you have had a BCG vaccine within the past year
  • you have active tuberculosis (TB), a severe infection (eg, sepsis), or any other active infection

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Psoriasis - Treatment Options to Manage Your Symptoms

Before using Stelara:

Some medical conditions may interact with Stelara. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances, including rubber or latex
  • if you are receiving or have received allergy shots, especially for serious allergic reactions
  • if you have a history of infections or an infection that keeps coming back; TB infection or positive TB skin test; cancer; liver or kidney problems; or a neurological disorder called reversible posterior leukoencephalopathy syndrome (RPLS)
  • if you have immune system problems, you have or a member of your household has recently received a vaccine, or you are scheduled to receive a vaccine or to have surgery
  • if you have open cuts or sores on your body, have flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or are using medicine to treat an infection
  • if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB
  • if you are having or have had phototherapy or light therapy
  • if you are taking or have taken medicine that may decrease your immune system (eg, cyclosporine)

Some MEDICINES MAY INTERACT with Stelara. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Cyclosporine or warfarin because the risk of their side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Stelara may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Stelara:

Use Stelara as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Stelara comes with an extra patient information sheet called a Medication Guide. It also comes with an extra patient leaflet with detailed instructions for use. Read them carefully. Read them again each time you get Stelara refilled. Ask your doctor, nurse, or pharmacist any questions that you may have about this information.
  • Stelara is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Stelara at home, a health care provider will teach you how to use it. Be sure you understand how to use Stelara. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle or a vein.
  • Injection sites within an injection area (stomach area, buttocks, or thighs; outer area of the upper arm if someone else is giving you Stelara) must be rotated from one injection to the next. Do not inject Stelara into an area that is irritated, bruised, red, hard, infected, scarred, or has stretch marks.
  • Do not shake Stelara. Stelara is colorless to light yellow and may contain a few small, white particles. Do not use Stelara if it contains other particles, is cloudy or discolored, or if the vial or syringe is cracked or damaged.
  • After you use Stelara, throw away any medicine left in the vial or syringe.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Stelara, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Stelara.

Important safety information:

  • Patients should receive a TB skin test before using Stelara. Patients who test positive for TB should begin treatment for TB before starting Stelara. All patients should also be monitored for signs of TB while using Stelara even if their TB test is negative.
  • Stelara may lower the ability of your body to fight infection and increase your risk of infections. Serious infections, including TB infections, fungal infections, and other types of infections, have occurred in patients using Stelara. Avoid contact with people who have colds or infections. Contact your doctor immediately if you develop signs of TB or any other type of infection (eg, cough; muscle aches; unexplained weight loss; fever, sweats, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin or sores on your body; increased or painful urination; diarrhea or stomach pain; blood in phlegm).
  • Stelara may increase the risk of developing certain types of cancer (eg, skin cancer). Discuss any questions or concerns with your doctor.
  • A serious brain problem called reversible posterior leukoencephalopathy syndrome (RPLS) has occurred with the use of Stelara. This can be fatal. Contact your doctor at once if you develop symptoms such as vision problems, confusion, trouble thinking, headache, or seizures. Talk with your doctor for more information.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Tell your doctor or dentist that you take Stelara before you receive any medical or dental care, emergency care, or surgery.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Stelara. Talk with your doctor before you or a member of your household receives any vaccine.
  • Do not receive a BCG vaccine for 1 year before, during, or 1 year after treatment with Stelara.
  • Lab tests, including TB tests, may be performed while you use Stelara. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Stelara with caution in the ELDERLY; they may be more sensitive to its effects.
  • Stelara should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Stelara while you are pregnant. Stelara is found in breast milk. If you are or will be breast-feeding while you use Stelara, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Stelara:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; symptoms of upper respiratory infection (eg, mild cough, runny or stuffy nose, sneezing, mild sore throat); tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; feeling faint; tightness in the chest or throat; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); change in the appearance or size of a mole; confusion; open sore that does not heal; seizures; severe or persistent headache; severe or persistent pain, swelling, or redness at the injection site; signs of infection (eg, fever, sweats, chills, or persistent sore throat; cough; muscle aches; shortness of breath; warm, red, or painful skin or sores on your body; increased or painful urination; stomach pain or diarrhea; blood in phlegm; unexplained weight loss); unusual lump or skin growth; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Stelara:

Stelara is usually handled and stored by a health care provider. Keep Stelara out of the reach of children and away from pets.

General information:

  • If you have any questions about Stelara, please talk with your doctor, pharmacist, or other health care provider.
  • Stelara is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Stelara or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Stelara. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Stelara. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Stelara.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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