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Ustekinumab

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

Ustekinumab 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.

Ustekinumab 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 ustekinumab if:

  • you are allergic to any ingredient in ustekinumab
  • 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 ustekinumab:

Some medical conditions may interact with ustekinumab. 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 ustekinumab. 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 ustekinumab 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 ustekinumab:

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

  • Ustekinumab 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 ustekinumab refilled. Ask your doctor, nurse, or pharmacist any questions that you may have about this information.
  • Ustekinumab is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using ustekinumab at home, a health care provider will teach you how to use it. Be sure you understand how to use ustekinumab. 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 ustekinumab) must be rotated from one injection to the next. Do not inject ustekinumab into an area that is irritated, bruised, red, hard, infected, scarred, or has stretch marks.
  • Do not shake ustekinumab. Ustekinumab is colorless to light yellow and may contain a few small, white particles. Do not use ustekinumab if it contains other particles, is cloudy or discolored, or if the vial or syringe is cracked or damaged.
  • After you use ustekinumab, 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 ustekinumab, contact your doctor right away.

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

Important safety information:

  • Patients should receive a TB skin test before using ustekinumab. Patients who test positive for TB should begin treatment for TB before starting ustekinumab. All patients should also be monitored for signs of TB while using ustekinumab even if their TB test is negative.
  • Ustekinumab 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 ustekinumab. 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).
  • Ustekinumab 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 ustekinumab. 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 ustekinumab 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 ustekinumab. 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 ustekinumab.
  • Lab tests, including TB tests, may be performed while you use ustekinumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use ustekinumab with caution in the ELDERLY; they may be more sensitive to its effects.
  • Ustekinumab 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 ustekinumab while you are pregnant. Ustekinumab is found in breast milk. If you are or will be breast-feeding while you use ustekinumab, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of ustekinumab:

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 ustekinumab:

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

General information:

  • If you have any questions about ustekinumab, please talk with your doctor, pharmacist, or other health care provider.
  • Ustekinumab 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 ustekinumab 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 ustekinumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ustekinumab. 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 ustekinumab.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
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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