Generic Name: ustekinumab (YOO sti KIN ue mab)
Brand Name: Stelara PFS

What is ustekinumab?

Ustekinumab is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation.

Ustekinumab is used to treat plaque psoriasis (raised, silvery flaking of the skin) in adults.

Ustekinumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ustekinumab?

You should not use this medication if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.

Serious infections may occur during treatment with ustekinumab. Call your doctor right away if you have signs of infection such as: fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.

Slideshow: Psoriasis: Treatment Options to Manage Your Symptoms

What should I discuss with my health care provider before using ustekinumab?

You should not use this medication if you are allergic to ustekinumab or if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.

Before you receive ustekinumab, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure ustekinumab is safe for you, tell your doctor if you have:

  • an active infection;

  • a history of chronic infections;

  • active tuberculosis infection that is not being treated;

  • high blood pressure;

  • a weak immune system;

  • if you are receiving phototherapy (light therapy); or

  • if you have ever received allergy shots or used an Epi-Pen (for severe allergic reaction).

Some people using ustekinumab have developed skin cancer (non-melanoma). However, these people may have had a higher risk of skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

FDA pregnancy category B. Ustekinumab is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Ustekinumab can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use ustekinumab?

Before you start treatment with ustekinumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Ustekinumab is injected under the skin. A healthcare provider will give you this injection.

Ustekinumab injections are usually given every 12 weeks, but your first two injections will be 4 weeks apart. Follow your doctor's instructions.

While using ustekinumab, you will need frequent blood tests at your doctor's office.

You must remain under the care of a doctor while you are receiving ustekinumab.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your ustekinumab injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using ustekinumab?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using ustekinumab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

BCG vaccine should not be given for at least 1 year after you receive your last dose of ustekinumab.

Non-live vaccines (including flu shots) may not work as well during your treatment, and may not fully protect you from disease. Make sure you are current on all vaccines before you begin treatment with ustekinumab.

Ustekinumab side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with ustekinumab. Call your doctor right away if you have signs of infection such as: fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.

Also call your doctor at once if you have:

  • swelling, pain, tenderness, or redness anywhere on your body;

  • stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation);

  • stabbing chest pain, wheezing, cough with yellow or green mucus;

  • blood in your urine; or

  • severe headache, confusion, change in mental status, vision problems, and/or seizure (convulsions).

Common side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • headache; or

  • mild tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect ustekinumab?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ustekinumab, especially:

  • a blood thinner such as warfarin, Coumadin;

  • drugs that weaken your immune system (such as cancer medicine or steroids); or

  • medicines to prevent organ transplant rejection--cyclosporine, sirolimus, tacrolimus.

This list is not complete. Other drugs may interact with ustekinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about ustekinumab.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.01. Revision Date: 2013-04-01, 3:27:27 PM.

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