| WHY is this medicine prescribed?
| HOW should this medicine be used?
| Are there OTHER USES for this medicine?
| What SPECIAL DIETARY instructions should I follow?
| What SIDE EFFECTS can this medicine cause?
| What should I do in case of OVERDOSE?
| What OTHER INFORMATION should I know?
WHY is this medicine prescribed?
Ustekinumab injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in people whose psoriasis is too severe to be treated by topical medications alone. Ustekinumab injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain cells in the body that cause the symptoms of psoriasis.
HOW should this medicine be used?
Ustekinumab comes as a solution to inject subcutaneously (under the skin) by a nurse or doctor. It is usually given in a doctor's office every 4 weeks for the first two doses and then every 12 weeks.
Ustekinumab injection controls plaque psoriasis but does not cure it. Ustekinumab injection helps to treat psoriasis only as long as you receive regular injections. It is important that you receive your ustekinumab injection once every 12 weeks for as long as your healthcare provider prescribes it.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ustekinumab injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before receiving ustekinumab injection,
- tell your doctor and pharmacist if you are allergic to ustekinumab, any other medications, latex, or any of the ingredients in ustekinumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin); medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf); or oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone (Sterapred). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had any type of cancer. Also tell your doctor if you are receiving phototherapy (treatment for psoriasis that involves exposing the skin to ultraviolet light) or are receiving or have received allergy shots.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving ustekinumab injection, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using ustekinumab injection.
- check with your doctor to see if you need to receive any vaccinations. It is important to have all vaccines appropriate for your age before beginning your treatment with ustekinumab injection. Do not have any vaccinations during your treatment without talking to your doctor. It is especially important not to receive the BCG vaccine for one year before your treatment, during your treatment, and for one year after your treatment. Also talk to your doctor if anyone in your household needs to receive a vaccine during your treatment with ustekinumab injection.
- you should know that ustekinumab injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with ustekinumab injection, call your doctor immediately: weakness; sweating; chills; muscle aches; sore throat; cough; shortness of breath; fever; weight loss; extreme tiredness; flu-like symptoms; warm, red, or painful skin; painful, difficult, or frequent urination; diarrhea; stomach pain; or other signs of infection.
- you should know that using ustekinumab injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using ustekinumab injection. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, chest pain, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What SIDE EFFECTS can this medicine cause?
Ustekinumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- back pain
- redness or irritation at the injection site
Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:
- vision changes
- feeling faint
- swelling of the face, eyelids, tongue, or throat
- difficulty breathing
- tightness in the chest or throat
Ustekinumab may increase the risk that you will develop cancer. Talk to your doctor about the risks of taking this medication.
Ustekinumab may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at
] or by phone [1-800-332-1088].
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ustekinumab injection.
Ask your pharmacist any questions you have about ustekinumab injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: April 15, 2011.