Stelara

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

What is Stelara?

Stelara (ustekinumab) is an immunosuppressant that reduces the effects of a substance in the body that can cause inflammation.

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

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

Important information about Stelara

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

Before using Stelara, tell your doctor if you have an active infection, a history of tuberculosis or recurrent infections, high blood pressure, a weak immune system, or if you are receiving phototherapy (light therapy).

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Make sure you are current on all vaccines before you start treatment with Stelara.

Stelara can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses.

Contact your doctor right away if you have signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, swelling or redness, pain or burning when you urinate, blood in your urine, severe stomach pain, changes in your bowel habits, cough with yellow or green mucus, stabbing chest pain, or severe headache with confusion, vision problems, or seizure.

Treatment with Stelara may increase your risk of developing cancer. Talk to your doctor about your individual risk.

Before using Stelara

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

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Stelara:

• an active infection;

• a history of recurrent infections;

• a history of tuberculosis;

• high blood pressure;

• a weak immune system; or

• if you are receiving phototherapy (light therapy).

FDA pregnancy category B. Stelara 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 Stelara without telling your doctor if you are breast-feeding a baby.

See also: Stelara pregnancy and breastfeeding warnings (in more detail)

Treatment with Stelara may increase your risk of developing cancer. Talk to your doctor about your individual risk.

How should I use Stelara?

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

Stelara is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection.

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

Stelara can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Contact your doctor right away if you have signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness, mouth sores, swelling or redness, severe stomach pain, cough with mucus, or severe headache. These may be early signs of a severe infection.

To be sure Stelara is not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments. You must remain under the care of a doctor while you are receiving Stelara.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Symptoms of a ustekinumab overdose are not known.

What should I avoid while using Stelara?

Avoid injecting Stelara into skin that is bruised, red, tender, or hardened.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with Stelara, 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), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

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

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 Stelara.

Stelara side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Stelara: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using Stelara and call your doctor at once if you have a serious side effect such as:

• signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness;

• mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;

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

• pain or burning when you urinate, blood in your urine;

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

• cough with yellow or green mucus;

• stabbing chest pain, feeling short of breath; or

• severe headache, confusion, vision problems, and/or seizure (convulsions).

Less serious Stelara side effects may include:

• cold symptoms (runny or stuffy nose, sore throat);

• headache, tired feeling;

• mild diarrhea; or

• mild skin rash or itching.

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: Stelara side effects (in more detail)

What other drugs will affect Stelara?

Tell your doctor about all other medications you use, especially:

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

• a blood thinner such as warfarin (Coumadin);

• cyclosporine (Gengraf, Neoral, Sandimmune);

• digoxin (digitalis, Lanoxin, Lanoxicaps);

• sirolimus (Rapamune) or tacrolimus (Prograf);

• theophylline (Elixophyllin, Theo-24, Uniphyl);

• seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene); or

• a heart rhythm medication such as disopyramide (Norpace), procainamide (Procan, Pronestyl), or quinidine (Quinidex, Quin-Release Quin-G).

This list is not complete and there may be other drugs that can interact with Stelara. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about Stelara.

• 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 1996-2009 Cerner Multum, Inc. Version: 1.01. Revision Date: 10/31/2009 1:54:51 PM.