Stelara (ustekinumab)

Generic name: ustekinumab (YOO sti KIN ue mab)
Brand name: Stelara, Stelara PFS
Drug class: Interleukin inhibitors

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

Stelara is used to treat plaque psoriasis in adults and children who are at least 6 years old. It is also used to treat psoriatic arthritis in adults, and is sometimes given with another medicine called methotrexate.

Stelara is used in adults to treat moderately to severely active Crohn's disease after other medicines have been tried without success.

Stelara is also used in adults to treat moderately to severely active ulcerative colitis.

Warnings

You should not use Stelara if you have received a BCG (Bacillus Calmette and Guérin) vaccine within 1 year prior to, during, or 1 year following treatment.

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

Serious infections may occur during treatment with Stelara. 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.

Ustekinumab may also cause a rare but serious condition affecting the brain. Tell your doctor right away if you have a headache, confusion, vision problems, or a seizure.

Before taking this medicine

You should not use Stelara if you are allergic to ustekinumab, or if you have:

• active tuberculosis; or
• if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.

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 Stelara is safe for you, tell your doctor if you have:

• signs of infection (fever, chills, cough, muscle aches, painful skin sores, diarrhea, pain when you urinate, feeling very tired);
• chronic infections;
• new or changing skin lesions;
• a latex allergy;
• phototherapy (light therapy);
• allergy shots; or
• if you recently received or are scheduled to receive any vaccine.

Some people using Stelara 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.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ustekinumab on the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You must remain under the care of a doctor while you are receiving Stelara.

Stelara is injected under the skin, or as an infusion into a vein, usually once every 12 weeks. Your first and second dose may be only 4 weeks apart.

A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself. Read and carefully follow any Instructions for Use provided with your medicine. Do not use Stelara if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you the best places on your body to inject Stelara. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Avoid injecting the medicine into skin that is red, bruised, swollen, or tender.

Ustekinumab doses are typically based on weight. Your dose needs may change if you gain or lose weight.

Call your doctor if you have any signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling constantly tired.

You will need frequent medical tests.

Each prefilled syringe or single-use vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Store in the refrigerator. Protect from light. Do not freeze and not shake the medicine. Store the vials in an upright position.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

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 Stelara?

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 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), 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 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 this medicine.

Stelara side effects

Get emergency medical help if you have signs of an allergic reaction to Stelara: hives; chest pain, difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with Stelara. 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:

• a mole that has changed in size or color;
• swelling, pain, warmth, or redness anywhere on your body;
• stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation);
• new or worsening cough, sudden chest pain, feeling short of breath;
• pain or burning when you urinate; or
• severe headache, confusion, change in mental status, vision problems, and/or seizure (convulsions).

Common Stelara side effects may include:

• fever, flu-like symptoms;
• infection;
• itching;
• stomach pain, nausea, vomiting, diarrhea;
• vaginal itching or discharge;
• pain or burning when you urinate;
• cough with mucus, shortness of breath, chest discomfort;
• headache, tiredness; or
• redness at the injection site.

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.

What other drugs will affect Stelara?

Other drugs may interact with ustekinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.