ustekinumab

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

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.

What is ustekinumab?

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

Ustekinumab is also used in adults to treat moderately to severely active Crohn's disease or ulcerative colitis.

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

What should I discuss with my health care provider before using 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.

Tell your doctor if you have ever had:

• 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 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.

Tell your doctor if you are pregnant or breastfeeding.

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

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 ustekinumab.

Ustekinumab 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 ustekinumab 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 ustekinumab. 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 based on weight. Your dose needs may change if you gain or lose weight.

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.

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?

What happens if I overdose?

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.

What are the possible side effects of ustekinumab?

• 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 side effects may include:

• fever, flu-like symptoms;
• 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 where ustekinumab was injected.

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 ustekinumab?

Other drugs may affect 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.

Where can I get more information?

Your doctor or pharmacist can provide more information about ustekinumab.