Stelara contains ustekinumab, a monoclonal antibody that acts as an interleukin-12 and -23 antagonist. It is formulated as a sterile, preservative-free injection, presented as a colorless to light yellow solution. This medication is produced using DNA recombinant technology in a murine cell line.

How should I use this medication?

This medication is injected under the skin or into a vein. It is usually given by your care team in a hospital or clinic setting. It may also be given at home. If you get this medication at home, you will be taught how to prepare and give it. Use it exactly as directed. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop. It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medication at the hospital or clinic: It is important not to miss your dose. Call your care team if you are unable to keep an appointment. If you give yourself this medication at home: If you miss a dose, take it as soon as you can. Then continue your normal schedule. Do not take double or extra doses. Call your care team with questions.

Where should I keep my medication?

Keep out of the reach of children and pets. See product label for storage information. Each product may have different instructions. Get rid of any unused medication as instructed or after the expiration date, whichever is first. It is preferred to store unopened vials and prefilled syringes in the refrigerator. Do not freeze. Keep this medication in the original carton. Protect from light. Store the vials upright. To get rid of medications that are no longer needed or have expired: -Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, ask your pharmacist or care team how to get rid of the medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Change in your skin, such as a new growth, a sore that doesn't heal, or a change in a mole -Dry cough, shortness of breath or trouble breathing -Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell -Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES) Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Diarrhea -Dizziness -Fatigue -Headache -Pain, redness, or irritation at injection site -Runny or stuffy nose -Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Cancer -Diabetes -History of skin cancer -Immune system problems -Infection, such as a bacterial or viral infection, chickenpox, cold sores, herpes, or history of infections -New or changing lesions on your skin -Receiving or have received allergy shots -Receive or have received phototherapy for the skin -Recently received or scheduled to receive a vaccine -Tuberculosis, a positive skin test for tuberculosis, or recent close contact with someone who has tuberculosis -An unusual or allergic reaction to ustekinumab, latex, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Live virus vaccines This medication may also interact with the following: -Biologic medications, such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, secukinumab, tocilizumab -Cyclosporine -Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Your condition will be monitored carefully while you are receiving this medication. Tell your care team if your symptoms do not start to get better or if they get worse. You will be tested for tuberculosis (TB) before you start this medication. If your care team prescribes any medication for TB, you should start taking the TB medication before starting this medication. Make sure to finish the full course of TB medication. This medication may increase your risk of getting an infection. Call your care team for advice if you get fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication. Certain genetic factors may decrease the safety of this medication. Your care team may use genetic tests to determine treatment.