Ustekinumab (By injection)

Ustekinumab (us-te-KIN-ue-mab)

Treats Crohn disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

Brand Name(s):

Stelara

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to ustekinumab.

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.
• The medicine should be clear to slightly yellow in color. Do not use the medicine if it is cloudy, discolored, or has large particles in it. Do not shake the medicine.
• Crohn disease: You will receive your first dose of this medicine in a hospital. This is injected through a vein by your doctor. Then after 8 weeks, you will receive a maintenance dose that is injected under your skin and every 8 weeks thereafter.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep the medicine in the original carton until you are ready to use it. Store vials standing up straight.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ustekinumab works. Tell your doctor if you are using cyclosporine, allergy shots, or a blood thinner (including warfarin).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Tell your doctor if you have received BCG vaccine or if anyone in your family is given any vaccine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have any type of infection or a history of cancer. Tell your doctor if you have tuberculosis (TB) or a history of TB, or have been in close contact with someone who has active TB. Tell your doctor if you have an allergy to latex. Tell your doctor if you have any new or changing lesions within psoriasis areas or on normal skin or have received phototherapy for your psoriasis.
• This medicine may cause the following problems:
  • Increased risk of infection
  • Increased risk of cancer (including skin cancer)
  • Posterior reversible encephalopathy syndrome (PRES)
  • Non-infectious pneumonia
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Burning feeling when urinating, change in how much or how often you urinate, lower back or side pain
• Chest pain or tightness, trouble breathing
• Diarrhea, stomach pain, vomiting
• Fever, chills, cough, sore throat, stuffy or runny nose, body aches
• Headache, seizures, confusion, blurred vision
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache with no other symptoms
• Redness, pain, swelling, or itching where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 12/4/2023