When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use this medicine 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. This medicine is given as a shot under your skin, often on the upper arms, buttocks, abdomen (stomach), or thighs.
• 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.
• 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.
• 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 foods and medicines can affect how ustekinumab works. Tell your doctor if you are receiving the following:
  
  • Allergy shots
  • Cyclosporine
  • Blood thinner (such as 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 a history of cancer or have any type of infection. 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.
• This medicine may cause the following problems:
  
  • Higher risk of infection (including bacteria, virus, or fungus infections)
  • Cancer (including skin cancer)
  • Reversible posterior leukoencephalopathy syndrome (RPLS, a nervous system disorder)
• 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
• Diarrhea or stomach pain
• Fever, chills, cough, sore throat, and body aches
• Headache, seizures, confusion, and blurred vision

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
• Stuffy or runny nose

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