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

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

Brand Name(s):

Stelara

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed into a vein or as a shot under your skin, usually in the upper arms, stomach, buttocks, 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. Do not inject into skin areas that are tender, red, bruised, or hard.
• Prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Check the liquid in the syringe. It should be clear and colorless to light yellow with few white particles. Do not use it if it is frozen, cloudy, discolored, or has large particles in it. Do not use the syringe if it has been dropped. Do not shake.
  • Remove the needle cover when you can inject this medicine. Do not touch the plunger while removing the needle cover.
  • Hold the syringe with one hand, and pull the needle cover straight off.
  • Gently pinch the skin with the other hand. Insert the needle in a quick, dart-like motion at about a 45 degree angle into the pinched skin. Push the plunger all the way down with your thumb until the plunger head is completely between the needle guard wings. Keep pressure on the plunger head. Take the needle out of the skin.
  • Slowly take your thumb off the plunger head. This will let the empty syringe move up until the entire needle is covered by the needle guard.
• Vial for subcutaneous use:
  • Wash your hands with soap and water before and after using this medicine.
  • Check the liquid in the vial. it should be clear and colorless to light yellow with few white particles. Do not use it if it is frozen, cloudy, discolored, or has large particles in it. Do not shake.
  • Remove the cap from the vial. Do not touch the rubber stopper.
  • Carefully pull back on the plunger to the line that matches the prescribed dose. Hold the vial between your thumb and index finger. Use your other hand to push the syringe needle through the center of the rubber stopper.
  • Push down the plunger until all the air is gone from the syringe. Turn the vial upside down. Pull back the syringe plunger with your other hand.
  • Fill the syringe until the black tip of the plunger lines up with the mark. Do not remove the needle from the vial. Hold the syringe with the needle pointing up to see if it has any air bubbles. If you see air bubbles, gently tap the side of the syringe.
  • Slowly press the plunger up until all of the air bubbles are out. Remove the syringe from the vial. Do not lay the syringe down or allow the needle to touch anything.
  • Gently pinch the skin with the other hand. Insert the needle in a quick, dart-like motion at about a 45 degree angle into the pinched skin. Push the plunger all the way down with your thumb. Pull the needle out and let go of the skin.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. If needed, you may store the prefilled syringe at room temperature for up to 30 days. Do not put it back in the refrigerator. Throw away unused medicine after 30 days.
• 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. You should not receive live vaccines while you are using this medicine. You should not receive BCG vaccines 1 year before and 1 year after receiving this medicine.

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)
  • Lung or breathing problem, including 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
• 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
• Sores or white patches on your lips, mouth, or throat
• Unusual tiredness or weakness

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

• Headache
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given or needle is placed

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