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

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

Brand Name(s):

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, 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.
• This medicine is available in 2 forms: a vial and prefilled syringe.
• Prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow 30 minutes for the syringe to warm up to room temperature. Do not warm using other heat sources (including hot water, sunlight, or microwave).
  • Check the liquid in the syringe. It should be clear to white, like an opal, and colorless to light yellow. Do not use it if it is frozen, cloudy, discolored, or has particles in it. Do not use the syringe if it is damaged or has been dropped. It is normal to see air bubbles in the liquid. Do not shake.
  • Remove the needle cap when you can inject this medicine right away (within 5 minutes) because the medicine can dry out.
  • Do not hold the plunger or plunger head while removing the needle cap. Do not twist or bend the needle cap. Do not put the needle cap back on.
  • Pinch the skin with one hand between the thumb and index finger to create a bump for the injection. Insert the needle into the pinched skin at about a 45 degree angle. Do not place your finger on the plunger rod while inserting the needle.
  • Slowly press the plunger head all the way down with your thumb until it is completely between the needle guard clips. Do not pull back on the plunger rod any time. Do not remove the syringe until all medicine has been injected.
  • Slowly take your thumb off the plunger head. This will let the empty syringe move up until the entire needle is automatically covered by the needle guard.
• 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: Call your doctor or pharmacist for instructions.
• 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-auub 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 vaccine 1 year before and 1 year after receiving this 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 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, nausea, 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