Ustekinumab injection

What is this medication?

USTEKINUMAB (US te KIN ue mab) is used to treat plaque psoriasis and psoriatic arthritis. It is also used to treat Crohn's disease and ulcerative colitis. It is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Stelara

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 (especially a virus infection such as chickenpox, cold sores, or 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 have recently been in close contact with someone who has tuberculosis
• an unusual reaction to ustekinumab, latex, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection under the skin or infusion into a vein. It is usually given by a health care professional in a hospital or clinic setting. If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

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 healthcare provider 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 pediatrician regarding the use of this medicine in children. While this drug 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 miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• live virus vaccines

This medicine may also interact with the following medications:

• cyclosporine
• biologic medicines such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, secukinumab, tocilizumab
• 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?

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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• confusion
• headache
• persistent headache
• seizures
• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine
• swollen lymph nodes in the neck, underarm, or groin areas
• unexplained weight loss
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• nausea, vomiting
• redness, itching, swelling, or bruising at site where injected
• stomach pain
• tiredness

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.

Where should I keep my medication?

Keep out of the reach of children.

Store the prefilled syringes or vials in a refrigerator between 2 to 8 degrees C (36 to 46 degrees F). Keep in the original carton. Protect from light. Do not freeze. Do not shake. The vials should be stored upright. Throw away any unused medicine that has been stored in the refrigerator after the expiration date.

If needed, a prefilled syringe may be stored at room temperature up to 30 degrees C (86 degrees F) for a maximum of 30 days. Keep it in the original carton to protect from light. Record the date when it is removed from the refrigerator on the carton. Once a syringe has been stored at room temperature, do not put it back in the refrigerator. Throw the syringe away after 30 days at room temperature, even if it still has medicine in it.

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.