Ustekinumab, Injection

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KEY POINTS

• This medicine is given by injection to treat chronic plaque psoriasis or psoriatic arthritis. Use it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause life-threatening changes in the brain, or cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: immunosuppressant; monoclonal antibody; antipsoriatic

Generic and brand names: ustekinumab, injection; Stelara

What is this medicine used for?

This medicine is given by injection (shots) to treat:

• Chronic plaque psoriasis (scaly patches on the skin)
• Psoriatic arthritis

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• An allergic reaction to any medicine or to latex (the needle cover of the prefilled syringe contains latex)
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection, or allergy immunotherapy
• Cancer or risk factors for cancer
• Problems with infections that keep coming back
• Tuberculosis (TB)

Tell your healthcare provider if you:

• Are receiving phototherapy
• Have an infection or any symptoms of infection
• Have recently had, or are scheduled to have any kind of vaccination such as flu shots, or pneumonia, polio, or measles vaccines

You should NOT receive any live vaccines while taking this medicine. You should not receive the BCG vaccine during the 1 year before taking this medicine or for 1 year after your stop taking this medicine. Tell your healthcare provider if anyone in your house needs a vaccine while you are taking this medicine.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide before you start treatment with this medicine and each time you get an injection.

The injections are usually given by your healthcare provider. Sometimes you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 18.

What if I miss a dose?

If you miss your regular dose of this medicine, call your healthcare provider right away.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Long-term use of this medicine may increase your risk of cancer. Talk with your healthcare provider about this.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections.

Do not have any vaccines such as for flu, pneumonia, or measles, without getting your healthcare provider's approval first.

This medicine may cause a rare condition called RPLS. RPLS affects the brain and can be life-threatening. Contact your healthcare provider right away if you have any new or worsening confusion, vision problems, headache, or seizures.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chest pain; unexplained fever, sore throat, chills, or cough; shortness of breath; severe tiredness; muscle or joint pain; unexplained weight loss; coughing up blood; unusual bruising or bleeding; severe diarrhea or abdominal pain; burning when you urinate or urinating more often than normal; skin growths or worsening of psoriasis; sores that don't heal; new or worsening headache; seizures; confusion; vision problems.

Other: Dizziness, headache, irritation at the injection site, runny or stuffy nose, diarrhea, tiredness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Denosumab (Prolia, Xgeva)
• Echinacea
• Fingolimod (Gilenya)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), pimecrolimus (Elidel), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Infliximab (Remicade)
• Natalizumab (Tysabri)
• Other medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), belimumab (Benlysta), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), and leflunomide (Arava)
• Roflumilast (Daliresp)
• Tofacitinib (Xeljanz)
• Vaccines

Tell your healthcare provider if you need to receive any vaccines BEFORE you start treatment with this medicine. Do not receive any vaccines while using this medicine without your healthcare provider’s approval. You should NOT receive any live vaccines while taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Keep the vials upright and do not shake them. Keep the container tightly closed. Store this medicine in the refrigerator inside the original carton. Do not freeze. Protect it from heat, high humidity, and bright light. Discard any unused portions of the medicine.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.