Ustekinumab (Injection)

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®) or a blood thinner (such as warfarin, Coumadin®). Tell your doctor about all other treatments you are using for your psoriasis, including phototherapy and other medicines that weaken the immune system (such as steroids, cancer medicines, or radiation).
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have cancer, or any type of infection (including tuberculosis).
• Avoid people who are sick or have infections.
• Call your doctor right away if you start to have a cough, weight loss, night sweats, shortness of breath, fever, chills, unusual tiredness or weakness, or flu-like symptoms, such as a runny or stuffy nose, headache, or feeling generally ill. These may be signs that you have an infection.
• You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test or been exposed to tuberculosis.
• This medicine may increase your risk of getting some forms of cancer. Talk to your doctor about this risk if you have concerns.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving the medicine.
• Stop using this medicine and check with your doctor if you have headache, seizures, confusion, blurred vision or other visual problems. These may be symptoms of a rare and serious condition called reversible posterior leukoencephalopathy syndrome (RPLS).
• The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start receiving this medicine.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

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 sensation when urinating, or 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.
• Shortness of breath, night sweats, or weight loss.
• Unusual tiredness or weakness.
• Warm, red, or painful skin or sores on your body.

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

• Back pain.
• Dizziness.
• Feeling depressed.
• Redness, pain, swelling, or itching where the shot was given.

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

Introduction

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

Treats plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments.

Brand Name(s)

Stelara

When This Medicine Should Not Be Used

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.
• A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• Call your doctor or pharmacist for instructions.