What is Stelara?

Ustekinumab injection is used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. This medicine may be used alone or in combination with methotrexate to treat active psoriatic arthritis.

Ustekinumab injection is also used to treat moderate to severely active Crohn's disease in adult patients who have already received other medicines (eg, corticosteroids, azathioprine, 6-mercaptopurine, methotrexate) but did not work well or were not well-tolerated.

This medicine is available only with your doctor's prescription.

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually on the upper arms, buttocks, abdomen (stomach), or thighs.

This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Ustekinumab injection may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

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. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, or hard.

This medicine is available in two forms: a prefilled syringe or a vial (glass container). You can use these forms at home.

You might not use all of the medicine in each vial or prefilled syringe. Use each vial or prefilled syringe only one time. Do not save an open vial or syringe. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it. Do not shake.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled syringe):
  • For Crohn's disease:
    • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 260 to 520 milligrams (mg) injected into your vein as a single dose. After 8 weeks, a maintenance dose of 90 mg is injected under your skin as a single dose, then every 8 weeks after.
    • Children—Use and dose must be determined by your doctor.
  • For plaque psoriasis:
    • Adults weighing more than 100 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The starting dose is 90 milligrams (mg) injected under your skin as a single dose, and then one dose (90 mg) after 4 weeks, followed by 90 mg every 12 weeks.
    • Adults weighing 100 kg or less—Dose is based on body weight and must be determined by your doctor. The starting dose is 45 mg injected under your skin as a single dose, and then one dose (45 mg) after 4 weeks, followed by 45 mg every 12 weeks.
    • Children 12 years of age and older—Dose is based on body weight and must be determined by your doctor.
      • Weighs more than 100 kilograms (kg)—90 milligrams (mg) at Weeks 0 and 4, then every 12 weeks after.
      • Weighs 60 kg to 100 kg—45 mg at Weeks 0 and 4, then every 12 weeks after.
      • Weighs less than 60 kg—0.75 mg per kg body weight at Weeks 0 and 4, then every 12 weeks after.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For psoriatic arthritis:
    • Adults—At first, 45 milligrams (mg) injected under your skin as a single dose, and then one dose (45 mg) after 4 weeks, followed by 45 mg every 12 weeks.
    • Children—Use and dose must be determined by your doctor.

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep the medicine in the original carton until you are ready to use it. Store the vials in an upright position.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of ustekinumab injection in children younger than 12 years of age to treat moderate to severe plaque psoriasis. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ustekinumab injection in the elderly.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Infliximab
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Tofacitinib
• Typhoid Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer, or history of—Use with caution. May increase risk for cancer.

• Infection (bacteria, fungus, virus)—Ustekinumab is not recommended in patients with an active infection. Caution should be used if you have a chronic infection or history of a recurring infection.

• Tuberculosis infection, inactive—Should be treated first before starting therapy with this medicine.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is important to check with your doctor if you have any symptoms of an infection such as fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

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 (eg, non-melanoma skin cancer). This is more likely to occur if you are over 60 years of age or if you are receiving PUVA therapy (psoralen and ultraviolet A treatment) or medicines that weaken the immune system (eg, steroids) in the past. Talk to your doctor about this risk if you have concerns.

This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. 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.

Check with your doctor if you have headache, seizures, confusion, or blurred vision or other visual problems. These may be symptoms of a rare and serious condition called reversible posterior leukoencephalopathy syndrome (RPLS).

This medicine may cause non-infectious pneumonia (eg, interstitial pneumonia, eosinophilic pneumonia, cryptogenic organizing pneumonia). Check with your doctor right away if you have chest pain, cough, fever or chills, sneezing, sore throat, troubled breathing, or tightness in the chest.

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.

While you are being treated with ustekinumab and after you stop treatment with it, do not have any immunizations (especially live vaccines) without your doctor's approval. Ustekinumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, the other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also avoid persons who have recently taken oral polio vaccine. Do not get close to them or stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective mask that covers the nose and mouth. Tell your doctor if you have received a BCG vaccine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.