What is STELARA (Ustekinumab)?
STELARA is a prescription medicine used to treat:
- Adults and children 12 years and older with moderate or severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
- Adults 18 years and older with active psoriatic arthritis. STELARA can be used alone or with the medicine methotrexate.
- Adults 18 years and older with moderately to severely active Crohn’s disease.
- adults 18 years and older with moderately to severely active ulcerative colitis.
It is not known if STELARA is safe and effective in children less than 12 years of age.
What is the most important information I should know about STELARA?
STELARA is a medicine that affects your immune system. STELARA can increase your risk of having serious side effects, including:
- Serious infections. STELARA may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections while taking STELARA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.
- After starting STELARA, call your doctor right away if you have any symptoms of an infection (see above). STELARA can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections. These infections can spread throughout the body and cause death. People who take STELARA may also be more likely to get these infections.
- Cancers. STELARA may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your doctor if you have ever had any type of cancer. Some people who are receiving STELARA and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with STELARA, tell your doctor if you develop any new skin growths
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS). RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: Headache, Seizures, Confusion, Vision problems
- Serious allergic reactions. Serious allergic reactions can occur with STELARA. Stop using STELARA and get medical help right away if you have any of the following symptoms of a serious allergic reaction: Feeling faint, Swelling of your face, Eyelids, Tongue, or Throat, Chest tightness, Skin rash.
- Lung inflammation. Cases of lung inflammation have happened in some people who receive STELARA, and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STELARA.
- Common side effects of STELARA include: Nasal congestion, Sore throat, and runny nose, Redness at the injection site, Upper respiratory infections, Vaginal yeast infections, Fever, Urinary tract infections, Headache, Sinus infection, Tiredness, Stomach pain, Itching, Diarrhea, Nausea and vomiting
How should I take STELARA?
- Use STELARA exactly as your doctor tells you to.
- The needle cover on the STELARA prefilled syringe contains latex. Do not handle the needle cover if you are sensitive to latex.
- Adults with Crohn’s disease and ulcerative colitis will receive the first dose of STELARA through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour to receive the full dose of medicine. You will then receive STELARA as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of STELARA,
- Adults with psoriasis or psoriatic arthritis and children 12 years and older with psoriasis will receive STELARA as an injection under the skin (subcutaneous injection)
- Injecting STELARA under your skin
- Insert text hereSTELARA is intended for use under the guidance and supervision of your doctor. In children 12 years and older, it is recommended that STELARA be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA at home, you should receive training on the right way to prepare and inject STELARA. Your doctor will determine the right dose of STELARA for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA yourself until you or your caregiver have been shown how to inject STELARA by your doctor or nurse
- Inject STELARA under the skin (subcutaneous injection) in your upper arms, buttocks, upper legs (thighs) or stomach area (abdomen).
- Do not give an injection in an area of the skin that is tender, bruised, red or hard.
- Use a different injection site each time you use STELARA.
- If you inject more STELARA than prescribed, call your doctor right away
- Be sure to keep all of your scheduled follow-up appointments
Important Safety Information
- Do not take STELARA if you are allergic to ustekinumab or any of the ingredients in STELARA
- The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before receiving STELARA or one year after you stop receiving STELARA.
- The syringe, needle and vial must never be re-used. After the cap is punctured, STELARA can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused portion of STELARA.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking STELARA?
Before you receive STELARA, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements and about all of your medical conditions, including if you:
- If you think you have an infection or have symptoms of an infection such as: Fever, sweat, or chills, Warm, red, or painful skin or sores on your body, Muscle aches, Diarrhea or stomach pain, Cough, Shortness of breath, Blood in phlegm, Weight loss, Burning when you urinate or urinate more often than normal, Feel very tired
- Ever had an allergic reaction to STELARA. Ask your doctor if you are not sure.
- Are allergic to latex. The needle cover on the prefilled syringe contains latex
- Have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA should not receive live vaccines
- Have any new or changing lesions within psoriasis areas or on normal skin.
- Are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with STELARA. STELARA may also increase your risk of having an allergic reaction to an allergy shot
- Receive or have received phototherapy for your psoriasis
- Are pregnant or planning to become pregnant. It is not known if STELARA can harm your unborn baby. You and your doctor should decide if you will receive STELARA
- Are breastfeeding or plan to breastfeed
General information about STELARA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use STELARA for a condition for which it was not prescribed. Do not give STELARA to other people, even if they have the same symptoms that you have. It may harm them
What are the ingredients in STELARA?
Active ingredient: Ustekinumab
Inactive ingredient: Single-dose prefilled syringe for subcutaneous use contains L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, and sucrose. Single-dose vial for subcutaneous use contains L-histidine, L-histidine hydrochloride monohydrate, Polysorbate 80 and sucrose. Single-dose vial for intravenous infusion contains EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 80, and sucrose.