Stelara (generic: ustekinumab) is a prescription medication used to treat adults with psoriasis (a skin disease in which red, scaly patches form on some areas of the body). Stelara belongs to a group of drugs known as monoclonal antibodies. It works by binding to specific proteins of the body that are involved in inflammation and immune response, thereby preventing these proteins from binding to other cells and causing the symptoms of psoriasis.
This medication comes in an injectable form to be given just under the skin by a healthcare provider.
Common side effects include upper respiratory tract infections, headache, and tiredness.
Stelara is a prescription medication used to treat adults with psoriasis.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Stelara can increase your chances of having serious side effects. See "Drug Precautions" section.
Common side effects of Stelara include:
- upper respiratory infections
These are not all of the possible side effects of Stelara. Tell your doctor about any side effect that bothers you or that does not go away. For more information, ask your doctor or pharmacist.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- other medicines that affect your immune system.
- certain medicines that can affect how your liver breaks down other medicines.
Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
Stelara is a medicine that affects your immune system. Stelara can increase your chances 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.
- Your doctor should check you for TB before starting Stelara.
- If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Stelara and during treatment with Stelara.
- Your doctor should watch you closely for signs and symptoms of TB during treatment with Stelara.
- You should not start taking Stelara if you have any kind of infection unless your doctor says it is okay.
Before starting Stelara, tell your doctor if you think you have an infection or have symptoms of an infection such as:
- fever, sweats, or chills
- muscle aches
- shortness of breath
- blood in your phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more often than normal
- feel very tired
- are being treated for an infection
- get a lot of infections or have infections that keep coming back
- have TB, or have been in close contact with someone who has TB.
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. It is not known if people who take Stelara will get any of these infections, because of the effects of Stelara on these proteins in your body.
- 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.
- 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:
- vision problems
- Serious Allergic reactions. Serious allergic reactions can occur with Stelara. 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
- trouble breathing, throat tightness
- chest tightness
- skin rash
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Stelara there are no specific foods that you must exclude from your diet when receiving Stelara.
Before you receive Stelara, tell your doctor if you:
- have any of the conditions or symptoms listed in the section "Drug Precautions"
- have recently received or are scheduled to receive an immunization (vaccine). People who take Stelara should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of 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 taking Stelara or one year after you stop taking Stelara.
- 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 phototherapy for your psoriasis.
- have any other medical conditions.
- are pregnant or planning to become pregnant.
- are breastfeeding or plan to breastfeed.
- ever had an allergic reaction to Stelara.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your doctor if you are pregnant or planning to become pregnant. It is not known if Stelara will harm your unborn baby. You and your doctor should decide if you will take Stelara.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is thought that Stelara passes into your breast milk. You should not breastfeed while taking Stelara without first talking with your doctor.
- Stelara is given by injection under the skin (subcutaneous injection).
- Stelara should only be given by a healthcare provider as directed by your doctor.
- Your doctor will decide the right dose of Stelara for you and how often you should receive it.
- Be sure to keep all of your scheduled follow-up appointments.
Stelara is given by subcutaneous injection (under skin) by a healthcare provider.
- For patients weighing ≤100 kg (220 lbs), the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
- For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
In subjects weighing >100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects.
Stelara is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.
Active ingredient: ustekinumab
Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, and sucrose.
Keep all medical and laboratory appointments. It is important you receive your scheduled Stelara doses to get the most benefit.
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