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). It is also approved to treat moderate-to-severe psoriatic arthritis. Ustekinumab 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.
Ustekinumab is a prescription medication used to treat adults with psoriasis. It is also approved to treat moderate-to-severe psoriatic arthritis.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Ustekinumab can increase your chances of having serious side effects. See "Drug Precautions" section.
Common side effects include:
- upper respiratory infections
These are not all of the possible side effects of ustekinumab. Ask your doctor or pharmacist, for more information.
Tell your doctor about any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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.
This is not a complete list of ustekinumab drug interactions. Ask your doctor or pharmacist for more information.
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.
Ustekinumab is a medicine that affects your immune system. Ustekinumab can increase your chances of having serious side effects, including:
- Serious Infections: Ustekinumab 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 ustekinumab.
- If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with ustekinumab and during treatment with ustekinumab.
- Your doctor should watch you closely for signs and symptoms of TB during treatment with ustekinumab.
- You should not start taking ustekinumab if you have any kind of infection unless your doctor says it is okay.
Before starting ustekinumab, 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 ustekinumab, call your doctor right away if you have any symptoms of an infection (see above).
Ustekinumab 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 ustekinumab will get any of these infections, because of the effects of ustekinumab on these proteins in your body.
- Cancers: Ustekinumab 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 ustekinumab. 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 ustekinumab there are no specific foods that you must exclude from your diet when receiving ustekinumab.
Before you receive ustekinumab, 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 ustekinumab 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 ustekinumab or one year after you stop taking ustekinumab.
- are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with ustekinumab. Ustekinumab 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 ustekinumab.
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 plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
This medication falls into category B. There are no well-controlled studies of ustekinumab in pregnant women. Animal studies found no evidence of harm. Ustekinumab should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn baby.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is thought that ustekinumab passes into your breast milk. You should not breastfeed while taking ustekinumab without first talking with your doctor.
- Ustekinumab is given by injection under the skin (subcutaneous injection).
- Ustekinumab should only be given by a healthcare provider as directed by your doctor.
- Your doctor will decide the right dose of ustekinumab for you and how often you should receive it.
- Be sure to keep all of your scheduled follow-up appointments.
Ustekinumab is given by subcutaneous injection (under skin) by a healthcare provider.
Dosing for the treatment of psoriasis
- 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.
- The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
- For patients with co-existent moderate-to-severe plaque psoriasis weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
If ustekinumab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
Keep all medical and laboratory appointments. It is important you receive your scheduled ustekinumab doses to get the most benefit.
Ustekinumab may lower the ability of your immune system to fight infections and may increase your risk of infections. Contact your health care provider if you signs/ symptoms of an infection.
Your doctor should check you for TB before starting ustekinumab. Your doctor should watch you closely for signs and symptoms of TB during treatment with ustekinumab
People who take ustekinumab should not receive live vaccines.
Before you receive ustekinumab, tell your doctor if you receive phototherapy for your psoriasis.