Ustekinumab

Ustekinumab is a prescription medication used to treat adults and adolescents 12 years or older with moderate to severe psoriasis (a skin disease in which red, scaly patches form on some areas of the body). It is also approved to treat adults with psoriatic arthritis and Crohn’s disease.

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.

This medication comes in an injectable form to be given just under the skin or into the vein by a healthcare provider.

Common side effects include upper respiratory tract infections, headache, and tiredness.

Ustekinumab is a prescription medication used to treat adults and adolescents 12 years or older with:

• moderate or severe psoriasis that involves large areas of the body and may benefit from using injections, pills, or phototherapy

Ustekinumab is a prescription medication used to treat adults with:

• psoriatic arthritis (​​​​​​​Ustekinumab may be used alone or with methotrexate)
• moderate to severe active Crohn’s disease in those who have tried taking other medications but did not work or was not tolerated

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ustekinumab may be found in some form under the following brand names:

• Stelara

Ustekinumab can increase your chances of having serious side effects. See "Drug Precautions" section.

Common side effects include:

• upper respiratory infections
• headache
• tiredness
• itching
• vomiting
• vaginal yeast infections
• urinary tract infections
• redness at the injection site

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 allergic reactions. Stop using ustekinumab and seek immediate medical attention if you notice any of the following:
  • feeling faint
  • chest tightness
  • swelling of your face, eyelids, tongue, or throat
  • skin rash
• Cancers. This medication may affect your immune system and in turn, increase your risk for certain types of cancers. Tell your healthcare provider if you have ever had any type of cancer. Report any skin growths to your healthcare provider. 
• A serious and rare condition that affects the brain. This condition is referred to as reversible posterior leukoencephalopathy syndrome (RPLS): The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your healthcare provider right away if you notice:
  • headache
  • confusion
  • seizures
  • vision problems
• 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
• cough
• 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.

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"
• ever had an allergic reaction to ustekinumab. 
• 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 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.
• 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 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.

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.

It is not known if this medication can harm your unborn baby. You and your doctor should decide if you will take this medication. There is a pregnancy registry for women who take ustekinumab during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you are pregnant or become pregnant while taking ustekinumab, talk to your doctor about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

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) for the treatment of psoriasis and psoriatic arthritis. 
• Ustekinumab is given by injection into the vein for the treatment of Crohn’s disease
• 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.

The dosing for the treatment of psoriasis in adults:

The dosing for the treatment of Crohn’s disease is a one-time infusion and is as follows:

• Up to 55 kg (up to 121 lbs): 260 mg 
• Greater than 55 kg (121 lbs) but less than 85 kg (187lbs): 390 mg
• Greater than 85 kg (187lbs): 520 mg

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.