What is ustekinumab?

Why is ustekinumab prescribed?

What are the possible side-effects?

What are the risks?

What else should I know about ustekinumab?

What is ustekinumab?

Ustekinumab (trade name Stelara) is a type of biologic therapy. It is an active substance known as a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body. Ustekinumab belongs to a group of medicines known as immunosuppressants. These drugs have the effect of dampening down part of the immune system (the body’s own defence system), which may be overactive in some conditions.

What are the brand names of ustekinumab?

The originator drug is Stelara.

What type of drug is ustekinumab?

Ustekinumab is a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.

What does it do?

It works by blocking certain substances in the body that affect inflammation and the body’s immune system.

What is it used for?

It is used to treat plaque psoriasis in adults and children aged 12 years and older and psoriatic arthritis in adults.

How is it taken?

It is usually given as an injection under the skin (subcutaneous injection) at week 0, week 4 and then every 12 weeks thereafter.

Are there any side-effects?

In some patients ustekinumab can cause diarrhoea, nausea and tiredness.

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Why is ustekinumab prescribed?

Ustekinumab is prescribed for people with moderate to severe plaque psoriasis. It is also used to treat active psoriatic arthritis alone or with methotrexate. It may also be used for other conditions as determined by your doctor.

When and how do I take ustekinumab?

Ustekinumab is given as an injection under the skin (subcutaneous injection). The prescribed dose will depend on your weight. For children and adolescents aged 12 years and over the doctor will work out the correct dose depending on body weight at the time of administrating the drug. After the starting dose, the next dose will be given 4 weeks later and then every 12 weeks. The following doses are usually the same as the starting dose.

How long does ustekinumab take to work?

It can take between 3 and 12 weeks to feel the benefit of ustekinumab.

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What are the possible side-effects?

In some patients ustekinumab can cause nausea (feeling sick), diarrhoea, feeling tired, feeling dizzy, headache, itching (pruritus), back, muscle or joint pain, sore throat, tooth infections or redness and pain where the injection is given.

As ustekinumab affects the immune system (the body’s own defence system), you may be more likely to develop infections. You should tell your doctor straight away if you notice any of the following:

  • fever, flu-like symptoms, night sweats
  • feeling tired or short of breath, cough which will not go away
  • warm, red and painful skin, or a painful skin rash with blisters
  • burning when passing water
  • diarrhoea

Some patients may experience allergic reactions which may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs:

  • difficulty breathing or swallowing
  • low blood pressure which can cause dizziness or light-headedness
  • swelling of the face, lips mouth or throat
  • skin rash and hives

You should always read the patient information leaflet included with your medicines package to keep you informed about any possible side effects of your prescribed medications.

What should I look out for?

You should stop ustekinumab and see your doctor immediately if any of the symptoms listed above persist or worry you or if you have recently come in contact with anyone who might have tuberculosis.

Taking ustekinumab can increase your risk of infection including serious infections which may require hospitalization including tuberculosis (TB). Your doctor will give you a TB skin test before using ustekinumab. Patients who test positive for TB should begin treatment for TB before starting ustekinumab. You will also be monitored for signs of TB while using ustekinumab even if your TB test is negative.

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What are the risks?

There may be a slightly increased risk of certain types of cancers in patients using drugs like ustekinumab which interfere with the immune system. People who have or have had risk factors for skin cancer may be more susceptible and should tell their doctor about any new skin growths while taking ustekinumab.

Tell your doctor straight away if you have any new or worsening medical problems including: headache, seizures, and confusion and or vision problems.

How can I reduce the risk of infection?

Because of its effects on the immune system, ustekinumab may make you more likely to pick up infections. You should try to avoid close contact with people with severe active infections, and visit the Food Safety Authority of Ireland website www.fsai.ie for information on reducing your risk of infection from foods.

Will it affect vaccinations?

If you are taking ustekinumab it is recommended that you avoid live vaccines such as measles and mumps. Inform your doctor if anyone in your house needs a vaccine as the viruses used in some types of vaccines can spread to people with a weakened immune system and cause serious problems. Your doctor will discuss the possible risks and benefits of any vaccinations with you.

If you are in your 70s and are offered shingles vaccination (Zostavax) your doctor may advise you to have this before starting ustekinumab.

If possible, children over 12 years of age should be brought up to date with their immunisations before starting ustekinumab.

Pneumovax (which gives protection against the commonest cause of pneumonia) and yearly flu vaccines do not interact with ustekinumab and are recommended; however, the new nasal flu vaccination is live and should not be given with ustekinumab.

Can I drink alcohol while on ustekinumab?

There is no known interaction between alcohol and ustekinumab but it is well recognised that alcohol can make your psoriasis worse. Alcohol consumption should not exceed the recommended amounts (1-2 units per day for women and 2-3 units per day for men). Your doctor may advise lower limits.

Does ustekinumab affect fertility or pregnancy?

The effects of ustekinumab in pregnancy are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using ustekinumab and for at least 15 weeks after the last ustekinumab treatment. Similarly, the effects of ustekinumab on men trying to father a child are uncertain. Talk to your doctor if you are pregnant; think you may be pregnant or planning to have a baby.

Does it affect breastfeeding?

You should also talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should decide if you should breast-feed or use ustekinumab.

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What else should I know about ustekinumab?

If you are being prescribed ustekinumab it is recommended that you carry a biological therapy alert card, which you can get from your doctor or rheumatology nurse specialist. Then if you become unwell, anyone treating you will know that you are on ustekinumab and that you are therefore at risk of its side-effects, including infections.

Are there any alternatives?

A number of other drugs are used in the treatment of plaque psoriasis and psoriatic arthritis. Your doctor will discuss these other options with you.

Will I need any special checks while on ustekinumab?

Before you start ustekinumab you will have a chest x-ray and blood tests and a screening to check whether you have ever been exposed to tuberculosis (TB) or hepatitis. Some patients may need a course of treatment for latent (asymptomatic) TB before starting ustekinumab. You may have further blood tests while you are on ustekinumab to monitor its effects.

Can I take other medicines alongside ustekinumab?

Ustekinumab can be used alongside methotrexate; however, some other medicines may interact with ustekinumab. Tell your health care provider if you are taking any other medications because the risk of their side-effects may be increased.

You should also tell your doctor or health care provider if you are having any other treatment for psoriasis / and or psoriatic arthritis such as phototherapy (when your body is treated with a type of ultraviolet (UV) light). These treatments may also weaken part of the immune system and it is possible that using both together may increase the chance of diseases related to a weaker immune system.

Can I continue with ustekinumab if I am going to have an operation?

Taking ustekinumab may increase your risk of getting an infection after a surgical procedure. You must tell your doctor or dentist that you are taking ustekinumab before any operation or dental surgery.

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Page updated 13 May 2021