Stelara (ustekinumab)

How is Stelara given?

• Ustekinumab is only prescribed by specialists in these diseases.
• The Stelara injection is given under the skin (subcutaneously). If possible the areas of the skin that are affected by psoriasis should be avoided.
• Your doctor or consultant will administer your first Stelara injection. This will be repeated after four weeks and then every 12 weeks. You may be taught how to use the injection yourself, so that you can administer the next injections yourself and do not have to visit the clinic. If this applies to you it is important to make sure you understand what to do and ask questions if you don't.
• The length of your treatment will be decided by your doctor; this will depend on the severity of the condition and the response to the treatment. Treatment should be stopped if no improvements in symptoms are seen after 28 weeks.

Important information about Stelara

• This medicine can compromise the body's ability to fight infections and can increase the risk of tuberculosis (TB) and other serious infections. You should be tested for TB before treatment is started. Tell your doctor immediately if you experience weight loss, fever or persistent coughing during treatment, as these can be symptoms of TB.
• It is important to try and avoid exposure to infections during your treatment. Let your doctor know as soon as possible if you get any symptoms of any infection, so that it can be treated without delay. If you develop a serious infection, treatment with this medicine should be stopped until the infection is controlled. Your doctor may want to continue to monitor you for infections for a period of time after treatment with this medicine is stopped.
• You should consult your doctor promptly if you notice increased redness, itching, scaling or shedding of your skin over a larger area of your body while you are having treatment with this medicine, because this may be a sign of an adverse reaction to the medicine.
• If you are due to have any surgery or dental procedures, it is important to tell your doctor or dentist that you are having treatment with this medicine.
• Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment with this medicine and for at least 15 weeks after their last injection. Seek medical advice from your doctor.

Stelara should be used with caution in

• People with a dormant (currently inactive) tuberculosis infection.
• People with a chronic infection or history of recurrent infections.
• People at risk of infections.
• People who are or who have recently been receiving treatment that suppresses the activity of the immune system, eg long-term oral corticosteroids, chemotherapy, radiotherapy, medicines to prevent transplant rejection.
• People who have had PUVA treatment.
• People with cancer or a history of cancer.
• People who are allergic to latex (the syringe cover contains latex).
• People over 65 years of age.
• Stelara should not be used in
• People with active tuberculosis.
• People with other serious active infections.
• Women who are pregnant or breastfeeding.
• This medicine is not recommended for children and adolescents under 12 years of age.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

• Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
• There is no information about the safety of this medicine if used during pregnancy. It is not recommended for use during pregnancy as it could potentially be harmful to a developing baby.
• Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment and for at least 15 weeks after their last injection. If you think you could be pregnant at any point during treatment you should tell your doctor straight away. Seek further medical advice from your doctor.
• It is not known if this medicine passes into breast milk. Women should not breastfeed during treatment with this medicine, or for at least 15 weeks after their last dose. Seek further medical advice from your doctor.

Possible side effects of Stelara

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Inflammation of the nose and throat, causing a blocked or runny nose and sore throat (nasopharyngitis).
• Upper respiratory tract infections, eg coughs and colds.
• Headache.
• Dizziness.
• Tooth infections.
• Pain in the throat, nose or mouth.
• Diarrhoea.
• Nausea.
• Itching.
• Back pain.
• Pain in the muscles or joints (myalgia or arthralgia).
• Feeling tired or weak.
• Redness and pain at site of injection.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Bacterial infections of the skin or soft tissue, eg cellulitis.
• Shingles (herpes zoster).
• Depression.
• Facial palsy (Bell's palsy).
• Blocked nose.
• Pustular psoriasis (psoriasis where blisters or pustules containing fluid appear on the skin).
• Skin scaling, flaking or peeling.
• Reaction at site of injection such as bleeding, swelling, bruising, hardness and itching.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Serious allergic reactions, including anaphylaxis and swelling of the face, throat and tongue (angioedema).
• Severe skin reaction called exfoliative dermatitis, which involves widespread redness, scaling, itching and shedding of the skin.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.

How can Stelara affect other medicines?

• You should tell your doctor if you are taking any other medicines, including over-the-counter and herbal medicines, before you start treatment with this medicine. Similarly, always seek advice from your doctor or pharmacist before taking any new medicines while you are receiving treatment with this medicine, so they can check that the combination is safe.

This medicine suppresses part of the immune system. This means that vaccines may potentially be less effective if given during treatment, and live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, BCG, oral polio, oral typhoid and yellow fever. It is recommended that live vaccines are not given to people being treated with this medicine, or for 15 weeks after treatment with this medicine is stopped.

References:

https://www.rxlist.com/stelara-side-effects-drug-center.htm

https://www.netdoctor.co.uk/medicines/skin-hair/a8849/stelara-ustekinumab/

https://www.stelarainfo.com/crohns-disease

https://www.hpra.ie/docs/default-source/3rd-party-documents/educational-materials/stelara_hcp-guide.pdf?sfvrsn=2

https://www.stelarahcp.com

https://www.webmd.com/ibd-crohns-disease/crohns-disease/news/20161117/drug-stelara-may-ease-crohns-disease#1