Ustekinumab is a human monoclonal antibody that blocks Interleukin-12 (IL-12) and Interleukin-23 (IL-23), reducing inflammation associated with autoimmune disease.

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It may be prescribed for:

☐ Crohn's Disease

☐ Ulcerative Colitis

☐ Plaque Psoriasis

☐ Psoriatic Arthritis

☐ Other specialist indication

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MY TREATMENT PLAN

My treatment will be administered as:

☐ Intravenous induction dose

followed by

☐ Subcutaneous maintenance injections

OR

☐ Subcutaneous therapy only

I understand my specialist will determine my treatment schedule.

 

EXPECTED BENEFITS

Treatment may:

☐ Reduce inflammation

☐ Improve disease control

☐ Promote remission

☐ Improve bowel healing

☐ Improve skin disease

☐ Improve joint symptoms

☐ Reduce corticosteroid use

☐ Improve quality of life

☐ Reduce hospital admissions

I understand treatment response varies between individuals.

 

ALTERNATIVE TREATMENTS

Reasonable alternatives discussed include:

☐ Corticosteroids

☐ Thiopurines

☐ Methotrexate

☐ Anti-TNF biologics

☐ Vedolizumab

☐ Risankizumab

☐ JAK inhibitors

☐ Surgery

☐ Observation

☐ No treatment

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BEFORE STARTING TREATMENT

Before commencing treatment I understand assessment may include:

☐ Tuberculosis screening

☐ Hepatitis B screening

☐ Hepatitis C screening

☐ Blood tests

☐ Pregnancy assessment

☐ Vaccination review

☐ Infection screening

 

I HAVE INFORMED MY CLINICIAN IF I HAVE

Current infection 

Fever

Tuberculosis 

Hepatitis

HIV 

Previous biologic reaction

Cancer 

Pregnancy 

Breastfeeding 

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COMMON SIDE EFFECTS

☐ Headache

☐ Fatigue

☐ Mild upper respiratory tract infection

☐ Nasopharyngitis

☐ Nausea

☐ Injection site reactions (maintenance injections)

☐ Mild infusion reactions (IV induction)

☐ Joint pain

☐ Mild skin rash

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MATERIAL RISKS

Although serious complications are uncommon, I understand Ustekinumab may increase the risk of:

☐ Serious infection

☐ Opportunistic infection

☐ Tuberculosis reactivation

☐ Fungal infection

☐ Viral infection

☐ Skin infections

☐ Allergic reactions

☐ Infusion reactions

☐ Injection site reactions

☐ Delayed hypersensitivity

☐ Severe allergic reaction

☐ Anaphylaxis (rare)

☐ Rare neurological disorders

☐ Rare malignancy

☐ Requirement for hospital admission

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INFUSION / INJECTION REACTIONS

These reactions may occur during or after treatment.

Symptoms may include:

☐ Rash

☐ Itching

☐ Hives

☐ Flushing

☐ Fever

☐ Chills

☐ Chest discomfort

☐ Wheezing

☐ Shortness of breath

☐ Facial swelling

☐ Low blood pressure

☐ Dizziness

If these symptoms occur treatment may be stopped and emergency treatment commenced.

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VACCINATIONS

I understand:

☐ My vaccination history should be reviewed before treatment.

☐ Live vaccines should generally be avoided while receiving Ustekinumab unless specifically recommended by my specialist.

☐ I should inform all healthcare providers that I am receiving Ustekinumab.

 

PREGNANCY & BREASTFEEDING

I understand:

☐ Pregnancy should be discussed with my treating specialist before treatment.

☐ I should notify my clinician immediately if I become pregnant.

☐ Breastfeeding should be discussed with my treating specialist.

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WHEN SHOULD I SEEK URGENT MEDICAL REVIEW?

I should seek urgent medical attention if I develop:

☐ Fever

☐ Persistent cough

☐ Shortness of breath

☐ Severe rash

☐ Facial swelling

☐ Chest pain

☐ Severe abdominal pain

☐ Persistent diarrhoea

☐ New neurological symptoms

☐ Signs of serious infection

☐ Any symptoms that concern me

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BIOSIMILAR ACKNOWLEDGEMENT

I understand:

☐ My specialist may prescribe a TGA-approved biosimilar instead of the original brand.

☐ Approved biosimilars have been evaluated by the Therapeutic Goods Administration (TGA) for quality, safety and efficacy.

☐ I have had the opportunity to discuss any questions regarding biosimilar medicines.

 

PATIENT ACKNOWLEDGEMENT

I acknowledge that:

☐ My diagnosis has been explained.

☐ The reason Ustekinumab has been recommended has been explained.

☐ My treatment schedule (IV induction and/or SC maintenance) has been explained.

☐ Expected benefits have been discussed.

☐ Reasonable alternatives have been discussed.

☐ I understand the common side effects.

☐ I understand the material risks relevant to my circumstances.

☐ I understand that serious infections may occur.

☐ I understand infusion or injection reactions may occur.

☐ I understand vaccinations should be discussed before treatment.

☐ I understand emergency treatment may become necessary.

☐ I understand treatment effectiveness cannot be guaranteed.

☐ I have had sufficient opportunity to ask questions.

☐ My questions have been answered.

☐ I understand I may withdraw my consent before treatment commences.