Vedolizumab is a gut-selective monoclonal antibody used to treat inflammatory bowel disease (IBD).

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It works by blocking the movement of certain white blood cells into the gastrointestinal tract, helping to reduce inflammation while having less effect on the immune system elsewhere in the body.

It may be prescribed for:

☐ Crohn's Disease

☐ Ulcerative Colitis

☐ Other (specialist indication)

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EXPECTED BENEFITS

Treatment may:

☐ Reduce intestinal inflammation

☐ Improve diarrhoea

☐ Improve abdominal pain

☐ Promote healing of the bowel

☐ Achieve clinical remission

☐ Reduce corticosteroid requirements

☐ Reduce hospital admissions

☐ Reduce surgery risk

☐ Improve quality of life

I understand improvement may take several weeks or months and individual responses vary.

 

ALTERNATIVE TREATMENTS

Reasonable alternatives discussed include:

☐ Corticosteroids

☐ Thiopurines

☐ Methotrexate

☐ Anti-TNF therapy

☐ Ustekinumab

☐ Risankizumab

☐ Janus Kinase (JAK) inhibitors

☐ Surgery

☐ No treatment

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BEFORE STARTING TREATMENT

Before commencing Vedolizumab, I understand my treating clinician may recommend:

☐ Blood tests

☐ Tuberculosis screening

☐ Hepatitis B screening

☐ Hepatitis C screening

☐ Vaccination review

☐ Pregnancy assessment (where appropriate)

☐ Infection screening

 

I HAVE INFORMED MY CLINICIAN IF I HAVE

Fever

Current infection 

Tuberculosis 

Hepatitis

HIV 

Previous biologic reaction 

Pregnancy 

Breastfeeding

Recent vaccination 

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COMMON SIDE EFFECTS

Common side effects may include:

☐ Headache

☐ Fatigue

☐ Nausea

☐ Fever

☐ Joint pain

☐ Mild upper respiratory tract infections

☐ Nasopharyngitis

☐ Mild infusion reactions

☐ Itching

☐ Rash

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MATERIAL RISKS

Although Vedolizumab is considered gut-selective and generally has a lower risk of systemic immunosuppression than some biologic therapies, important risks remain.

I understand these include:

☐ Infusion reactions

☐ Allergic reactions

☐ Serious infection

☐ Opportunistic infection

☐ Delayed hypersensitivity reactions

☐ Liver injury

☐ Elevated liver function tests

☐ Progressive worsening of inflammatory bowel disease

☐ Requirement to change biologic therapy

☐ Hospital admission

☐ Rare severe allergic reaction

☐ Rare anaphylaxis

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INFUSION REACTIONS

Infusion reactions may occur during or shortly after treatment.

Symptoms may include:

☐ Flushing

☐ Rash

☐ Itching

☐ Hives

☐ Fever

☐ Chills

☐ Chest discomfort

☐ Shortness of breath

☐ Wheezing

☐ Facial swelling

☐ Hypotension

☐ Dizziness

☐ Collapse

If these occur, treatment may be slowed or stopped and emergency treatment commenced.

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PML (PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY)

Progressive Multifocal Leukoencephalopathy (PML) is a very rare but serious viral brain infection.

To date, the risk with Vedolizumab appears to be extremely low, but patients should report any new neurological symptoms immediately.

Symptoms may include:

☐ Weakness

☐ Difficulty walking

☐ Changes in vision

☐ Difficulty speaking

☐ Confusion

☐ Memory problems

☐ Personality changes

I understand I should seek urgent medical attention if these symptoms develop.

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VACCINATIONS

I understand:

☐ Vaccination status should be reviewed before commencing therapy.

☐ Live vaccines should generally be avoided during treatment unless specifically recommended by my treating clinician.

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

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WHEN SHOULD I SEEK URGENT MEDICAL REVIEW?

Following treatment I should seek urgent medical attention if I develop:

☐ Fever

☐ Persistent diarrhoea

☐ Severe abdominal pain

☐ Blood in stool

☐ Persistent cough

☐ Shortness of breath

☐ Severe rash

☐ Facial swelling

☐ Jaundice

☐ Severe headache

☐ New neurological symptoms

☐ Signs of serious infection

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PATIENT ACKNOWLEDGEMENT

I acknowledge that:

☐ My diagnosis has been explained.

☐ The reason Vedolizumab has been recommended 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 still occur.

☐ I understand that infusion reactions may occur.

☐ I understand the importance of reporting neurological symptoms immediately.

☐ 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.