Anifrolumab is a fully human monoclonal antibody that blocks the Type I Interferon (IFN) receptor, helping reduce immune system activation associated with Systemic Lupus Erythematosus (SLE).

 

It has been prescribed because your treating specialist believes it is an appropriate treatment for your condition.

Approved indication:

☐ Moderate to severe Systemic Lupus Erythematosus (SLE)

Other specialist indication (if applicable)

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EXPECTED BENEFITS

☐ Reduce lupus disease activity

☐ Reduce disease flares

☐ Improve skin manifestations

☐ Improve joint pain and stiffness

☐ Reduce fatigue associated with lupus

☐ Reduce corticosteroid requirements

☐ Improve quality of life

☐ Reduce long-term disease complications

I understand that treatment response varies between individuals and cannot be guaranteed.

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ALTERNATIVE TREATMENTS

Reasonable alternatives discussed include:

☐ Hydroxychloroquine

☐ Corticosteroids

☐ Methotrexate

☐ Azathioprine

☐ Mycophenolate mofetil

☐ Belimumab

☐ Cyclophosphamide

☐ Rituximab (off-label)

☐ Observation

☐ No treatment

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BEFORE STARTING TREATMENT

Before commencing Anifrolumab, I understand my clinician may review:

☐ Full Blood Count (FBC)

☐ Kidney function

☐ Liver function

☐ Urinalysis (where appropriate)

☐ Tuberculosis screening (where clinically indicated)

☐ Hepatitis B screening (where clinically indicated)

☐ Pregnancy assessment

☐ Vaccination history

☐ Current medications

☐ History of recurrent infections

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I HAVE INFORMED MY CLINICIAN IF I HAVE

Current infection 

Fever

Recurrent herpes (cold sores/shingles)

Tuberculosis 

Hepatitis

HIV 

Cancer 

Pregnancy

Breastfeeding

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COMMON SIDE EFFECTS

☐ Upper respiratory tract infection

☐ Nasopharyngitis

☐ Headache

☐ Nausea

☐ Fatigue

☐ Mild infusion reactions

☐ Cough

☐ Joint pain

☐ Mild skin rash

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MATERIAL RISKS

Although uncommon, I understand Anifrolumab may increase my risk of:

☐ Serious infection

☐ Opportunistic infection

☐ Viral infections

☐ Herpes zoster (shingles)

☐ Herpes simplex infection

☐ Bronchitis

☐ Pneumonia

☐ Infusion reactions

☐ Severe allergic reaction

☐ Anaphylaxis

☐ Delayed hypersensitivity

☐ Requirement for hospital admission

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HERPES ZOSTER (SHINGLES)

Anifrolumab has been associated with an increased risk of shingles.

I understand:

☐ Vaccination may be recommended before treatment where appropriate.

☐ I should seek medical advice promptly if I develop:

• painful skin rash

• blisters

• burning pain

• facial rash

• eye symptoms

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INFUSION REACTIONS

Symptoms may include:

☐ Rash

☐ Itching

☐ Hives

☐ Flushing

☐ Fever

☐ Chills

☐ Chest discomfort

☐ Wheezing

☐ Shortness of breath

☐ Facial swelling

☐ Low blood pressure

☐ Dizziness

☐ Collapse

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

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PREGNANCY & BREASTFEEDING

I understand:

☐ The safety of Anifrolumab during pregnancy has not been fully established.

☐ I should discuss pregnancy planning with my treating rheumatologist.

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

☐ Breastfeeding should be discussed with my treating specialist.

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VACCINATIONS

I understand:

☐ Vaccination status should be reviewed before commencing treatment.

☐ Live vaccines are generally not recommended during treatment unless specifically advised by my treating specialist.

☐ Vaccination against shingles may be recommended before treatment where appropriate.

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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

☐ Painful blistering rash

☐ Eye pain associated with a rash

☐ Persistent chest pain

☐ Any signs of serious infection

☐ Any symptoms that concern me

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PATIENT ACKNOWLEDGEMENT

I acknowledge that:

☐ My diagnosis has been explained.

☐ The reason Anifrolumab 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 my increased risk of viral infections, including shingles.

☐ I understand that infusion reactions may occur.

☐ 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.