Ocrelizumab is a monoclonal antibody that targets CD20-positive B lymphocytes, reducing inflammation and abnormal immune activity involved in Multiple Sclerosis (MS).

 

It is approved for treatment of:

☐ Relapsing-Remitting Multiple Sclerosis (RRMS)

☐ Active Secondary Progressive MS (where applicable)

☐ Primary Progressive Multiple Sclerosis (PPMS)

☐ Other specialist indication

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ROUTE OF ADMINISTRATION

My treatment will be administered as:

☐ Intravenous infusion (IV)

☐ Subcutaneous injection (SC)

I understand that my neurologist may recommend changing between IV and SC administration where clinically appropriate.

 

EXPECTED BENEFITS

Treatment may:

☐ Reduce relapse frequency

☐ Reduce MRI disease activity

☐ Slow disability progression

☐ Reduce inflammatory lesions

☐ Delay disease progression

☐ Improve long-term neurological outcomes

☐ Improve quality of life

I understand treatment response varies between individuals and no benefit can be guaranteed.

 

ALTERNATIVE TREATMENTS

Reasonable alternatives discussed include:

☐ Other anti-CD20 therapies

☐ Natalizumab

☐ Alemtuzumab

☐ Cladribine

☐ Ofatumumab

☐ Fingolimod or S1P modulators

☐ Dimethyl fumarate

☐ Teriflunomide

☐ Interferon therapy

☐ Glatiramer acetate

☐ No treatment

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BEFORE STARTING TREATMENT

Before commencing Ocrelizumab I understand assessment may include:

☐ Hepatitis B screening

☐ FBC

☐ Liver function tests

☐ Immunoglobulin levels

☐ Vaccination review

☐ Pregnancy assessment

☐ MRI review

☐ Neurological examination

☐ Infection screening

 

I HAVE INFORMED MY CLINICIAN IF I HAVE

Current infection

Fever

Hepatitis B

HIV

Previous serious infection

Cancer

Pregnancy

Breastfeeding

Previous biologic reaction

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PREMEDICATIONS

I understand I may receive medications before treatment including:

☐ Corticosteroids

☐ Antihistamines

☐ Paracetamol

☐ Other

These medicines are intended to reduce infusion or injection-related reactions.

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COMMON SIDE EFFECTS

☐ Fatigue

☐ Headache

☐ Mild fever

☐ Flushing

☐ Itching

☐ Rash

☐ Mild upper respiratory infection

☐ Nasopharyngitis

☐ Injection site reactions (SC)

☐ Infusion reactions (IV)

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MATERIAL RISKS

I understand Ocrelizumab may increase my risk of:

☐ Infusion reactions (IV)

☐ Injection reactions (SC)

☐ Serious infection

☐ Respiratory infection

☐ Herpes virus infection

☐ Opportunistic infection

☐ Reduced antibody levels (hypogammaglobulinaemia)

☐ Delayed wound healing

☐ Hepatitis B reactivation

☐ Progressive Multifocal Leukoencephalopathy (PML) (very rare)

☐ Malignancy (including a possible increased risk of breast cancer reported in clinical studies)

☐ Severe allergic reaction

☐ Anaphylaxis

☐ Requirement for hospital admission

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INFUSION / INJECTION REACTIONS

These reactions may occur during treatment or within 24 hours afterwards.

Symptoms may include:

☐ Flushing

☐ Fever

☐ Chills

☐ Itching

☐ Rash

☐ Hives

☐ Throat irritation

☐ Chest tightness

☐ Wheezing

☐ Difficulty breathing

☐ Swelling of the face

☐ Dizziness

☐ Low blood pressure

☐ Rapid heart rate

☐ Nausea

☐ Injection site pain (SC)

☐ Injection site swelling (SC)

If these occur treatment may be slowed, stopped or delayed and emergency medications administered

 

Progressive Multifocal Leukoencephalopathy (PML) is an extremely rare but potentially life- threatening viral brain infection.

Symptoms may include:

☐ Weakness

☐ Vision changes

☐ Difficulty speaking

☐ Memory problems

☐ Personality changes

☐ Balance problems

☐ New neurological symptoms

I understand I should seek urgent medical attention if these occur.

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PREGNANCY & BREASTFEEDING

I understand:

☐ Ocrelizumab may affect an unborn baby.

☐ Effective contraception is recommended during treatment and for the period advised by my treating neurologist after my last dose.

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

☐ Breastfeeding should be discussed with my treating neurologist.

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VACCINATIONS

I understand:

☐ Vaccinations should ideally be completed before commencing treatment.

☐ Live vaccines are generally contraindicated during treatment and until B-cell recovery.

☐ Vaccine responses may be reduced during treatment.

 

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

☐ Severe infusion or injection reaction

☐ New neurological symptoms

☐ Vision changes

☐ Severe headache

☐ Persistent diarrhoea

☐ Any signs of serious infection

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PATIENT ACKNOWLEDGEMENT

I acknowledge that:

☐ My diagnosis has been explained.

☐ The reason Ocrelizumab has been recommended has been explained.

☐ I understand whether my treatment will be administered intravenously or subcutaneously.

☐ 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 Ocrelizumab may increase my risk of infections.

☐ I understand vaccinations may be less effective during treatment.

☐ I understand that PML is a very rare but serious complication.

☐ I understand that infusion or injection 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.