Rituximab for the treatment of autoimmune hepatitis

This leaflet will provide you with information about the drug and can answer any questions you may have.

What is rituximab?

Rituximab is used for patients with autoimmune hepatitis (AIH), affecting the liver. Rituximab is unlicensed for AIH and is sometimes used in patients who cannot have other treatments.

AIH can develop when your body’s own immune system attacks the cells in your liver. If left untreated, this can lead to the cirrhosis (scarring of the liver), which increases the risk of liver cancer. Rituximab is a biological medicine. It can help suppress your immune system to stop it attacking your liver, and we can use it to try to reduce your dependence on steroid treatment.

How do I take rituximab?

Rituximab is given as an infusion. You will typically receive two infusions of 1000mg two weeks apart at the Cambridge Infusion Centre (Tel: 01223 586 967).

We will arrange an appointment for you after we perform some checks and counsel you on the medication. The infusion centre will then contact you to confirm your time and date of your appointment. Please note each appointment is 6 hours long, therefore please arrive on time to avoid any delays to your treatment.

You can find more information and directions on the Cambridge Infusion Centre webpage.

On the day of your infusion, if you usually take blood pressure medicines or paracetamol, please do not take them before you come in. Please bring them in and we will tell you when to take them that day.

When you have your first infusion, you will be asked to give your consent for the infusion and go through safety checks including some blood tests. You will also be given an alert card to carry with you, so that everyone will know that you had a rituximab infusion and that your immune system may be affected. Always keep this on you until 1 year after the infusion.

Do I need any special checks or tests whilst on rituximab?

You will need regular tests and checks whilst on rituximab to confirm the treatment is effective and to detect important side effects.

These include:

• Full blood count (FBC)
• Liver function tests (LFT)
• Kidney function tests - Urea and electrolytes (U&Es)
• Varicella zoster (chickenpox) antibodies
• Epstein-Barr Virus (EBV)
• HIV
• Hepatitis B and C
• Tuberculosis (TB)
• Cytomegalovirus (CMV)
• Inflammation markers – C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)
• Immunoglobulins
• Body Weight
• Recent history of infection, rashes, stomach pain, diarrhoea
• Any planned surgical or dental procedures
• Pregnancy and breastfeeding status if relevant

You will be under the care of the autoimmune hepatitis team and we will schedule regular appointments with you to check how you are responding to treatment.

Side effects

Like all drugs, rituximab can sometimes cause side effects. But not everyone gets them.

Common side effects include:

• Headache
• Fever
• Nightsweats
• Vomiting
• Low mood
• Constipation
• Cough

A few people feel unwell or experience wheeziness, fever, a rash or a fall in blood pressure while they are having the infusion, or shortly afterwards. Your blood pressure, heart rate, respiratory rate and temperature will be monitored closely during the infusion, so please tell a nurse if you start feeling unwell.

Although very rare (less than 1 in 10,000 people), rituximab can cause a condition called progressive multifocal leukoencephalopathy (PML). This is a serious viral brain infection which can be fatal. You should seek medical help immediately if you notice any of the following symptoms: pins and needles, weakness or difficulty moving your face, arms or legs, shaky movements or unsteadiness, loss of vision, difficulty in speaking or changes in your behaviour or mood.

Rituximab affects your immune system, which can make you more likely to pick up some infections. Please tell us if you develop any signs of infection (e.g. a fever).

You should also see your doctor if you develop chickenpox or shingles or come into contact with someone who has developed these illnesses. These illnesses can be more severe if you’re taking rituximab. You may need to get treatment, and your rituximab may be stopped until you’re better.

Taking rituximab with other medicines

Rituximab can decrease your blood pressure during the infusion, so you should not take any blood pressure medication on the day of the infusion.

It is safe to drink alcohol in moderation whilst on rituximab, but if you have nausea, it can make it worse.

Drugs that you can buy over the counter (such as in supermarkets) do not interact with rituximab. However, for supplements and herbal medicines, please check with us. Rituximab may also interact with some other prescribed drugs, so it is important that you tell us about any other medication you are taking.

Vaccines

Rituximab is likely to reduce your body's resistance to infection. You can become seriously unwell from the viruses that cause chickenpox, shingles, and pneumococcal disease. If you are not already immune, we will recommend you get shingles (Shingrix brand only) and pneumonia vaccines. We also recommended everyone to get their yearly flu and COVID-19 jabs.

However, you should avoid live vaccines whilst on treatment and for 6 months after the last dose. Live vaccines include the live varicella/shingles immunisation (Zostavax brand), oral polio, oral typhoid, BCG, MMR and yellow fever. We will be able to advise you if you need these.

Pregnancy, breastfeeding and fertility

If you’re planning to try for a baby, if you become pregnant, or if you’re thinking of breastfeeding, it is important that you discuss this with us.

Because rituximab is a relatively new drug, we don’t yet know how it might affect pregnancy or an unborn baby. If you’re a woman of childbearing age, you must use effective contraception during and until 12 months after your last rituximab infusion.

You must tell us if you become pregnant whilst taking rituximab.

We don’t yet know whether rituximab can pass into breastmilk, so current advice is not to breastfeed while taking this drug and until 6 months after the last infusion.

It is considered safe for men to continue taking rituximab while trying to father a baby.

Biosimilars

Rituximab was originally only available with a brand name called MabThera.

However, newer versions of biological therapies are becoming available, so you may be prescribed rituximab under a different brand name, such as Truxima, Ruxience or Rixathon. These drugs are known as biosimilars and work in a similar way. We will let you know if you need to switch brands.

More information about biological medicines and biosimilars is availble here: Starting a biologic or biosimilar medicine | CUH

Contacts

1. Autoimmune Hepatology Helpline: 01223 216 109
2. Cambridge Infusion Centre: 01223 586 967
   Cambridge Infusion Centre
3. Message via MyChart

Medication

Bring all of your medicines (including inhalers, injections, creams, eye drops or patches) and a current repeat prescription from your GP

Please tell the ward staff about all of the medicines you use. During your stay If you wish to take your medication yourself (self-medicate) please speak with your nurse. Pharmacists visit the wards regularly and can help with any medicine queries.

MyChart

We would encourage you to sign up for MyChart. This is the electronic patient portal at Cambridge University Hospitals that enables patients to securely access parts of their health record held within the hospital’s electronic patient record system (Epic). It is available via your home computer or mobile device

Further information on MyChart

Further information

Effective contraception guidance | GOV.uk (opens in a new tab)

Choosing a method of contraception | NHS (opens in a new tab)

Starting a biologic or biosimilar medicine leaflet

British Liver Trust autoimmune hepatitis resource is available on the British Liver Trust website. (opens in a new tab)

British Liver Trust autoimmune hepatitis booklet (opens in a new tab).

Cambridge Infusion Centre webpage

Privacy and dignity

Same sex bays and bathrooms are offered in all wards except critical care and theatre recovery areas where the use of high-tech equipment and/or specialist one to one care is required.