• Reference Number: HEY-971/2022
• Departments: Pharmacy
• Last Updated: 1 June 2022

Introduction

This leaflet offers more information about your medicines for your medical conditions and our plans to switch your treatment over from your current Rituximab to Rixathon. If you have any further questions or concerns after reading this leaflet, please speak to your doctor or the nurses at the Rheumatology Department.

What are biological medicines (biologics)?

Biologics are drugs that mimic or block natural chemicals in your body. They are manufactured by the pharmaceutical industry in a complex process which involves producing the molecule and then purifying and cleaning it. Rituximab works by binding to a naturally occurring chemical present on the surface of cells, called an antigen, which then stops an immune reaction from occurring.

Biologics are extensively used in the treatment of inflammatory diseases such as rheumatoid arthritis.

What is a biosimilar?

The World Health Organization (WHO) has defined a biosimilar as a drug that is similar in terms of quality, safety and efficacy (effectiveness) to the original licensed product. This means that biosimilars (such as Truxima and Rixathon) are allowed to have small structural differences from the original licensed product (Mabthera) but this must not alter how well the drug works, how safe it is, or how the drug reacts with the body’s immune system.

The process for manufacturing Mabthera, the original Rituximab, has itself altered several times since it was first introduced resulting in a cleaner drug with fewer side effects. Rixathon has been assessed against the last versions of Mabthera.

Biosimilars are regulated in a similar way to the original licensed product. The European Medicines Agency has approved the use of Rixathon as it has been shown to be as safe and as effective as Mabthera and Truxima.

Do biosimilars work as well?

There have been a number of research studies comparing how well biosimilars work and their safety. There appear to be no differences between the original biologics and the new biosimilars. Over the years, experience with biosimilars of other drugs has been acquired in this hospital and we have no new issues reported. We expect patients on a biosimilar to have the same response as if they had stayed on the original biologic. Unfortunately, all drugs may stop being effective at some point in time, but this is no more likely to happen with any brand of rituximab.

Are biosimilars safe?

Biosimilars have a similar safety profile to the original biologics. The regulator of new drugs, the European Medicines Agency, has declared biosimilar drugs safe and interchangeable with the original drugs. National Institute for Clinical Excellence and Care (NICE) has also supported this position.

Why am I receiving this leaflet?

You may be aware that the patent for Mabthera expired several years ago and now several biosimilars have been approved and are available to patients. The biosimilar drug for rituximab currently used at HEY NHS Hospitals Trust is marketed under the trade name Truxima. We will now be changing from this brand over to rituximab biosimilar called Rixathon. Since Rixathon offers cost savings and enables us to deliver care more effectively, we aim to gradually switch all patients over to Rixathon.

What does this mean for me?

As Truxima and Rixathon contain the same active product (rituximab), treatment for your medical condition remains unchanged. You will receive Rixathon at your next appointment in the Medical Day Unit. The appointment will last the same amount of time and the same amount of monitoring will be done by the Nurses.

What happens if I change to a biosimilar and develop side effects?

Please be assured that we would not be offering this alternative medicine unless we were completely confident that it was just as safe and effective as your current medication. When switching to a biosimilar it is not expected that there will be any issues. However, if you do develop a side effect, you will be informed of the process which is in place to manage any complications and deal with them promptly.

Contact us

If you have any further questions, please contact the

Rheumatology Nursing Team Advice Line 01482 608779; Monday to Friday 9-11am

Additional services and information 

NHS Choices: NHS Choices provides online information and guidance on all aspects of health and healthcare, to help you make decisions about your health.

Web: www.nhs.uk

NHS 111: You can call 111 when you need medical help fast but it’s not a 999 emergency. NHS 111 is available 24 hours a day, 365 days a year. Calls are free from landlines and mobile phones

This leaflet was produced by the Pharmacy Department, Hull and East Yorkshire Hospitals NHS Trust and will be reviewed in 2 years 

Ref: (Supplied by Clinical Governance Directorate Ratification group)

General Advice and Consent

Most of your questions should have been answered by this leaflet, but remember that this is only a starting point for discussion with the healthcare team.

Consent to treatment

Before any doctor, nurse or therapist examines or treats you, they must seek your consent or permission. In order to make a decision, you need to have information from health professionals about the treatment or investigation which is being offered to you. You should always ask them more questions if you do not understand or if you want more information.

The information you receive should be about your condition, the alternatives available to you, and whether it carries risks as well as the benefits. What is important is that your consent is genuine or valid. That means:

• you must be able to give your consent
• you must be given enough information to enable you to make a decision
• you must be acting under your own free will and not under the strong influence of another person

Information about you

We collect and use your information to provide you with care and treatment. As part of your care, information about you will be shared between members of a healthcare team, some of whom you may not meet. Your information may also be used to help train staff, to check the quality of our care, to manage and plan the health service, and to help with research. Wherever possible we use anonymous data.

We may pass on relevant information to other health organisations that provide you with care. All information is treated as strictly confidential and is not given to anyone who does not need it. If you have any concerns please ask your doctor, or the person caring for you.

Under the General Data Protection Regulation and the Data Protection Act 2018 we are responsible for maintaining the confidentiality of any information we hold about you. For further information visit the following page: Confidential Information about You.

If you or your carer needs information about your health and wellbeing and about your care and treatment in a different format, such as large print, braille or audio, due to disability, impairment or sensory loss, please advise a member of staff and this can be arranged.