Rituximab for chronic inflammatory conditions

Rituximab (brand name MabThera®) is a relatively new medicine which works on the immune system. It removes some of the white blood cells in the body which are called B cells. Removing these stops the production of antibodies that may play a role in your child’s illness.

Rituximab can help to treat children who may have one of the following:

Your child may have been given other medicines which affect the immune system such as steroids, azathioprine, mycophenolate mofetil, tacrolimus, ciclosporin, methotrexate, anti-TNF and cyclophosphamide. For some children these other medicines are not enough, and for these children Rituximab can be a helpful treatment.

How is it given?

Your child will need to visit the ward to have rituximab because it is given slowly into a vein (also known as an intravenous infusion). Your doctor will decide on the number of doses you will need and the time between doses. It will usually be given twice with two weeks in between. Cyclophosphamide is sometimes given the day after the rituximab treatment. Some patients may require repeat rituximab treatments within a year or two. Blood pressure checks are performed by the nurses while the rituximab is given.

Who should not use rituximab?

Rituximab must not be given to patients who may be pregnant, are likely to become pregnant in the near future or are breatsfeeding. If your daughter is ten years old or older, we will ask her about her periods and any possibility that she could be pregnant. Reliable contraception is advised for both male and female patients for twelve months after finishing rituximab.

What are the side effects?

Like all immune system medicines there is an increased risk of infection (especially viruses such as chicken pox, herpes or shingles). There is a risk of an allergic reaction at the time the medicine is given so all patients need to be given this medication in hospital. To reduce any allergic reaction, other medicines are given at the same time such as steroids, anti-histamines and paracetamol.

There have been some very rare reports of adults who have had rituximab, developing a virus infection in the brain. Research is ongoing and it is not clear whether this is due to rituximab itself or to other medicines that the patients have received. The virus infection of the brain is called progressive multifocal leucoencephalopathy and is caused by the JC virus (which is a polyomavirus).

Rituximab and other medicines

Always check with your doctor or pharmacist before giving your child any other medicine, including medicines on prescription from your family doctor (GP), medicines bought from a pharmacy (chemist) or any herbal or complementary medicines. However, no medicines have been reported as interacting with rituximab.

Important information about rituximab

Chicken pox or tuberculosis – if your child has not had chicken pox or tuberculosis and is in direct contact with a child who has it or develops it within 48 hours, you must contact the hospital immediately. Chicken pox and tuberculosis can be more severe in children who are taking rituximab. A blood test will be arranged to check your child’s antibodies to chicken pox. Your child may need treatment to protect them. Your doctor or nurse will discuss this with you. If your child has chicken pox, it may be necessary to stop your child’s medication for a short while. Your doctor will discuss this with you.

Immunisations – as rituximab affects your child’s immune system, children and young people taking these medicines should not be given any live vaccines. However, children may be very ill if they catch one of the vaccine preventable diseases, so it is important that they are up to date with their vaccinations. Your other children should be immunised according to the usual schedule and although chicken pox vaccine is not routinely given to all children, it may be advisable for the siblings or other close family members of a child who is receiving rituximab. If you have any questions about immunisations, please ask your doctor.

Alert card – we recommend that your child carries a biological therapy alert card at all times. This could be important if your child needs emergency treatment for any reason.

Compiled by: 
The Nephrology and Pharmacy departments in collaboration with the Child and Family Information Group
Last review date: 
March 2013
Ref: 
2012F0217

Disclaimer

Please read this information sheet from GOSH alongside the patient information leaflet (PIL) provided by the manufacturer. If you do not have a copy of the manufacturer’s patient information leaflet please talk to your pharmacist. A few products do not have a marketing authorisation (licence) as a medicine and therefore there is no PIL.

For children in particular, there may be conflicts of information between the manufacturer’s patient information leaflet (PIL) and guidance provided by GOSH and other healthcare providers. For example, some manufacturers may recommend, in the patient information leaflet, that a medicine is not given to children aged under 12 years. In most cases, this is because the manufacturer will recruit adults to clinical trials in the first instance and therefore the initial marketing authorisation (licence) only covers adults and older children.  

For new medicines, the manufacturer then has to recruit children and newborns into trials (unless the medicine is not going to be used in children and newborns) and subsequently amend the PIL with the approved information. Older medicines may have been used effectively for many years in children without problems but the manufacturer has not been required to collect data and amend the licence. This does not mean that it is unsafe for children and young people to be prescribed such a medicine ‘off-licence/off-label’. However, if you are concerned about any conflicts of information, please discuss with your doctor, nurse or pharmacist.