Information for the public

Summary of possible benefits and harms

Summary of possible benefits and harms

How well does rituximab work?

It is difficult to say how well rituximab works for treating ITP in children, young people and adults.

Some of the studies in adults showed that rituximab helped to increase the number of platelets in a person's blood. Most of the studies didn't compare rituximab with other treatments for ITP so it is hard to say how well rituximab worked compared with other treatments. Although, there were some studies that compared how well rituximab worked with other treatments or a dummy treatment (a treatment that doesn't contain any medicine, also known as a placebo), the number of people in the studies were small and the studies were not well designed making it difficult to say how well rituximab works for treating ITP compared with other treatments.

Some of the studies in children and young people also showed that rituximab helped to increase the number of platelets in a person's blood. The studies didn't compare rituximab with any other treatments for ITP and were not well designed. This makes is difficult to say how well rituximab works in children and young people with ITP.

Studies that are of better quality and have more people in them are needed to be able to say how well rituximab works for treating ITP, especially in children and young people.

What are the possible harms or side effects?

Out of 10 people who have treatment with rituximab through a drip, more than 1 can have a reaction to it; this usually happens during or within the first 2 hours of treatment. The reaction might include fever, chills and shivering. Less often, some people might get reactions including pain where the drip is put in, blisters, itching, sickness, tiredness, headache, breathing difficulties, swelling in the tongue or throat, an itchy or runny nose, vomiting, flushing or palpitations, a heart attack, or a low number of platelets. If people get any of these symptoms, the drip might need to be slowed down or stopped or they might need to take an antihistamine or paracetamol. These reactions are more likely to happen the first time a person is treated with rituximab and are less likely to happen after further treatments. However the person's doctor may decide to stop treatment if the reactions are serious.

People who are receiving rituximab can get infections more easily during or after treatment with it. These infections will often be minor, for example, a person may get a viral infection such as a cold after being treated, but there have been cases of more severe infections such as pneumonia or urinary infections. Rituximab shouldn't be used by people who already have a severe infection, or by people who have hepatitis B.

Rituximab can cause a serious infection of the brain (called progressive multifocal leukoencephalopathy or PML) which can be fatal, but getting this type of infection is very rare. If a person has memory loss, trouble thinking, difficulty walking or sight loss during treatment with rituximab, they should tell their doctor immediately. Rituximab can also very rarely cause skin reactions including severe blistering skin conditions that can be life-threatening. Redness (often with blisters) may appear on the skin or on mucous membranes (such as inside the mouth, the genital areas or the eyelids) and sometimes people get a fever. People should talk to their doctor immediately if they have any of these symptoms.

All people who are being treated for rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis must be given a 'patient alert card' each time they are given rituximab. The alert card contains important safety information.

Please note that the results of the research studies only indicate the benefits and harms for the population in the studies. It is not possible to predict what the benefits and harms will be for an individual patient being treated with rituximab.