Truxima

Truxima can only be obtained with a prescription. It is given by infusion (drip) into a vein. Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine to prevent fever). Depending on the condition being treated, patients may receive other medicines as well. In addition, the medicine should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.

For more information about using Truxima, see the package leaflet or contact your doctor or pharmacist.

The active substance in Truxima, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B lymphocytes (types of white blood cells). When rituximab attaches to CD20, it causes the death of B lymphocytes, which helps in lymphoma and CLL (where B-lymphocytes have become cancerous) and in rheumatoid arthritis (where B lymphocytes are involved in joint inflammation). In GPA and MPA, destroying the B lymphocytes lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.

Extensive laboratory studies comparing Truxima with MabThera have shown that rituximab in Truxima is highly similar to rituximab in MabThera in terms of structure, purity and biological activity.

Truxima has been compared with MabThera given into a vein in a study involving 372 patients with active rheumatoid arthritis. The study showed that Truxima and MabThera led to similar levels of rituximab in the blood. In addition, the two medicines had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Truxima and 73% (43 of 59 patients) with MabThera. Supportive studies in patients with rheumatoid arthritis and in patients with advanced follicular lymphoma also indicated that the medicines produced similar responses.

Because Truxima is a biosimilar medicine, the studies on effectiveness and safety carried out for MabThera do not all need to be repeated for Truxima.

The safety of Truxima has been evaluated and, on the basis of all the studies, its side effects are considered comparable to those of the reference medicine MabThera.

The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in the majority of patients after the first infusion. The risk of such reactions decreases with subsequent infusions. The most common serious side effects are infusion reactions, infections (which may affect more than half of all patients) and heart-related problems. Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare severe infection known as progressive multifocal leukoencephalopathy (PML). For the full list of side effects of Truxima, see the package leaflet.

Truxima must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients. It must also not be used in patients with a severe infection or a severely weakened immune system. Patients with rheumatoid arthritis, GPA, MPA or pemphigus vulgaris must also not receive Truxima if they have severe heart problems.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Truxima has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way. In addition, a study comparing Truxima to MabThera in rheumatoid arthritis adult patients showed that both medicines are similarly effective.

All these data were considered sufficient to conclude that Truxima will behave in the same way as MabThera in terms of effectiveness and safety in its authorised uses. Therefore, the Agency’s view was that, as for MabThera, the benefits of Truxima outweigh the identified risks and it can be authorised for use in the EU.

The company marketing Truxima will provide doctors and patients using the medicine for non-cancer conditions with educational material on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML. Patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they have any of the listed symptoms of infection.

Doctors prescribing Truxima for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truxima have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Truxima are continuously monitored. Side effects reported with Truxima are carefully evaluated and any necessary action taken to protect patients.

Truxima received a marketing authorisation valid throughout the EU on 17 February 2017.

The full EPAR for Truxima can be found on the Agency’s website: ema.europa.eu/medicines/human/EPAR/truxima.

This overview was last updated in 10-2020.