What is Blitzima and Rituximab used for?
Blitzima is a medicine used in adults for the treatment of blood cancers and inflammatory conditions described below:
- follicular lymphoma and diffuse large B-cell non-Hodgkin's lymphoma (two forms of non-Hodgkin's lymphoma, a blood tumor);
- chronic lymphatic leukemia (LLC, another blood cancer that affects white blood cells);
- granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of blood vessels.
Depending on the condition to be treated, Blitzima can be given in combination with chemotherapy (other anticancer medicines) or medicines used for inflammatory disorders (corticosteroids). Blitzima contains the active ingredient rituximab.
Blitzima is a "biosimilar medicine". This means that it is very similar to a biological medicine (the "reference medicine") that has already been authorized in the European Union (EU). The reference medicine for Blitzima is MabThera. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Blitzima - Rituximab used?
Blitzima can only be obtained with a prescription. It is available as a concentrate for the preparation of a solution to be administered by infusion (drop by drop) into a vein. Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an antipyretic (a fever-lowering medicine). Blitzima should be administered under the strict supervision of an experienced healthcare professional and in a place where patient resuscitation equipment is readily available.
For more information, see the package leaflet.
How does Blitzima - Rituximab work?
The active substance in Blitzima, rituximab, is a monoclonal antibody (a type of protein) designed to recognize a protein called CD20, present on the surface of B cells (types of white blood cells), and bind to it. When it binds to CD20, rituximab causes B cells to die, which is beneficial in the case of lymphoma and CLL, in which B cells have become cancerous. In the case of GPA and MPA, the destruction of B cells reduces the production of antibodies, which are believed to play a decisive role in attacking blood vessels and causing inflammation.
What benefit has Blitzima - Rituximab shown during the studies?
Laboratory studies that have compared Blitzima and MabThera have shown that the active ingredient of Blitzima is very similar to that of MabThera in terms of structure, purity and biological activity. Studies have also shown that the administration of Blitzima produces levels of active ingredient in the body similar to those of MabThera.
In addition, Blitzima was compared to a vein-administered MabThera in one main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease). The study showed that Blitzima and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the percentage of patients with a 20% improvement in symptom score (referred to as ACR20) was 74% (114 of 155 patients) with Blitzima and 73% (43 patients out of 59) with MabThera.
Further evidence emerged from supportive studies including one involving 121 patients with advanced follicular lymphoma, in which the addition of Blitzima to chemotherapy drugs was at least as effective as the addition of Rituxan, the US version of MabThera. In this study an improvement was observed in 96% of cases (67 of 70 patients) with Blitzima and in 90% (63 of 70 patients) with Rituxan.
Because Blitzima is a biosimilar medicine, studies of MabThera regarding the efficacy and safety of rituximab should not all be repeated for Blitzima.
What are the risks associated with Blitzima - Rituximab?
The most common side effects of rituximab are infusion-related reactions (such as fever, chills and tremors) that occur in most cancer patients and in more than 1 in 10 patients with GPA or MPA at the time of the first infusion. The risk of such reactions decreases in subsequent infusions. The most common serious side effects are infusion reactions, infections and, in cancer patients, heart problems. Other serious side effects include reactivation of hepatitis B (reappearance of a previously active hepatitis B virus infection) and a rare severe brain infection known as progressive multifocal leukoencephalopathy (PML). For the full list of all side effects reported with Blitzima, see the package leaflet.
Blitzima should not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other components. It must also not be used in patients with a severe infection or a strongly weakened immune system. Not even patients with GPA or MPA should take Blitzima if they have severe heart problems.
Why has Blitzima - Rituximab been approved?
The European Medicines Agency has decided that, in accordance with EU requirements for biosimilar medicines, Blitzima has structure, purity and biological activity very similar to MabThera and is distributed in the body in the same way. Furthermore, a study that compared Blitzima with MabThera in patients with rheumatoid arthritis (which may support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are equally effective and a study supportive in follicular lymphoma has demonstrated its efficacy in cancer. Consequently, all these data were considered sufficient to conclude that Blitzima will behave in the same way as MabThera in terms of effectiveness in the approved indications. Therefore, the Agency considered that, as in the case of MabThera, the benefits outweigh the identified risks and recommended that Blitzima be given marketing authorization.
What measures are being taken to ensure the safe and effective use of Blitzima - Rituximab?
The company that markets Blitzima will provide doctors and patients using the non-cancer medicine with educational materials including information on the need to administer the medicine where resuscitation equipment is available and the risk of infection, including progressive multifocal leukoencephalopathy. Patients must also be given an alert card to take with them at any time, containing instructions to contact their doctor immediately if they have any of the listed infection symptoms.
Doctors who prescribe Blitzima for cancer will be provided with educational material that reminds them of the need to use the medicine only for infusion into a vein.
Recommendations and precautions to be followed by healthcare professionals and patients for Blitzima to be used safely and effectively have also been included in the summary of product characteristics and the package leaflet.
More information on Blitzima - Rituximab
For the full EPAR and the summary of the Blitzima risk management plan, see the Agency website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Blitzima therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
