EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TEVAGRASTIM EPAR summary for the public

What is Tevagrastim?

Tevagrastim is a solution for injection or for infusion (drip into a vein). It contains the active substance filgrastim.

Tevagrastim is a ‘biosimilar’ medicine. This means that Tevagrastim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine’). The reference medicine for Tevagrastim is Neupogen. For more information on biosimilar medicines, see the question-and-answer document here.

What is Tevagrastim used for?

Tevagrastim is used to stimulate the production of white blood cells in the following situations:

•    to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);

•    to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;

•    to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;

•    to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.

Tevagrastim can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.

The medicine can only be obtained with a prescription.

How is Tevagrastim used?

Tevagrastim is given by injection under the skin or infusion into a vein. How it is given, the dose and the duration of treatment depend on why it is being used, the patient’s body weight and the response to treatment. Tevagrastim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately. For more information, see the Package Leaflet.

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How does Tevagrastim work?

The active substance in Tevagrastim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). Filgrastim is produced by a method known as ‘recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim. The replacement acts in same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.

How has Tevagrastim been studied?

Tevagrastim was studied to show that it is comparable to the reference medicine, Neupogen. Tevagrastim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer. The study looked at the duration of severe neutropenia during the patients’ first cycle of cytotoxic chemotherapy.

To study the safety of Tevagrastim, two further studies were carried out in patients with lung cancer and with non-Hodgkin’s lymphoma.

What benefit has Tevagrastim shown during the studies?

Treatment with Tevagrastim and Neupogen brought about similar reductions in duration of severe neutropenia. During the first 21-day chemotherapy cycle, patients treated with either Tevagrastim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo. Therefore, the effectiveness of Tevagrastim was shown to be equivalent to that of Neupogen.

What is the risk associated with Tevagrastim?

The most common side effect with Tevagrastim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). Other side effects may be seen in more than 1 patient in 10, depending on the condition that Tevagrastim is being used for. For the full list of all side effects reported with Tevagrastim, see the Package Leaflet.

Tevagrastim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.

Why has Tevagrastim been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Tevagrastim has been shown to have a comparable quality, safety and efficacy profile to Neupogen. Therefore, the CHMP’s view was that, as for Neupogen, the benefit outweighs the identified risk. The Committee recommended that Tevagrastim be given marketing authorisation.

Other information about Tevagrastim:

The European Commission granted a marketing authorisation valid throughout the EU for Tevagrastim to Teva Generics GmbH on 15 September 2008.

The full EPAR for Tevagrastim can be found here.

This summary was last updated in 09-2008.

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