MedPath
EMA Approval

Tevagrastim

L03AA02

filgrastim

Immunostimulants

filgrastim

Hematopoietic Stem Cell TransplantationCancer

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeL03AA02
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

Authorisations (1)

EMEA/H/C/000827

Teva GmbH,Wasastraße 50,DE-01445 Radebeul,Germany

Authorised

September 15, 2008

Biosimilar

Active Substances (1)

filgrastim

Documents (8)

Tevagrastim : EPAR - Product information

October 18, 2009

DRUG_PRODUCT_INFORMATION

CHMP summary of positive opinion for Tevagrastim

July 24, 2008

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Tevagrastim : EPAR - Procedural steps taken and scientific information after authorisation

October 18, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Tevagrastim : EPAR - Public assessment report

September 28, 2008

CHANGES_SINCE_INITIAL_AUTHORISATION

Tevagrastim : EPAR - Public assessment report

September 28, 2008

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

CHMP summary of positive opinion for Tevagrastim

July 24, 2008

CHANGES_SINCE_INITIAL_AUTHORISATION

Tevagrastim : EPAR - Summary for the public

September 28, 2008

OVERVIEW_DOCUMENT

Tevagrastim : EPAR - All Authorised presentations

October 18, 2009

AUTHORISED_PRESENTATIONS

Overview Q&A (9)

Question

How is Tevagrastim used?

Answer

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.

Question

How does Tevagrastim work?

Answer

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.

Question

Other information about Tevagrastim

Answer

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

Question

How has Tevagrastim been studied?

Answer

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.

Question

What benefit has Tevagrastim shown during the studies?

Answer

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.

Question

What is Tevagrastim?

Answer

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.

Question

What is Tevagrastim used for?

Answer

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 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.

Question

Why has Tevagrastim been approved?

Answer

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.

Question

What is the risk associated with Tevagrastim?

Answer

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.

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