Nivestim

Active Substance: filgrastim
Common Name: filgrastim
ATC Code: L03AA02
Marketing Authorisation Holder: Hospira UK Ltd
Active Substance: filgrastim
Status: Authorised
Authorisation Date: 2010-06-08
Therapeutic Area: Neutropenia Hematopoietic Stem Cell Transplantation Cancer
Pharmacotherapeutic Group: Immunostimulants

Therapeutic indication

Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.

The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.

Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).

In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤0.5 x 10⁹/l and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

Filgrastim is indicated for the treatment of persistent neutropenia (ANC ≤1.0 x 10⁹/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

What is Nivestim?

Nivestim is a solution for injection or infusion (drip into a vein) that contains the active substance filgrastim. It is available as prefilled syringes (12, 30 or 48 million units).

Nivestim is a ‘biosimilar medicine'. This means that Nivestim is similar to a biological medicine (the ‘reference medicine’) that is already authorised in the European Union (EU) and contains the same active substance as the reference medicine. The reference medicine for Nivestim is Neupogen.

What is Nivestim used for?

Nivestim 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 (medicines to treat cancer) 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 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.

Nivestim can also be used in people 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 Nivestim used?

Nivestim 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. Nivestim 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.

How does Nivestim work?

The active substance in Nivestim, 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 the same way as naturally produced G‑CSF by encouraging the bone marrow to produce more white blood cells.

How has Nivestim been studied?

Nivestim was studied to show that it is comparable to the reference medicine, Neupogen. Nivestim was compared with Neupogen in one main study involving 279 women with breast cancer who were being treated with anticancer medicines. The main measure of effectiveness was based on the reduction in the length of time that the patients had severe neutropenia.

What benefit has Nivestim shown during the studies?

Studies carried out with Nivestim showed that it was comparable to Neupogen. In the main study, the patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen.

What is the risk associated with Nivestim?

The most common side effect with Nivestim (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 Nivestim is being used for. For the full list of all side effects reported with Nivestim, see the package leaflet.

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

Why has Nivestim been approved?

The CHMP decided that, in accordance with EU requirements, Nivestim 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 Nivestim be given marketing authorisation.

Other information about Nivestim:

The European Commission granted a marketing authorisation valid throughout the EU for Nivestim to Hospira UK Limited on 8 June 2010. The marketing authorisation is valid for five years, after which it can be renewed.

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