Nivestim | European Medicines Agency (EMA)

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Overview

Nivestim is a medicine that stimulates the production of white blood cells and is used:

to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes). Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections.
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.

Nivestim is a ‘biosimilar’ medicine. This means that Nivestim is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Nivestim is Neupogen. For more information on biosimilar medicines, see below.

Nivestim contains the active substance filgrastim.

Nivestim can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment. The medicine is available in pre-filled syringes and is given by injection under the skin or infusion (drip) into a vein.

The way Nivestim is given, its dose and the duration of treatment depend on why it is being used, the patient’s body weight and the response to treatment. For more information about using Nivestim, see the package leaflet or contact your doctor or pharmacist.

The active substance in Nivestim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G CSF). Filgrastim works in the same way as naturally produced G CSF by encouraging the bone marrow to produce more white blood cells.

Laboratory studies comparing Nivestim with Neupogen have shown that the active substance in Nivestim is highly similar to that in Neupogen in terms of structure, purity and biological activity. Studies have also shown that giving Nivestim produces similar levels of the active substance in the body to giving Neupogen.

In addition, a study in 279 female adult patients with breast cancer who were being treated with cancer medicines showed that Nivestim is comparable to the reference medicine, Neupogen. The main measure of effectiveness was the duration of severe neutropenia. The patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen.

Because Nivestim is a biosimilar medicine the studies on effectiveness and safety of filgrastim carried out with Neupogen do not all need to be repeated for Nivestim.

The safety of Nivestim has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neupogen.

The most common side effects with Nivestim (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick). Other side effects may be seen in more than 1 in 10 patients, depending on the condition that Nivestim is being used for. For the full list of side effects and restrictions with Nivestim, see the package leaflet.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Nivestim has a highly similar structure, purity and biological activity to Neupogen and is distributed in the body in the same way.

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

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

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

Nivestim received a marketing authorisation valid throughout the EU on 8 June 2010.

English (EN)
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First published: 23/06/2010Last updated: 08/10/2019

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English (EN)
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First published: 24/04/2024

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Product information

English (EN)
(1015.06 KB – PDF)

First published: 23/06/2010Last updated: 05/02/2025

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Latest procedure affecting product information:
N/0085

04/02/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(26.39 KB – PDF)

First published: 23/06/2010Last updated: 31/08/2016

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Product details

Name of medicine

Nivestim

Active substance

filgrastim

International non-proprietary name (INN) or common name

filgrastim

Therapeutic area (MeSH)

Hematopoietic Stem Cell Transplantation
Cancer

Anatomical therapeutic chemical (ATC) code

L03AA02

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.

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