What is Neulasta?
Neulasta is a solution for injection that contains the active substance pegfilgrastim. The medicine is available in pre-filled syringes and pens (SureClick), containing a dose of 6 mg of pegfilgrastim each.
What is Neulasta used for?
Neulasta is used in cancer patients to relieve some side effects of their treatment. Cytotoxic (cell-destroying) chemotherapy (cancer treatment) also kills white blood cells, which can lead to neutropenia (low level of white blood cells) and the development of infections. Neulasta is used to reduce the duration of neutropenia and the incidence of febrile neutropenia (ie neutropenia combined with fever).
Neulasta can be used for various types of cancer, with the exception of chronic myeloid leukemia (a type of cancer that affects the white blood cells). Likewise, the medicine cannot be given to patients with myelodysplastic syndromes (a disease that causes an increase in excess of white blood cells in the blood and which can degenerate into leukemia).
The medicine can only be obtained with a prescription.
How is Neulasta used?
Neulasta therapy should be initiated and supervised by physicians experienced in oncology or hematology. Neulasta comes in single doses of 6 mg, given by injection under the skin (under the skin) approximately 24 hours after the end of each chemotherapy cycle. The injection can be administered by the patient himself, provided that he is properly instructed. The use of Neulasta on children is not recommended, as there are insufficient data on the safety and efficacy of the drug for this group of patients.
How does Neulasta work?
The active substance in Neulasta, pegfilgrastim, is an immunostimulant from the group of 'colony stimulating factors'. The medicine contains filgrastim, a copy of a human protein known as granulocyte colony stimulating factor (G-CSF), in a 'pegylated' form (ie coated with a chemical called polyethylene glycol). Filgrastim works by stimulating the bone marrow to produce more white blood cells, increasing the white blood cell count and treating neutropenia. Within the European Union (EU), filgrastim has been found in other medicines for several years. In pegfilgrastim, filgrastim is present in a pegylated form, this treatment slows its absorption by the body, thereby reducing the frequency of administration.
Filgrastim, contained in Neulasta, is produced according to a method known as the "recombinant DNA technique": it is derived from a bacterium into which a gene (DNA) has been grafted, which makes it capable of producing filgrastim. The replacement bacterium acts identically to naturally produced G-CSF.
What studies have been performed on Neulasta?
Neulasta has been studied in two main studies, involving a total of 467 breast cancer patients treated with cytotoxic chemotherapy. In both studies, the efficacy of a single injection of Neulasta was compared with multiple daily injections of filgrastim during each of the four chemotherapy cycles. The main index of efficacy was based on the duration of severe neutropenia over the course of the course. of the first course of chemotherapy.
What benefit has Neulasta shown during the studies?
Neulasta was as effective as filgrastim in shortening the duration of severe neutropenia. In both studies, patients suffered from severe neutropenia for an interval of approximately 1.7 days during the first course of chemotherapy.
What is the risk associated with Neulasta?
Most of the side effects seen in subjects treated with Neulasta during the studies were related to the underlying malignancy or chemotherapy. The most common side effects with Neulasta (seen in more than one in ten patients) are bone pain and increased levels of lactate dehydrogenase (an enzyme that promotes the breakdown of red blood cells in the blood). For the full list of side effects reported with Neulasta, see the package leaflet.
Neulasta must not be used in people who may be hypersensitive (allergic) to pegfilgrastim or any of the other ingredients.
Why has Neulasta been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Neulasta's benefits are greater than its risks in order to shorten the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for cancer. The Committee therefore recommended. the release of the authorization for the marketing of Neulasta.
Other information about Neulasta:
On 22 August 2002, the European Commission issued Amgen Europe B.V. a "Marketing Authorization" for Neulasta, valid throughout the European Union. The "Marketing Authorization" was renewed on 22 August 2007.
For the complete version of Neulasta's EPAR click here.
Last update of this summary: 02-2008
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