What is Neulasta?
Neulasta is a solution for injection containing the active substance pegfilgrastim. The medicine is available in syringes and pre-filled pens (SureClick), containing a dose of 6 mg of pegfilgrastim each.
What is Neulasta used for?
Neulasta is used in cancer patients to alleviate some undesirable effects of their treatment. Cytotoxic chemotherapy (cancer treatment) that destroys cells also kills white blood cells, which can induce neutropenia (low level of white blood cells in the blood) 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 white blood cells). Equally the medicine cannot be administered to patients suffering from myelodysplastic syndromes (a disease that causes an excessive increase in white blood cells in the blood and that can degenerate into leukemia).
The medicine can only be obtained with a prescription.
How is Neulasta used?
Neulasta therapy should be started and followed by doctors with experience in oncology or hematology. Neulasta is presented in single doses of 6 mg, administered by subcutaneous injection (under the skin) about 24 hours after the end of each chemotherapy cycle. The injection can be administered by the patient himself, provided he is properly instructed. We do not recommend the use of Neulasta on children, as there are insufficient data concerning the safety and efficacy of the drug for this group of patients.
How does Neulasta work?
The active ingredient contained in Neulasta, pegfilgrastim, is an immunostimulant of the group of "colony stimulating factors". The medicine contains filgrastim, a copy of a human protein known as a factor that stimulates the formation of granulocyte colonies (G-CSF), in a "pegylated" form (ie covered with a chemical agent called polyethylene glycol). Filgrastim works by stimulating the bone marrow to produce more white blood cells in the blood, increasing the count of white blood cells in the blood and treating neutropenia. Within the European Union (EU), filgrastim has been available in other medicines for several years. In pegfilgrastim, filgrastim is present in pegylated form, this treatment slows down the body's absorption, thus reducing the frequency of administration.
Filgrastim, contained in Neulasta, is produced according to a method known as "recombinant DNA technique": it derives from a bacterium, in which a gene (DNA) has been grafted which makes it capable of producing filgrastim. The replacement bacterium acts in the same way as the naturally produced G-CSF.
What studies have been carried out on Neulasta?
Neulasta has been studied in two main studies, for a total of 467 patients suffering from breast cancer, treated with cytotoxic chemotherapy. In both studies, the efficacy of a single injection of Neulasta was compared with more daily injections of filgrastim during each of the four cycles of chemotherapy. The main efficacy index was based on the duration of severe neutropenia during the first cycle 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, the patients suffered from severe neutropenia for an interval of approximately 1.7 days during the first cycle of chemotherapy.
What is the risk associated with Neulasta?
Most of the undesirable effects found in subjects treated with Neulasta during the studies are due to the underlying neoplasm or to chemotherapy. The most common side effects with Neulasta (seen in more than one patient in ten) 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 all side effects reported with Neulasta, see the Package Leaflet.
Neulasta should 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 the benefits of Neulasta outweigh the risks in order to shorten the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for neoplasms. The Committee therefore recommended that Neulasta be given marketing authorization.
Other information on Neulasta:
On 22 August 2002, the European Commission granted a marketing authorization for Neulasta, valid throughout the European Union, to Amgen Europe BV. The marketing authorization was renewed on 22 August 2007.
The full EPAR for Neulasta can be found here.
Last update of this summary: 02-2008
