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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/426716/2011

EMEA/H/C/000420

EPAR summary for the public

Neulasta

pegfilgrastim

This is a summary of the European public assessment report (EPAR) for Neulasta. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Neulasta.

What is Neulasta?

Neulasta is a solution for injection that contains the active substance pegfilgrastim. It is available in a pre-filled syringe containing 6 mg pegfilgrastim.

What is Neulasta used for?

Neulasta is used in cancer patients to help with some of the side effects of their treatment. Chemotherapy (medicines to treat cancer) that is cytotoxic (cell-killing) also kills white blood cells, which can lead to neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the development of infections. Neulasta is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).

Neulasta cannot be used in patients with chronic myeloid leukaemia (a cancer of the white blood cells). It also cannot be used in patients with myelodysplastic syndromes (a disease in which too many white blood cells are produced, which can develop into leukaemia).

The medicine can only be obtained with a prescription.

How is Neulasta used?

Neulasta treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.

Neulasta is given as a single 6 mg injection under the skin around 24 hours after the end of each cycle of chemotherapy. Patients can inject themselves if they have been trained appropriately.

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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

How does Neulasta work?

The active substance in Neulasta, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte colony stimulating factor (G-CSF), that has been 'pegylated' (attached to a chemical called polyethylene glycol). Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and treating neutropenia.

Filgrastim has been available in other medicines in the European Union (EU) for a number of years. Because it is pegylated in pegfilgrastim, the rate at which the medicine is removed from the body is decreased, allowing the medicine to be given less often.

The filgrastim in Neulasta 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.

How has Neulasta been studied?

Neulasta has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy. In both studies, the effectiveness of a single injection of Neulasta was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles. The main measure of effectiveness was 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 reducing the duration of severe neutropenia. In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle, compared with around five to seven days when no stimulating factor is used.

What is the risk associated with Neulasta?

The most common side effects with Neulasta (seen in more than 1 in 10 patients) are bone and muscle pain, headache and nausea (feeling sick). 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 CHMP decided that Neulasta's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Neulasta:

The European Commission granted a marketing authorisation valid throughout the EU for Neulasta to Amgen Europe B.V. on 22 August 2002. The marketing authorisation is valid for an unlimited period.

The full EPAR for Neulasta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Neulasta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 05-2011.

Neulasta

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