What is Ristempa - pegfilgrastim used for?
Ristempa is a medicine used in cancer patients to alleviate some side effects of therapy. Chemotherapy (anticancer treatment), which is cytotoxic (ie that destroys cells), also kills white blood cells; this can induce neutropenia (low level of neutrophils, a type of white blood cell that fights infections) and the development of infections. Ristempa is used to reduce protracted neutropenia and the incidence of febrile neutropenia (ie neutropenia combined with fever). Ristempa cannot be used in patients with chronic myelogenous leukemia (a type of cancer that affects white blood cells). Equally the medicine cannot be administered to patients with myelodysplastic syndromes (a disease that causes an excessive increase in white blood cells and can degenerate into leukemia). Ristempa contains the active ingredient pegfilgrastim. This medicine is the same as Neulasta, already authorized in the European Union (EU). The manufacturer of Neulasta has accepted that its scientific data can be used for Ristempa ("informed consent").
How is Ristempa - pegfilgrastim used?
Ristempa can only be obtained with a prescription and the therapy must be started and followed by doctors with experience in the treatment of tumors or blood disorders.
Ristempa is available as a solution for injection in pre-filled syringes containing 6 mg of pegfilgrastim. It is given as a single 6 mg subcutaneous injection about 24 hours after the end of each chemotherapy cycle. The injection can be administered by the patient himself, provided he is properly instructed.
How does Ristempa - pegfilgrastim work?
The active ingredient in Ristempa, pegfilgrastim, is composed of filgrastim, which is very similar to a human protein known as granulocyte colony-stimulating factor (G-CSF), in a "pegylated" form (ie aggregated to an agent chemical called polyethylene glycol). Filgrastim works by stimulating the bone marrow to produce more white blood cells, increasing the counts 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 already. In pegfilgrastim, filgrastim is present in pegylated form. This slows down the elimination of the drug by the body and thereby reduces the frequency of administration.
What benefit has Ristempa - pegfilgrastim shown during the studies?
Ristempa has been studied in two main studies involving 467 breast cancer patients treated with cytotoxic chemotherapy. In both studies, the efficacy of a single injection of Ristempa was compared with more daily injections of filgrastim during each of the four cycles of chemotherapy. The main measure of effectiveness was the duration of severe neutropenia during the first cycle of chemotherapy. Ristempa was as effective as filgrastim in reducing the duration of severe neutropenia. In both studies, patients suffered from severe neutropenia for approximately 1.7 days during the first course of chemotherapy, compared to an interval of about 5-7 days in the absence of either drug.
What is the risk associated with Ristempa - pegfilgrastim?
The most common side effects of Ristempa (which may affect more than 1 in 10 people) are bone and muscle pain, headache and nausea. For the full list of side effects and limitations, see the package leaflet.
Why has Ristempa - pegfilgrastim been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ristempa's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Ristempa - pegfilgrastim?
A risk management plan has been developed to ensure that Ristempa is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ristempa, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Ristempa - pegfilgrastim
On 13 April 2015, the European Commission issued a marketing authorization for Ristempa, valid throughout the European Union. For more information about treatment with Ristempa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 04-2015.
