Aranesp - darbepoietin alfa

What is Aranesp?

Aranesp is a solution for injection available in a vial, a pre-filled syringe or a pre-filled pen. It contains the active substance darbepoietin alfa. There are different dosages of Aranesp, from 10 micrograms / ml to 500 micrograms / ml. For more information, see the package leaflet.

For more information, see the package leaflet.

What is Aranesp used for?

Aranesp is indicated in the treatment of anemia (abnormal insufficiency of red blood cells in the blood) in two groups of patients:

adults and children from the age of one year with anemia caused by chronic renal failure, when the body is unable to produce a sufficient amount of the natural hormone erythropoietin;
adult patients with some types of cancer undergoing chemotherapy (medicines used to treat cancer), when chemotherapy prevents the bone marrow from producing enough red blood cells. The types of cancer in which Aranesp can be used are those of the "non-myeloid" type (which do not affect the bone marrow).

The medicine can only be obtained with a prescription.

How is Aranesp used?

Treatment with Aranesp should be started by a doctor who has experience in treating the two forms of anemia described above. Aranesp is given intravenously (injected into a vein) or subcutaneously (under the skin). The dose used depends on the reasons for the use of Aranesp, and ranges from 0.45 micrograms / kg once a week (or 0.75 micrograms / kg once every two weeks) in adults and children over 11 years of age with kidney failure, up to 6.75 micrograms / kg once every three weeks in cancer patients. For children with kidney failure younger than 10 years, lower doses may be required. However, doses are adequate to achieve hemoglobin levels that fall within the recommended range. Hemoglobin is the protein in red blood cells that carries oxygen throughout the body.

The doses and frequency of administration (ie how often Aranesp is taken) are adjusted according to the patient's response. Aranesp is supplied ready for use in syringes or pre-filled pens, which can be used by the patient or by the person caring for them. For complete indications of use please consult the package leaflet.

How does Aranesp work?

A hormone, erythropoietin, stimulates the production of red blood cells in the bone marrow. Darbepoetin alfa, the active ingredient of Aranesp, acts exactly like the natural erythropoietin produced by the body, but has a slightly different structure, so darbepoetin alfa has a longer duration of action and can be administered more rarely than to natural erythropoietin. Darbepoetin alfa is produced by a method known as "recombinant DNA technology": that is, it is obtained from a cell in which a gene (DNA) has been introduced which makes it capable of producing darbepoetin alfa. In patients with chronic renal failure the main cause of anemia is the lack of natural erythropoietin. Natural erythropoietin deficiency is one of the causes of anemia even in patients undergoing chemotherapy. Aranesp works by stimulating the production of red blood cells in the same way as natural erythropoietin.

How has Arenesp been studied?

The efficacy of Aranesp has been studied in patients with chronic renal failure, in which the medicine was compared with recombinant human erythropoietin in four studies, with over 1 200 patients and in patients receiving chemotherapy for tumors such as lung cancer, myeloma or lymphoma, in which the medicine was compared with placebo (a dummy treatment) in two studies, 669 patients). The main index to measure effectiveness in patients with renal insufficiency was the increase in hemoglobin (the protein found in red blood cells and responsible for transporting oxygen to the whole body). In chemotherapy patients, the main measure of effectiveness was the reduction in the number of patients to be transfused with blood.

Arenesp has also been studied in 124 children with chronic renal failure to verify that it is absorbed in the same way as in adults.

What benefit has Arenesp shown during the studies?

Aranesp administered both intravenously and subcutaneously proved as effective as recombinant human erythropoietin in increasing hemoglobin rates in patients with renal failure and keeping these rates unchanged after their increase. Among patients with cancer chemotherapy, those treated with Aranesp needed less transfusions than patients treated with placebo.

What is the risk associated with Arenesp?

The most frequent side effects of Aranesp (seen in between one and 10 patients in 100) are: headache, hypertension (high blood pressure), thrombosis (blood clots), pain at the injection site, arthralgia (joint pain) and peripheral edema (fluid retention).

For the full list of all side effects reported with Aranesp, see the Package Leaflet.

Aranesp should not be used in people who may be hypersensitive (allergic) to darbepoetin alfa or any of the excipients or to patients with inadequately controlled hypertension.

Why has Arenesp been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Aranesp outweigh the risks for the treatment of anemia associated with chronic renal failure in adults and in children as well as symptomatic anemia in adult patients with non-cancers myeloids undergoing chemotherapy. The CHMP therefore recommended the granting of the marketing authorization for Aranesp.