What is it?

NeoRecormon is a white powder and solvent in a vial, which is made up into a solution for injection. NeoRecormon is also available in a cartridge and a pre-filled syringe. NeoRecormon exists in various strengths, from 1000 IU/ml to 60,000 IU/ml (see the Package Leaflet for full details). NeoRecormon contains the active ingredient epoetin beta.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

NeoRecormon is used for the prevention or treatment of anaemia (fewer than normal red blood cells in the blood) of various causes. It may be used in babies, children, and adults depending on the cause of the anaemia:

  • Treating anaemia caused by long-term kidney failure, when the body does not produce enough of the natural hormone erythropoietin
  • Preventing anaemia in premature babies
  • Treating anaemia in adult patients with cancer who are receiving chemotherapy (the medicines used for the treatment of cancer ), when the chemotherapy stops the bone marrow producing enough blood cells. It can also be used in patients who are going to have an operation and donate their own blood before surgery (autologous blood transfusion) to increase the amount of blood that can be taken. Please see the Package Leaflet for full details. The medicine can only be obtained with a prescription.

How is it used?

NeoRecormon can be given intravenously (injected into a vein) or subcutaneously (injected under the skin). A doctor who has experience in the care of patients with the types of anaemia NeoRecormon should start treatment with NeoRecormon. The doses and dosage schedules (how often NeoRecormon is injected, and for how long) vary depending on why NeoRecormon is used, and are adjusted according to the response. Please see the Package Leaflet for full details.

How does it work?

A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow. Epoetin beta, the active ingredient of NeoRecormon, is a copy of the erythropoietin found in the body. Epoetin beta is produced by a method known as ?recombinant DNA technology?: it is made by a cell that has received a gene (DNA), which makes it able to produce it. In patients receiving chemotherapy or in patients with long-term kidney failure and other conditions, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally. NeoRecormon works by stimulating production of red blood cells in the same way as erythropoietin.

How has it been studied?

The effectiveness of NeoRecormon to treat or prevent anaemia has been studied in many studies including anaemia in chronic kidney failure (1663 patients, including some comparative studies against placebo [dummy treatment]), autologous blood transfusion (419 patients, comparison with placebo), anaemia in premature babies (177 babies, comparison to no treatment), and in cancer patients (1204 patients with different types of cancer, comparison with placebo). The main measure of effectiveness in most clinical studies was whether NeoRecormon increased the red blood cells in the blood (by measuring haemoglobin levels, the protein found in red blood cells that carries oxygen around the body, or the volume of red cells), or reduced the need for blood transfusion.

What benefits has it shown during the studies?

NeoRecormon was significantly more effective than placebo (dummy treatment) at increasing haemoglobin levels in patients with various types of anaemia, including those with kidney disease. It increases the amount of blood that can be taken from patients before surgery for autologous blood transfusion. It reduces the need for transfusion in premature babies and in cancer patients receiving chemotherapy.

What is the risk associated?

Most side effects occur in patients with chronic renal failure or cancer. The most common side effects are an increase in blood pressure or the worsening of an existing headache or hypertension (high blood pressure). For the full description of the side effects reported with NeoRecormon, please see the Package Leaflet.
NeoRecormon should not be used in people who may be hypersensitive (allergic) to epoetin beta or any of the other ingredients, and in patients who have poorly controlled high blood pressure.

Why has it been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that NeoRecormon?s benefits are greater than its risks to patients to treat and prevent various types of anaemia. They recommended that NeoRecormon be given marketing authorisation.

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