What is Abseamed?
Abseamed is a solution for injection. It is available in pre-filled syringes containing 1, 000 to 10, 000 international units (IU) of the active substance epoetin alfa.
Abseamed is a "biosimilar" medicine, meaning that it is similar to a biologic medicine already authorized in the European Union (EU) that contains the same active ingredient (also called the "reference medicine"). The reference medicine for Abseamed is Eprex / Erypo. For more information on biosimilar medicines, see the document available here which contains a series of questions and answers on the subject.
What is Abseamed used for?
Abseamed is used in the following cases:
- in the treatment of anemia (low number of red blood cells) which cause symptoms in patients with "chronic renal failure" (prolonged and progressive decrease in the functional capacity of the kidneys) or from other problems affecting the kidneys;
- in the treatment of anemia in adult patients undergoing chemotherapy for certain types of cancer and to reduce the need for blood transfusions;
- to increase the amount of blood that can be taken in adult patients with moderate anemia who are about to undergo an operation and donate their own blood before surgery (autologous blood transfusion);
- to reduce the need for blood transfusions in adults with mild anemia and about to undergo an important orthopedic (bone) procedure, such as the hip. It is used in patients with normal blood iron levels who could have complications if given a transfusion, in the event that they cannot donate blood before the operation and for which a loss of 900-1 800 ml of blood is expected.
The medicine can only be obtained with a prescription.
How is Abseamed used?
Treatment with Abseamed should be started under the supervision of a doctor experienced in managing patients with the medical conditions for which the medicine is indicated.
For patients with kidney problems and for patients who are about to donate their own blood, Abseamed must be injected into a vein. Patients undergoing chemotherapy or near orthopedic surgery should be given an injection under the skin. Abseamed can be injected under the skin by the patient or by
who takes care of them as long as they are properly instructed. Dose, frequency of injections and duration of treatment depend on why Abseamed is used and adjusted according to the patient's response. In patients with chronic renal failure or undergoing chemotherapy, hemoglobin levels should remain within the recommended ranges (10-12 grams per deciliter in adults and 9.5-11 g / dl in children). Hemoglobin is the protein in red blood cells that carries oxygen throughout the body. For these patients, use the minimum dose that guarantees adequate symptom control.
Before treatment, all patients should be checked for iron levels to prevent them from being too low; iron supplements should be administered throughout the treatment. For complete information, see the package leaflet.
How does Abseamed work?
A hormone called erythropoietin stimulates the production of red blood cells in the bone marrow. Erythropoietin is produced by the kidneys.
In patients undergoing chemotherapy or with kidney problems, anemia may be caused by a deficiency of erythropoietin or an insufficient response of the organism to naturally occurring erythropoietin. In such cases erythropoietin is used to replace the missing hormone or to increase the number of red blood cells.
Erythropoietin is also used before surgery to increase the number of red blood cells and to help minimize the effects of blood loss.
The active substance in Abseamed, epoetin alfa, is a replica of human erythropoietin and works exactly like the natural hormone in stimulating red blood cell production. Epoetin alfa in Abseamed is produced with "recombinant DNA technology": that is, it is obtained from a cell in which a gene (DNA) has been introduced which makes it able to produce epoetin alfa.
How has Abseamed been studied?
Abseamed was studied to demonstrate its comparability with the reference medicine, Eprex / Erypo, in experimental models and in humans.
Abseamed, injected under the skin, was compared with the reference medicine in a main study involving 479 patients with anemia caused by kidney problems. All patients had been previously treated with Eprex / Erypo intravenously for at least eight weeks before switching to Abseamed or continuing treatment with Eprex / Erypo. The main measure of effectiveness was the change in hemoglobin levels between the start of the study and the evaluation period, between weeks 25 and 29.
The company also presented the results of a study that compared the effects of Abseamed injected skin and the effects of Eprex / Erypo on 114 cancer patients undergoing chemotherapy.
What benefit has Abseamed shown during the studies?
Abseamed was as effective as Eprex / Erypo in elevating and maintaining the number of red blood cells.
In the study of patients with anemia caused by kidney problems, hemoglobin levels were maintained in patients who switched to Abseamed to the same extent as in patients who continued to take Eprex / Erypo. On average the levels of patients treated with Abseamed increased by 0.147 g / dl compared to the initial value of 11.7 g / dl. In comparison, in patients who continued treatment with Eprex / Erypo there was an increase of 0.063 g / dl compared to the initial value of 12.0 g / dl.
The study conducted on chemotherapy patients also showed that Abseamed is as effective as Eprex / Erypo when administered with an under-skin injection.
What is the risk associated with Abseamed?
The most common side effect associated with Abseamed is an increase in blood pressure which can sometimes induce symptoms of encephalopathy (brain disorders) such as sudden and stabbing attacks of migraine-like headache and confusion. Abseamed can also cause skin rash and flu symptoms. For the full list of all side effects reported with Abseamed, see the Package Leaflet.
Abseamed should not be used in patients who may be hypersensitive (allergic) to epoetin alfa or any of the other ingredients. It should not be used in the following groups:
- patients who developed pure erythroid aplasia (reduced or blocked red blood cell production) after treatment with any erythropoietin;
- patients with uncontrolled elevated blood pressure;
- patients who are about to donate blood and have had heart attacks in the last month, angina pectoris (severe chest pain) or are at risk of deep vein thrombosis (DVT: formation of blood clots in the deep veins of the organism, usually in the legs);
- patients not treatable with drugs against clot formation;
- patients about to undergo major orthopedic surgery with serious cardiovascular problems (ie those affecting the heart and blood vessels) including recent heart attack or stroke.
Abseamed is not recommended for injection under the skin in the treatment of kidney problems as further studies are needed to rule out that it may cause allergic reactions.
Why has Abseamed been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the requirements in the European Union, Abseamed demonstrated a comparable profile to that of Eprex / Erypo with regard to quality, safety and efficacy. The CHMP therefore considers that, as in the case of Eprex / Erypo, the benefits outweigh the identified risks and therefore recommended that the product be given marketing authorization.
What measures are being taken to ensure the safe use of Abseamed?
The manufacturer of Abseamed will provide healthcare professionals in all Member States with information material including instructions on the safety of the medicine. The company will also provide refrigerated containers for patients, accompanied by illustrations showing how to use the medicine.
More information on Abseamed
On 28 August 2007, the European Commission issued a marketing authorization for Abseamed, valid throughout the European Union, to Medice Arzneimittel Pütter GmbH & Co KG.
The full EPAR for Abseamed can be found here.
Last update of this summary: 12-2008.
