Epoetin Alfa Hexal - epoetin alfa

What is Epoetin Alfa Hexal?

Epoetin Alfa Hexal is a solution for injection. It is available in pre-filled syringes containing 1, 000 to 40, 000 international units (IU) of the active substance epoetin alfa.

Epoetin Alfa Hexal is a "biosimilar" medicine, meaning that it is similar to a biologic drug already authorized in the European Union (EU) that contains the same active ingredient (also called the "reference medicine"). The reference medicine for Epoetin Alfa Hexal 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 Epoetin Alfa Hexal used for?

Epoetin Alfa Hexal 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 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 who are about to undergo an important orthopedic (bone) procedure, such as the hip. It is used in patients with normal blood levels of iron who could have complications when subjected to blood transfusion, if they cannot donate blood before surgery 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 Epoetin Alfa Hexal used?

Treatment with Epoetin Alfa Hexal 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 patients about to donate blood, Epoetin Alfa Hexal is injected into a vein. In patients undergoing chemotherapy or near orthopedic surgery should be injected under the skin. Epoetin Alfa Hexal can be injected under the skin by the patient or caregiver as long as they are properly trained. Dose, frequency of injections and duration of treatment depend on why Epoetin Alfa Hexal is used and are 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 Epoetin Alfa Hexal 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 Epoetin Alfa Hexal, epoetin alfa, is a replica of human erythropoietin and works exactly like the natural hormone in stimulating red blood cell production. Epoetin alfa in Epoetin Alfa Hexal 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 that makes it able to produce epoetin alfa.

How has Epoetin Alfa Hexal been studied?

Epoetin Alfa Hexal was studied to demonstrate its comparability with the reference medicine, Eprex / Erypo. Epoetin Alfa Hexal, given by injection into a vein, was compared with the reference medicine in one 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 Epoetin Alfa Hexal 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 Epoetin Alfa Hexal by injection under the skin with the effects of Eprex / Erypo on 114 cancer patients during chemotherapy.

What benefit has Epoetin Alfa Hexal shown during the studies?

Epoetin Alfa Hexal was found to be 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 in patients who switched to Epoetin Alfa Hexal remained the same as in patients who continued to take Eprex / Erypo. The study conducted on chemotherapy patients also showed that Epoetin Alfa Hexal is as effective as Eprex / Erypo when administered with an under-skin injection.

What is the risk associated with Epoetin Alfa Hexal?

The most common side effect with Epoetin Alfa Hexal (seen in more than 1 patient in 10) is nausea. In cancer patients, headache and pyrexia (fever) were observed in more than 1 in 10 patients, while in patients with chronic renal failure, arthralgia (joint pain) and flu-like disease were observed in more than 1 patient in 10. For the full list of all side effects reported with Epoetin Alfa Hexal, see the Package Leaflet.

Epoetin Alfa Hexal 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 not treatable with clot formation drugs.

Epoetin Alfa Hexal should not be used in patients about to donate blood if they have had a stroke or heart attack in the last month, in patients who have angina pectoris (severe form of chest pain) or who are at risk of deep vein thrombosis ( DVT: formation of blood clots in the deep veins of the body, usually in the legs). Epoetin Alfa Hexal should not be used in patients about to undergo major orthopedic surgery if they have severe cardiovascular problems (ie those affecting the heart and blood vessels) including recent heart attacks or strokes.

Epoetin Alfa Hexal 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 Epoetin Alfa Hexal been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, according to EU regulations, Epoetin Alfa Hexal 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 Epoetin Alfa Hexal?

The manufacturer of Epoetin Alfa Hexal will provide health professionals in all Member States with information material including instructions on the safety of the medicine. The company will also provide thermal containers for patients, accompanied by illustrations showing how to use the medicine.