What is Biopoin?
Biopoin is a solution for injection, available in pre-filled syringes containing 1 000 to 30 000 international units (IU) of the active substance epoetin theta.
What is Biopoin used for?
Biopoin is used to treat anemia (low levels of red blood cells or hemoglobin) that is symptomatic. The medicine is used in adult patients with chronic renal failure (prolonged and progressive decrease in the ability of the kidneys to function properly) and in adult patients with non-myeloid cancer (a tumor that does not originate in the bone marrow) undergoing chemotherapy .
The medicine can only be obtained with a prescription.
How is Biopoin used?
Treatment with Biopoin should be started by a doctor who has experience in the treatment of symptomatic anemia in patients with chronic renal failure and non-myeloid cancer.
In patients with renal insufficiency, in the "correction phase", the recommended starting dose is 20 IU / kg body weight three times a week by subcutaneous injection, or 40 IU / kg body weight by intravenous injection. These doses can be doubled after four weeks if the improvement is not sufficient and can be further increased at monthly intervals by 25% of the previous dose until the correct level of hemoglobin (the protein present in red blood cells that carries oxygen in the body). When anemia has been corrected, the dose in the "maintenance phase" must be adjusted to maintain the correct hemoglobin level. In any case, the weekly dose of Biopoin should not exceed 700 IU / kg body weight.
In cancer patients the drug should be administered by subcutaneous injection. The recommended starting dose for all patients is 20 000 IU, regardless of body weight, given once a week. This dose can be doubled after four weeks if the hemoglobin level has not increased by at least 1 g / dl and a further increase up to 60 000 IU is possible after another four weeks if necessary. The weekly dose of Biopoin should not exceed 60 000 IU. Patients with cancer must continue therapy up to four weeks after the end of chemotherapy.
Patients to whom Biopoin is given by subcutaneous injection may self-inject themselves after receiving appropriate instructions. For more information, see the package leaflet.
How does Biopoin work?
The active substance in Biopoin, epoetin theta, is a copy of a human hormone called erythropoietin, which stimulates the production of red blood cells in the bone marrow. Erythropoietin is produced by the kidneys. In patients undergoing chemotherapy or in patients with renal insufficiency, anemia may be caused by the lack of erythropoietin or an insufficient response of the organism to naturally produced erythropoietin. Epoetin theta contained in Biopoin acts in the body in the same way as the natural hormone to stimulate the production of red blood cells. It is produced by a method known as "recombinant DNA technology", ie it is manufactured by a cell in which a gene (DNA) has been inserted which makes it capable of producing epoetin theta.
What studies have been carried out on Biopoin?
The effects of Biopoin were first tested in experimental models before being studied in humans. Four main studies were conducted involving 842 patients with chronic renal failure and three main studies involving 586 patients with non-myeloid cancer chemotherapy.
In the four studies concerning patients with renal insufficiency, the latter were treated alternately with Biopoin (subcutaneously or intravenously) or with epoetin beta (another medicine that acts in a similar way to erythropoietin used in the treatment of anemia). The main measure of effectiveness in two of these studies was based on the observation of possible improvements in hemoglobin levels brought about by the increase in the dose of Biopoin from 20 or 40 IU / kg body weight to 120 IU / kg body weight in course of the correction phase. The two additional studies compared Biopoin with epoetin beta during the maintenance phase. The main measure of effectiveness was the average change in hemoglobin levels in the 15-26 weeks following treatment.
In studies of cancer patients, the main measure of effectiveness was the number of patients who reported an increase in hemoglobin level of 2 g / dl in the course of taking Biopoin or placebo (a dummy treatment) 12-16 week course.
What benefit has Biopoin shown during the studies?
Biopoin was effective in treating anemia in patients with chronic renal failure and in patients with non-myeloid cancer chemotherapy.
In patients with chronic renal failure, it has been shown in the correction phase that, by increasing the starting dose of Biopoin, hemoglobin levels improve. The hemoglobin level increased on average weekly by 0.73 and 0.58 g / dl in patients who were given the highest dose of Biopoin compared to the increase of 0.20 and 0.26 g / dl found in patients who were given a lower dose of Biopoin. The other two studies concerning patients with renal insufficiency have shown, during the maintenance phase, changes in analogous hemoglobin levels in patients treated with Biopoin or with epoetin beta.
In the studies conducted on cancer patients, between 64 and 73% of the patients who received Biopoin reported an increase in the hemoglobin level of 2 g / dl compared to 20-26% of the placebo-treated patients.
What is the risk associated with Biopoin?
The most common side effects of Biopoin (seen in between 1 and 10 patients in 100) are shunt thromboses (clots that can form in the blood vessels of dialysis patients, a blood clearance technique), headache, hypertension (high blood pressure) ), hypertensive crisis (sudden, dangerous increase in blood pressure), skin reactions, arthralgia (joint pain) and flu-like illness. For the full list of all side effects reported with Biopoin, see the Package Leaflet.
Biopoin should not be used in people who may be hypersensitive (allergic) to epoetin teta or any other epoetin or substances derived from them, or to any of the other ingredients of Biopoin. The medicine should not be given to patients with uncontrolled hypertension.
Due to the risk of hypertension, it is necessary to monitor and accurately monitor patients' blood pressure to avoid complications such as hypertensive crises.
Why has Biopoin been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Biopoin's benefits are greater than its risks for the treatment of symptomatic anemia associated with chronic renal failure in adult patients and in the treatment of symptomatic anemia in adult cancer patients not myeloid in chemotherapy. The Committee recommended that Biopoin be given marketing authorization.
More information on Biopoin:
On October 23, 2009, the European Commission issued a marketing authorization valid for Biopoin, valid throughout the European Union, to CT Arzneimittel GmbH.
The full EPAR for Biopoin can be found here.
Last update of this summary: 10-2009.
