Product Overview
Contents
The solution for in/in and n/c administration is transparent, colorless.
Epoietin alpha (human erythropoietin recombinant)
Auxiliary substances:
sodium chloride - 2.92 mg,
sodium citrate pentasesquevigidrate - 2.9 mg or sodium citrate dihydrate - 2.388 mg,
albumin solution (in terms of dry albumin) - 1.25 mg,
citric acid monohydrate - 0.0285 mg,
water d/i - up to 0.5 ml.
Pharmacological effect
After repeated intravenous administration of T1/2 in adult healthy patients it is 4 hours, in patients with renal failure - about 6 hours; in children - about 6 hours.
Indications
Treatment of anemia associated with chronic renal failure in adult patients on hemo- or peritoneal dialysis or who are shown to perform dialysis; in children on hemodialysis.
Treatment of anemia in cancer patients (receiving or not receiving chemotherapy) in non-myeloid tumors.
Prevention of anemia in cancer patients with non-myeloid tumors receiving a long course of chemotherapy.
Treatment of anemia in HIV-infected patients receiving zidovudine therapy (at endogenous erythropoietin ≤ 500 IU/ml).
Under the pre-deposit program before extensive surgery in patients with 33-39% hematocrit levels, to facilitate the collection of autologous blood and reduce the risk associated with the use of allogenous hemotransfusions (with the expected need for transfusions, higher than the amount that can be obtained without the use of epoietin alpha).
Before performing extensive surgery with expected average blood loss (2-4 units or 900-1800 ml) in adult patients with mild to moderate anemia (hemoglobin >10 and ≤ 13 g/dl) to reduce the need for allogenous hemotransfusions and improve erythropoiesis recovery.
Contraindications
Uncontrolled arterial hypertension, hypersensitivity to the alpha epoetine.
Before extensive surgery not within the framework of the pre-posit program using autologous blood, it is contraindicated for severe vascular pathology (including coronary, carotid, cerebral, peripheral) and in recent myocardial infarction or acute cerebral circulation disorders.
Side effects
Influenza-like syndrome: dizziness, drowsiness, fever, headache, joint and muscle pain (mainly at the beginning of treatment) are possible.
From the cardiovascular system: dose-dependent increase in BP is possible; deterioration of arterial hypertension (most often in patients with chronic renal failure); in some cases - hypertension, malignant arterial hypertension with symptoms of encephalopathy (headache, confusion) and generalized tonic-clonic seizures.
From the hematopoietic system: rarely - plateletosis.
From the clotting system: in some cases - shunt thrombosis (in patients with a tendency to hypotension or in the presence of stenosis, aneurysm).
Urinary system: hyperkalemia, hyperphosphatemia, increased concentration of urea, creatinine, uric acids in blood plasma (in patients with chronic renal failure) are possible.
Allergic reactions: in some cases - weak or moderate skin rash, eczema, urticaria, itching, angioneurotic edema.
Local reactions: redness, burning sensation, weak or moderate soreness at the place of administration (more often occur during administration).
Others: rarely - potentially serious complications related to respiratory disorders or reduced BP; immune reactions (has a minimum ability to induce the formation of antibodies).
Interaction
The effect of epoetine alpha can be increased by simultaneous administration of blood preparations.
Simultaneous use of epoetine alpha with cyclosporin may reduce the concentration of the latter in plasma due to an increase in its binding to red blood cells (when using this combination, it is necessary to control the concentration of cyclosporin in plasma and, if necessary, increase its dose).
The alpha edpoetine should not be mixed with solutions of other drugs.
How to take, course of administration and dosage
Special instructions
Carefully used in patients with seizure reactions in the history; patients with an increased risk of thrombosis or other vascular complications require careful medical control.
They use gout with caution.
Before starting use, it should be made sure that patients with arterial hypertension received effective antihypertensive therapy.
Against the background of application, it is necessary to control the level of BP, paying attention to the occurrence or increase of unusual headaches. It may require correction of therapy or prescription of antihypertensive drugs. If, despite adequate BP therapy, the epoetine alpha should be abolished.
Before using epoetine alpha, it is necessary to assess the condition of the iron depot in the body. In most patients with chronic renal failure, cancer and HIV-infected patients, the level of ferritin in blood plasma decreases simultaneously with an increase in hematocrit. Ferritin levels should be determined throughout the course of treatment. If it is less than 100 ng/ml, iron substitution therapy is recommended. Patients who donate autologous blood and are in the pre- or postoperative period should also receive additional adequate amounts of iron.
During use, hemoglobin levels should be monitored at least once a week until stable levels are reached, then slightly less often. In the pre- and postoperative period, hemoglobin levels should be checked more often if the initial level was less than 14 g/dl. Hematocrit levels should also be regularly monitored. During the first 8 weeks of therapy, platelet count should be regularly monitored, as epoetine alpha can cause a moderate dose-dependent increase in platelet numbers, which returns to normal independently during the course of therapy; plateletosis rarely develops.
It should be taken into account that preoperative increase in hemoglobin levels can be a predisposing factor to the development of thrombotic complications. Before performing routine surgery, patients should receive adequate preventive antithrombotic therapy.
In the pre- and postoperative period, it is not recommended to use epoetin alpha at an initial hemoglobin level of more than 15 g/dl.
Use with caution in patients with porphyria. In case of chronic renal failure against the background of epoetine alpha therapy, porphyria may worsen.
Correction of anemia can be accompanied by improved appetite and increased absorption of potassium and proteins. Keep in mind the possible need for periodic correction of dialysis parameters to maintain urea, creatinine and potassium levels within the norm. In patients with chronic renal failure, it is necessary to control the level of electrolytes in the blood serum.
Patients on hemodialysis, against the background of epoetine alpha therapy, often need an increase in the dose of heparin during dialysis due to an increase in hematocrit. If the dialysis system may be occlusioned with inadequate dose of heparin.
In patients with chronic renal failure and clinically pronounced CHD or congestive heart failure, the maintenance level of hemoglobin should not exceed the upper limit of the optimal recommended level (no more than 10-12 g/dl in adults).
When used in patients with liver dysfunction, biotransformation of epoetine alpha may slow down and a pronounced increase in erythropoiesis may occur. The safety of epoetine alpha use in this category of patients has not been established.
The possibility of the effect of epoetine alpha on the growth of some types of tumors, especially malignant bone marrow neoplasms, cannot be completely excluded.
All special warnings and precautions related to the autologous blood collection program should be observed (this applies to all patients receiving epoetine alpha).
The therapeutic effectiveness of epoetine alpha can be reduced by iron deficiency, folic acid, vitamin B12, aluminum intoxication, intercurrent diseases, latent bleeding, hemolysis, bone marrow fibrosis.
In experimental animal studies, in the study of chronic toxicity of epoietin alpha, subclinical fibrosis of bone marrow tissues was observed in some cases, as well as anemia with or without signs of bone marrow hypoplasia. It is believed that this is due to the appearance of antibodies to the epoethin alpha.
No mutagenic action has been detected.
Impact on the ability to drive vehicles and control mechanisms
When using epoetine alpha, patients with CPN should avoid potentially dangerous activities before establishing an optimal supporting dose due to the increased risk of arterial hypertension at the beginning of therapy.
