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Instructions

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Instruction for use: Epoetin theta

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Trade name of the drug Eporatio

The Latin name of the substance Epoetin theta

Epoetinum theta (genus. Epoetini theta)

Chemical name

Human erythropoietin (1-165) -peptide, theta glycoform

Gross formula

C809H1301N229O240S5

Pharmacological group:

Stimulators of hematopoiesis

The nosological classification (ICD-10)

D63.0 Anemia in neoplasm: Anemia in chronic diseases; Anemia due to radiation damage; Radiation anemia; Anemia in patients with solid tumors; Pernicious anemia

D63.8 Anemia in other chronic diseases classified elsewhere: Anemia in chronic diseases; Anemia in immunological disorders; Anemia in peptic ulcer; Anemia in kidney diseases; Anemia with HIV treatment; Anemia in the background of chronic renal failure; Anemia in patients with myeloma; Symptomatic anemia; Symptomatic anemia of renal genesis; Anemia in HIV-infected patients; Renal anemia

Z49.1 Aids that include extracorporeal dialysis: hemodialysis; Chronic hemodialysis; Extracorporeal circulation; Thrombosis of hemodialysis shunt

Z51.1 Chemotherapy for neoplasm: Cystitis hemorrhagic, caused by cytostatics; Urotoxicity of cytostatics

CAS Code

762263-14-9

Pharmacology

Mode action - Hematopoietic, erythropoietic.

Pharmacodynamics

Human erythropoietin is an endogenous glycoprotein hormone that is the main regulator of erythropoiesis through specific interactions with erythropoietin receptors on erythroid marrow precursors. It acts as a factor stimulating mitosis, and a differentiating hormone. The production of erythropoietin primarily occurs and is regulated by the kidney in response to changes in oxygen concentration in tissues. In patients with CKD, the production of endogenous erythropoietin is disrupted, and the main cause of anemia is the deficiency of erythropoietin. In patients with malignant neoplasms receiving chemotherapy, the etiology of anemia is multifactorial in character; The cause of anemia is both a deficiency of erythropoietin and a reduced response of erythroid precursor cells to endogenous erythropoietin.

Pharmacokinetics

The pharmacokinetics of epoetin a theta has been studied in healthy volunteers, patients with CKD, and patients with oncological diseases who received chemotherapy. The pharmacokinetics of epoetin theta does not depend on age or sex.

Bioavailability of epoetin a theta with n / k introduction is 31% of the bioavailability index for intravenous administration. Tmax in blood plasma for 10-14 hours.

In patients with chronic renal failure after 40 mg IU / kg, the final T1 / 2 is higher than after intravenous administration, an average of 25 hours after a single dose and 34 hours in a stable state after repeated doses 3 times a week. The effect of accumulation of epoetin theta was not detected.

In patients with oncological diseases receiving chemotherapy, T1 / 2 with the administration of 20,000 IU of epoetin theta once a week was 29 hours after the first dose and 28 hours with repeated application. The effect of accumulation of epoetin theta was not detected.

Vd is approximately equal to volume of blood circulation.

In patients with chronic renal failure who received hemodialysis, T1 / 2 epoetin theta is 6 hours after a single dose and 4 hours after repeated iv injection of epoetin a theta at a dose of 40 IU / kg 3 times a week. The effect of accumulation of epoetin theta was not detected.

Pharmacokinetics in special clinical cases. The pharmacokinetics of epoetin a theta in patients with hepatic insufficiency has not been studied.

Application of the substance Epoetin theta

Treatment of anemia associated with CKD, incl. In patients on hemodialysis.

Treatment of anemia in patients with non-myeloid tumors receiving chemotherapy (only SC administration).

Contraindications

Hypersensitivity to epoetin theta, pregnancy, breast-feeding period, true erythrocyte aplasia, uncontrolled arterial hypertension, insufficiency of liver function, sickle cell anemia, age over 75 years, anemia in patients with malignant tumors who are not receiving chemotherapy and radiotherapy; Anemia at a Hb concentration of more than 12 g / dL (7.45 mmol / L) in patients with malignant tumors receiving chemotherapy and radiation therapy; Age under 18 years (no experience of use).

Restrictions

Cardiovascular diseases, incl. Diseases of the vessels of the brain and peripheral vessels; Patients with a risk of thrombosis and thromboembolism.

Application of pregnancy and breastfeeding

Information on the efficacy and safety of epoetin a theta during pregnancy and during breastfeeding is absent.

Side effects of the substance Epoetin theta

Side effects are classified according to frequency according to WHO recommendations: very often (not less than 10%); Often (not less than 1%, but less than 10%); Infrequently (not less than 0.1%, but less than 1%); Rarely (not less than 0.01%, but less than 0.1%); Very rarely (less than 0.01%, including single messages).

On the part of the blood and lymphatic system: often - shunt thrombosis (can occur mainly in patients who are prone to hypotension, or in the presence of complications of arteriovenous fistula: stenosis or aneurysm); Very rarely - thrombocytosis, thromboembolic disorders, true erythrocyte aplasia.

From the immune system: often - skin rash, itching, urticaria; Very rarely anaphylactoid reactions.

From the side of the central nervous system: often - a headache.

On the part of the CVS: often - the emergence or strengthening of the existing arterial hypertension, hypertensive crisis with the phenomena of encephalopathy (headache, confusion, sensory and motor disturbances up to tonic-clonic seizures).

From the musculoskeletal system and articular tissue: often - arthralgia.

Other: often - influenza-like syndrome (especially at the beginning of therapy), the symptoms of which are usually mild or moderate and disappear after a few hours or days, incl. Fever, chills, headache, pain in the extremities or bones, general malaise.

Interaction

The data obtained so far have not revealed any interaction of epoetin with other drugs.

To avoid incompatibility or decrease in activity, epoetinethate should not be mixed with other drugs or injectable solutions.

Overdose

Symptoms: The therapeutic index of epoetin theta is very broad, but individual response to therapy at the beginning of treatment should be taken into account. An excessive pharmacodynamic response is possible, i.e. Polycythemia with life-threatening cardiovascular complications.

Treatment: with polycithemia, therapy with epoetinic theta is discontinued. If necessary, conduct a phlebotomy.

Routes of administration

IV.

Precautions for the substance Epoetin theta

For all patients with serum ferritin values less than 100 mkg / l or with transferrin saturation less than 20%, additional iron therapy is recommended. To ensure effective erythrocytopoiesis, the iron content of each patient should be carefully assessed before and during therapy. The absence of effect in the therapy with epoetinic theta should be considered the basis for the search for other etiopathogenetic factors of the development of anemia. Therefore, before the start of treatment, it is necessary to exclude the deficiency of cyanocobalamin and folic acid, which can reduce the effectiveness of epoetins.

The erythropoietic reaction can also be weakened by intercurrent infections, inflammatory processes or trauma, hidden blood loss, hemolysis of erythrocytes, aluminum intoxication, latent hematologic disorders or bone marrow fibrosis.

In the case of the elimination of the most common causes of the absence of an erythropoietic reaction, when a patient is found to have a sharp decrease in the Hb concentration associated with reticulocytopenia, a determination of anti-erythropoietin antibodies and a bone marrow examination for a differential diagnosis with true erythrocyte aplasia, which is an indication for discontinuing epoetin theta therapy, should be performed. The cases when the true erythrocyte aplasia was caused by the neutralizing effect of anti-erythropoietin antibodies in connection with epoetin therapy of theta are described. It has been shown that these antibodies cross-react with all epoetins, so patients with suspicion or confirmation of the presence of neutralizing antibodies should not use epoetin.

With epoetin therapy, patients may have higher blood pressure, especially at the initial stage of treatment. BP should be monitored before and during therapy to avoid acute complications such as hypertensive crisis with symptoms of encephalopathy (headache, confusion, speech impairment, gait disturbance) and associated complications (convulsions) that may also occur in patients Both with normal and low blood pressure. Particular attention should be paid to a sudden acute migraine-like headache as a possible warning signal.

Increased blood pressure may require treatment with antihypertensive drugs or increase their dose. If blood pressure remains high, it may be necessary to temporarily discontinue epoetin theta therapy. With the stabilization and successful control of AD, epoetinetic therapy should begin anew in a reduced dose.

The erroneous use of epoetin a theta in healthy people can cause an excessive increase in the concentration of Hb and hematocrit, which can lead to life-threatening cardiovascular complications.

Due to limited clinical experience, the effectiveness and safety of epoetin has not been established in patients with impaired hepatic function or homozygous sickle cell anemia.

In clinical studies, patients older than 75 years of age had a higher incidence of serious and severe adverse events, regardless of the cause-effect relationship with epoetin therapy. In addition, deaths were more frequent in this group of patients compared to younger patients.

Anemia associated with CRF, incl. In patients on hemodialysis. The possibility of using epoetin a theta in patients with nephrosclerosis who have not undergone dialysis should be determined individually, since the possible accelerated development of renal failure cannot be ruled out.

During hemodialysis, patients receiving epoetin theta may require an increase in the dose of an anticoagulant to prevent thrombosis of the arteriovenous shunt.

In patients with CRF, the Hb concentration in the stabilization phase should not exceed the upper limit. In clinical studies, increased mortality and serious cardiovascular complications were observed when epoetins were administered to patients with a Hb concentration of more than 12 g / dL (7.45 mmol / L).

Anemia in patients with non-myeloid tumors receiving chemotherapy. Erythropoietins are growth factors that mainly stimulate the production of red blood cells. Receptors to erythropoietin can be expressed on the surface of various tumor cells. As with any growth factor, there is a suggestion that erythropoietins are capable of stimulating the growth of any type of malignancy.

In a number of controlled clinical studies, the use of epoetins in patients with anemia associated with cancer has not demonstrated an increase in overall survival or a decrease in the risk of tumor progression. According to controlled clinical studies, the use of epoetin can lead to:

- to shorten the time to tumor progression in patients with head and neck cancer receiving radiotherapy, while achieving a target Hb concentration of more than 14 g / dl (8.69 mmol / L);

- to a reduction in overall survival and an increase in the number of deaths associated with disease progression within 4 months from the start of treatment in patients with metastatic breast cancer receiving chemotherapy while achieving a target Hb concentration of 12 to 14 g / dl (from 7, 45 to 8.69 mmol / L);

- to an increased risk of death in patients with active malignancy not receiving chemotherapy and radiation therapy, while achieving a target Hb concentration of 12 g / dl (7.45 mmol / L).

The epoetin of theta is contraindicated for use in these patients.

Based on the above, in some clinical situations, blood transfusion is preferable for the treatment of anemia in patients with oncological diseases.

The solution for the use of recombinant erythropoietins should be based on an estimate of the ratio of expected benefit to the possible risk for a particular patient, in which a specific clinical picture should be taken into account.

Influence on the ability to drive vehicles and mechanisms. The epoetin of the theta has no significant effect on the ability to drive vehicles and perform potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

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