Symptoms: The therapeutic index of Eporatio is very broad, but the 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: in polycythemia, Eporatio therapy is discontinued. If necessary, a phlebotomy is performed.
hypersensitivity to epoetin theta or one of the components of the drug,
true red blood cell aplasia (IECA),
uncontrolled arterial hypertension,
the impairment of liver function,
sickle cell anemia,
age older than 75 years,
anemia in patients with malignant tumors who do not receive chemotherapy and radiation therapy,
anemia at Hb concentrations greater than 12 g/dl (7.45 mmol/l) in patients with malignant tumors receiving chemotherapy and radiation therapy,
pregnancy,
breastfeeding period,
age under 18 years (no experience with the drug).
With caution: cardiovascular diseases, including diseases of the blood vessels of the brain and peripheral vessels, patients at risk of developing thrombosis and thromboembolism.
The data obtained so far have not revealed any interaction of epoetin theta with other drugs.
To avoid incompatibility or reduce the activity of the drug, do not mix epoetin theta with other drugs or injectable solutions.
NASAL Reduction, Solution, Nebulizer Solution, Solution for Injection or Infusion, Solution for Injection / Infusion
Side effects are classified by frequency according to WHO recommendations: very common-at least 10%, often-at least 1%, but less than 10%, infrequently - at least 0.1%, but less than 1%, rarely-at least 0.01%, but less than 0.1%, very rarely-less than 0.01%, including isolated reports.
From the blood and lymphatic system: often-shunt thrombosis (can occur mainly in patients who have a tendency to hypotension or in the presence of complications of arteriovenous fistula: stenosis or aneurysm), very rarely — thrombocytosis, thromboembolic disorders, IECA.
On the part of the immune system: often-skin rash, itching, urticaria: very rarely-anaphylactoid reactions.
From the central nervous system: often-a headache.
From the CCC side: often-the occurrence or increase of already existing arterial hypertension, a hypertensive crisis with the phenomena of encephalopathy (headaches, confusion, sensory and motor disorders up to tonic-clonic seizures).
Musculoskeletal and joint tissue disorders: often-arthralgia.
Other: often-flu-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, including fever, chills, headache, pain in the limbs or bones, general malaise.
treatment of anemia associated with chronic renal failure, including in patients undergoing hemodialysis,
treatment of anemia in patients with non-myeloid tumors receiving chemotherapy (only n / a administration).
Human erythropoietin is an endogenous glycoprotein hormone that is the main regulator of erythropoiesis through specific interactions with erythropoietin receptors on erythroid progenitor cells of the bone marrow. It acts as a mitosis-stimulating factor and a differentiating hormone.
The production of erythropoietin primarily occurs and is regulated by the kidneys in response to changes in the oxygen concentration in the tissues. In patients with CRF, the production of endogenous erythropoietin is disrupted and the main cause of anemia is erythropoietin deficiency. In patients with malignant neoplasms receiving chemotherapy, the etiology of anemia is multifactorial. In such patients, the cause of anemia is both a deficiency of erythropoietin and a reduced response of erythroid progenitor cells to endogenous erythropoietin.
Epoetin theta is identical in its amino acid sequence and similar in its carbohydrate composition (glycosylation) to endogenous human erythropoietin.
The pharmacokinetics of epoetin theta have been studied in healthy volunteers, in patients with CRF, and in cancer patients receiving chemotherapy.
The pharmacokinetics of epoetin theta do not depend on age or gender.
The bioavailability of epoetin theta with n / a administration is 31% of the bioavailability index with intravenous administration. Time to reach Cmax The blood plasma content of epoetin theta is 10-14 hours.
In patients with CRF after n / A administration of 40 IU / kg, the final T1/2 higher than after intravenous administration, on average 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 cancer receiving chemotherapy, after repeated administration of 20000 ME of epoetin theta once a week, T1/2 - 29 hours after the first dose and 28 hours with repeated use. The effect of accumulation of epoetin theta was not detected.
Vd approximately equal to the BCC.
In patients with CRF undergoing hemodialysis, T1/2 epoetin theta is 6 hours after a single dose and 4 hours after repeated intravenous administration of epoetin theta 40 IU / kg 3 times a week. The effect of accumulation of epoetin theta was not detected.
Special clinical cases. The pharmacokinetics of epoetin theta in patients with hepatic insufficiency have not been studied.
Biopoin
Epoetin Theta
Treatment is carried out under the supervision of a doctor.
V/v slow introduction for 2 minutes and p/c slow insertion into the abdomen, shoulder, or hip area. It is necessary to regularly change the injection site for p / c administration to avoid the development of local reactions.
Before use, make sure that the syringe is suitable for use, filled with a clear solution and has no suspended visible particles. Do not shake the injection solution. Before use, the injection solution should reach room temperature.. If the drug Eporatio is replaced with another drug of epoetin, then it is necessary to maintain the same method of administration. The goal of treatment is to increase the concentration of Hb. The effectiveness of therapy depends on an adequately selected individual treatment regimen. Since the individual response to treatment with Eporatio cannot be predicted, the Hb concentration can be adjusted by changing the dose of Eporatio, maintaining it in the range of at least 10 g/dl (6.21 mmol/L), but not more than 12 g/dl (7.45 mmol/L)
Treatment of anemia associated with chronic renal failure, including patients on hemodialysis
P/c and v / v introduction. In patients who do not receive hemodialysis, it is preferable to use a p/c injection to avoid repeated punctures of the peripheral veins. For patients on hemodialysis-through an arteriovenous shunt at the end of the dialysis session.
If the Hb concentration increases by more than 2 g/dl (1.24 mmol/L) for 4 weeks or the Hb concentration increases by more than 12 g/dl (7.45 mmol/L), the dose of Eporatio is reduced by 25-50%.
It is recommended to monitor the Hb concentration every 2 weeks before and after achieving stabilization of the indicators. If the Hb concentration continues to increase, then therapy is interrupted until the Hb concentration begins to decrease, after which therapy is resumed at a dose equal to about 25% of the initial dose. In concomitant cardiovascular diseases, including arterial hypertension, diseases of the cerebral vessels and peripheral vessels, the increase in Hb concentration and the target Hb concentration should be determined individually for each patient, taking into account the clinical picture.
Stage of correction of Hb concentration.
P/c: the initial dose is 20 IU / kg 3 times a week. In case of insufficient increase in Hb concentration (less than 1 g/dl (0.62 mmol / L) for 4 weeks), the dose is increased to 40 IU/kg 3 times a week every 4 weeks. If necessary, further increase the dose of Eporatio by 25% from the previous dose at an interval of 1 month until the individual target Hb concentration is reached.
V/v: the initial dose is 40 IU / kg 3 times a week. Additionally, the dose is increased after 4 weeks to 80 IU / kg 3 times a week. If necessary, the dose is increased by 25% from the previous dose at intervals of 1 month. The maximum dose for n / a and IV administration should not exceed 700 IU / kg / week.
The stage of stabilization of the Hb concentration. The maintenance dose is adjusted to maintain the individual target Hb concentration of at least 10 g/dl (6.21 mmol/L), but not more than 12 g/dl (7.45 mmol / L). If necessary, the dose is changed by about 25%.
P/c: the total weekly dose is administered at a time or divided into 3 doses during the week.
V/v: If the Hb concentration is stable, the total weekly dose is divided into 3 injections during the week or 2 injections during the week.
When changing the administration mode, the Hb concentration should be monitored and, if necessary, make adjustments to the dose and administration mode.
The maximum dose for n / a and IV administration should not exceed 700 IU / kg / week.
Treatment of anemia in patients with non-myeloid tumors receiving chemotherapy
Only p / c introduction. The initial dose is 20000 ME 1 time per week. In the case of an increase in the Hb concentration by 1 g/dl (0.62 mmol/L) for 4 weeks, therapy is continued at the initial dose. In case of insufficient increase in Hb concentration (less than 1 g/dl (0.62 mmol / L) for 4 weeks), the dose is increased to 40,000 ME. If after 4 weeks the increase in Hb concentration is still insufficient, consider increasing the total weekly dose to 60,000 ME. The maximum dose should not exceed 60,000 ME/week.
If, after 12 weeks of therapy, there is no increase in the Hb concentration by at least 1 g/dl (0.62 mmol/L), the effectiveness of treatment with Eporatio is evaluated and, if necessary, treatment is discontinued.
If the increase in Hb concentration exceeds 2 g / dl (1.24 mmol / L) for 4 weeks or the Hb concentration exceeds 12 g/dl (7.45 mmol/L), the dose is reduced by 25-50%. If the Hb concentration is greater than 13 g / dl (8.07 mmol / L), therapy is interrupted until the Hb concentration drops to 12 g/dl (7.45 mmol/L) or lower, after which therapy is resumed at a dose equal to approximately 25% of the initial dose.
Therapy with Eporatio should continue for up to 4 weeks after the end of chemotherapy.
Recommendations for the use of the drug
First, make sure that the patient has everything necessary for the injection: a filled syringe with Eporatio, a cotton swab soaked in alcohol, a piece of gauze dressing or a sterile gauze swab, a puncture-resistant container for used syringes.
What should the patient do before injecting the drug
1. Take one blister with Eporatio from the refrigerator.
2. Open the blister and remove the filled syringe and the container with the needle. Do not pull the filled syringe by the plunger or the protective cap.
3. Check the expiration date on the label of the filled syringe (Valid until:). Do not use the drug if the date of the last day indicated on the label of the month has expired.
4. Evaluate the appearance of the drug Eporatio. It should be a clear and colorless liquid. Do not use the drug if there are particles in it or if the solution is cloudy.
5. There is a cap at the end of the needle container, open the marked seal / label and remove the cap (see Figure 1).
Figure 1.
6. Remove the protective cap from the filled syringe (see Figure 2).
Figure 2.
7. Connect the needle to the syringe (see Figure 3). Do not remove the cap protecting the needle yet.
Figure 3.
8. For a more comfortable injection procedure, leave the filled syringe for 30 minutes to warm up to room temperature (no higher than 25 °C) or, with caution, hold the syringe in your hand for a few minutes. Do not heat Eporatio in any other way (for example, do not heat it in a microwave oven or in hot water).
9. Do not remove the protective cap from the needle if the patient is not yet ready to inject.
10. Choose a comfortable, well-lit place. The materials required for the injection (a filled syringe with Eporatio, a cotton swab soaked in alcohol, a piece of gauze dressing or a sterile gauze swab and a puncture-resistant container) should be spread out so that the patient can easily reach them.
11. Wash your hands thoroughly.
How to prepare for the injection
Before the injection of the drug Eporatio, the patient should do the following:
12. Take the syringe and carefully remove the protective cap from the needle, avoiding rotation. The cap should be pulled along the axis of the syringe, as shown in Figure 4. Do not touch the needle or press the plunger.
Figure 4.
13. There may be a small amount of air bubbles in the filled syringe. If air bubbles are present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. By pointing the syringe upward, remove the air from the syringe by slowly pressing the plunger upward.
14. There is a scale on the cylinder of the syringe. Press the plunger to the unit (ME) of the scale corresponding to the dose of Eporatio prescribed to the patient by the doctor.
15. Re-check the correctness of the established dose of Eporatio on the syringe scale.
16. Now the filled syringe is ready for use.
Choosing the injection site
The most suitable places for injection are the following areas:
- upper thigh,
- the abdomen, with the exception of the umbilical region (see the areas shaded in gray in Figure 5).
Figure 5.
It is possible to inject into the back and side of the shoulder if the patient is assisted by someone to inject (see the areas shaded in gray in Figure 6). It is preferable to change the injection sites each time to avoid the risk of developing pain in the same area.
Figure 6.
How to make an injection
17. Disinfect the skin area at the injection site with a cotton swab soaked in alcohol, and gently fold the skin into a fold with your thumb and index finger, without squeezing it (see Figure 7).
Figure 7.
18. Fully insert the needle, protected by the nozzle, under the skin. The angle between the syringe and the skin should not be too sharp (at least 45°, see Figure 8). The protective nozzle on the needle will retract when the needle is inserted under the skin.
Figure 8.
19. Pull the plunger slightly back to make sure that the blood vessel has not been punctured. If the patient sees blood in the syringe, remove the needle and re-insert it in another place.
20. Slowly and evenly inject the drug solution under the skin, holding the fold (see Fig. 9).
Figure 9.
21. After administration of the drug, remove the needle and release the skin. The needle will again be protected by the nozzle and automatically closed so that the patient can not accidentally prick himself (see Figure 10).
Figure 10.
22. Press on the injection site with a piece of gauze bandage or a sterile gauze swab and hold for a few seconds.
23. Use the syringe for only one injection. Do not use the remaining solution of the drug Eporatio in the syringe.
