Mircera, 50 mcg, solution for intravenous and subcutaneous administration, 0.3 ml, 1 pc.

Instructions for use of MIRCERA

Given the longer T1/2, Mircera should be administered less frequently than other erythropoiesis stimulants.

Treatment with Mircera should only be started under the supervision of a specialist.

Rules for storing the solution in outpatient and inpatient settings

Mircera solution is sterile and does not contain preservatives. Only a clear, colorless or slightly yellowish solution that does not contain visible impurities should be used. Before administration, the solution is brought to room temperature if the drug was stored in the refrigerator.

The syringe tube can be stored for 1 month at room temperature not exceeding 30°C and must be used within this month.

Unused solution must be destroyed. Each syringe tube can only be used once. Do not shake.

Mode of application

The drug can be administered either subcutaneously or intravenously.

The subcutaneous drug is administered only to the shoulder area, the anterior surface of the thigh or the anterior abdominal wall.

Hemoglobin content should be monitored once every two weeks until it stabilizes and periodically after stabilization.

Standard dosage regimen

Patients not currently receiving an erythropoiesis stimulant

Recommended starting dose:

• 0.6 mcg/kg IV or SC once every 2 weeks, target hemoglobin >110 g/L (6.83 mmol/L).

The dose of Mircera can be increased by 25-50% of the previous one if after a month the increase in hemoglobin is less than 10 g/l (0.621 mmol/l). Further dose increases of approximately 25-50% can be carried out at monthly intervals until the individual target hemoglobin level is achieved.

The Mircera dose is reduced by 25-50% from the previous one if after a month the increase in hemoglobin is more than 20 g/l (1.24 mmol/l). If hemoglobin exceeds 130 g/l (8.07 mmol/l), then therapy must be interrupted until hemoglobin decreases to less than 130 g/l (8.07 mmol/l) and then resumed at a dose of 50% of the previous one. With a target hemoglobin value of 120 g/l, the dose of the drug changes by 25%.

After cessation of therapy, hemoglobin decreases by approximately 3.5 g/l (0.22 mmol/l) per week.

The dose of the drug is adjusted no more than once a month.

Patients currently receiving an erythropoiesis stimulant

Patients receiving another erythropoiesis stimulant can be switched to Mircera therapy with a once-a-month or once-every-2-week s.c. or i.v. regimen. The starting dose is based on the weekly dose of the previously administered drug, darbepoetin alfa or epoetin (alpha or beta) (Tables 1 and 2). The first Myrcera injection is given on the day of the next scheduled injection of previously used darbepoetin alfa or epoetin (alpha or beta).

Table 1. Switching from epoetin (alpha or beta).

Table 2. Switching from darbepoetin alfa.

If dose adjustment is required to maintain the target hemoglobin level above 110 g/L (6.83 mmol/L), the monthly dose can be adjusted by 25%.

The Mircera dose is reduced by 25-50% from the previous one if after a month the increase in hemoglobin level is more than 20 g/l (1.24 mmol/l). If hemoglobin exceeds 130 g/l (8.07 mmol/l), then therapy must be interrupted until hemoglobin decreases to a level less than 130 g/l (8.07 mmol/l) and then resumed at a dose of 50% of the previous one.

At a target hemoglobin level of 120 g/l, the dose of the drug changes by 25%.

After cessation of therapy, hemoglobin decreases by approximately 3.5 g/l (0.22 mmol/l) per week.

The dose of the drug is adjusted no more than once a month.

Break in treatment

Treatment of anemia, incl. and therapy with Mircera is usually long-term. But if necessary, therapy with Mircera can be interrupted at any time.

Missed dose

A missed single injection of Mircera should be administered as soon as possible and the drug should be administered at the prescribed dosing frequency.

Dosing in special cases

In patients with liver failure of any severity

no dose adjustment of the drug is required.

In elderly patients (over 65 years old)

no adjustment of the initial dose of the drug is required.

Rules for handling a syringe tube

1. Remove the transparent blister pack with the medicinal product from the cardboard box without opening the protective film.

2. Wash your hands thoroughly with warm water and soap.

3. Remove the protective film from the blister pack, take out the syringe tube and a transparent plastic container with a needle.

4. Hold the container with the needle and remove the cap by turning it clockwise. Remove the cap from the top of the needle container.

5. Hold the syringe tube and remove the rubber tip by first bending and pulling.

6. Holding the transparent container with the needle, firmly insert the needle into the syringe tube, as shown in the figure.

Preparation and administration of the injection

1. To administer the drug, select one of the recommended places:

• the anterior abdominal wall, excluding the area around the navel, the anterior surface of the mid-thigh, or the outer surface of the shoulder. Do not inject the drug into birthmarks, scar tissue, hematomas or into the navel, in places with induration and/or reactions after previous injections. The injection site of the drug should be changed each time. Avoid areas that may be irritated by belts or clothing.

2. Thoroughly clean the skin at the injection site with a swab moistened with alcohol. Wait until the treated area dries.

3. Gently holding the syringe tube without pressing the plunger, carefully remove the transparent container from the needle.

4. Using two fingers, gather the skin into a fold at the site of the intended injection. Insert the needle into the skin fold at a right angle.

5. Slowly introduce the entire drug, gently pressing on the piston. Do not stop pressing the plunger of the syringe tube until you remove the needle from the skin.

6. After administering the entire dose, remove the needle from the skin without releasing the plunger of the syringe tube, as shown in the figure.

7. If the plunger is released, the safety device will release and close the needle.

8. Press the injection site with a cotton swab. If necessary, cover the injection site with a bandage.

Mircera, 50 mcg, solution for intravenous and subcutaneous administration, 0.3 ml, 1 pc.

P/c and i.v.

Given the longer T1/2, Mircera should be administered less frequently than other erythropoiesis stimulants.

Treatment with Mircera should only be started under the supervision of a specialist.

Rules for storing the solution in outpatient and inpatient settings

The Mircera solution is sterile and does not contain preservatives. Only a clear, colorless or slightly yellowish solution that does not contain visible impurities should be used. Before administration, the solution is brought to room temperature if the solution was stored in the refrigerator.

The syringe tube can be stored for 1 month at room temperature (not higher than 25 °C) and should be used within a month.

The bottle can be stored for 7 days at room temperature (not above 25 °C) and must be used within 7 days.

Unused solution must be destroyed. Each bottle or syringe tube can only be used once. Do not shake.

Mode of application. The drug should be administered subcutaneously into the shoulder area, the anterior surface of the thigh or the anterior abdominal wall.

The Hb content should be monitored once every 2 weeks until it stabilizes and periodically after stabilization.

Standard dosage regimen

Patients not currently receiving an erythropoiesis stimulant. The recommended initial dose is 0.6 mcg/kg IV or SC once every 2 weeks, target hemoglobin >110 g/L (6.83 mmol/L).

The dose of Mircera can be increased by 25–50% of the previous one if after 1 month the increase in Hb is <10 g/l (0.621 mmol/l). Further dose increases of approximately 25–50% can be carried out at monthly intervals until the individual target Hb level is achieved.

The dose of Mircera is reduced by 25–50% from the previous one if after 1 month the increase in Hb is >20 g/l (1.24 mmol/l). If Hb exceeds 130 g/l (8.07 mmol/l), then therapy must be interrupted until Hb decreases <130 g/l (8.07 mmol/l) and then resumed at a dose of 50% of the previous one. With a target Hb of 120 g/l, the dose of the drug changes by 25%.

After discontinuation of therapy, Hb decreases by approximately 3.5 g/l (0.22 mmol/l) per week.

The dose of the drug is adjusted no more than once a month.

Patients currently receiving an erythropoiesis stimulant. Patients receiving another erythropoiesis stimulator can be transferred to therapy with Mircera with a regimen of administration once a month or once every 2 weeks subcutaneously or intravenously.

Initial dose: depends on the weekly dose of the previously administered drug - darbepoetin alfa or epoetin (alpha or beta) (see Tables 1 and 2). The first injection of Mircera is given on the day of the next scheduled injection of previously used darbepoetin alfa or epoetin (alpha or beta).

Table 1

Switching from epoetin (alpha or beta)

table 2

Switching from darbepoetin alfa

If dose adjustment is required to maintain target Hb above 110 g/L (6.83 mmol/L), the monthly dose can be adjusted by 25%.

The dose of Mircera is reduced by 25–50% from the previous one if after 1 month the increase in Hb is more than 20 g/l (1.24 mmol/l). If Hb exceeds 130 g/l (8.07 mmol/l), then therapy must be interrupted until Hb decreases to a level less than 130 g/l (8.07 mmol/l) and then resumed at a dose of 50% of the previous one.

With a target Hb of 120 g/l, the dose of the drug changes by 25%.

After discontinuation of therapy, Hb decreases by approximately 3.5 g/l (0.22 mmol/l) per week.

The dose of the drug is adjusted no more than once a month.

Break in treatment. Treatment of anemia, incl. and therapy with Mircera is usually long-term. But if necessary, therapy with Mircera can be interrupted at any time.

Missed dose. A missed single injection of Mircera should be administered as soon as possible and the drug should be administered at the prescribed dosing frequency.

Dosing in special cases

In patients with liver failure of any severity, no adjustment of the initial dose of the drug or dosage regimen is required.

In old age (over 65 years), no adjustment of the initial dose of the drug is required.

Instructions for handling the syringe tube

1. Remove the transparent blister pack with the medicinal product from the cardboard box without opening the protective film.

2. Wash your hands thoroughly with warm water and soap.

3. Remove the protective film from the blister pack, take out the syringe tube and a transparent plastic container with a needle.

4. Hold the needle container and remove the cap using a clockwise rotation motion as shown in Figure 1. Remove the cap from the top of the needle container.

Drawing. 1. Cap removal technique.

5. Holding the syringe tube, remove the rubber tip by first bending and pulling, as shown in Figure 2.

Drawing. 2. Technique for removing the rubber tip.

6. Holding the transparent container with the needle, firmly insert the needle into the syringe tube, as shown in Figure 3.

Drawing. 3. Technique for attaching a needle to a syringe tube.

Preparation and administration of the injection

1. To administer the drug, select one of the recommended sites as shown in Figure 4: the anterior abdominal wall (excluding the area around the navel), the anterior surface of the mid-thigh or the outer surface of the shoulder. Do not inject the drug into birthmarks, scar tissue, hematomas or navel, areas with induration and/or reactions after previous injections. The injection site should be changed every time. Avoid areas that may be irritated by belts or clothing.

Drawing. 4. Recommended injection sites.

2. Thoroughly clean the skin at the injection site with a swab moistened with alcohol, as shown in Figure 5. Wait until the treated area dries.

Drawing. 5. Technique for treating the injection site.

3. Gently holding the syringe tube without pressing the plunger, carefully remove the transparent container from the needle.

4. Using two fingers, gather the skin into a fold at the site of the intended injection. Insert the needle into the skin fold at a right angle, as shown in Figure 6.

Drawing. 6. Injection technique.

5. Slowly inject the entire medication, gently pressing the plunger, as shown in Figure 7. Do not stop pressing the plunger of the syringe tube until the needle is removed from the skin!

Drawing. 7. Technique for drug administration.

6. After administering the entire dose, remove the needle from the skin without releasing the plunger of the syringe tube, as shown in Figure 8.

Drawing. 8. Technique for removing the needle.

7. Release the piston, which will release the safety device and close the needle, as shown in Figure 9.

Drawing. 9. Technique for using a protective device.

8. Press the injection site with a cotton swab. If necessary, cover the injection site with a bandage.

Buy Mircera solution for injection 75mcg/0.3ml syringe tube No. 1 in pharmacies

Instructions for use of Mircera solution d/in. 75mcg/0.3ml syringe tube No. 1 Dosage forms injection solution 75mcg 0.3ml Synonyms There are no synonyms. Group Hematopoiesis stimulants International nonproprietary name Epoetin beta (methoxypolyethylene glycol) Composition Methoxypolyethylene glycol-epoetin beta. Manufacturers Roche Diagnostics GmbH (Germany), Roche Diagnostics GmbH, packaged by Ortat CJSC (Germany) Pharmacological action Mircera is a chemically synthesized representative of a new class of long-acting erythropoietin receptor activators. Mircera has different activity at the receptor level from erythropoietin and is characterized by longer association with the receptor and faster dissociation from the receptor, reduced specific activity in vitro and increased activity in vivo, as well as an increased half-life, which allows Mircera to be administered once a month. In 97.5% of patients with chronic kidney disease who are not on dialysis, correction of anemia was noted during Mircera therapy. In 93.3% of patients with chronic kidney disease on dialysis, treatment with Mircera showed correction of anemia. In patients on dialysis, when switching from darbepoetin alfa or epoetin therapy to Mircera therapy, a stable target hemoglobin (Hb) level is maintained. The clearance and volume of distribution of methoxypolyethylene glycol-epoetin beta are not dose dependent. Long-term administration does not affect the clearance, volume of distribution and bioavailability of methoxypolyethylene glycol-epoetin beta. Administration of methoxypolyethylene glycol-epoetin beta once every 4 weeks does not lead to significant accumulation of the drug. Hemodialysis does not affect the pharmacokinetics of methoxypolyethylene glycol-epoetin beta. Pharmacokinetics, pharmacodynamics and local tolerability do not depend on the site of subcutaneous injection of the drug (shoulder, anterior thigh, anterior abdominal wall). The time to reach the maximum serum concentration of methoxypolyethylene glycol-epoetin beta when administered subcutaneously is 72 hours. Side effects: Arterial hypertension (common), shunt thrombosis (rare), headache (rare), hypertensive encephalopathy (very rare), hypersensitivity reactions (very rare), maculopapular rash (very rare), thrombocytopenia. Indications for use Anemia in chronic renal failure (according to the NKF K/DOQI classification - in chronic kidney disease). Contraindications Hypersensitivity to methoxypolyethylene glycol-epoetin beta or any other component of the drug, uncontrolled arterial hypertension, children under 18 years of age (safety and effectiveness have not been established). With caution: pregnancy, breastfeeding, hemoglobinopathies, liver failure, epilepsy, thrombocytosis. Method of administration and dosage Treatment with Mircera should be started under the supervision of a specialist. The treatment regimen is determined by the doctor. No adjustment of the initial dose of the drug or dosage regimen is required in patients with liver failure of any severity and in elderly patients (over 65 years). Overdose Symptoms: excessive erythropoiesis possible. Treatment: If hemoglobin levels are high, Mircera therapy should be temporarily interrupted. If necessary, phlebotomy can be performed. Interaction Do not mix methoxypolyethylene glycol-epoetin beta with other medications or injection solutions. Special instructions Before and during treatment with Mircera, it is necessary to exclude iron deficiency. Iron supplementation is recommended if serum ferritin is below 100 mcg/L or transferrin iron saturation is below 20%. The most common causes of incomplete response to treatment with erythropoiesis-stimulating agents are iron deficiency, inflammation, chronic blood loss, bone marrow fibrosis, a sharp increase in aluminum concentration due to hemodialysis, folic acid or vitamin B12 deficiency, and hemolysis. If all of these conditions are excluded and the patient experiences a sudden decrease in hemoglobin, reticulocytopenia, and antibodies to erythropoietin are detected, a bone marrow examination must be performed to exclude partial red cell aplasia (PRCA). If PRCA develops, Mircera therapy should be discontinued and patients should not be transferred to therapy with other erythropoiesis stimulants. Patients with confirmed or suspected antibodies to erythropoietin should not be transferred to Mircera therapy. Before and during treatment with Mircera, as with other erythropoiesis stimulants, it is necessary to monitor blood pressure. If blood pressure cannot be controlled with medication, it is necessary to reduce the dose or interrupt Mircera therapy. It is possible that erythropoiesis-stimulating agents can stimulate the growth of any type of malignancy. Storage conditions Store at a temperature of 2-8°C, protected from light. Do not freeze. Keep out of the reach of children.