Mircera® (Mircera®)

Given a longer half-life, Mircera should be administered less frequently than other stimulants of erythropoiesis.

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

Rules for storing the solution in outpatient and inpatient settings.

The solution of Mirsera is sterile and does not contain preservatives.Apply only a clear, colorless or slightly yellowish solution that does not contain visible impurities. Before administration, the solution is brought to room temperature, if pre- the parat was stored in the refrigerator.

The syringe tube can be stored for 1 month at room temperature (no higher than 30 ° C) and should be used during this month.

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

Unused solution must be disposed of. Each vial or syringe-tube - can only be used once. Do not shake.

Vials and syringe-tubes should be stored in a cardboard box in accordance with storage requirements (see section "Storage conditions").

Mode of application

The drug can be administered as a s / c, and / in, depending on clinical preferences.

The drug should be injected s / c into the shoulder area, the front of the thigh or the anterior abdominal wall. All of the above areas of administration are equally suitable for injections.

Content Hb should be monitored once every 2 weeks before stabilization and periodically after stabilization.

Standard dosing regimen

Patients not receiving an erythropoiesis stimulant currently Patients not on dialysis

The recommended initial dose: 1.2 mcg / kg po 1 time per month, target Hb> 110 g / l (6.83 mmol / l). An alternative dosing regimen of Mircera® is possible at an initial dose of 0.6 mcg / kg iv or p / c once every 2 weeks, with a target Hb> 110 g / l (6.83 mmol / l).

Patients on dialysis

Recommended initial dose: 0.6 μg / kg IV or SC once every 2 weeks, target Hb> 110 g / l (6.83 mmol / l).

The dose of Mircera® can be increased by 25-50% from the previous one, if after a month the increase in Hb is less than 10 g / l (0.621 mmol / l). Further increase in dose approximately 25-50% can be performed at intervals of 1 time per month until the achievement of an individual target Hb.

The dose of Mircera® is reduced by 25-50% from the previous one, if after a 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 should be interrupted to reduce Hb less than 130 g / l (8.07 mmol / l) and then resume; in a dose of 50% of the previous.

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.

When the target Hb> 110 g / l (6.83 mmol / l) is reached, patients receiving therapy Mirtser's preparation, once in 2 weeks, can be transferred to the mode of administration of the drug once a month in a dose twice as high as the previous one.

Correction of the dose of the drug is carried out no more than 1 time per month.

Patients receiving an erythropoiesis stimulant are currently

Patients receiving another stimulant of erythropoiesis can be transferred to therapy with Mirtsera ® with the regimen once a month or once in 2 weeks after or after IV.

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

Table 1. Transition from epoetin (alpha or beta)

Table 2. Transition from darbepoetin alfa

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

The dose of Mircera® is reduced by 25-50% from the previous one, if after a month the increase in Hb is more than 20 g / l (1.24 mmol / l). If nb (8.07 mmol / l), then the therapy should be interrupted before the decrease of Hb 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 Hb of 120 g / l, the dose of the drug is changed by 25%.

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

Correction of the dose of the drug is carried out no more than 1 time per month.

Interruption in treatment

Treatment of anemia, including therapy with Mirtsera®, is usually long-term. But if necessary, therapy with Mirtsera can be interrupted at any time.

Missing dose

A missed single injection of MIRCER® should be administered as soon as possible and then administered with the prescribed dosage frequency.

Dosing in special cases

Liver failure: it is not necessary to correct the initial dose of the drug and the dosing regimen in patients with hepatic insufficiency of any severity (see the section "Pharmacological action", subsection "Pharmacokinetics in special patient groups").

Elderly (65 years and over): no correction of the initial dose of the drug is required (see the section "Pharmacological action", subsection "Pharmacokinetics in special patient groups").

Children: use of Mirtsera ® in children under 18 years is not recommended, due to insufficient data on the safety and efficacy of the drug in this category

Instructions for handling a syringe tube

1. Remove the transparent contour mesh package with the drug from the cardboard bundle without opening the protective film.

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

3. Remove the protective film from the outline of the cell package, remove the syringe and a transparent plastic container with a needle.

4. While holding the container with the needle, detach the cap by turning it clockwise, as shown. Remove the cap from the top of the container with the needle.

5. Holding the syringe tube, remove the rubber tip, pre-bending and pulling, as shown in the figure.

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

Preparation and injection

1.For the introduction of the drug, choose one of the recommended places: the anterior abdominal wall, excluding the area around the navel, the front surface of the middle of the thigh or the outer surface of the shoulder. Do not inject the medication into birthmarks, scar tissue, hematoma or in the navel, in places with seals and / or reaction after previous injections. Each time the injection site should be changed. Avoid areas that can be irritated by a belt or belt of clothing.

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

3. Gently hold the syringe tube, without pressing the plunger, gently remove the transparent container from the needle.

4. Two fingers to collect the skin in the crease at the site of the proposed injection. Insert the needle into the skin fold at a right angle.

5. Slowly introduce the entire medication, gently pressing on the piston. Do not stop squeezing the syringe until the needle is removed from the skin!

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

7. Having released the piston, the protective device will be released and the needle will be closed.

8.Press the swab with the cotton swab. If necessary, seal the injection site with a patch.