Mircera injection solution 100 µg/0.3 ml Roche treat anemia (1 tree x 0.3ml)

Dosage form Box of 1 tree x 0.3ml
Specifications Methoxy polyethylene glycol-epetin beta

Ingredient

Thành phần cho 0.3ml

Composition information	Content
Methoxy polyethylene glycol-epetin beta	100mcg

Uses

Indications

Mircera® medicine are indicated in the following cases:

Treatment Anemia due to chronic kidney disease in both patients who are being hemoglobin and patients who have not been hemoglobin.

Mircera stimulates red blood cells by interacting with erythropoietin receptors on stem cells in the bone marrow. As the main growth factor for the development of Erythroid, natural hormone erythropoietin is produced from the kidneys and releases into the blood when there is a decrease in oxygen. Reacting with hypoxemia, natural hormones erythropoietin will affect Erythroid stem cells to increase red blood cell production.

pharmacokinetics

absorption after subcutaneous injection

After being injected into the skin of patients with chronic kidney disease, the concentration of methoxy polyethylene glycol - Epoetin Beta is achieved maximum after 72 hours of injection (midpoint value) in patients with hemolysis and 95 hours in patients without hemolysis.

Absolute bioavailability of methoxy polyethylene glycol - Epoetin beta after subcutaneous injection in patients with hemolysis is 62% and in patients with no hemolysis is 54%.

Distribution

A test on 400 patients with chronic kidney disease shows the distribution of polyethylene methoxylene glycol - Epoetin beta at about 5L.

Elimination

After intravenous injection for patients with chronic kidney disease, the semi -waste time of methoxy polyethylene glycol - Epoetin beta is 134 hours (or 5.6 days), and the body clearance is 0.494 ml/hour/kg. After subcutaneous injection, the last waste sale time (T1/2) in patients is 139 hours in patients with hemolysis and 142 hours in patients without hemolysis.

Before taking Mircera injection solution 100 µg/0.3 ml Roche treat anemia (1 tree x 0.3ml)

How to use

Inject subcutaneously or intravenously.

Dosage

Standard dose

The number of Mircera uses will be less than other erythrocytes because the drug has a longer selling time.

Mircera treatment must be started under the supervision of a doctor.

Treatment of patients with chronic renal anemia

The solution may be subcutaneously or intravenously, depending on the clinical scene. Mircera can be injected into the skin in the abdomen, arms or thighs. All three positions are equally convenient to inject Mircera under the skin.

Should monitor the patient's hemoglobin level every two weeks until this level is stable, and monitored periodically later.

The patient has not been treated with any erythrocytes

Patients who are not hemorrhagic

To increase the amount of hemoglobin higher than 11g/dl (6.83 mmol/l), the recommended starting dose is 1.2 μg/kg of one -time weight per month by injection under the skin. Or otherwise, the starting dose of 0.6μg/kg can be used 1 time every 2 weeks by intravenous injection or subcutaneous injection.

Patients who are hemolysis

To increase the amount of hemoglobin higher than 11 g/dl (6.83 mmol/l), the recommended dose is 0.6μg/kg of weight once every 2 weeks by intravenous or subcutaneous injection.

If after a month of treatment, the hemoglobin growth rate is less than 1.0 g/dl (0.621mmol/l), the Mircera dose can be increased by about 25 to 50% of the previous dose. Every month, the dose can be increased by about 25 to 50% until the level of hemoglobin is reached for each patient.

If after one month of treatment, the growth rate of hemoglobin is more than 2 g/dl (1.24 mmollll), the dose can be reduced by about 25 to 50%. If the hemoglobin level exceeds 13 g/dl (8.07 mmol/l), the treatment must be stopped until the hemoglobin level drops below 13 g/dl and then, caught the treatment with a dose of approximately 50% of the previous dose. For countries that apply high -limit hemoglobin levels of 12 g/dl, the dose adjustment at 25% should be considered. After suspending the drug, hemoglobin drops about 0.35 g /di per week.

Patients are treated once every 2 weeks and hemoglobin concentration exceeds 11 g/dl (6.83 mmol/l) that can be used Mircera once a month at a dose twice compared to the one -time dose every two weeks earlier.

Do not adjust the dose more than once a month.

Patients are currently being dispatched with an erythrocyte stimulant

Patients currently being treated with a erythrocyte stimulant can be transferred to single -dose intravenous or mircera injection once a month or, if necessary, every two weeks. The starting dose of Mircera depends on the dose of epoetin or Darbepoetin Alfa has been calculated earlier that the patient is being used weekly at the time of switching to Mircera. This starting dose is presented in Table 1 and 2 below. The first mircera injection should be conducted at the time of planning Epoetin or Darbepoetin Alfa next in the previous treatment regimen.

Table 1: Switch from epetin to Mircera treatment:

Epoetin dose used week earlier (unit/week)

Mircera dose

once a month (μg/month)

Once every two weeks (μg/every two weeks)

120

8000 - 16000

200

100

16000

360

180

Darbepoetin alfa dose

Used weekly earlier (μg/week)

Mircera dose

once a month (μg/month)

Once every two weeks (μg/every two weeks)

120

40 - 80

200

100

360

180

If after one month of treatment, the hemoglobin growth rate is more than 2 g/dl (1.24 mmol/l), the dose can be reduced by about 25-50%. If the hemoglobin level exceeds 13 g/dl (8.07 mmol/l), the treatment must be stopped until the hemoglobin level drops below 13 g/dl and then, begins to re -treat with approximately 50% of the previous dose. For countries that apply high -limit hemoglobin levels of 12 g/dL, the dose adjustment at 25% should be considered. After suspending the drug, hemoglobin drops about 0.35 g /di per week. Do not adjust the dose more than once a month.

used for children

Do not use mircera for children under 18 years old because they do not have enough data on safety and effectiveness of the drug on these objects.

Old people

No initial dose adjustment in patients aged 65 and over.

In people with liver failure

No need to adjust or change the initial dose in patients with liver failure at all levels.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Overdose can lead to an expression of an excessive pharmacological impact, such as excessive red blood cells.

In case the hemoglobin level is too high, it is advisable to suspend Mircera. If clinically indicated, venous blood extraction may be required.

What to do when forgetting a dose?

Side Effects

When using Mircera® , you may experience unwanted effects (ADR).

Clinical trials

Common, 1/100 1/10

Vascular disorders: Hypertension .

Lesions, poisoning and common complications: vascular thrombosis.

Nervous system disorders: headache.

Rare, 1/10,000 ADR

immune system disorders: hypersensitivity.

Nervous system disorders: hypertension.

Skin and subcutaneous disorders: Ban (lumpy, heavy).

All other unwanted effects are thought to be caused by Mircera, which has been reported at a rare rate and most of the level from light to medium. These unwanted effects do not change according to the accompanying disease situation in the population.

The abnormalities in subclinical tests

In clinical trials, it was observed that there was a slight reduction in the number of platelets but still within the normal limit, during the treatment period with Mircera.

The number of platelets below 100x109/l has been recorded in 7.5% of patients treated with Mircera and 4.4% of patients treated with other erythrocytes.

after the drug to the market

The information about safety collected after the Tuong Tuong drug has reflected the unwanted effects that are forecasted in these population groups and the ADR characteristics of Methoxy Polyethylene Glycol - Epoetin Beta.

Instructions on how to handle ADR

Notice to the doctor if any side effects are related to medication.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Mircera® drugs contraindicated in the following cases:

Patients with high blood pressure uncontrolled.

Patients are known to have hypersensitivity to the active ingredient or any excipients of the drug.

Precautions when using

Iron supplements are recommended for all patients with low serum ferritin than 100ug/l or transfer saturation below 20%. To ensure effective red blood cells, it is advisable to assess the iron condition of all patients first and during treatment with drugs.

ineffective

The most common causes of failing to fully respond to erythrocytes are caused by iron deficiency and inflammation. The following cases can also reduce the effectiveness of treatment with stimulating elements of red blood cells: chronic blood loss, bone marrow fibrosis, severe aluminum overload due to kidney failure, folic acid deficiency or vitamin B12 and hemolysis.

If all of the above and sudden hemoglobin can be excluded, accompanied by red blood cells and anti -Erythropoietin antibodies, bone marrow testing should be considered for diagnosis as a mere red blood cell syndrome (PRCA). If it is true, Prca, must stop using Mircera and should not switch to any other erythrocyte stimulus factor for patients.

Soldier syndrome simply red blood cells (PRCA) due to anti -Erythropoietin antibodies have been reported to be related to the use of erythrocytes stimulating factors. It is found that these antibodies have a cross -reactive reaction to all stimulating elements of red blood cells, and should not be switched to mircera for patients suspected or certainly anti -Erythropoietin antibodies.

Monitoring blood pressure

As well as other stimulating stimulants, during the treatment of anemia with Mircera, blood pressure may increase. Adequate blood pressure should be controlled before treatment, at the beginning of treatment and during the treatment process with Mircera. If high blood pressure is difficult to be controlled by drugs or by real secretions, it is necessary to reduce the dose or stop using Mircera (see the dosage and usage).

affect the development of tumors

Mircera as well as other stimulating stimulants are a growth and stimulation factor in the process of creating red blood cells. The receptors of erythropoietin are present on the surface of many cancer cells. As other growth factors, stimulants that create red blood cells can stimulate the growth of any type of malignant tumor. In verified clinical studies, EpoetIns has been used for patients with many different types of cancer, including head -neck cancer and breast cancer, which has been recorded an increase in unexplained mortality.

Safety and effectiveness of Mircera therapy has not been established for patients with hemoglobin disease, severe liver disease, epilepsy or platelet quantity higher than 500x109/l. Therefore, it is necessary to be cautious when taking medicine for these patients.

The ability to drive and operate machinery

There are no studies on the impact of the drug on the ability to drive and operate machinery. However, based on the mechanism of action and safety data of Mircera, it is thought that the drug does not affect the ability to drive and operate machinery.

Pregnancy

There is no enough data on using mircera for pregnant women.

Animal tests do not record the direct or indirect harmful effects of the drug on pregnancy, the development of embryos/fetal embryos, birth or development after birth. Should be cautious when appointed to use mircera for pregnant women.

Breastfeeding period

It is still unknown whether methoxy polyethylene glycol - Epoetin beta has excreted in breast milk in humans or not. An animal test has shown that polyethylene polyethylene glycol - Epoetin beta is secreted into breast milk. Must consider the benefits of breastfeeding and the benefits of using mircera for mothers who decide to continue or stop breastfeeding or continue or stop using Mircera.

Drug interaction

There has been no research on drug interactions that have been conducted. Clinical results do not indicate any interaction between Mircera and other drugs. The effects of other drugs on pharmacokinetics and Mircera's pharmacokinetics have been explored through an analysis survey. There is no sign that the impact of the drugs used on the pharmacokinetics and pharmacological force of Mircera.

Storage

Store at a temperature of 2 - 8 ° C (in the refrigerator).

Keep the vial in a paper box to avoid light.

Keep the injecting pump in the paper box to avoid light.

Do not freeze medicine.

For pre -closed syringes: Patients can take medicine from the refrigerator for storage at room temperature (not more than 30 ° C) for a dose for 1 month. After being removed from the refrigerator, the drug must be used during this time.

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