Mircera 30mcg/ 0.3ml Roche treatment for chronic kidney disease (0.3ml)

Dosage form Tube
Specifications Methoxy polyethylene glycol-epetin beta

Ingredient

Thành phần cho 0.3ml

Composition information	Content
Methoxy polyethylene glycol-epetin beta	30mcg

Uses

Indications

Mircera 30mcg/0.3ml drug is indicated in the following cases:

Treatment of symptomatic anemia caused by chronic kidney disease in both patients who are being hemoglobin and patients who have not been hemoglobin. Methoxy Polyethylene Glycol - Epoetin Beta is different from erythropoietin at the amid bridge in this molecule or between polyethylene polyethylene acid glycol butanoic and N - Terminal amino or between polyethylene glycol butanoic acid with ε - amino group of lysine Lys45.

The result is the creation of polyethylene glycol - Epoetin Beta with molecular weight of about 60,000 Daltons with PEG base with a molecular weight of about 30,000 Dalons.

In contrast to Erythropoietin, Mircera shows a different activity at a receptor level, manifested by: combining more slowly and separating faster with receptors, reducing specific operations on in vitro and increasing activity on in vivo and increasing half -time time. Differences in terms of pharmacological characteristics help build a regime of treatment once a month for patients.

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, erythropoietin will affect Erythroid stem cells to increase red blood cell production.

pharmacokinetics

mircera used once a month thanks to the drug with long selling time. The sale time after the Mircera intravenous injection is 15-20 times longer than when using Erythropoietin recombinant.

Mircera's pharmacokinetics have been studied in healthy volunteers and in patients with chronic kidney anemia, which is hemoglobin and has not yet been hematuric.

In patients with chronic kidney disease, the clearance and distribution of methoxy polyethylene glycol - Epoetin beta regardless of the dose.

absorption

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 (median values) in patients with hemolysis and 95 hours after injection 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 methoxy polyethylene glycol - Epoetin beta at about 5L.

Elimination

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

pharmacokinetics in special subjects

Patients with liver failure

Mircera's pharmacokinetics in patients with liver failure is like a healthy object.

Other special subjects

The object group analysis has evaluated the potential effects of demographic characteristics on Mircera's pharmacokinetics. The results of these analysis show that it is not necessary to adjust the starting dose for each age, each gender or each race. A pharmacokinetic analysis in groups of subjects also shows no difference in pharmacokinetics between patients with blood decomposes and patients who are not hemoglobin.

Before taking Mircera 30mcg/ 0.3ml Roche treatment for chronic kidney disease (0.3ml)

How to use

Mircera injections 30mcg/0.3ml Inj used intravenously or subcutaneous injection.

Dosage

The number of mircera use less than other erythrocytes stimulants because the drug has a longer half -life.

Mircera treatment must be started under the supervision of a doctor who has experience in patient control of kidney failure.

Treatment of symptomatic anemia in adult patients with chronic kidney disease

The solution can be injected subcutaneously or intravenously (depending on clinical convenience).

Mircera can be injected under the skin in the abdomen, arm or thigh. 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 regularly monitored.

The patient has not been treated with any erythrocytes

Patients who are not hemorrhagic

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

Patients who are being hemoglobin

To increase the amount of hemoglobin higher than 11g/dl (6.83mmol/l), the recommended dose is 0.6μg/kg 1 time every 2 weeks by intravenous injection or subcutaneous injection.

If after one month of treatment, the growth rate of hemoglobin is less than 1.0g/dl (0.621mmol/l), the Mircera dose can be increased by about 25-50% 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 2g/dl (1.24mmol/l), the dose can be reduced by about 25-50%. If the hemoglobin level exceeds 13g/dl (8.07mmol/l), the treatment must be stopped until the hemoglobin level drops below 13g/dL and then, begins to re -treat at approximately 50% of the previously used dose. For countries that apply high -limit hemoglobin levels of 13g/dL, the dose adjustment at 25% should be considered.

After suspending medication, hemoglobin is expected to decrease by about 0.35g/dl (0.22mmol/l) per week.

Patients treated once every 2 weeks and hemoglobin concentration exceeds 11g/dl (6.83mmol/l) 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 treated with an erythrocyte stimulant

Patients are currently being treated with a erythrocyte stimulant that can be transferred to intravenous injection or subcutaneous injection of single -dose Mircera doses once a month or, if necessary, every two weeks.

The starting dose of Mircera depends on the dose of Darbepoetin Alfa or Epoetin previously calculated that the patient is being used weekly at the time of switching to Mircera as presented in Table 1 and 2.

Table 1. Switch from epetin to Mircera treatment

Epoetin dose weekly before (Unit/week) MIRCERA dose 120 60 Darbepoetin Alfa dose weekly earlier (µg/week) Mircera dose once a month (µg/month) once every two weeks (tdg/td) 120 60

After suspending medication, hemoglobin is expected to decrease by about 0.35g/dl (0.22mmol/l) per week.

Use 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.

Older people

In clinical trials, 24% of patients are treated with Mircera is between the ages of 65 and 74, and 20% is aged 75 and above. 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.

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 effect, 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 30mcg/0.3ml Inj, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Hypertension.

Uncommon, 1/1000

Neurological: headache.

complications: vascular thrombosis.

Rare, 1/10000

Immune: Hypersensitivity.

Neurological: Hypertension.

Skin and subcutaneous tissue: Ban.

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug.

Warnings

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

Contraindicated

Mircera 30mcg/0.3ml Inj drugs in the following cases:

Patients with uncontrolled hypertension.

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

Precautions when used

recommended iron supplements are recommended for all patients with low serum ferritin than 100μg/l or transferrin 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.

Inefficient treatment may be due to iron deficiency and inflammatory conditions. The following cases can also reduce the effectiveness of treatment: chronic blood loss, bone fibrosis, severe aluminum overload due to the treatment of kidney failure, folic acid deficiency or vitamin B12 and hemolysis. Can consider evaluation by the number of red blood cells.

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): PRCA due to anti -Erythropoietin antibodies have been reported to be related to the use of erythrocytes that include Mircera. 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.

affect the growth of tumors: Mircera, as well as other stimulating stimulants, is a growth factor, stimulating the main process of 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, epetin has been used for patients with many different types of cancer, including head - neck and breast cancer, which has been recorded an increase in uncontrolled death rate.

Safety and effectiveness of Mircera therapy has not been established for patients with hemoglobin disease, severe liver disease, epilepsy or platelet quantities higher than 500 x 109/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 - 8oC (in the refrigerator).

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

Do not freeze medicine.

Patients can remove the drug from the refrigerator and store at room temperature (no more than 30 ° C) within 1 month. Once taken out of the refrigerator, the drug must be used up during this period.

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