Eprex Prefill 2000iu Janssen injection is anemia (6 tubes)

Dosage form 6 tube box
Specifications Epoetin Alfa

Ingredient

Thành phần cho 0.5ml

Composition information	Content
Epoetin Alfa	2000iu

Uses

indications

Eprex Prefill 2000 drug is indicated in the following cases:

Epoetin Alfa is designated to treat anemia with symptoms related to chronic kidney failure (CRF). In adult patients who are using chemotherapy to treat solid tumors, malignant lymphoma or bone marrow tumors and are at risk of blood transfusion (assessed based on the patient's condition, for example: cardiovascular condition, anemia at the time before the beginning of chemotherapy) to treat anemia and reduce blood transfusions. Okay. Blood or more for men). Medical medium anemia patients should be limited (for example, haemoglobin concentration from 10 to 13 g/dl or 6.2 to 8.1 mmol/l) has no plan to transfuse itself and in patients expected to only lose blood at the average level (900 to 1800 ml). Glycoprotein hormone is produced mainly in the kidneys to respond to tissue deficiency and is a key conditioner in the production of red blood cells. EPO is involved in all stages of red blood cell growth and the main effect on the predecessor cells. After EPO attaches to the cell surface receptor, this molecule will activate the path of signal transmission to participate in the cell death process according to the cycle and stimulate the proliferation of red blood cells.

EPO recombinant (EPOETIN ALFA) is manifested on Chinese mouse ovary cells, which is a series of 165 amino acids with the same sequence as EPO in human urine; It is not possible to distinguish these 2 eppo based on functional exploration tests. Erythropoietin's apparent molecular weight ranges from 32000 to 40000 Dalton.

erythropoietin is a growth factor, mainly stimulating the process of red blood cells. Erythropoietin receptors can manifest on the surface of many types of cancer cells.

Pharmacokinetics

absorption

After subcutaneous injection, the peak concentration of Epoetin Alpha in serum is reached from 12 to 18 hours after taking the drug. Do not record the accumulation of drugs after using the weekly dose of 600 IU/g of subcutaneous injection.

On a healthy volunteer, absolute bioavailability according to Epoetin Alpha's subcutaneous injection is about 20%.

Distribution

The average distribution volume is 49.3 ml/kg after the dose of 50 and 100 IU/kg of intravenous sugar on healthy volunteers. After using intravenous alpha Epoetin in patients with chronic renal impairment, the distribution integral ranges from 57 - 107 ml/kg after single dose (12 IU/kg) to 42 - 64 ml/kg after repeated dose (48 - 192 IU/kg). Therefore, the integral distribution is slightly higher than the plasma volume.

Elimination

The half -life of Epoetin alpha after using the dosage is repeated in the vein for about 4 hours on a healthy volunteer. Half of the lifetime of the drug when used according to the subcutaneous injection is about 24 hours on a healthy volunteer.

Average CL/F ratio for 150 IU/kg mode three times per week and 40000 IU once a week on healthy volunteers are 31.2 and 12.6 ml/hour/kg. The average CL/F ratio for the dose mode 150 IU/kg three times a week and 40000 IU once a week on cancer patients with anemia are 45.8 and 1.3 ml/hour/kg. On most cancer patients with anemia received chemotherapy regimen in the cycle, the ratio Cl/F after the subcutaneous injection of 40000 IU once a week and 150 IU/kg three times a week is lower than on a healthy volunteer.

linear/non -linear

On healthy volunteers, Epoetin alpha concentration in serum increases linear at the dose after the dose 150 and 300 IU/kg of intravenous sugar, 3 times a week. The linear relationship between the average cmax and the dose and between the average AUC and the dose are recorded when using a single dose of 300 to 2400 IU/kg Epoetin alpha injected subcutaneously. There is a correlation inversely proportional between the apparent clearance and the dose on healthy volunteers.

In studies assessing the effects of dilation of the dose (40000 IU once a week and 80000 IU, 100000 IU and 120000 IU once a week), has recorded a linear relationship but is not proportional to the dose between medium and doses and between the average and between AUC and the dose at a stable state.

Relationship PK/PD

Effect of Epoetin Alpha on hematological parameters depends on the dose but regardless of the medication line.

Pediatric subjects

Half of the lifetime elimination of the drug in children with chronic renal failure after using epidetin alpha is repeated by intravenously 6.2 to 8.7 hours. Epoetin alpha pharmacokinetics in children and teenagers similar to adult data.

Mobile pharmacokinetics in newborns are limited

A study on 7 mild infants with premature birth and 10 healthy adults using erythropoietin intravenously shows that the volume of distribution in premature babies is about 1.5 to 2 times higher than healthy adults and newborns are also about 3 times higher than healthy adults.

kidney failure

Half of the lifetime of Epoetin Alpha when using intravenous sugar on patients with chronic renal impairment (about 5 hours) increased slightly compared to healthy people.

Before taking Eprex Prefill 2000iu Janssen injection is anemia (6 tubes)

How to use

Use intravenously or subcutaneously.

intravenous injection

intravenous injection for at least 1 to 5 minutes depending on the total dose. In patients with hemolytic refinement, venous bolus can be injured during the process of separating through a suitable channel on the separation line. In addition, it is possible to be injected at the end of the stage of the vein through the intravenous conduit, then add 10 ml of the isometric saline to wash the tube and ensure the drug is completely circulating.

In patients with drug reactions with symptoms of "fake influenza", need to be injected slower.

Do not use EPOETIN ALFA to infusion intravenously or in combination with other drug products.

subcutaneous injection

Overall, should not be injected exceeding the maximum volume of 1ml at each injection site. In case of injection with larger volume, should choose injection in multiple positions.

Injections in the position or abdominal wall first

In the case of a doctor, patients or family members can use an effective and safe subcutaneous injection, need to guide patients on dosage and medication.

Dosage

Need to evaluate and treat all other causes of anemia (iron deficiency, vitamin B12 or folat, aluminum toxicity, infection or inflammation, blood loss, hemolysis and bone fibrosis due to any cause) before starting using EPOETIN ALFA and when deciding to increase the dose. To ensure optimal response to EPOETIN ALFA, there should be enough iron reserves and supplements if necessary.

Adults

Treatment of anemia with symptoms in patients with adult chronic kidney failure

Should only use drugs by intravenously for patients with chronic renal failure.

Symptoms and sequelae of anemia may vary with age, gender and attached diseases; Clinical examination is needed to assess the condition of each patient.

The target hemoglobin concentration is recommended from 10 g/dl to 12 g/dl (6.2 to 7.5 mmol/l). It is necessary to use Epoetin Alfa so that hemoglobin increases not exceeding 12 g/dl (7.5 mmol/l). Hemoglobin should be avoided in excess of 2 g/dl (1.25 mmol/l) for 4 weeks. If this happens, the dose adjustment should be made.

Due to the individual oscillation among patients, hemoglobin value on each patient can sometimes be above or below the target hemoglobin concentration range. Hemoglobin variation can be resolved by changing the dose to achieve the target hemoglobin concentration range from 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l).

It is necessary to avoid the maintenance of hemoglobin levels exceeding 12 g/dl (7.5 mmol/l). If the concentration of hemoglobin increases> 2 g/dl (1.25 mmol/l) per month, or the concentration of hemoglobin maintains exceeds 12 g/dL (7.5 mmol/l), reducing 25% of the doses of Epoetin Alfa. If the concentration of hemoglobin exceeds 13 g/dl (8.1 mmol/l), stop treatment until this concentration drops below 12 g/dl (7.5 mmol/l) and then reuses EPOETIN ALFA at a lower dose of 25%lower than the initial dose.

Patients need to be closely monitored to ensure the lowest dose of EPOETIN ALFA is the lowest dose in the recommended dose range that has the ability to control anemia symptoms while maintaining hemoglobin levels smaller than or equal to 12 g/dl (7.5 mmol/l).

Be cautious when increasing the dose of Epoetin Alfa in patients with chronic renal failure. For patients with poorly increased hemoglobin response when using epetin alfa, it is necessary to consider other causes of poor response.

Treatment with Epoetin Alfa is divided into two stages - the dose adjustment stage and the maintenance stage.

Adult patients must be clinical

In patients who are getting an abuse of blood intravenously, prioritizing the use of intravenously.

The adjustment phase: The starting dose is 50 IU/kg, 3 times/week. When needed, it is possible to adjust the dose to increase or decrease 25 IU/kg (3 times/week) until the concentration of hemoglobin is reached between 10 g/dl to 12 g/dL (6.2 to 7.5 mmol/l) (this dose adjustment should be done step by step with a minimum distance of 4 weeks/time).

Maintenance phase: The total dose is recommended per week from 75 IU/kg to 300 IU/kg. The appropriate dose is needed to maintain hemoglobin levels in the target range from 10g/dl to 12 g/dl (6.2 to 7.5 mmol/l). Patients with initial hemoglobin concentrations are very low ( 8 g/dl or> 5 mmol/l).

Patients with adult kidney failure have not been separated

In case there is no intravenously, Epoetin Alfa may be injected under the skin.

The adjustment phase: The starting dose of 50 IU/kg, 3 times/week, then if necessary, gradually increase the dose every 25 IU/kg (3 times/week) until the concentration of Haemoglobin is reached in the target range (the dose adjustment should be done step by step at least 4 weeks/time).

Maintenance phase: In the maintenance phase, Epoetin Alfa can be used 3 times/week, and in case of subcutaneous injection can be used once a week or every 2 weeks. The appropriate dose is needed to maintain hemoglobin levels in the target range from 10 to 12 g/dl (6.2 to 7.5 mmol/l). There may be a need to increase the dose when using the dosage distance. The maximum dose should not exceed 150 IU/kg 3 times/week, 240 IU/kg (maximum 20,000 IU) 1 time/week, or 480 IU/kg (maximum 40000 IU) 1 time/2 weeks.

Patients with peritoneal mandarins

In case there is no intravenously, Epoetin Alfa may be injected under the skin.

Merchief phase: starting dose of 50 IU/kg, 2 times/week.

Maintenance phase: The maintenance dose is recommended from 25 IU/kg to 50 IU/kg, 2 times/week. It is necessary to adjust the appropriate dose to maintain hemoglobin levels in the target range from 10 g/dl to 12 g/dl (6.2 to 7.5 mmol/l).

Treatment for adult patients with anemia due to chemotherapy

Symptoms and sequelae of anemia may vary with age, gender and accompanying disease; Clinical examination is required to assess the condition of each patient.

Use Epoetin Alfa by subcutaneous injection for anemia patient (for example, hemoglobin concentration ≤ 10 g/dl (6.2 mmol/l)). The starting dose of 150 IU/kg under the skin 3 times/week.

In addition, Epoetin can start 450 IU/kg injected under the skin once a week.

Need to adjust the appropriate dose to maintain hemoglobin concentration in the target range from 10 g/dl to 12 g/dl (6.2 to 7.5 mmol/l).

Due to the individual oscillation among patients, hemoglobin value on each patient can sometimes be above or below the target hemoglobin concentration range. Hemoglobin concentration variation can be resolved by changing the dose to achieve the target hemoglobin concentration range from 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l). Hemoglobin concentration should be avoided in excess of 12 g/dl (7.5 mmol/l); Guide to adjust the dose when hemoglobin concentration exceeds 12 g/dl (7.5 mmol/l) given in the following section.

If the concentration of hemoglobin increases at least 1 g/dl (0.62 mmol/l) or the number of red blood cells increases ≥ 40,000 cells/µl compared to the original after 4 weeks of treatment, the dose should be maintained at 150 IU/kg 3 times/week or 450 IU/kg once a week. If the concentration of hemoglobin increases

If the hemoglobin concentration increases

Dose adjustment to maintain Haemoglobin concentration from 10 g/dl to 12 g/dl (6.2 to 7.5 mmol/l)

If hemoglobin concentration increases more than 2 g/dl (1.25 mmol/l) per month, or hemoglobin concentration exceeds 12 g/dl (7.5 mmol/l), reducing the dose of alfa from 25 to 50%. If the concentration of hemoglobin exceeds 13 g/dl (8.1 mmol/l), stop treatment until this concentration drops below 12 g/dl (7.5 mmol/l) and continue treatment with Epoetin ALFA at 25% dosage compared to the previous dose.

Patients need to be closely monitored to ensure that the lowest dose level is the lowest dose in the recommended dose range of erythrocytes (ESA) that can fully control anemia symptoms.

Should continue using Epoetin Alfa within a month after the end of chemotherapy.

Treatment for mature patients who have surgery and planning a plan of blood transfusion

Patients with mild anemia (haematocrit 33 - 39%) need to store at least 4 units of blood should be treated with Epoetin Alfa at a dose of 600 IU/kg intravenously, 2 times per week for 3 weeks before surgery.

Should use Epoetin Alfa after completing the blood reserve process.

Treatment for adult patients planned to have orthopedic surgery

The recommended dose is 600 IU/kg eppoetin Alfa, subcutaneous injection, weekly for 3 weeks (on 21, 14 and 7) before surgery and on surgery date (day 0).

In case the surgery is less than 3 weeks before surgery, the daily EPOETIN ALFA should be used with a dose of 300 IU/kg by subcutaneous injection for 10 consecutive days before surgery, on surgery day and 4 days immediately after.

If the concentration of hemoglobin reaches 15 g/dl (9.38 mmol/l) or higher, it is advisable to stop using Epoetin Alfa and should not reuse the drug later.

Pediatric patients

Treatment of anemia with symptoms in patients with chronic kidney failure must be clinical

Symptoms and sequelae of anemia may vary with age, gender and accompanying disease; Clinical examination is required to assess the condition of each patient.

On the pediatric patient, the hemoglobin concentration is recommended from 9.5 g/dl to 11 g/dl (5.9 to 6.8 mmol/l). Epoetin alfa should be used to increase hemoglobin levels but not exceeding 11 g/dl (6.8 mmol/l). Hemoglobin concentration should be avoided more than 2 g/dl (1.25 mmol/l) within 4 weeks. If this happens, the dose should be adjusted as recommended.

Patients need to be closely monitored to ensure that the dose of Epoetin Alfa is used as the lowest dose in the recommended dose range that has the ability to control anemia and the symptoms of anemia.

Treatment with Epoetin Alfa is divided into two stages - The dose and maintenance stage of maintenance: on patients with children must have an intravenous blood separation, priority is given to the use of intravenous drugs.

Merchief phase:

starting dose of 50 IU/kg intravenously, 3 times/week.

When needed, it may increase or decrease the dose every 25 IU/kg (3 times/week) until the target haemoglobin concentration is reached from 10 g/dl to 12 g/dL (6.2 to 7.5 mmol/l) (the dose adjustment should be done at a minimum distance of 4 weeks).

Maintenance phase:

Need to adjust the appropriate dose to maintain hemoglobin concentration in the target range from 9.5 to 11 g/dl (5.9 6.8 mmol/l).

In general, children under 30 kg need a higher maintenance dose than children over 30 kg and adults.

Pediatric patients with very low initial hemoglobin levels ( 6.8 g/dl or> 4.25 mmol/l).

Anemia in patients with chronic renal impairment before starting hemorrhage or peritoneal discharge

The safety and effectiveness of Epoetin Alfa in patients with chronic renal failure with anemia before the start of a separation or the peritoneal is not yet established.

Existing data with Epoetin Alfa injected under the skin on this group of patients is described in the pharmacological section but has no recommendations about the dose.

Treatment for patients with anemia due to chemotherapy

Safety and effectiveness of Epoetin Alfa has not been established in anemia is using chemotherapy.

Treatment for pediatric patients with surgery and self -blood transfusion plan

The safety and effectiveness of EPOETIN ALFA has not been established. There is currently no data.

Treatment for pediatric patients with orthopedic plans

The safety and effectiveness of EPOETIN ALFA has not been established. There is currently no data.

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 do

do when overdose? The overdose of Epoetin Alfa can cause excessive pharmacological effects of this hormone. It is possible to open veins if the blood hemoglobin is too high. Can use supportive treatments when necessary.

What to do when forgetting a dose?

Side Effects

When using Eprex Prefill 2000, you may experience unwanted effects (ADR).

Blood disorders and lymphatic systems

Rare: Soldier red blood cells via antibody antibody antibody Erythropoietin, platelet increase.

immune system disorders

Unknown: Anaphylaxis, hypersensitivity.

Metabolic and nutrition disorders

Uncommon: hyperkalemia.

Nervous system disorders

Common: headache.

Uncommon: convulsions.

circuit disorders

Common: venous thrombosis and artery, hypertension.

Unknown: drama hypertension.

Respiratory disorders, chest and mediastinum

Common: cough.

Uncommon: Respiratory obstruction.

Gastrointestinal disorders

Very common: diarrhea, nausea, vomiting.

Skin and subcutaneous skin disorders

Common: rash.

Unknown: Neurbita, urticaria.

Musculoskeletal and connective tissue disorders

Common: joint pain, bone pain, muscle aches, pain.

congenital, family and genetic disorders

Unknown: Porphyrin metabolism disorders.

Systemic disorders and at the position of drugs

Very popular: Fever.

Common: chills, symptoms of influenza, response at the injection site, peripheral edema.

Unknown: The drug is not effective.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Eprex prefill 2000 contraindications in the following cases:

Hypersensitivity to active ingredients or any excipients of the drug.

Patients who have experienced simple red blood cell complications (PRCA) after treatment with erythropoietin -containing preparations must not use Epoetin Alfa or any other erythropoietin -containing preparations.

Uncontrolled hypertension.

It is important to respect all contraindications related to self -blood transfusion when the patient is used for additional EPOETIN ALFA.

Contraindicated Epoetin alpha in patients with orthopedic surgery but there is no plan to transfuse itself, and suffer from serious diseases related to coronary artery, peripheral artery, artery or cerebral vascular, including patients with myocardial infarction or stroke recently.

Patients with surgery can not receive prophylactic treatment with appropriate thrombotic drugs due to any cause.

Be cautious when using

all patients using EPOETIN ALFA should be monitored and controlled strict blood pressure. Caution should be used when using Epoetin Alfa for hypertension patients who are not treated, incomplete treatment or poor control. It may be necessary to start or enhance the treatment of hypertension. If the blood pressure is not controlled, it is recommended to stop using Epoetin Alfa.

Hypertension with brain disease and convulsions, need an immediate intervention of a doctor and active treatment, which has been recorded during EPOETIN ALFA treatment in patients who have previously had normal or low blood pressure. Special attention should be paid to the throbbing pain that appears suddenly, similar to the first half, because this can be a warning sign.

Epoetin Alfa should be used carefully in epilepsy patients, a history of convulsions, or pathological condition leading to an increase in the risk of menstrual periods such as central nerve infections and brain metastases.

Epoetin Alfa should be used cautiously in patients with chronic liver failure. The safety of the use of EPOETIN ALFA has not been established in patients with liver dysfunction.

Increasing the rate of thrombosis in the blood vessels (TVES) has been recorded in patients using epetin. These events include venous thrombosis, arteries and embolism (including some cases leading to death), such as deep vein thrombosis, pulmonary embolism, retinal thrombosis and myocardial infarction. In addition, stroke (including cerebral infarction, cerebral hemorrhage and transient ischemia) have been recorded.

It is necessary to consider the risk of thrombosis in the vascular heart and benefits from Epoetin Alfa treatment, especially in patients with risk factors for thromboembolism in the artery, including obesity and a history of thrombosis in the artery (eg deep venous thrombosis, pulmonary embolism, and stroke).

On all patients, hemoglobin concentration should be closely monitored due to embolism and death events increased when hemoglobin concentration exceeds the recommended concentration corresponding to each treatment indication.

Increase the number of platelets average, within normal limits and dependent dose may appear when treated with Epoetin Alfa. This increase gradually lost during treatment. In addition, the number of platelets above the normal limit has been recorded. Recommendations regularly tracking platelets within the first 8 weeks of treatment.

It is necessary to evaluate and treat all other causes of anemia (iron deficiency, folat deficiency or vitamin B12 deficiency, aluminum toxicity, infection or inflammation, blood loss, hemolysis and bone fibrosis) before using EPOETIN ALFA and when increased dose. In most cases, serum ferritin will decrease simultaneously with an increase in the number of red blood cells. To ensure optimal response to EPOETIN ALFA, it is necessary to ensure adequate reserves of iron and indicate the use of iron supplements if necessary.

Recommendations for iron supplements, for example oral 200 - 300 mg of elemental iron/day (children 100-200 mg/day) in the case of patients with chronic renal failure with ferritin levels below 100 ng/ml.

Additional oral supplementation is 200 - 300 mg of elemental iron/day for all cancer patients with saturated transferrin below 20%.

For patients in the autonomous blood transfusion program, it is necessary to supplement iron (element iron 200 mg/day orally) a few weeks before starting to get blood to achieve higher iron reserves before starting treatment and during EPOETIN ALFA treatment.

For patients preparing surgery, iron supplements (elemental iron is 200 mg/day orally) during the process of treatment with Epoetin Alfa. If possible, supplementing iron should start before treatment with Epoetin Alfa for adequate iron reserves.

In very rare cases, the outbreak of the porphyrin metabolic syndrome has been recorded in patients treated with Epoetin Alfa. Caution should be used when using Epoetin Alfa for patients with Porphyrin metabolism disorders.

To increase the traceability of erythrocytes (ESA), the trade name of the use of red blood cells should be clearly stated in the patient's records.

Patients should only switch from this erythrocyte stimulus drug to other erythrocytes with appropriate supervision.

Slow erythrocytes (PRCA)

Soldness of red blood cells (PRCA) related to the use of erythropoietin has been recorded at a very rare rate. Prca occurs mainly in patients with chronic kidney disease using erythropoietin injections under the skin. This syndrome is described by the phenomenon of sudden loss of effectiveness of the drug, severe anemia, hemoglobin decrease (1 - 2 g/dl or 0.62 - 1.25 mmol/l per month), low number of red blood cells ( Need to closely monitor patient response during treatment. If the effect is reduced or lost suddenly, anemia is more serious, it is necessary to assess other causes that may cause non -response to drugs such as iron deficiency, folat, vitamin B12; Aluminum poisoning, bacterial or inflammation, blood loss and hemorrhage. If suspected of red blood cell property (PRCA) and no other causes are not detected, it is necessary to stop using epetin alpha, testing antibody antibodies Erythropoietin and bone marrow. Other Erythropoietin should not be switched because antibodies are likely to react cross -reactions between erythropoietin. Other causes should be eliminated and applied appropriate management measures.

Simply red blood cell property cases have been recorded in hepatitis C patients treated simultaneously with interferon, ribavirin, and erythrocyte stimulus (ESA). Epoetin Alfa is not approved to treat anemia related to hepatitis c.

Treatment of anemia with symptoms on adults and children with chronic kidney failure

Need to regularly monitor Haemoglobin concentration in patients with chronic renal impairment treated with epetin alfa until this value is stable, and periodically monitored later.

In patients with chronic renal failure, the rate of hemoglobin increases should be about 1 g/dl (0.62 mmol/l) per month and not exceeding 2 g/dl (1.25 mmol/l) per month to minimize the risk of hypertension.

In patients with chronic renal failure, the maintenance hemoglobin level should not exceed the upper limit of the target hemoglobin concentration as recommended in the dosage and usage. In clinical trials, increasing the risk of death, serious cardiovascular events have also been observed when the erythrocyte stimulant is used for the purpose of increasing hemoglobin above 12 g/dl (7.5 mmol/l).

In patients with chronic renal impairment, caution should be cautious when increasing the dose of Epoetin ALFA due to increased accumulated dose of epetin may be associated with increased risk of death, stroke and serious cardiovascular events. In patients with poor hemoglobin response when using epetin, it is necessary to consider other causes of poor response to the drug.

When using Epoetin Alfa injected subcutaneously in patients with chronic renal impairment, regular monitoring should be monitored regularly, which is defined as a condition that is not responded or reduced in response to Epoetin Alfa in patients who responded to this treatment regimen before. The characteristic of this phenomenon is to reduce the prolonged haemoglobin concentration despite increasing the dose of EPOETIN ALFA.

Some patients using Epoetin Alfa with a wider dosage distance (greater than once a week) may not maintain the appropriate hemoglobin level and may need to increase the dose of EPOETIN ALFA. Hemoglobin concentration should be monitored regularly.

thrombosis at the bridge (shunt) has appeared in patients with hemorrhage, especially for patients with low blood pressure or patients with problems at the dynamic - veins (such as narrow, aneurysm ...). Early venous shunts and drug prevention with drugs such as acetylsalicylic acid are recommended for these patients.

Some special cases have hyperkalemia, although the cause is not well known. Electrolytes should be monitored in serum in patients with chronic renal failure. If you see high serum potassium concentration, it is advisable to consider stopping the use of Epoetin Alfa until overcome the condition of hyperkalemia.

Due to increased volume of red blood cells, patients treated with Epoetin Alfa often need to increase heparin dose during hemorrhage. If the anticoagulant treatment regimen with heparin is not optimal, the separation system may be blocked.

Based on existing information, treating anemia with Epoetin Alfa in patients with adult kidney failure without dialysis does not accelerate the progression of renal failure.

Treatment for patients with chemotherapy anemia

Need to regularly monitor Haemoglobin concentration in cancer patients treated with Epoetin Alfa until this value is stable, and periodically monitored later.

Epoetin is a growth factor, mainly stimulating the production of red blood cells. The erythropoietin receptors can be found on many cancer cells. Like all other growth factors, eppoetin can stimulate the growth of tumors.

cannot exclude the effects of ESA on tumor progression or reduce the time of life without progress.

In control clinical studies, using Epoetin Alfa and other erythrocytes (ESA) stimulants are associated with reducing the ability to control tumor progressive or reduced life time.

Reducing topical tumor control on head and neck cancer patients with radiation therapy, and using ESA to achieve the target hemoglobin concentration greater than 14 g/dl (8.7 mmol/l).

Shorten the total life time and increase the death rate due to progressive disease at 4 months in patients with metastatic breast cancer patients using chemotherapy, and are used for ESA to achieve the target hemoglobin concentration from 12 - 14 g/dl (7.5 - 8.7 mmol/l).

Increased risk of death when using ESA to achieve hemoglobin concentration 12 g/dl (7.5 mmol/l) in patients with malignant tumors to use chemotherapy or radiation. Do not only use the use of stimulants to create red blood cells for these patients.

recorded an increase of 9% of the risk of disease progression or death in the group using Epoetin Alfa combined with standard treatment in the main analysis and an increase of 15% (not excluded in statistical significance) in metastatic breast cancer patients using chemotherapy when ESA is used to achieve the target haemoglobin concentration ranging from 10 to 12 g/dL (6.2 to 7.5 mmol/l).

From the above perspective, in some clinical situations, it is advisable to prioritize blood transfusion therapy to control anemia in cancer patients. The decision to use recombinant erythropoietin should be considered based on the assessment of benefits - the risk for the patient's participation, and also need to be based on each specific clinical scene. Factors should be considered include the type and stage of the tumor; anemia level; Expected life time, treatment environment for patients and patient aspirations.

In cancer patients using chemotherapy, the delay of 2-3 weeks between the use of erythropoietin and the appearance of red blood cells produced by erythropoietin should be taken into account when evaluating the suitability of the treatment regimen with EPOETIN ALFA (especially in patients at risk of blood transfusion).

Patients with surgery planning self -blood transfusion

It is necessary to perform all the special warnings and cautions of the autologous blood transfusion program, especially to replace the regular volume of blood.

Patients with orthopedic plans

Need to follow good blood management during surgery.

Patients with orthopedic plans need to be treated with adequate thrombosis due to thrombosis and blood vessels can appear in surgical patients, especially for patients with a history of cardiovascular disease. In addition, it is necessary to be particularly cautious in patients at high risk of deep vein thrombosis. Moreover, on patients with initial hemoglobin> 13 g/dl (> 8.1 mmol/l), it is not possible to rule out the ability to treat with eppoetin Alfa may increase the risk of thrombosis/postoperative blood vessel. Therefore, it should not be used for patients with initial hemoglobin> 13 g/dl (> 8.1 mmol/l).

The ability to drive and operate machinery

has not recorded adverse reactions and no research on the effects of drugs on the ability to operate machinery, train driving, higher working and other cases.

During pregnancy

No or only very few data on the use of EPOETIN ALFA for pregnant women. Animal studies have shown that this drug has reproductive toxicity.

Therefore, EPOETIN ALFA should only be used for pregnant women if the expected benefits are superior to the potential risk to the fetus.

It is not recommended to use epetin alfa for pregnant patients to have surgery and planning blood transfusion.

Reproduction

There is no research to evaluate the potential effect of Epoetin Alfa on the fertility of men and women.

Breastfeeding period

It is unclear whether the external episode is excreted in breast milk or not.

Be careful when using epetin for breastfeeding women. Need to stop breastfeeding or stop treatment with Epoetin Alfa based on the benefit of breast milk for the child and the benefits of Epoetin Alfa with the mother.

It is not recommended to use epetin alfa for breastfeeding patients to have surgery and planning blood transfusion.

Drug interaction

There is no evidence that epetin changes the metabolism of other drugs.

Medications that reduce the process of red blood cells can reduce response to Epoetin Alfa.

Because cyclosporin is linked to red blood cells, drug interactions may occur. If Epoetin Alfa is used simultaneously with cyclosporin, the blood cyclosporin level should be monitored and the dose adjustment of cyclosporin when hematocrit increases.

There is no evidence of interactive between EPOETIN ALFA and a grain leukemia (G -CSF) or a factor that stimulates macrophages (GM - CSF) when evaluating the differentiation or hypernipation of blood cells on In vitro tumor biopsy samples.

In mature female patients with metastatic breast cancer, simultaneous use of Epoetin Alfa 40000 IU/ml and trastuzumab 6 mg/kg by subcutaneous injection does not affect the pharmacokinetics of trastuzumab.

Storage

Cold storage at 2 - 8 ° C in the original packaging to avoid light, not to freeze.

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