RETACRIT 4000 IU / 0.6 ml. 6 ampoules
Retacrit contains protein called epoetin zeta, which stimulates bone marrow to produce a large number of red blood cells, which carry hemoglobin (a substance that carries oxygen). Epoetin zeta is a copy of human erythropoietin and protists act the same way.
Retacrit is used
in adults, children and adolescents on hemodialysis to treat symptomatic anemia (low red blood cells) associated with chronic renal failure (kidney disease);
in adults on peritoneal dialysis for the treatment of symptomatic anemia associated with chronic renal failure (renal disease);
in adult patients with renal failure who are not yet on dialysis to treat severe anemia associated with kidney disease associated with clinical symptoms;
in adult patients receiving chemotherapy for solid tumors, malignant lymphoma (cancer of the lymphatic system) or multiple myeloma (bone marrow cancer) to treat anemia and reduce the need for blood transfusion, if the doctor decides there may be an increased risk and the need for blood transfusions;
in moderately anemic patients who have surgery and prior to it, donate blood so that their own blood can be given back to them during or after surgery (autologous transfusion);
in moderately anemic adult patients who major orthopedic (bone) surgery (e.g., substitution of the hip or knee) in order to reduce the need for blood transfusions.
2. What announces to know before using Retacrit?
Do not use Retacrit:
if you are allergic (hypersensitive) to erythropoietins or any of the other ingredients of this medicine (listed in section 6);
if you have acquired (pure) red cell aplasia (PRCA, erythroblastopenia, the lack of very young red blood cells) following treatment with any erythropoietin;
if you have high blood pressure, which is controlled with the help of lowering medicines;
if you do not have to take medication to thin the blood to prevent blood clots;
If you are donating your own blood before surgery, and:
you had a heart attack or stroke in the month before treatment with Retacrit;
you have unstable angina (angina pectoris) - new or increasing pain in the chest area;
You are at risk of blood clots in the veins (deep venous thrombosis) - for example. if you have previously had blood clots;
if need be undergoing major orthopedic surgery such as hip replacement or knee replacement surgery, and:
you have severe heart disease or severe vascular disorders of the veins and arteries;
You recently spent a heart attack or stroke.
Warnings and Precautions
Talk to your doctor before using Retacrit, if you know you suffer, or have suffered, from any of the following:
anemia from other causes;
cardiovascular disease (such as angina pectoris);
violation of blood circulation in the body, leading to a feeling of discomfort and tingling in the limbs and cold extremities and belief, paralysis or painful cramping of the leg muscles;
blood clots / breaches in the clotting process;
During treatment with Retacrit
Your doctor will monitor your hemoglobin does not exceed a certain level as high hemoglobin concentrations could create a risk of heart problems or problems with blood vessels and can increase the risk of myocardial infarction, stroke and death.
Your doctor should try to keep your hemoglobin levels between 10 and 12 g / dl. The hemoglobin values should not exceed the limit of 12 g / dl.
During treatment with Retacrit, your doctor will measure your blood pressure regularly. If you get headaches, practical sudden, severe, stabbing, migraine-like headaches or start to feel disoriented and / or have fits, tell your doctor or nurse. This can be warning signs of a sudden rise in blood pressure requiring immediate treatment.
During treatment, the amount of platelets in the blood can rise (cells that help the blood to clot). It will stabilize over the course of treatment. It is recommended to regularly monitor the platelet count during the first 8 weeks of treatment.
If need to visit the hospital or family doctor for any treatment that requires a blood test, remember that you should tell your doctor that you are being treated with Retacrit, as Retacrit may affect the results.
Take special care with other products that stimulate the production of red blood cells:
Retacrit is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin. Your healthcare professional will always record the exact product that you use.
Patients with kidney disease
Acquired (pure) red cell aplasia (erythroblastopenia, PRCA) has been observed rarely after months to years of treatment with other products containing erythropoietins administered subcutaneously and can not be ruled out during treatment with Retacrit. Acquired (pure) red cell aplasia (PRCA) means the inability to produce red blood cells in the bone marrow. If it appears, can cause severe anemia, symptoms of which are unusual tiredness, dizziness or difficulty breathing. PRCA may be caused by the production of antibodies against the erythropoietin product and, subsequently, to your own erythropoietin.
You should discuss this information with your doctor. If an acquired (pure) red cell aplasia (rare), treatment with Retacrit should be stopped and your doctor will determine the best way to treat anemia. Although these complications are rare, you should be aware that if PRCA develop with you, it will need regular blood transfusion, with likely to be lifelong, to treat your anemia and treatment Retacrit will be discontinued. Immediately tell your doctor if you suddenly feel very tired or dizzy or if you have shortness of breath. Your doctor will decide whether Retacrit working properly for you and if necessary stop your treatment.
In patients with chronic renal insufficiency receiving erythropoietin level of hemoglobin (the part of the red blood cells that carries oxygen) should be regularly measured until a stable value and periodically thereafter to minimize the risk by an increase in blood pressure.
If you are a patient with chronic kidney disease, your doctor will check your hemoglobin does not exceed a certain level as high hemoglobin could be a risk factor for heart or vascular problem and can increase the risk of death.
Increase blood potassium have happened in isolated cases. In patients with chronic renal failure, treatment of anemia can lead to increased appetite, and potassium and protein. If you are on dialysis, you begin treatment with Retacrit, may require adjustment of dialysis regimen to maintain urea, creatinine and potassium in the blood. Your doctor will take this decision.
The amount of serum electrolytes (substances in your blood) should be monitored in patients with chronic renal failure. If it is determined that the level of serum potassium is elevated (or increases), the physician should consider to stop the treatment with Retacrit until the level is back to normal.
Increasing the dose of a particular drug to thin the blood (heparin) during hemodialysis is often needed during long-term treatment with Retacrit, to minimize the likelihood of blood clots. Occlusion of the dialysis system is possible if heparinisation is not optimum.
Patients with cancer are more likely to suffer from blood clots if receiving erythropoietin medicines, like Retacrit (see section 4). Therefore, you should discuss the benefits of Retacrit with your doctor, especially if you are overweight or have had blood clots or breaches in the clotting process.
The level of hemoglobin (the part of the red blood cell that carries oxygen) in cancer patients treated with erythropoietin should be measured regularly until stable level is achieved and periodically thereafter.
If you are a cancer patient, be aware that Retacrit can act as a growth factor for blood cells and in certain circumstances may adversely impact on your tumor. Depending on the individual history, blood transfusion may be preferable. Please discuss this with your doctor.
Other medicines and Retacrit
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
In particular, if you are taking a medicine containing the active substance ciclosporin to suppress your immune system after a kidney transplant, your doctor may prescribe a special blood test that will determine the level of cyclosporin in your blood while you are taking Retacrit.
Iron supplements and other blood stimulants may increase the effectiveness of Retacrit. Your doctor will evaluate and decide whether it is right to take them.
Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
If you are pregnant or breast-feeding, Retacrit should be used only if the benefit outweighs the potential risk to the fetus.
Ask your doctor before taking any medicine.
Driving and using machines
Retacrit has no or negligible effect on ability to drive and use machines.
Retacrit contains phenylalanine
This medication contains phenylalanine and may be harmful to persons with phenylketonuria (genetic enzyme deficiency, which increases the secretion of a particular chemical (phenylketone) in the urine and can lead to disorders of the nervous system).
Retacrit contains sodium
This product contains less than 1 mmol sodium (23 mg) per dose, i.e. contains virtually no sodium.
3. How to use Retacrit?
Retacrit therapy is usually started under medical supervision. Injections can be inserted by a doctor, trained nurse or other medical professional.
In case Retacrit is injected under the skin (subcutaneously) you can also inject the solution yourself once you have been shown how to do this. Always use this medicine exactly as your doctor has told you. If you're not sure, ask your doctor.
The dose you receive is based on your body weight in kilograms.
Your doctor will conduct investigations, for example. Blood tests will help determine whether it is necessary to take Retacrit. He / she will calculate the correct dose of Retacrit, to take, how long is the treatment and how to introduce the medicinal product. These decisions will be influenced by what is causing your anemia.
You may be given iron supplements before and during treatment with Retacrit.
Use in patients with renal disease
Retacrit should be administered either under the skin (subcutaneously) or as an injection into a vein or into a vein.
Use in adult patients receiving hemodialysis
Your doctor will maintain your hemoglobin concentration between 10 and 12 g / dl (6,2 - 7,5 mmol / l).
Retacrit can be administered during the dialysis session or after it has ended.
The recommended starting dose of Retacrit is 50 IU / kg (International Units per kg. Body weight). This is given 3 times a week. If the solution is administered into a vein, it has to be injected for 1-5 minutes.
Depending on how the anemia responds to treatment, the dose may be adjusted approximately every 4 weeks until the condition is under control.
Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly. When your condition has been brought under control, you will receive regular doses of Retacrit, 2 or 3 times a week. These doses may not be as high as the dose received at the beginning of treatment.
Use in children and adolescents up to 18 years on dialysis
In children the doctor will maintain hemoglobin levels between 9.5 and 11 g / dl.
Retacrit should be administered after the patient has received a dialysis session.
The dose for children and adolescents is based on body weight in kilograms. The recommended starting dose is 50 IU / kg. It is administered three times a week by injection into a vein (over 1-5 minutes).
Depending on how the anemia responds to treatment, the dose may be adjusted approximately every 4 weeks until the condition is under control. Your doctor will prescribe regular blood tests to determine whether this is achieved.
Use in adult patients on peritoneal dialysis
Your doctor will maintain your hemoglobin concentration between 10 and 12 g / dl.
The recommended starting dose is 50 IU / kg. Apply 2 times a week.
Depending on how the anemia responds, the dose may be adjusted approximately every 4 weeks until the condition is under control. The total weekly dose that you receive should not exceed 200 IU / kg.
Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly.
Use in patients with renal disease who are not on dialysis
The recommended starting dose is 50 IU / kg. This is given 3 times a week.
Your doctor may adjust the initial dose until your condition is under control. Once your condition is under control, you will receive regular doses of Retacrit (3 times a week or if your injections are administered subcutaneously, it is possible to apply once a week or once every two weeks). The maximum daily dose should not exceed 150 IU / kg 3 times per week 240 IU / kg (up to a maximum of 20 000 IU) per week or 480 IU / kg (up to a maximum 40 IU 000) once every two weeks.
Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly.
If you are on an extended dosing interval (the interval between doses is longer than one week), you may not be able to maintain adequate levels of hemoglobin and may be necessary to increase the dose of Retacrit or frequency of administration.
Use in adult patients receiving chemotherapy
Your doctor may initiate treatment with Retacrit, if your hemoglobin is 10 g / dl or lower.
Following initiation of therapy, your doctor will maintain your hemoglobin concentration between 10 and 12 g / dl.
The recommended starting dose is 150 IU / kg. Given 3 times a week by subcutaneous injection. Alternatively, your doctor may recommend a starting dose of 450 IU / kg, once a week. The starting dose may be adjusted by the doctor, depending on your weight and how your anemia responds to treatment; You will usually receive Retacrit until 1 month after the end of chemotherapy.
Use in patients enrolled in the program in advance depositing of autologous blood
The recommended starting dose is 600 IU / kg. Apply 2 times a week by injection into a vein. You will receive Retacrit during the 3 weeks prior to surgery. Furthermore, in order to increase the effectiveness of the drug, you will accept and iron supplements before and during the whole treatment with Retacrit.
Adult patients scheduled for major orthopedic (bone) surgery
Dose of 600 IU / kg is given by injection under the skin once a week for three weeks before surgery and on the day of surgery. In cases where appropriate period before the transaction can be shortened, a dose of 300 IU / kg per day 10 days prior to surgery, on the day of surgery and for 4 days immediately thereafter. If blood tests in the period before the operation show too high hemoglobin levels, treatment should be discontinued.
It is also important, the level of iron in the blood are normal during treatment with Retacrit. If appropriate, you will receive iron orally, it is best to start before beginning treatment with Retacrit.
The pre-filled syringe is ready for use. Each syringe should only be used for one injection. Retacrit must not be shaken or mixed with other liquids.
If Retacrit is injected under the skin the amount injected in any one place should not exceed 1 ml. Suitable sites for injection are the upper thigh and abdomen, but away from the navel. Change the site every day.
Always follow these instructions when using Retacrit:
1. Take one sealed blister pack with a syringe prior to use, let it stand for a few minutes until it reaches room temperature.