Recormon
Rx10000 IU/0.6 ml • IV/SC Injection
More from Recormon
Other strengths and forms by Radiant Pharmaceuticals Ltd.
Indications & Uses
Pharmacology
Erythropoietin beta has the same amino acid and carbohydrate make-up as the erythropoietin that has been isolated from the urine of anemic patients. Erythropoietin is a glycoprotein. As a growth factor, it mainly stimulates the formation of erythrocytes from their committed progenitors. It acts as a mitosis-stimulating factor and as a differentiation hormone.
Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors, and it works as a mitosis-stimulating factor and differentiation hormone.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Erythropoietin Beta treatment should be started by a physician who has experience with the indications mentioned above. Anaphylactoid reactions have been seen in isolated cases, so the first dose should be given under medical supervision. Substitution by any other biological medicinal product needs the consent of the prescribing physician.
The Erythropoietin Beta pre-filled syringe is ready for use. Inject only a solution that is clear or slightly opalescent, colourless and practically free of visible particles. The syringe is sterile but unpreserved, so never give more than one dose from a single syringe.
Treatment of anemic patients with chronic renal failure: the solution can be given subcutaneously or intravenously. For intravenous use, inject it over approximately 2 minutes. In hemodialysis patients, for example, this can be done through the arteriovenous fistula at the end of dialysis. In non-hemodialysed patients, subcutaneous administration should always be preferred, to avoid puncture of peripheral veins.
The recommended hemoglobin target is 10 to 12 g/dl. If the patient has hypertension, or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the target hemoglobin should be decided individually. Hemoglobin should be checked at regular intervals (e.g. every two to four weeks) until it is stable, and periodically after that.
Treatment with Erythropoietin Beta is divided into two stages.
Correction phase
Subcutaneous administration: the initial dosage is 3 x 20 IU/kg body weight per week. If the Hb increase is not adequate (Hb <1.5 g/L per week), the dosage may be raised every 4 weeks by 3 X 20 IU/kg body weight/week. The weekly dose can also be divided into daily doses.
Intravenous administration: the initial dosage is 3 x 40 IU/kg per week. After 4 weeks it may be raised to 80 IU/kg three times per week, and then by further increments of 20 IU/kg three times per week if needed, at monthly intervals.
For both routes, the maximum dose should not exceed 720 IU/kg per week.
Side Effects
Skin reactions such as rash, itching (pruritus), urticaria or reactions at the injection site may occur with Erythropoietin Beta, but only rarely (≥1/10,000 to ≤1/1,000). Anaphylactoid reactions have been reported in very rare cases (≤1/10,000). Even so, controlled clinical studies found no increase in hypersensitivity reactions. Flu-like symptoms are also very rare (≤1/10,000), and they show up particularly when treatment is starting. These include fever, chills, headaches, pain in the limbs, malaise and/or bone pain. The reactions were mild or moderate, and they subsided after a couple of hours or days.
Cautions & Contraindications
Contraindications
Erythropoietin Beta must not be given to patients who are known to be hypersensitive to the active substance or to any of the excipients. It is also contraindicated in patients whose hypertension is poorly controlled. There are extra restrictions when Erythropoietin Beta is used to increase the yield of autologous blood. In that case it must not be used in patients who have had a myocardial infarction or stroke in the month before treatment, or in patients with unstable angina pectoris. It must also not be used in patients at increased risk of deep venous thrombosis, such as those with a history of venous thromboembolic disease.
Pregnancy & Breastfeeding
Pregnancy: Animal studies don't point to any direct or indirect harmful effects on pregnancy, embryonal/fetal development, parturition or postnatal development. For epoetin beta, all the safety information on exposure to Erythropoietin Beta during pregnancy comes from post-marketing experience. A review of the post-marketing data available shows no evidence of a causal link between treatment with Erythropoietin Beta and harmful effects on pregnancy, embryonal/fetal development or postnatal development. But there are no clinical study data, so caution should be used when prescribing to pregnant women.
Lactation: Experience in human lactation is limited. Endogeneous erythropoietin is excreted in breast milk and is readily absorbed by the neonatal gastrointestinal tract. Whether to continue or stop breastfeeding, or to continue or stop therapy with epoetin beta, should be decided by weighing the benefit of breastfeeding to the child against the benefit of epoetin beta therapy to the woman.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric use: Studies in children show that, on average, the younger the patient, the higher the dose of Erythropoietin Beta needed. Even so, the recommended dosing schedule should be followed, because no one can predict how an individual child will respond.
Geriatric use: No studies were done specifically in elderly patients. Many elderly patients did take part in the clinical trials of Erythropoietin Beta, though, and no need for special dose adjustments in this age group was found.
Hepatic impairment: No clinical trials were carried out in patients with hepatic impairment, so there are no special dosage instructions for them.
Overdose
Erythropoietin Beta has a wide therapeutic range, but each person responds differently, so this has to be kept in mind when treatment is started. An overdose can produce an exaggerated effect of the medicine, such as excessive erythropoiesis, and this may bring life-threatening complications of the cardiovascular system. If haemoglobin levels become too high, Erythropoietin Beta should be withheld for the time being. If it is clinically indicated, phlebotomy may be performed.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Erythropoietin Beta in a refrigerator at 2°C to 8°C. Leave the vial, cartridge or pre-filled syringe in its outer carton so the light can't reach it.
Drug Interactions
Common questions about Recormon 10000 IU/0.6 ml
What is Recormon 10000 IU/0.6 ml IV/SC Injection?
Recormon 10000 IU/0.6 ml IV/SC Injection is a medicine that contains Erythropoietin Beta. It is made by Radiant Pharmaceuticals Ltd. It belongs to the Drugs for Haemolytic Hypoplastic & Renal Anemia group of medicines.
What is Recormon used for?
Recormon is used for: Anemia, Cancer.
What are the side effects of Recormon?
Skin reactions such as rash, itching (pruritus), urticaria or reactions at the injection site may occur with Erythropoietin Beta, but only rarely (≥1/10,000 to ≤1/1,000). Anaphylactoid reactions have been reported in very rare cases (≤1/10,000).
Can I take Recormon during pregnancy or while breastfeeding?
Pregnancy: Animal studies don't point to any direct or indirect harmful effects on pregnancy, embryonal/fetal development, parturition or postnatal development. For epoetin beta, all the safety information on exposure to Erythropoietin Beta during pregnancy comes from post-marketing experience. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Recormon?
Erythropoietin Beta has a wide therapeutic range, but each person responds differently, so this has to be kept in mind when treatment is started. An overdose can produce an exaggerated effect of the medicine, such as excessive erythropoiesis, and this may bring life-threatening complications of the cardiovascular system. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Recormon?
Keep Erythropoietin Beta in a refrigerator at 2°C to 8°C. Leave the vial, cartridge or pre-filled syringe in its outer carton so the light can't reach it.
Can I take other medicines with Recormon?
Some medicines can interact with Erythropoietin Beta, for example: Fluorouracil, Cyclophosphamide, Cisplatin, Etoposide. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Recormon?
Recormon is a prescription (Rx) medicine. Take it as your doctor advises.