Therapy with Recormon should be initiated by physicians experienced in the previously mentioned indications. As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision.
Substitution by any other biological medicinal product requires the consent of the prescribing physician.
Lyophilisate and solvent for solution for injection:
The multidose preparation can be used for several patients. To avoid the risk of cross-infection always follow aseptic techniques and use disposable sterile syringe, and needles for each administration.
Solution for injection in pre-filled syringe:
The Recormon pre-filled syringe is ready for use. Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only. (See Special Instructions for Use, Handling and Disposal under Cautions for Usage.)
Treatment of patients with anemia due to chronic kidney disease:
The reconstituted solution can be administered subcutaneously or intravenously. In case of intravenous administration, the solution should be injected over approx. 2 minutes, e.g. in hemodialysis patients via the arterio-venous fistula at the end of dialysis.
For non-hemodialysed patients, subcutaneous administration should always be preferred in order to avoid puncture of peripheral veins.
In CKD patients, the aim of treatment is to reach a target Hb level of 10-12 g/dl. An Hb level of 12 g/dl should not be exceeded. If the rise in hemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, an appropriate dose reduction should be considered. In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture. Patients should be monitored closely to ensure that the lowest dose of Recormon is used to provide adequate control of the symptoms of anemia.
Treatment with Recormon is divided into two stages.
1. Correction phase: Subcutaneous administration (all dosage forms):
The initial dosage is 3 x 20 IU/kg body weight per week. The dosage may be increased every 4 weeks by 3 x 20 IU/kg per week if the increase of Hb is not adequate (< 0.25 g/dl per week).
The weekly dose can also be divided into daily doses.
Intravenous administration (powder and solvent for solution for injection and pre-filled syringes only):
The initial dosage is 3 x 40 IU/kg per week. The dosage may be raised after 4 weeks to 80 IU/kg - three times per week and by further increments of 20 IU/kg if needed, three times per week, at monthly intervals.
For both routes of administration, the maximum dose should not exceed 720 IU/kg per week.
2. Maintenance phase:
To maintain a target Hb value of approximately 10-12 g/dl, the dosage is initially reduced to half of the previously administered amount. Subsequently, the dose is adjusted at intervals of two to four weeks individually for the patient (maintenance dose). In the case of subcutaneous administration, the weekly dose can be given as one injection per week or in divided doses three or seven times per week. Patients who are stable on a once weekly dosing regimen may be switched to once every two weeks administration. In this case dose increases may be necessary.
Treatment with Recormon is normally a long-term therapy. It can, however, be interrupted, if necessary, at any time. Data on the once weekly dosing schedule are based on clinical studies with a treatment duration of 24 weeks.
Treatment of symptomatic anemia in cancer patients receiving chemotherapy:
The reconstituted solution is administered subcutaneously; the weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week.
The recommended initial dose is 30,000 IU per week (corresponding to approximately 450 IU/kg body weight per week, based on an average weighted patient).
Recormon treatment is indicated if the hemoglobin value is ≤11 g/dl (6.83 mmol/l). Hemoglobin levels should not exceed 13 g/dl (8.07 mmol/l) (see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies under Actions).
If, after 4 weeks of therapy, the hemoglobin value has increased by at least 1 g/dl (0.62 mmol/l), the current dose should be continued. If the hemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), a doubling of the weekly dose should be considered. If, after 8 weeks of therapy, the hemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), response is unlikely and treatment should be discontinued.
The therapy should be continued up to 4 weeks after the end of chemotherapy.
The maximum dose should not exceed 60,000 IU per week.
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to maintain hemoglobin at that level. If required, further dose reduction may be instituted to ensure that hemoglobin level does not exceed 13 g/dl.
If the rise in hemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, the dose should be reduced by 25 to 50%.
Treatment for increasing the amount of autologous blood:
The reconstituted solution is administered intravenously over approx. 2 minutes or subcutaneously.
Recormon is administered twice weekly over 4 weeks. On those occasions where the patient's PCV allows blood donation, i.e. PCV ≥33%, Recormon is administered at the end of blood donation. During the entire treatment period, a PCV of 48% should not be exceeded.
The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve: The required amount of pre-donated blood depends on the anticipated blood loss, use of blood conserving procedures and the physical condition of the patient.
This amount should be that quantity which is expected to be sufficient to avoid homologous blood transfusions.
The required amount of pre-donated blood is expressed in units whereby one unit in the nomogram is equivalent to 180 ml red cells.
2. The ability to donate blood depends predominantly on the patient's blood volume and baseline PCV. Both variables determine the endogenous red cell reserve, which can be calculated according to the following formula.
Endogenous red cell reserve = blood volume [ml] x (PCV 33) ÷ 100
Women: blood volume [ml] = 41 [ml/kg] x body weight [kg] + 1200 [ml]
Men: blood volume [ml] = 44 [ml/kg] x body weight [kg] + 1600 [ml] (body weight ≥45 kg)
The indication for Recormon treatment and, if given, the single dose should be determined from the required amount of pre-donated blood and the endogenous red cell reserve according to the following graphs. (See figure.)
Click on icon to see table/diagram/image
The single dose thus determined is administered twice weekly over 4 weeks. The maximum dose should not exceed 1600 IU/kg body weight per week for intravenous or 1200 IU/kg per week for subcutaneous administration.
Prevention of anemia of prematurity:
For this indication, only solution for injection in pre-filled syringes may be used.
The solution is administered subcutaneously at a dose of 3 x 250 IU/kg b.w. per week. Recormon treatment should start as early as possible, preferably by day 3 of life. Premature infants who have received a transfusion before starting Recormon treatment are not likely to benefit as much as infants who have not had a transfusion. The treatment should last for 6 weeks.
Treatment of patients with anemia in Myelodysplastic Syndromes (MDS) including other ineffective erythropoiesis:
The recommended initial dose is 30,000 IU per week administered subcutaneously.
Recormon treatment is indicated if the hemoglobin value is less or equal to 10 g/dl. Hemoglobin levels should not exceed 12 g/dl.
After 6-8 weeks, if the hemoglobin level increase less than 1 g/dl (0.62 mmol/l) from baseline hemoglobin level and hemoglobin level is less than 12 g/dl, a doubling of the weekly dose should be considered (60,000 IU weekly).
Special Dosage Instructions: Pediatric use:
Results of pediatric clinical studies have shown that, on average, the younger the patients, the higher the Recormon doses required. Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted (see Use in Special Populations: Pediatric use under Precautions).
No dedicated studies in geriatric patients were performed. A large proportion of geriatric patients were included in clinical trials with Recormon. A need for special dose adjustments in the elderly population was not identified.
No dedicated clinical trials were conducted in patients with hepatic impairment. No special Dosage Instructions are available.