Hema-Plus Dosage/Direction for Use

RECOMMENDED DOSE: Chronic renal failure patients: Starting dose: Intravenous route: 40 IU/kg three times weekly, Subcutaneous route: 20 IU/kg three times weekly. These doses have proved to be effective and safe in increasing hematocrit levels and eliminating transfusion dependency and need for transfusions. The dose of Hema-Plus should be reduced when the hematocrit reaches the target range of 36%.
Hema-Plus may be administered subcutaneously or intravenously. In patients on dialysis, it can be administered as an intravenous bolus. While the administration of the product should be independent of the dialysis procedure, it may be administered intravenously at the end of such process.
Dose adjustment: After treatment with Hema-Plus, a period of 2 to 4 weeks should be allowed for the parent erythroid cells to mature and be released for circulation, so an increase of the hematocrit takes place at the end.
This adjustment should not be made more than once a month unless clinically indicated.
If the level of the hematocrit approaches 36% the dose should be reduced to be withheld over the target range. Otherwise, the treatment should be suspended until the hematocrit reaches the target range.
If the level of the hematocrit increases by more than 4 points in a two-week period, the dose should be reduced and then the levels of the hematocrit should be monitored twice weekly for a 2 to 6-week period, before applying the maintenance dose.
If an increase of 5-6 points in the level of the hematocrit is not achieved after an 8-week period, the dose should be increased and evaluated again after 2-4 weeks, and then again it can be increased after 4 to 6 week periods.
Maintenance dose: Although the maintenance dose should be individually established, an average maintenance dose may be of 60 IU/kg for patients on dialysis three times weekly.
Diminished or delayed response: Approximately 95% of chronic renal failure patients treated with Epoetin alfa have responded to the treatment. If any patient is not responding, the iron stores should be evaluated, together with any other possible anemia-related etiology.
Cancer patients on chemotherapy: The level of endogenous serum erythropoietin should be evaluated prior to treatment, since available evidence suggests that patients with endogenous serum erythropoietin levels greater than 200 mIU/mL are unlikely to respond to treatment.
Starting dose: The recommended starting dose is 150 IU/kg three times weekly or 40000 IU weekly, subcutaneous route.
Dose adjustment: If the response is not satisfactory in terms of reducing transfusion requirements or increasing hematocrit after 8 weeks of therapy, the dose can be increased in 50 or 100 IU three times weekly and re-evaluated response after 4-8 weeks.
If it is needed, a further increase of the dose from 50-100 IU is needed only up to 300 IU/kg, higher doses are not recommended.
General: If the target hemoglobin concentration exceeds 12 g/dL, the dose should be withheld until a concentration of 12 g/dL is reached. Upon re-initiation of the treatment, the dose should be reduced in 25% and then re-adjusted to maintain the target hemoglobin concentration.
When the treatment is suspended, the target hemoglobin concentration diminishes to approximately 0.5 g/dL per week.
MODE OF ADMINISTRATION: Hema-Plus can be administered subcutaneously or intravenously.