Hemactiv Dosage/Direction for Use

The dosage will be established as medically indicated. Doses should be individualized to ensure the adequate hemoglobin level for each patient.
Recombinant human erythropoietin should be administered under the supervision of a qualified physician.
During treatment, hematological parameters should be monitored regularly. In patients on hemodialysis, the intravenous route is recommended.
Chronic renal failure: In patients with CRF on hemodialysis with venous access available, intravenous route of administration is preferred. It is suggested to administer erythropoietin after the dialysis procedure is completed. In adult patients with CRF without venous access (those who are not yet on hemodialysis or patients on peritoneal dialysis), subcutaneous injection is preferred.
The recommended starting dose of Hemactiv in adult patients is 50 to 100 Units/kg three times a week. In children, the available information suggests erythropoietin alpha doses between 25 and 50 IU/kg three times a week.
The treatment is divided into two stages: Phase of Correction: 50 IU/kg three times a week.
When a dose adjustment is required, it should be done at least in steps of four weeks. At each step, the increase or reduction in the dose should be of 25 IU/kg three times a week. The total maximum weekly dose should not exceed 3x200 IU/kg.
Phase of Maintenance: Dose adjustment in order to maintain hemoglobin values at the desired level: Hb between 10 and 12 mg/dL (6.2 to 7.5 mmol/L). The recommended total weekly dose is between 75 and 300 IU/kg.
Patients switching from SC to IV administration should use the same dose, and Hb should be closely monitored (e.g., weekly) to make the necessary adjustments in medication to achieve hemoglobin levels in a proper range.
Dose adjustments: if the hemoglobin increases and reaches 12 mg/dL, the dose should be reduced by 25%. If it continues to increase, discontinue the dose until the Hb begins to decrease, at which point the dose should be started at a value 25% lower than the last administered dose. If the Hb increases more than 1 mg/dL in 2 weeks, the dose should be decreased by 25%, either in the number of weekly injections, the total amount of EPO alpha in each dose, or both.
Adult patients with cancer: Erythropoietin should only be administered to cancer patients with anemia with Hb below 10 mg/dL. Subcutaneous route of administration is suggested. The hemoglobin variability should be addressed through dose adjustment, considering the target hemoglobin range between 10 mg/dL (6.2 mmol/L) and 12 mg/dL (7.5 mmol/L), preventing a sustained hemoglobin level above 12 mg/dL.
An initial SC dose of 150 IU/kg three times a week is suggested. If after 4 weeks of treatment, the hemoglobin has increased at least 1 mg/dL (0.62 mmol/L) or the reticulocytes count has increased ≥40,000 cells/μL above baseline, the dose should remain at 150 IU/kg three times a week or 450 IU/kg once a week. If the increase in hemoglobin is <1 mg/dl (<0.62 mmol/L) and the reticulocytes count has increased <40,000 cells/μL above baseline, increase the dose to 300 IU/kg 3 times a week. If after an additional 4 weeks of treatment with a dose of 300 IU/kg three times a week, the haemoglobin has increased ≥1 mg/dl (<0.62 mmol/L) or the reticulocytes count has increased <40,000 cells/μL, the dose should remain at 300 IU/kg three times a week. However, if the haemoglobin has increased < 1 mg/dl (<0.62 mmol/L) and the reticulocytes count has increased <40,000 cells/μL above baseline, the response is unlikely and the treatment should be discontinued. Patients should be carefully monitored to ensure that the lowest approved dose of erythropoiesis stimulating agents is used to ensure an adequate control of symptoms of anemia.
Dose adjustments: The risk of thrombotic adverse events could be increased in patients with rapid increases of normal haemoglobin concentrations (see Precautions).
If the haemoglobin increases 1 mg/dL biweekly or above 2mg/dL (1.25 mmol/L) a month, or if the haemoglobin is approaching 12 mg/dL (7.5 mmol/L), reduce the dose to 25-50%. If the haemoglobin exceeds 12mg/dL, discontinue treatment until the hemoglobin value drops and then restart the treatment with Hemactiv with a dose 25% lower than the previous dose.
Adult surgery patients in an autologous pre-donation program: Route of administration: Intravenous.
Doses of 300-600 IU/kg twice a week are suggested, for 3 weeks, with at least 200 mg of elemental iron.
Adult patients scheduled for elective surgery: Route of administration: Subcutaneous.
Before considering a treatment with erythropoiesis stimulating agents as Hemactiv, it is desirable to investigate other potential correctable causes of anemia.
The recommended Hemactiv dosing regimen is 600 IU/kg weekly for three weeks (days-21, -14 and -7) prior to surgery and the day of surgery. If the planned time before surgery is shortened to less than three weeks due to medical needs, EPO alpha 300 IU/kg daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately following the surgery should be administered. If when performing hematologic assessments during the preoperative period, the hemoglobin level reaches 15 mg/dl or higher, the administration of Hemactiv should be discontinued and subsequent doses should not be administered.
Adequate iron supplementation: It is recommended to evaluate the levels of iron stores, including transferrin saturation (serum iron divided by iron binding capacity) and serum ferritin before and during treatment with recombinant human erythropoietin. Most patients will require iron supplements (e.g., elemental iron 200mg orally) to increase or maintain transferrin saturation to levels adequate to support erythropoiesis stimulated by recombinant human erythropoietin. If possible, administer the supplement before initiating the therapy with EPO alpha to achieve the indicated reserves.
Instructions for use: All parenteral products should be visually inspected in order to identify any particulate matter and the product keeps colorless.
Do not use any parenteral product if particulate matter or discoloration is observed.
Avoid prolonged vigorous shaking with subsequent formation of foam, since this procedure can denaturate the protein recombinant human erythropoietin, with the possible inactivation of the product.
By using aseptic techniques, place a sterile needle in a sterile syringe. Remove the plastic cover (flip-off) of the vial containing Hemactiv solution and clean the top of the stopper with a disinfectant. Insert the needle into the vial and remove with the syringe the appropriate volume of solution to be injected.
Each vial of Hemactiv solution is for a single use because it contains no preservatives.
Dispose the unused remaining contents of the vial. Do not reuse the syringe. Hemactiv solution should not be diluted or administered mixed with other drug solutions.
Administer by subcutaneous or intravenous injection (as appropriate) in 1-2 minutes: Intravenous administration: In 1-2 minutes, at least. In patients on dialysis, injections should be performed after the dialysis, in the catheterization needle, followed by rinsing with 10 mL of isotonic solution for parenteral use to ensure the correct passage of product into the circulation. In patients who develop flu-like symptoms, it may be preferable a slower injection for5 minutes.
Subcutaneous administration: The maximum volume to be injected per site should not exceed 1 mL. If it is necessary to inject larger volumes, choose more than one site. Injections are made alternately in the limbs and the anterior abdominal wall.