Epoetin Beta-Methoxy Polyethylene Glycol Dosage

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Usual Adult Dose for:

Usual Geriatric Dose for:

Additional dosage information:

Usual Adult Dose for Anemia Associated with Chronic Renal Failure

1) For Patients Not Currently Treated with an erythropoiesis-stimulating agent (ESA):

Initial dose: 0.6 mcg/kg body weight administered as a single IV or subcutaneous injection once every two weeks

Epoetin beta-methoxy polyethylene glycol should be dosed to achieve and maintain hemoglobin between 10 and 12 g/dL. Once the hemoglobin has been maintained within this range, epoetin beta-methoxy polyethylene glycol may be administered once monthly using a dose that is twice that of the every two week dose and subsequently titrated as necessary.

2) For Patients Currently Treated with an erythropoiesis-stimulating agent (ESA):

Epoetin beta-methoxy polyethylene glycol can be administered once every two weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. The dose of epoetin beta-methoxy polyethylene glycol, given as a single IV or subcutaneous injection, should be based on the total weekly ESA dose at the time of conversion.

If the previous weekly epoetin alfa dose was less than 8000 units per week or the previous weekly darbepoetin alfa dose was less than 40 mcg per week, then the epoetin beta-methoxy polyethylene glycol dose would be 120 mcg per month or 60 mcg every two weeks.

If the previous weekly epoetin alfa dose was from 8000 units to 16,000 units per week or the previous weekly darbepoetin alfa dose was from 40 mcg to 80 mcg per week, then the epoetin beta-methoxy polyethylene glycol dose would be 200 mcg per month or 100 mcg every two weeks.

If the previous weekly epoetin alfa dose was greater than 16,000 units per week or the previous weekly darbepoetin alfa dose was greater than 80 mcg per week, then the epoetin beta-methoxy polyethylene glycol dose would be 360 mcg per month or 180 mcg every two weeks.

Usual Geriatric Dose for Anemia Associated with Chronic Renal Failure

Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

The dose of epoetin beta-methoxy polyethylene glycol should be reduced as the hemoglobin approaches 12 g/dL or increases by more than 1 g/dL in any two-week period. During therapy, hematological parameters should be monitored regularly. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

When epoetin beta-methoxy polyethylene glycol therapy is initiated or adjusted, the hemoglobin should be monitored every two weeks until stabilized, and every two to four weeks thereafter.

For patients whose hemoglobin does not attain a level within the range of 10 to 12 g/dL despite the use of appropriate epoetin beta-methoxy polyethylene glycol dose titrations over a 12-week period:
1. Do not administer higher epoetin beta-methoxy polyethylene glycol doses and use the lowest dose that will maintain a hemoglobin level sufficient to avoid the need for recurrent RBC transfusions.
2. Evaluate and treat for other causes of anemia.
3. Thereafter, continue to monitor the hemoglobin level and if responsiveness improves, make epoetin beta-methoxy polyethylene glycol dose adjustments as described above. Discontinue epoetin beta-methoxy polyethylene glycol if responsiveness does not improve and the patient needs recurrent RBC transfusions.

Dose adjustments should not be made more often than once a month. A significant change in hemoglobin may not be observed for several weeks after the dose is adjusted. If a dose adjustment is necessary to maintain the recommended hemoglobin level, the dose may be increased or decreased by approximately 25%, as needed.

During epoetin beta-methoxy polyethylene glycol therapy, if the increase in hemoglobin is greater than 1 g/dL in 2 weeks or if the hemoglobin is increasing and approaching 12 g/dL, the dose should be reduced by approximately 25%. If the hemoglobin continues to increase, epoetin beta-methoxy polyethylene glycol should be discontinued until the hemoglobin begins to decrease. Epoetin beta-methoxy polyethylene glycol may then be restarted at a dose approximately 25% below the previously administered dose.

For patients not converted from another ESA, if the increase in hemoglobin is less than 1 g/dL over the initial 4 weeks of treatment and iron stores are adequate, the dose of epoetin beta-methoxy polyethylene glycol may be increased by approximately 25%.

If a dose of epoetin beta-methoxy polyethylene glycol is missed, administer the missed dose as soon as possible and restart epoetin beta-methoxy polyethylene glycol at the prescribed dosing frequency.

Dialysis

The IV route is recommended for patients receiving hemodialysis because the IV route may be less immunogenic.

Therapy with epoetin beta-methoxy polyethylene glycol results in an increase in red blood cells and a decrease in plasma volume, which could reduce dialysis efficiency. Therefore, patients who are marginally dialyzed may require adjustments in their dialysis prescription.

Other Comments

Epoetin beta-methoxy polyethylene glycol is administered either intravenously (IV) or subcutaneously (SC). When administered subcutaneously, epoetin beta-methoxy polyethylene glycol should be injected in the abdomen, arm or thigh.

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