Evaluation of Iron Stores and Nutritional Factors

Evaluate iron status in all patients before and during treatment, and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Erythropoietin alfa.

Patients with Chronic Kidney Disease

For all patients with CKD:

When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then at least monthly. Consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability when adjusting therapy. A single hemoglobin excursion may not require a dose change.

Do not increase the dose more frequently than once every four weeks. Dose decreases can occur more frequently. Avoid frequent dose adjustments.

If hemoglobin rises rapidly (e.g., more than 1 g/dL in any two-week period), reduce the dose of Erythropoietin alfa by at least 25% to prevent rapid responses.

For patients who do not respond adequately, if hemoglobin has not increased by more than 1 g/dL after four weeks of therapy, increase the dose by 25%.

If there is no adequate response over a 12-week escalation period, further dose increases are unlikely to be beneficial and may increase risks. Use the lowest dose that maintains a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia, and discontinue Erythropoietin alfa if responsiveness does not improve.

For patients with CKD on dialysis:

Initiate Erythropoietin alfa treatment when hemoglobin is below 10 g/dL.
If hemoglobin approaches or exceeds 11 g/dL, reduce or interrupt the dose.
The recommended starting dose for adults is 50 to 100 units/kg, administered intravenously or subcutaneously three times per week.
For pediatric patients, a starting dose of 50 units/kg three times weekly is recommended. The intravenous route is preferred for patients on hemodialysis.

For patients with CKD not on dialysis:

Consider initiating Erythropoietin alfa only when hemoglobin is below 10 g/dL and if:
The rate of hemoglobin decline suggests a likelihood of requiring an RBC transfusion, and
Reducing the risk of alloimmunization or other RBC transfusion-related risks is a treatment goal.
If hemoglobin exceeds 10 g/dL, reduce or interrupt the dose and use the lowest effective dose to reduce the need for RBC transfusions.

The recommended starting dose for adults is 50 to 100 units/kg three times weekly, administered intravenously or subcutaneously.

Zidovudine-Treated HIV-Infected Patients

Starting Dose:

The recommended starting dose for adults is 100 units/kg, administered as an intravenous or subcutaneous injection three times per week.

Dose Adjustment:

If hemoglobin does not increase after eight weeks, increase the dose by 50 to 100 units/kg at four- to eight-week intervals until hemoglobin reaches a level sufficient to avoid RBC transfusions or 300 units/kg.

Withhold Erythropoietin alfa if hemoglobin exceeds 12 g/dL. Resume therapy at a 25% lower dose when hemoglobin declines to less than 11 g/dL.

Discontinue treatment if hemoglobin does not increase at a dose of 300 units/kg for eight weeks.

Patients on Cancer Chemotherapy

Initiate Erythropoietin alfa only if hemoglobin is below 10 g/dL and at least two additional months of planned chemotherapy remain.

Use the lowest dose necessary to avoid RBC transfusions.

Recommended Starting Dose:

Adults:

150 units/kg subcutaneously three times per week, or 40,000 units subcutaneously once weekly until completion of chemotherapy.

Pediatric patients (5 to 18 years):600 units/kg intravenously once weekly until chemotherapy is completed.

Prevention of Anemia of Prematurity

Administer Erythropoietin alfa subcutaneously at 250 IU/kg three times per week.
Begin treatment as early as possible, preferably by day three of life, for six weeks.

Premature infants who received a transfusion before starting Erythropoietin alfa may derive less benefit than those who have not.

Surgery Patients

The recommended regimens are:

300 units/kg per day subcutaneously for 15 days (10 days before surgery, on the day of surgery, and for four days after).
600 units/kg subcutaneously in four doses (administered 21, 14, and 7 days before surgery and on the day of surgery).

Deep venous thrombosis prophylaxis is recommended during Erythropoietin alfa therapy.

There are no adequate, well-controlled studies in pregnant women. Animal studies indicate reproductive toxicity.In patients with chronic renal failure, use during pregnancy only if the benefits outweigh potential fetal risks.Erythropoietin alfa is not recommended for pregnant or lactating surgical patients participating in an autologous blood predonation program.

It is unknown whether Erythropoietin alfa is excreted in human milk; use caution in nursing women.

No known clinically significant drug interactions exist. However, the effect of Erythropoietin alfa may be enhanced by simultaneous administration of a hematinic agent such as ferrous sulfate in cases of deficiency.

Uncontrolled hypertension.
Serious allergic reactions to Erythropoietin alfa.

Patients with Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa.

Common adverse reactions (≥5% of patients):

CKD Patients: Hypertension, arthralgia, muscle spasms, pyrexia, dizziness, vascular occlusion, and upper respiratory tract infection.

HIV Patients: Pyrexia, cough, rash, and injection site irritation.
Cancer Patients: Nausea, vomiting, myalgia, arthralgia, leukopenia, hyperglycemia, and thrombosis.
Surgery Patients: Nausea, vomiting, headache, deep vein thrombosis, and hypertension.
Premature Infants: Decrease in serum ferritin values.

Store at 2°C to 8°C. Do not freeze or shake. Protect from light

Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:

Treatment of anemia due to:

Chronic Kidney Disease (CKD) in patients on dialysis and those not on dialysis.
Zidovudine in HIV-infected patients.
The effects of concomitant myelosuppressive chemotherapy, provided there is a minimum of two additional months of planned chemotherapy upon initiation.
Reduction of allogeneic RBC transfusions in patients undergoing elective, non-cardiac, non-vascular surgery.

Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 g and a gestational age of less than 34 weeks.