Pegylated erythropoietin is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis and in patients not on dialysis.

It is not indicated for:

• Treatment of anemia due to cancer chemotherapy
• Use as a substitute for red blood cell (RBC) transfusion in patients requiring immediate correction of anemia

Pegylated erythropoietin is an erythropoietin receptor activator with increased in vivo activity and a prolonged half-life compared to erythropoietin. It is structurally modified by the attachment of a polyethylene glycol (PEG) chain through an amide bond formed between the N-terminal amino group or ε-amino group of lysine residues in erythropoietin, mainly Lys52 and Lys45. This pegylation process enhances stability and prolongs its biological activity.

Initiate Pegylated Erythropoietin treatment when the hemoglobin level is less than 10 g/dL. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Pegylated Erythropoietin.

If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2 week period), reduce the dose of Pegylated Erythropoietin by 25% or more as needed to reduce rapid responses. And for patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.

For patients who do not respond adequately over a 12 week escalation period, increasing the Pegylated Erythropoietin dose further is unlikely to improve response and may increase risks.

For patients with CKD on dialysis:

• The recommended starting dose of Pegylated Erythropoietin for the treatment of anemia in adult CKD patients who are not currently treated with an ESA is 0.6 mcg/kg body weight administered as a single IV or SC injection once every two weeks.
• Once the hemoglobin has been stabilized, it may be administered once monthly using a dose that is twice that of the every two-week dose and subsequently titrated as necessary.

For patients with CKD not on dialysis:

• The recommended starting dose of Pegylated erythropoietin for the treatment of anemia in adult CKD patients who are not currently treated with an ESA is 0.6 mcg/kg body weight administered as a single IV or SC injection once every two weeks.
• Once the hemoglobin has been stabilized, it may be administered once monthly using a dose that is twice that of the every two-week dose and subsequently titrated as necessary.
• Conversion from another ESA to Pegylated erythropoietin: It can be administered once every two weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA.

• Increased risk of mortality, myocardial infarction, stroke, and thromboembolism
• Increased mortality and/or tumor progression in cancer patients
• Hypertension
• Seizures
• Pure red cell aplasia
• Serious allergic reactions

Pregnancy Category C. It is not known whether Pegylated erythropoietin is excreted in human breast milk. Since many drugs are excreted in breast milk, caution should be exercised when administering it to nursing mothers.

Evaluation of iron stores: Iron supplementation is recommended in patients with serum ferritin <100 mcg/L or transferrin saturation <20%. Iron status should be evaluated before and during treatment to ensure effective erythropoiesis.

• Use of ESAs targeting hemoglobin levels >11 g/dL increases the risk of serious cardiovascular events
• Use with caution in patients with cardiovascular disease, stroke, or seizure disorders
• Blood pressure should be controlled before and during treatment
• Patients should be monitored for changes in seizure frequency or warning symptoms
• If severe anemia with low reticulocyte count occurs, discontinue treatment and evaluate for anti-erythropoietin antibodies

Overdose may cause hemoglobin levels to rise above the desired range. Management includes discontinuation or dose reduction and/or phlebotomy. Severe hypertension has been reported following ESA overdose.

Drugs for hemolytic, hypoplastic, and renal anemia

Store in a refrigerator at 2°C–8°C. Protect from light. Do not shake the syringe. Keep out of reach of children.