PEG-Epo IV/SC Injection

PEG-Epo is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis and patients, not on dialysis.

It is not indicated for use:

• In the treatment of anemia due to cancer chemotherapy.
• As a substitute for RBC transfusions in patients who require immediate correction of anemia.

Pegylated erythropoietin is an erythropoietin receptor activator with greater activity in vivo as well as increased half-life, in contrast to erythropoietin. It differs from erythropoietin through the integration of an amide bond between the N-terminal amino group or the ε-amino group of any lysine present in erythropoietin, predominantly Lys52 and Lys45 and Pegylated Erythropoietin (PEG).

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 Mortality, Myocardial Infarction, Stroke, and Thromboembolism
• Increased mortality and/or tumor progression in patients with cancer
• Hypertension
• Seizures
• Pure red cell aplasia
• Serious allergic reactions

Pregnancy Category C. It is not known whether it is excreted into human breast milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing woman.

Evaluation of Iron stores: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 mcg/L or with transferrin saturation below 20%. To ensure effective erythropoiesis, iron status has to be evaluated for all patients prior to and during treatment.

• Using ESA to target a hemoglobin level of >11 g/dL increase the rate of serious adverse cardiovascular reactions. It should be used with caution in patients with co-existant cardiovascular disease, stroke, seizure etc.
• Control hypertension prior to initiating of and during treatment with it
• Monitoring of patients for the change in seizure frequency or premonitory symptoms.
• If severe anemia and low reticulocyte count develop during the treatment, withhold it and evaluate patients for neutralizing antibodies to erythropoietin

PEG-Epo overdosage can elevate hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of PEG-Epo dosage and/or with phlebotomy. Cases of severe hypertension have been observed following overdose with ESAs.

Drugs for Haemolytic Hypoplastic & Renal Anemia

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