PEG-Epo(Pegylated Erythropoietin)
Therapeutic Group: Drugs for Haemolytic Hypoplastic & Renal Anemia
Presentation
Peg-Epo 50 mcg: Each pre-filled syringe contains 0.3 mL sterile solution which contains Pegylated Erythropoietin INN 50 mcg.
Peg-Epo 75 mcg: Each pre-filled syringe contains 0.3 mL sterile solution which contains Pegylated Erythropoietin INN 75 mcg.
Description
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).
Indications
Pegylated erythropoietin is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis and patients not on dialysis.
Limitation of use:
It is not indicated for use:
1.In the treatment of anemia due to cancer chemotherapy
2.As a substitute for RBC transfusions in patients who require immediate correction of anemia
Dosage & Administration
1. Initiate PEG-Epo 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 PEG-Epo.
2. If the hemoglobin rises rapidly (e.g, more than 1 g/dL in any 2 week period), reduce the dose of
PEG-Epo 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%
3. For patients who do not respond adequately over a 12 week escalation period, increasing the PEG-Epo
dose further is unlikely to improve response and may increase risks
For patients with CKD on dialysis:
1. 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.
2. 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:
1.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.
2.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.
Side Effects
1. Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism
2. Increased mortality and/or tumor progression in patients with cancer
3. Hypertension
4. Seizures
5. Pure red cell aplasia
6. Serious allergic reactions
Precautions
1. 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.
2. Control hypertension prior to initiating of and during treatment with it
3. Monitoring of patients for the change in seizure frequency or premonitory symptoms.
4. If severe anemia and low reticulocyte count develop during the treatment, withhold it and evaluate
patients for neutralizing antibodies to erythropoietin
Use in Pregnancy & Lactation
Pregnancy:
Pregnancy Category C.
Lactation
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.
Drug Interaction
No drug/drug interaction studies have been performed.
Over Dose
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.
Storage
Store at 2 0C to 8 0C at refrigerator. Protect from light. Do not shake the syringe.
Commercial Pack
PEG-Epoâ„¢ 50: Each box contains 1 pre-filled syringe containing 50 mcg of Pegylated Erythropoietin.
PEG-Epoâ„¢ 75: Each box contains 1 pre-filled syringe containing 75 mcg of Pegylated Erythropoietin.