The flexibility of EPOGEN® TIW (three times weekly) dosing allows for timely intervention to help address Hb changes1,2
- In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target a Hb level of greater than 11 g/dL.
- No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
- Individualize dosing and use the lowest dose of EPOGEN® sufficient to reduce the need for RBC transfusions.
- Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse reactions.
- Correct or exclude other causes of anemia before initiating EPOGEN®.
- Evaluate the iron status of all patients before and during treatment.
- Administer supplemental iron therapy if serum ferritin is < 100 mcg/L or serum transferrin saturation is < 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.
- In pregnant women, lactating women, neonates, and infants use only single-dose vials (the benzyl alcohol-free formulation). Do not mix EPOGEN® with bacteriostatic saline (which contains benzyl alcohol) when administering to these patients.
- Appropriately control hypertension prior to initiation of and during treatment with EPOGEN®.
- Reduce or withhold EPOGEN® if blood pressure becomes difficult to control.
TO INITIATE EPOGEN® FOR ADULT PATIENTS
The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. The intravenous route of administration is recommended for patients on hemodialysis.
TO INITIATE EPOGEN® FOR PEDIATRIC PATIENTS (ages 1 month or older)
The recommended starting dose for pediatric patients is 50 Units/kg 3 times weekly intravenously or subcutaneously. The intravenous route of administration is recommended for patients on hemodialysis.
MONITOR AND ASSESS Hb REGULARLY
- A single Hb excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks.
- Decreases in dose can occur more frequently.
- Avoid frequent dose adjustments.
REDUCE OR INTERRUPT DOSE
- If Hb rises rapidly (eg, more than 1 g/dL in any 2-week period), reduce the dose by 25% or more, as needed, to reduce rapid responses.
- Reduce or interrupt dose if the Hb level approaches or exceeds 11 g/dL.
- Reduce or interrupt dose if the Hb level approaches or exceeds 12 g/dL.
IMPORTANT SAFETY INFORMATION
- Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with EPOGEN®.
- This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration.
- PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which EPOGEN® is not approved).
- If severe anemia and low reticulocyte count develop during treatment with EPOGEN®, withhold EPOGEN® and evaluate patients for neutralizing antibodies to erythropoietin.
- Permanently discontinue EPOGEN® in patients who develop PRCA following treatment with EPOGEN® or other erythropoietin protein drugs. Do not switch patients to other ESAs.
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Patients who do not respond adequately to EPOGEN®
- For patients who do not respond adequately over a 12-week escalation period, increasing the EPOGEN® dose further is unlikely to improve response and may increase risks.
- Use the lowest dose that will maintain a Hb level sufficient to reduce the need for RBC transfusions.
- Evaluate other causes of anemia.
- If typical causes of lack or loss of Hb response are excluded, evaluate for pure red cell aplasia (PRCA).
- Discontinue EPOGEN® if responsiveness dose not improve.