IN A RETROSPECTIVE COHORT STUDY OF US EHR DATA
FOR PATIENTS WITH CKD NOT ON DIALYSIS WHO HAVE Hb < 10 g/dL*
*14,922 adults with eGFR results > 10 and < 60 mL/min/1.73 m2.
†IV iron, epoetin alfa, darbepoetin alfa, polyethylene glycol-epoetin beta, or RBC transfusion.
EHR = electronic health record; Hb = hemoglobin; KDIGO = Kidney Disease: Improving Global Outcomes;
glomerular filtration rate; IV = intravenous; RBC = red blood cell.KDIGO® is a registered trademark of the National Kidney Foundation, Inc.
In a retrospective observational cohort study of EHR data from a large US healthcare system
Proportion of patients with anemia stratified by population and CKD-NOD stages3
Hb < 10 g/dL
(n = 11,673)
*50,701 adults with stage 3a to 5 CKD not on dialysis.
US EHR data demonstrates
*14,922 adults with eGFR results > 10 and < 60 mL/min/1.73 m2; average follow-up was 1.96 years; anemia defined as Hb ≤ 10 g/dL.
†IV iron, epoetin alfa, darbepoetin alfa, polyethylene glycol-epoetin beta, or RBC transfusion.
‡Of the 14,922 adults with eGFR results > 10 and < 60 mL/min/1.73 m2, 7140 were treated; average follow-up was 1.96 years; anemia defined as Hb ≤ 10 g/dL.
NOD = not on dialysis; DPO = darbepoetin alfa; EPO = epoetin alfa.
In a multi-country analysis, nephrologists in the United States prescribed ESAs to fewer patients with CKD-NOD and Hb < 10 g/dL.4,*
*N = 6766 patients with stage 3a to 5 CKD (not on dialysis) who were sequentially or randomly selected from national samples of nephrology clinics in Brazil, France, Germany, and the United States as part of the CKDopps international prospective cohort study of non-dialysis patients (data from January 1, 2013 until April 13, 2018, which included patients entering CKDopps at different time points over a 5.3 year period); anemia defined as Hb < 10 g/dL.
CKDopps = Chronic Kidney Disease Outcomes and Practice Patterns Study.
ALLOSENSITIZATION
TRANSFUSION REACTIONS
VOLUME OVERLOAD
IRON OVERLOAD
HYPERKALEMIA
TRANSMISSION OF INFECTIONS
The KDIGO® Clinical Practice Guideline for Anemia in Chronic Kidney Disease (2012) recommends avoiding, when possible, red cell transfusions to minimize the general risks related to their use.2
KDIGO® is a registered trademark of the National Kidney Foundation, Inc.
ARANESP® can be used to reduce the need for RBC transfusion in your CKD-NOD patients with Hb < 10 g/dL.5
For adult patients with CKD not on dialysis:
In an analysis of DOPPS® data
Appropriate anemia management in the period before and during hemodialysis transition is important.6
*N = 4604 eligible patients from 21 countries in DOPPS® phases 4-5
after 4 months on hemodialysis; anemia defined asDOPPS® = Dialysis Outcomes and Practice Patterns Study.
DOPPS® is a registered trademark of Arbor Research Collaborative
Compared with Hb ≥ 11.0 g/dL the start of hemodialysis:
*N = 4604 hemodialysis patients from 21 countries in DOPPS phases 4-5 (2009-2011); anemia defined as Hb < 10 g/dL.
*N=22,643 hemodialysis patients from 20 countries in DOPPS phases 5-7 (2012-2022).
ARANESP® achieved median Hb concentrations of 9.9 g/dL in patients who received a titrated dose and 9.4 g/dL in patients who received a fixed dose.
*A double-blind, parallel-group phase 3 trial involving 756 adults with stage 3 to 5 CKD and anemia (Hb < 10.0 g/dL) randomized to receive ARANESP® given as a fixed dose (N = 379) versus administered according to a hemoglobin-based, titration-dose algorithm (N = 377), for up to 2 years. In the hemoglobin-based, titration-dose group, ARANESP® doses were titrated to maintain Hb ≥ 10.0 g/dL, with dose reduction if Hb exceeded 10.5 g/dL or if the Hb rise exceeded 1.0 g/dL over 4 weeks. In the fixed dose group, patients received a fixed dose of ARANESP® (0.45 mg/kg). All patients received ARANESP® as a subcutaneous injection once every 4 weeks. Patients received transfusions as deemed necessary by the treating physician.
*Refer to ARANESP® full Prescribing Information for additional detail on dosing in patients with CKD, including those on dialysis and pediatric patients (less than 18 years).
INITIATION
Consider initiating ARANESP® treatment only when the Hb level is < 10 g/dL and the following considerations apply:
Q4W recommended starting dose: 0.45 mcg/kg body weight as an IV or SC injection once at 4-week intervals as appropriate.
MONITORING
Following initiation of therapy and after each dose adjustment, monitor Hb at least weekly until the Hb is stable and sufficient to minimize the need for RBC transfusion.
DOSE ADJUSTMENTS
When adjusting therapy, consider Hb rate of rise, rate of decline, ESA responsiveness, and Hb variability:
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.
If the Hb level exceeds 10 g/dL, reduce or interrupt the dose of ARANESP®, and use the lowest dose of ARANESP® sufficient to reduce the need for RBC transfusions.
INCREASE DOSE
If the Hb has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25% when appropriate.
Patients with CKD and an insufficient Hb response to ESA therapy or a rate of Hb rise of > 1 g/dL over 2 weeks may be at an even greater risk for cardiovascular reactions and mortality than other patients.
Q4W = every 4 weeks; SC = subcutaneous.
Available as a prefilled syringe.
Extended dosing* with proven hemoglobin control
*Due to the longer serum half-life, ARANESP® should be administered less frequently than epoetin alfa. ARANESP® should be administered once a week (QW) if a patient was receiving epoetin alfa 2 to 3 times weekly.
ARANESP® should be administered once every 2 weeks (Q2W) if a patient was receiving epoetin alfa once per week.
References:
ARANESP® (darbepoetin alfa) and EPOGEN® (epoetin alfa) Important Safety Information, including Boxed WARNINGS
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
Cancer:
Perisurgery (EPOGEN®):
Please see ARANESP® full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Please see EPOGEN® full Prescribing Information, including Boxed WARNINGS and Medication Guide.
ARANESP® (darbepoetin alfa) and EPOGEN® (epoetin alfa) Important Safety Information, including Boxed WARNINGS
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
Cancer:
Perisurgery (EPOGEN®):
Please see ARANESP® full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Please see EPOGEN® full Prescribing Information, including Boxed WARNINGS and Medication Guide.