Indications

ARANESP® (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

EPOGEN® (epoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for READ MORE

EPOGEN® (epoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for red blood cell (RBC) transfusion.

Limitations of Use:

  • ARANESP® and EPOGEN® have not been shown to improve quality of life, fatigue, or patient well-being.
  • ARANESP® and EPOGEN® are not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
Home | Amgen ESA | HCP

ESAs: Standard of care you and your patients have come to rely on

Amgen ESAs have robust experience in helping HCPs manage anemia in CKD

esa_esa_experience_icons_1

20+ YEARS

Amgen ESAs are well-studied
and a proven option for patients
with anemia due to CKD1,2

esa_esa_experience_icons_2

300M VIALS

of Amgen ESAs
distributed to date3,*

esa_esa_experience_icons_3

1OM PATIENTS

treated in real-world
settings4,5,†


The risk-benefit profile of ESAs is well characterized1,2



*Distribution in the United States in the postmarketing setting from April 1, 2018 through December 31, 2020.

†Combined data for EPOGEN® and ARANESP® in the postmarketing setting from launch through December 31, 2020. For EPOGEN®, data on incident and prevalent number of patients on dialysis and market share are used to estimate number of patients exposed. For ARANESP®, the number of patients exposed are based on sales revenue data.

ESAs = erythropoiesis-stimulating agents; HCPs = healthcare providers; Hb = hemoglobin.


One hormone. One receptor.
One path to red blood cell formation.


Pioneering research by Amgen led to the development of ESAs, which are specifically designed to treat anemia due to CKD.1,2

Amgen ESAs utilize a well-characterized, targeted mechanism that is the same as endogenous erythropoietin to stimulate erythropoiesis1,2,6
Illustration of MOA for Amgen ESAs showing one hormone, one receptor, one path to red blood cell formation


BFU-E = burst-forming unit-erythroid; CFU-E = colony-forming unit-erythroid; EpoR = erythropoeitin receptor.

Real-world data over the past decade demonstrate
the Hb stability offered by ESAs in clinical practice



Amgen ESA efficacy demonstrated in clinical trials
  • In clinical studies, more than 95% of patients receiving EPOGEN® for 3 months avoided RBC transfusion1,†
  • In a multicenter, randomized, open-label study, more than 95% of patients on dialysis had their Hb successfully maintained with ARANESP® on the same dose frequency as baseline13,‡

Mean monthly Hb among ARANESP® and EPOGEN® patients10,*

Line graph showing real-world data that demonstrates stability of ESAs in clinical practice

Amgen ESA efficacy demonstrated in clinical trials
  • In clinical studies, more than 95% of patients receiving EPOGEN® for 3 months avoided RBC transfusion1,†
  • In a multicenter, randomized, open-label study, more than 95% of patients on dialysis had their Hb successfully maintained with ARANESP® on the same dose frequency as baseline13,‡

Data are derived from real-world sources and not from a controlled clinical study. Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusion of statistical or clinical significance can be drawn.

*Data from users of either EPOGEN® or ARANESP® were ascertained from Medicare claims in the United States Renal Data System (USRDS) Standard Analysis Files between January 2008 to December 2018. For each calendar month, all Medicare Part B claims in the USRDS Standard Analysis Files were collected. EPOGEN® use was defined by claims including Healthcare Common Procedure Coding System (HCPCS) codes J0885 and Q4081, whereas ARANESP® use was defined by claims including HCPCS codes J0881 and J0882. If more than one hemoglobin measurement was reported in a single month, the mean of all measurements was estimated.10

†Data from 13 clinical studies involving IV administration of EPOGEN® to 1010 anemic adult patients on dialysis. Starting doses were 50 to 150 Units/kg TIW. In the 3 largest studies, the median maintenance dose necessary to maintain the Hb between 10 and 12 g/dL was approximately 75 Units/kg TIW.1

‡Data from a multicenter, randomized, open-label study comparing epoetin, given 1, 2, or 3 times weekly IV or SC, with ARANESP®, at a reduced dose frequency, in dialysis patients (N = 522). Dose adjustments were made as necessary and per study protocol to maintain individual patients’ Hb within a target range of –1.0 to +1.5 g/dL of their baseline Hb and between 9 g/dL and 13 g/dL for up to 52 weeks. The primary endpoint was the change in Hb between baseline and the evaluation period at weeks 25 to 32 of treatment. The mean change in Hb from baseline to the evaluation period was similar in the ARANESP® and epoetin groups, and the difference between the two treatment groups was 0.03 g/dL. This was not a statistically significant or clinically relevant difference. 97% (178/183) of patients’ Hb levels were successfully maintained on ARANESP® QW or less after conversion from epoetin during the evaluation period.13

TIW = three times a week; IV = intravenous; SC = subcutaneous; QW = once weekly.

Following 2011 guideline changes, lower Hb and lower doses
for both ARANESP® and EPOGEN® have been observed10,*



Mean monthly Hb and mean weekly ARANESP® dose10

Line graph showing lower doses for ARANESP® and lower Hb levels after 2011 guideline changes

Mean monthly Hb and mean weekly EPOGEN® dose10

Line graph showing lower doses for EPOGEN® and lower Hb levels after 2011 guideline changes

In keeping with guideline changes, fewer patients receive higher doses

Percent of patients by ARANESP® dose (mcg/wk)10

2008 n = 17,630 2018 n = 38,337
< 60 mcg/wk 67.3% 82.5%
60-99 mcg/wk 16.3% 11.5%
≥ 100 mcg/wk 16.5% 6.0%
Average dose 59.0 mcg/wk 36.1 mcg/wk

Percent of patients by EPOGEN® dose (IU/wk)10

2008 n = 220,093 2018 n = 101,780
< 25,000 lU/wk 78.0% 93.3%
25,000-49,999 IU/wk 15.5% 6.0%
≥ 50,000 IU/wk 6.5% 0.7%
Average dose 17,384 IU/wk 10,550 IU/wk


*Data from users of either EPOGEN® or ARANESP® were ascertained from Medicare claims in the USRDS Standard Analysis Files between January 2008 to December 2018. For each calendar month, all Medicare Part B claims in the USRDS Standard Analysis Files were collected. EPOGEN® use was defined by claims including Healthcare Common Procedure Coding System (HCPCS) codes J0885 and Q4081, whereas ARANESP® use was defined by claims including HCPCS codes J0881 and J0882. If more than one hemoglobin measurement was reported in a single month, the mean of all measurements was estimated. The cumulative weekly dose of each ESA was derived by dividing the cumulative monthly dose by the number of calendar days in the month, and subsequently multiplying that quotient by 7.10

In any given month, less than 25% of patients
treated with an ESA had Hb < 10 g/dL10,*

Percent of patients with Hb < 10 g/dL and ≥ 10 g/dL10

Bar chart showing percentages of patients with Hb <10 g/dL in any given month from October 2018 through September 2019.

However, when patients experience Hb <10 g/dL
during ESA treatment, it is generally transient10,*

Average percent of patients experiencing consecutive months with Hb < 10 g/dL10,† Line graph showing how Hb <10% g/dL in many patients is transient over a 6-month period

Only
~7% of patients have Hb < 10 g/dL
for 3 months or longer
Only
~3%of patients have Hb < 10 g/dL
for 5 months or longer

Data are derived from real-world sources and not from a controlled clinical study. Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusion of statistical or clinical significance can be drawn.

*Data from users of either EPOGEN® or ARANESP® were ascertained from Medicare claims in the United States Renal Data System (USRDS) Standard Analysis Files between January 2008 to December 2018. For each calendar month, all Medicare Part B claims in the USRDS Standard Analysis Files were collected. EPOGEN® use was defined by claims including Healthcare Common Procedure Coding System (HCPCS) codes J0885 and Q4081, whereas ARANESP® use was defined by claims including HCPCS codes J0881 and J0882. Monthly data regarding the prevalence of k (k = 1, 2, …, 6) consecutive months with hemoglobin < 10 g/dL was estimated using CROWNWeb data in the USRDS Standard Analysis Files. For each calendar month, hemodialysis patients were identified, according to the presence of a single-pool Kt/V measurement. Those patients with a hemoglobin measurement in the month at hand and in each of the preceding 5 calendar months were retained for analysis. During that 6-month interval, the prevalence of k consecutive months with hemoglobin < 10 g/dL was estimated, using hemoglobin values during the month at hand and during the immediately preceding k-1 months (for k > 1).10

†Data from 10/2018 - 9/2019.

Underlying conditions may be responsible for inadequate
increases in Hb during ESA treatment1,2

Icon indicating inflammation that may be responsible for inadequate increases in Hb during ESA treatment

INFLAMMATION

Icon indicating iron deficiency that may be responsible for inadequate increases in Hb during ESA treatment

IRON DEFICIENCY

con indicating bleeding that may be responsible for inadequate increases in Hb during ESA treatment

BLEEDING

Icon indicating that infection may be responsible for inadequate increases in Hb during ESA treatment

INFECTION

It may be critical to focus on other causative factors that may be responsible for lack of Hb response irrespective of ESA treatment

Amgen ESAs are designed with flexible dosing
options and IV administration that you control

Individualized anemia management and well-established protocols1,2,*

ARANESP®
Icon of a vial and syringe representing multiple dosing options for ARANESP®

Multiple dosing options (single-dose vials and prefilled syringes)2

  • 10 mcg,† 25 mcg, 40 mcg, 60 mcg, 100 mcg, 150 mcg,† 200 mcg, 300 mcg, 500 mcg†
  • Can be combined for precise titration within 5 mcg intervals

Icons of calendars to illustrate QW and Q2W dosing options for ARANESP®

QW or Q2W administration2


EPOGEN®
Icon of 2 vials to illustrate that EPOGEN® is available in single-dose and multidose vials

Multiple dosing options (single-dose vials and multidose vials)1

  • 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, 20,000 Units/mL
  • Innovative dosing options for precise titration

Icon of a calendar to illustrate TIW dosing for EPOGEN®

TIW administration1



*The IV route of administration is recommended for adult patients on hemodialysis.

†Only available as prefilled syringe.

Q2W = once every 2 weeks.

LEARN MORE ABOUT ARANESP® 
LEARN MORE ABOUT EPOGEN®

References:

  1. EPOGEN® (epoetin alfa) prescribing information, Amgen.
  2. ARANESP® (darbepoetin alfa) prescribing information, Amgen.
  3. Data on file, Amgen; [ESA Units; 2021].
  4. Data on file, Amgen; [ARANESP® Patient Years; 2021].
  5. Data on file, Amgen; [EPOGEN® Patient Years; 2021].
  6. Elliott S, Sinclair A, Collins H. Progress in detecting cell-surface protein receptors: the erythropoietin receptor example. Ann Hematol. 2014;93:181-192.
  7. Hillman RS, Finch CA. General characteristics of the erythron.In: Hillman RS, Finch CA, eds. Red Cell Manual Edition. 7th ed. 1996. Philadelphia, PA: F.A. Davis Company; 1996:1-15.
  8. Dessypris EN. Erythropoiesis. In: Lee GR, Foerster J, Lukens J, Wintrobe MM, eds. Wintrobe’s Clinical Hematology. Vol. 1.10th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 1998:169-192.
  9. Bunn H. Pathophysiology of the anemias. In: Isselbacher KJ, Wilson JD, Braunwald E, eds. Harrison’s Principles and Practice of Internal Medicine. 13th ed. New York, NY: McGraw-Hill; 1994:1717-1721.
  10. Data on file, Amgen; [Amgen ESA Real-World Data; 2021].
  11. Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kidney Int Suppl. 2012;2, 279; doi:10.1038/kisup.2012.37.
  12. US FDA. FDA drug safety communication: modified dosing recommendations to improve the safe use of erythropoiesis-stimulating agents (ESAs) in chronic kidney disease. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-modified-dosing-recommendations-improve-safe-use-erythropoiesis. Accessed March 17, 2021.
  13. Vanrenterghem Y, Barany P, Mann JFE, et al. Randomized trial of darbepoetin alfa for treatment of renal anemia at a reduced dose frequency compared with rHuEPO in dialysis patients. Kidney Int. 2002;62:2167-2175.

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:

  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin 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.
  • Use the lowest ARANESP® or EPOGEN® dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer:

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
  • To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
  • Use ESAs only for anemia from myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.

Perisurgery (EPOGEN®):

  • Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended.
  • ARANESP® and EPOGEN® are contraindicated in patients with:
    • Uncontrolled hypertension
    • Pure red cell aplasia (PRCA) that begins after treatment with ARANESP®, EPOGEN®, or other erythropoietin protein drugs
    • Serious allergic reactions to ARANESP® or EPOGEN®
  • EPOGEN® from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women.
  • Use caution in patients with coexistent cardiovascular disease and stroke.
  • Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.
  • Control hypertension prior to initiating and during treatment with ARANESP® or EPOGEN®.
  • ARANESP® and EPOGEN® increase the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency.
  • For lack or loss of hemoglobin response to ARANESP® or EPOGEN®, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA.
  • 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 ARANESP® or 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 ARANESP® and EPOGEN® are not approved).
    • If severe anemia and low reticulocyte count develop during treatment with ARANESP® or EPOGEN®, withhold ARANESP® or EPOGEN® and evaluate patients for neutralizing antibodies to erythropoietin.
    • Permanently discontinue ARANESP® or EPOGEN® in patients who develop PRCA following treatment with ARANESP®, EPOGEN®, or other erythropoietin protein drugs. Do not switch patients to other ESAs.
  • Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with ARANESP® or EPOGEN®. Immediately and permanently discontinue ARANESP® or EPOGEN® if a serious allergic reaction occurs.
  • Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including ARANESP® and EPOGEN®) in the postmarketing setting. Discontinue ARANESP® or EPOGEN® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.
  • Serious and fatal reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including EPOGEN® multiple-dose vials. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breast-fed milk, respectively.
  • Adverse reactions (≥ 10%) in ARANESP® clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension.
  • Adverse reactions (≥ 5%) in EPOGEN® clinical studies in patients with CKD were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.

Please see ARANESP® full Prescribing Information, including Boxed WARNINGS and Medication Guide.

Please see EPOGEN® full Prescribing Information, including Boxed WARNINGS and Medication Guide.

See More

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease: • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin 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. • Use the lowest ARANESP® or EPOGEN® dose sufficient to reduce the need for red blood cell (RBC) transfusions.

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:

  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin 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.
  • Use the lowest ARANESP® or EPOGEN® dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer:

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
  • To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
  • Use ESAs only for anemia from myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.

Perisurgery (EPOGEN®):

  • Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended.
  • ARANESP® and EPOGEN® are contraindicated in patients with:
    • Uncontrolled hypertension
    • Pure red cell aplasia (PRCA) that begins after treatment with ARANESP®, EPOGEN®, or other erythropoietin protein drugs
    • Serious allergic reactions to ARANESP® or EPOGEN®
  • EPOGEN® from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women.
  • Use caution in patients with coexistent cardiovascular disease and stroke.
  • Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.
  • Control hypertension prior to initiating and during treatment with ARANESP® or EPOGEN®.
  • ARANESP® and EPOGEN® increase the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency.
  • For lack or loss of hemoglobin response to ARANESP® or EPOGEN®, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA.
  • 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 ARANESP® or 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 ARANESP® and EPOGEN® are not approved).
    • If severe anemia and low reticulocyte count develop during treatment with ARANESP® or EPOGEN®, withhold ARANESP® or EPOGEN® and evaluate patients for neutralizing antibodies to erythropoietin.
    • Permanently discontinue ARANESP® or EPOGEN® in patients who develop PRCA following treatment with ARANESP®, EPOGEN®, or other erythropoietin protein drugs. Do not switch patients to other ESAs.
  • Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with ARANESP® or EPOGEN®. Immediately and permanently discontinue ARANESP® or EPOGEN® if a serious allergic reaction occurs.
  • Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including ARANESP® and EPOGEN®) in the postmarketing setting. Discontinue ARANESP® or EPOGEN® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.
  • Serious and fatal reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including EPOGEN® multiple-dose vials. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breast-fed milk, respectively.
  • Adverse reactions (≥ 10%) in ARANESP® clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension.
  • Adverse reactions (≥ 5%) in EPOGEN® clinical studies in patients with CKD were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.

Please see ARANESP® full Prescribing Information, including Boxed WARNINGS and Medication Guide.

Please see EPOGEN® full Prescribing Information, including Boxed WARNINGS and Medication Guide.