Indications and Limitations of Use

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 red blood cell (RBC) transfusion.

For your practice

Amgen Anemia management Institute (AMI)® —

Anemia in CKD educational Programs

assesing-hemoglobin

Learn about factors that may affect hemoglobin (Hb) levels and how to evaluate trends in lab values for patients with anemia.

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kidney-physiology

This program provides an overview of the kidney’s role in the normal physiology of RBC production and the pathophysiology of RBC production due to inadequate erythropoietin levels in patients with anemia due to CKD on dialysis.

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pathophysiology

Explore the feedback loop that governs the normal production of red blood cells and how that process is disrupted through defective erythropoietin production in patients with CKD.

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role-of-iron

Discover the role of iron in normal red blood cell development, the mechanism of iron transport, and how absolute or functional iron deficiencies may disrupt red blood cell production.

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AMI® — Aranesp® (darbepoetin alfa) injection Treatment Training Programs

addressing-anemia

This program discusses the physiology of red blood cell (RBC) production, the role of Aranesp® in increasing hemoglobin (Hb) levels, and anemia treatment approaches in patients with CKD on dialysis.

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aranesp-case-study-dialysis-patient

This hypothetical case study examines the experience of a patient with CKD on hemodialysis who has acquired anemia and is being converted from epoetin alfa to Aranesp®.

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aranesp-case-study-post-hospitalized-patient

This hypothetical case study documents the experience of patients with anemia due to CKD who are on hemodialysis and receiving Aranesp®. Both patients experience hospitalization and changes in hemoglobin.

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aranesp-case-study-hemodialysis

This hypothetical case study documents the experience of a patient who has anemia due to CKD, and is new to hemodialysis. This program is promotional in nature and subject to Food and Drug Administration rules and Amgen internal policies for providing fair balance on the approved uses of their products, including full disclosure of the associated risks and benefits.

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Other

case-study-management

View a webinar presentation by Dr. Indu Lew about key considerations when using Aranesp® in your dialysis facility. Find out how Aranesp® could work for your anemia patients with CKD on dialysis and what support and services are available from Amgen.

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infection-and-inflammation

Learn how infection and inflammatory processes may contribute to red blood cell level reduction through inhibition of erythropoietin production and promotion of iron sequestration.

Read more
aranesp-erythrokinetics

Learn about the production/destruction cycle of red blood cells and how this process is disrupted in patients with CKD.

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*Case studies and patient profiles are hypothetical.

AMI = Anemia Management Institute; CKD = chronic kidney disease; Hb = hemoglobin; NKF = National Kidney Foundation.

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Assessing Hemoglobin (Hb) Trends for Anemia Management in CKD Patients

Learn about factors that may affect hemoglobin (Hb) levels and how to evaluate trends in lab values for patients with anemia.

Kidney Physiology and Anemia of CKD

This program provides an overview of the kidney’s role in the normal physiology of RBC production and the pathophysiology of RBC production due to inadequate erythropoietin levels in patients with anemia due to CKD on dialysis.

Pathophysiology of Anemia in Patients With CKD

Explore the feedback loop that governs the normal production of red blood cells and how that process is disrupted through defective erythropoietin production in patients with CKD.

Role of Iron

Discover the role of iron in normal red blood cell development, the mechanism of iron transport, and how absolute or functional iron deficiencies may disrupt red blood cell production.

Addressing Anemia Due to CKD in Patients on Dialysis: About Aranesp®

This program discusses the physiology of red blood cell (RBC) production, the role of Aranesp® in increasing hemoglobin (Hb) levels, and anemia treatment approaches in patients with CKD on dialysis.

Indications and Limitations of Use

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 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.

Please see Important Safety Information for Aranesp® and EPOGEN®, including Boxed WARNINGS about INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE, below and click to see Aranesp® full prescribing information and EPOGEN® full prescribing information, including Medication Guides.

Aranesp® Case Study: Anemia Due to CKD in the Dialysis Patient*

This hypothetical case study examines the experience of a patient with CKD on hemodialysis who has acquired anemia and is being converted from epoetin alfa to Aranesp®.

*Case studies and patient profiles are hypothetical.

Indications and Limitations of Use

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 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.

Please see Important Safety Information for Aranesp® and EPOGEN®, including Boxed WARNINGS about INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE, below and click to see Aranesp® full prescribing information and EPOGEN® full prescribing information, including Medication Guides.

Aranesp® Case Study: Anemia in CKD—Post-Hospitalized Patients on Dialysis*

This hypothetical case study documents the experience of patients with anemia due to CKD who are on hemodialysis and receiving Aranesp®. Both patients experience hospitalization and changes in hemoglobin.

*Case studies and patient profiles are hypothetical.

Indications and Limitations of Use

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 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.

Please see Important Safety Information for Aranesp® and EPOGEN®, including Boxed WARNINGS about INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE, below and click to see Aranesp® full prescribing information and EPOGEN® full prescribing information, including Medication Guides.

Aranesp® Case Study: Anemia in CKD—New Patient on Hemodialysis*

This hypothetical case study documents the experience of a patient who has anemia due to CKD, and is new to hemodialysis. This program is promotional in nature and subject to Food and Drug Administration rules and Amgen internal policies for providing fair balance on the approved uses of their products, including full disclosure of the associated risks and benefits.

*Case studies and patient profiles are hypothetical.

Indications and Limitations of Use

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 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.

Please see Important Safety Information for Aranesp® and EPOGEN®, including Boxed WARNINGS about INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE, below and click to see Aranesp® full prescribing information and EPOGEN® full prescribing information, including Medication Guides.

Case Study: Anemia in CKD Management Webinar*

View a webinar presentation by Dr. Indu Lew about key considerations when using Aranesp® in your dialysis facility. Find out how Aranesp® could work for your anemia patients with CKD on dialysis and what support and services are available from Amgen.

*Case studies and patient profiles are hypothetical.

Indications and Limitations of Use

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 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.

Please see Important Safety Information for Aranesp® and EPOGEN®, including Boxed WARNINGS about INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE, below and click to see Aranesp® full prescribing information and EPOGEN® full prescribing information, including Medication Guides.

Infection and Inflammation

Learn how infection and inflammatory processes may contribute to red blood cell level reduction through inhibition of erythropoietin production and promotion of iron sequestration.

Aranesp® Erythrokinetics

Learn about the production/destruction cycle of red blood cells and how this process is disrupted in patients with CKD.

*Case studies and patient profiles are hypothetical.

Important Safety Information

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.
  • 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® (darbepoetin alfa) and EPOGEN® (epoetin alfa) 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.

Indications and Limitations of Use

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 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.

Please click to see accompanying Aranesp® full prescribing information and EPOGEN® full prescribing information, including Boxed WARNINGS and Medication Guide.