Data from FDA - Curated by EPG Health - Last updated 11 July 2018

Indication(s)

1 INDICATIONS AND USAGE Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2). Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being (1.3). Aranesp is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy (1.3). In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.3). In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion (1.3). As a substitute for RBC transfusions in patients who require immediate correction of anemia (1.3). 1.1 Anemia Due to Chronic Kidney Disease Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. 1.2 Anemia Due to Chemotherapy in Patients with Cancer Aranesp is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. 1.3 Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being. Aranesp is not indicated for use: • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. • In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. • In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. • As a substitute for RBC transfusions in patients who require immediate correction of anemia.

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Advisory information

contraindications
4 CONTRAINDICATIONS Aranesp is contraindicated in patients with: Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )]. Pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs [see Warnings and Precautions ( 5.6 )]. Serious allergic reactions to Aranesp [see Warnings and Precautions ( 5.7 )]. Uncontrolled hypertension (4) Pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs (4) Serious allergic reactions to Aranesp (4)
Adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions ( 5.1 )] Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Seizures [see Warnings and Precautions ( 5.4 )] PRCA [see Warnings and Precautions ( 5.6 )] Serious allergic reactions [see Warnings and Precautions ( 5.7 )] Severe Cutaneous Reactions [see Warnings and Precautions ( 5.8 )] Patients with CKD: Adverse reactions in ≥ 10% of Aranesp-treated patients in clinical studies were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension (6.1). Patients with Cancer Receiving Chemotherapy: Adverse reactions in ≥ 1% of Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. Patients with Chronic Kidney Disease Adult Patients Adverse reactions were determined based on pooled data from 5 randomized, active-controlled studies of Aranesp with a total of 1357 patients (Aranesp 766, epoetin alfa 591). The median duration of exposure for patients receiving Aranesp was 340 days, with 580 patients exposed for greater than 6 months and 360 patients exposed for greater than 1 year. The median (25th, 75th percentiles) weight-adjusted dose of Aranesp was 0.50 mcg/kg (0.32, 0.81). The median (range) age for patients administered Aranesp was 62 years (18 to 88). In the Aranesp group, 55% were male, 72% were white, 83% were receiving dialysis, and 17% were not receiving dialysis. Table 5 lists adverse reactions occurring in ≥ 5% of patients treated with Aranesp. Table 5. Adverse Reactions Occurring in ≥ 5% of Patients with CKD Adverse Reaction Patients Treated w ith Aranesp (n = 766) Hypertension 31% Dyspnea 17% Peripheral edema 17% Cough 12% Procedural hypotension 10% Angina pectoris 8% Vascular access complications 8% Fluid overload 7% Rash/Erythema 5% Arteriovenous graft thrombosis 5% Rates of adverse reactions with Aranesp therapy were similar to those observed with other recombinant erythropoietins in these studies. Pediatric Patients Adverse reactions were determined based on pooled data from 2 randomized, controlled trials [see Clinical Studies ( 14.1 )]. In one study, Aranesp was administered to 81 pediatric patients with CKD who had stable hemoglobin concentrations while previously receiving epoetin alfa. In a second study, Aranesp was administered to 114 anemic pediatric patients with CKD receiving or not receiving dialysis for initial treatment of anemia. In these studies, the most frequently reported serious adverse reactions with Aranesp were hypertension and convulsions. The most commonly reported adverse reactions were hypertension, injection site pain, rash, and convulsions. Aranesp administration was discontinued because of injection site pain in 2 patients and hypertension in 3 patients. Patients with Cancer Receiving Chemotherapy Adverse reactions were based on data from a randomized, double-blind, placebo-controlled study of Aranesp in 597 patients (Aranesp 301, placebo 296) with extensive stage small cell lung cancer (SCLC) receiving platinum-based chemotherapy. All patients were white, 64% were male, and the median age was 61 years (range: 28 to 82 years); 25% of the study population were from North America, Western Europe, and Australia. Patients received Aranesp at a dose of 300 mcg or placebo weekly for 4 weeks then every 3 weeks for a total of 24 weeks, and the median duration of exposure was 19 weeks (range: 1 to 26 weeks). Adverse reactions were also based on data from 7 randomized, double-blind, placebo-controlled studies, including the SCLC study described above, that enrolled 2112 patients (Aranesp 1203, placebo 909) with non-myeloid malignancies. Most patients were white (95%), male (52%), and the median age was 63 years (range: 18 to 91 years); 73% of the study population were from North America, Western Europe, and Australia. Dosing and schedules varied by study from once weekly to once every 4 weeks, and the median duration of exposure was 12 weeks (range: 1 to 27 weeks). Table 6. Thrombovascular Adverse Reactions in Patients Receiving Chemotherapy SCLC Study All Placebo-controlled Studies Adverse Reaction Aranesp (n = 301) Placebo (n = 296) Aranesp (n = 1203) Placebo (n = 909) Thromboembolic Adverse Reactions, n (%) 24 (8.0%) 13 (4.4%) 73 (6.1%) 37 (4.1%) Arterial 10 (3.3%) 3 (1.0%) 15 (1.2%) 5 (0.6%) Myocardial infarction 5 (1.7%) 0 7 (0.6%) 2 (0.2%) Venous 14 (4.7%) 10 (3.4%) 60 (5.0%) 32 (3.5%) Pulmonary embolism 5 (1.7%) 3 (1.0%) 16 (1.3%) 6 (0.7%) Cerebrovascular disorders* 14 (4.7%) 9(3.0%) 20 (1.7%) 17 (1.9%) * “Cerebrovascular disorders” encompasses CNS hemorrhages and cerebrovascular accidents (ischemic and hemorrhagic). Events in this category may also be included under “thromboembolic adverse reactions.” In addition to the thrombovascular adverse reactions, abdominal pain and edema occurred at a higher incidence in patients taking Aranesp compared to patients on placebo. Among all placebo-controlled studies, abdominal pain (13.2% vs. 9.4%) and edema (12.8% vs. 9.7%) were reported more frequently in patients receiving Aranesp compared to the placebo group. In the SCLC study the incidence of abdominal pain (10.3% vs. 3.4%) and edema (5.6% vs. 5.1%) in the Aranesp-treated patients compared to those receiving placebo. 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of Aranesp. Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Seizures [ see Warnings and Precautions ( 5.4 ) ] PRCA [ see Warnings and Precautions ( 5.6 ) ] Serious allergic reactions [ see Warnings and Precautions ( 5.7 ) ] Severe Cutaneous Reactions [see Warnings and Precautions ( 5.8 )] 6.3 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. In clinical studies, the percentage of patients with antibodies to Aranesp was examined using the Biacore® assay. Sera from 1501 patients with CKD and 1159 patients with cancer were tested. At baseline, prior to Aranesp treatment, binding antibodies were detected in 59 patients (4%) with CKD and 36 patients with cancer (3%). During Aranesp therapy (range: 22 to 177 weeks), a follow-up sample was taken. One additional patient with CKD and 8 additional patients with cancer developed antibodies capable of binding Aranesp. In two studies of pediatric patients with CKD aged 2-16, 20 of 111 patients with CKD (18%) receiving dialysis and 6 of 69 patients (9%) not receiving dialysis had anti-ESA antibodies at baseline. During therapy, 4 additional patients receiving dialysis and 4 additional patients not receiving dialysis developed antibodies capable of binding Aranesp. None of the patients had antibodies capable of neutralizing the activity of Aranesp or endogenous erythropoietin at baseline or at end of study. No clinical sequelae consistent with PRCA were associated with the presence of these antibodies. The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Aranesp with the incidence of antibodies to other products may be misleading. Neutralizing antibodies to darbepoetin alfa that cross-react with endogenous erythropoietin and other ESAs can result in PRCA or severe anemia (with or without other cytopenias) [ see Warnings and Precautions ( 5.6 ) ].

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Recommended starting dose for patients with CKD on dialysis (2.2): - 0.45 mcg/kg intravenously or subcutaneously weekly, or - 0.75 mcg/kg intravenously or subcutaneously every 2 weeks - Intravenous route is recommended for patients on hemodialysis Recommended starting dose for patients with CKD not on dialysis (2.2): - 0.45 mcg/kg intravenously or subcutaneously at 4 week intervals Recommended starting dose for pediatric patients with CKD: - 0.45 mcg/kg intravenously or subcutaneously weekly - patients with CKD not on dialysis may also be initiated at 0.75 mcg/kg every 2 weeks Recommended starting dose for patients with cancer on chemotherapy (2.3): - 2.25 mcg/kg subcutaneously weekly, or - 500 mcg subcutaneously every 3 weeks 2.1 Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Monitoring of Response to Therapy Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Aranesp [ see Warnings and Precautions ( 5.10 ) ]. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. 2.2 Patients with 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, Aranesp dose, or dosing strategy that does not increase these risks. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions ( 5.1 )]. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies ( 14 ) ]. For all patients with CKD When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin 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. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Aranesp by 25% or more as needed to reduce rapid responses. 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%. For patients who do not respond adequately over a 12-week escalation period, increasing the Aranesp dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Aranesp if responsiveness does not improve. For adult patients with CKD on dialysis : Initiate Aranesp 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 Aranesp. The recommended starting dose is 0.45 mcg/kg intravenously or subcutaneously as a weekly injection or 0.75 mcg/kg once every 2 weeks as appropriate. The intravenous route is recommended for patients on hemodialysis. For adult patients with CKD not on dialysis : Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply: ° The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and, ° Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal. If the hemoglobin 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. The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. For pediatric patients with CKD : Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. The recommended starting dose for pediatric patients (less than 18 years) is 0.45 mcg/kg body weight administered as a single subcutaneous or intravenous injection once weekly; patients not receiving dialysis may also be initiated at a dose of 0.75 mcg/kg once every 2 weeks. When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions ( 5.1 and 5.2 ). Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis Aranesp is administered less frequently than epoetin alfa. Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. Estimate the starting weekly dose of Aranesp for adults and pediatric patients on the basis of the weekly epoetin alfa dose at the time of substitution (see Table 1). Maintain the route of administration (intravenous or subcutaneous injection). Table 1. Estimated Aranesp Starting Doses (mcg/week) for Patients with CKD on Dialysis Based on Previous Epoetin alfa Dose (Units/week) Previous Weekly Epoetin alfa Dose (Units/week) Aranesp Dose (mcg /week ) Adult Pediatric < 1,500 6.25 * 1,500 to 2,499 6.25 6.25 2,500 to 4,999 12.5 10 5,000 to 10,999 25 20 11,000 to 17,999 40 40 18,000 to 33,999 60 60 34,000 to 89,999 100 100 ≥ 90,000 200 200 *For pediatric patients receiving a weekly epoetin alfa dose of < 1,500 Units/week, the available data are insufficient to determine an Aranesp conversion dose. Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis Refer to Table 1. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. 2.3 Patients on Cancer Chemotherapy Initiate Aranesp in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. Recommended Starting Dose The recommended starting dose and schedules are: 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. Table 2. Dose Adjustment Dose Adjustment Weekly Schedule Every 3 Week Schedule If hemoglobin increases greater than 1 g/dL in any 2-week period or If hemoglobin reaches a level needed to avoid RBC transfusion Reduce dose by 40% Reduce dose by 40% If hemoglobin exceeds a level needed to avoid RBC transfusion Withhold dose until hemoglobin approaches a level where RBC transfusions may be required Reinitiate at a dose 40% below the previous dose Withhold dose until hemoglobin approaches a level where RBC transfusions may be required Reinitiate at a dose 40% below the previous dose If hemoglobin increases by less than 1 g/dL and remains below 10 g/dL after 6 weeks of therapy Increase dose to 4.5 mcg/kg/week No dose adjustment If there is no response as measured by hemoglobin levels or if RBC transfusions are still required after 8 weeks of therapy Following completion of a chemotherapy course Discontinue Aranesp Discontinue Aranesp 2.4 Preparation and Administration The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Do not shake. Do not use Aranesp that has been shaken or frozen. Protect vials and prefilled syringes from light. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. Discard unused portion of Aranesp in vials or prefilled syringes. Do not re-enter vial. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. Self-Administration of the Prefilled Syringe Training should aim to demonstrate to those patients and caregivers how to measure the dose of Aranesp, and the focus should be on ensuring that a patient or caregiver can successfully perform all of the steps in the Instructions for Use for a prefilled syringe. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of Aranesp or whether the patient would benefit from a different Aranesp presentation. If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire contents of the Aranesp prefilled syringe, use of the Aranesp vial may be considered.
Use in special populations
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. Pregnancy Surveillance Program is available (8.1). Nursing Mothers: Exercise caution when Aranesp is administered to a nursing woman (8.3). 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of Aranesp use in pregnant women. In animal reproduction and developmental toxicity studies, Aranesp increased early post-implantation loss. Use Aranesp during pregnancy only if the potential benefit justifies the potential risk to the fetus. When Aranesp was administered intravenously to healthy pregnant rats and rabbits, there was no evidence of embryofetal toxicity or other adverse outcomes at the intravenous doses tested, up to 20 mcg/kg/day. This animal dose level of 20 mcg/kg/day is approximately 20-fold higher than the clinical recommended starting dose, depending on the patient’s treatment indication. Slightly reduced fetal weights were observed when healthy rat and rabbit mothers received doses of 1 mcg/kg or more. This dose of 1 mcg/kg is near the clinical recommended starting dose. While no adverse effects on uterine implantation occurred in animals, there was an increase in early post-implantation loss in animal fertility studies. It is not clear whether the increased post-implantation loss reflects a drug effect on the uterine environment or on the conceptus. No significant placental transfer of Aranesp was detected. In a peri/postnatal development study, pregnant female rats received Aranesp intravenously every other day from implantation throughout pregnancy and lactation. The lowest dose tested, 0.5 mcg/kg, did not cause fetal toxicity; this dose is approximately equivalent to the clinical recommended starting dose. At maternal doses of 2.5 mcg/kg and higher, pups had decreased fetal body weights, which correlated with a slight increase in the incidence of fetal deaths, as well as delayed eye opening and delayed preputial separation [see Nonclinical Toxicology ( 13.3 )]. Women who become pregnant during Aranesp treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800-772-6436 (1-800-77-AMGEN) to enroll. 8.3 Nursing Mothers It is not known whether Aranesp is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Aranesp is administered to a nursing woman. 8.4 Pediatric Use Pediatric Patients with CKD Aranesp safety and efficacy were similar between adults and pediatric patients with CKD when Aranesp was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Aranesp [ see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ) , and Clinical Studies ( 14.1 ) ]. Pediatric Patients with Cancer The safety and efficacy of Aranesp in pediatric patients with cancer have not been established. 8.5 Geriatric Use Of the 1801 patients with CKD in clinical studies of Aranesp, 44% were age 65 and over, while 17% were age 75 and over. Of the 873 patients in clinical studies receiving Aranesp and concomitant cancer chemotherapy, 45% were age 65 and over, while 14% were age 75 and over. No differences in safety or efficacy were observed between older and younger patients.
Pregnancy and lactation
8.3 Nursing Mothers It is not known whether Aranesp is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Aranesp is administered to a nursing woman.

Interactions

7 DRUG INTERACTIONS No formal drug interaction studies have been conducted with Aranesp.

More information

Category Value
Authorisation number BLA103951
Agency product number 15UQ94PT4P
Orphan designation No
Product NDC 55513-028,55513-098,55513-023,55513-111,55513-110,55513-027,55513-032,55513-005,55513-004,55513-006,55513-025,55513-003,55513-002,55513-021,55513-053,55513-057
Date Last Revised 25-01-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 731167
Marketing authorisation holder Amgen Inc
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 [ see Warnings and Precautions ( 5.1 )]. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks [see Dosage and Administration ( 2.2 )] . Use the lowest Aranesp dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions ( 5.1 )]. 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 [ see Warnings and Precautions ( 5.2 )]. To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration ( 2.3 )]. Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage ( 1.2 )]. ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage ( 1.3 )]. Discontinue following the completion of a chemotherapy course [see Dosage and Administration ( 2.3 )]. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. 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 ( 5.1 ). No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks ( 2.2 ) . Use the lowest Aranesp dose sufficient to reduce the need for red blood cell (RBC) transfusions ( 5.1 ). 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 ( 5.2 ) . Use the lowest dose to avoid RBC transfusions ( 2.3 ) . Use ESAs only for anemia from myelosuppressive chemotherapy ( 1.2 ) . ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.3 ) . Discontinue following the completion of a chemotherapy course ( 2.3 ) .