FDA announced the approval of peginesatide (Omontys—Affymax, Takeda) for the management of anemia in adult patients who have chronic kidney disease (CKD) and are receiving dialysis. This new erythropoiesis-stimulating agent (ESA) is a once-monthly injection, minimizing the need for more frequent injections.This new ESA is unique in that its amino acid sequence is unrelated to that of erythropoietin; therefore, it is unlikely to induce a cross-reactive immune response against either endogenous or recombinant erythropoietin. In addition, it is the only ESA not manufactured by Amgen. The product will be marketed in single-use vials, multiuse vials, and single-use prefllled syringes.Anemia in CKDApproximately 26.3 million people in the United States have CKD, and a 2011 report from the U.S. Renal Data System estimated that 571,414 Americans have end stage renal disease, with approximately 398,861 of these patients on dialysis. CKD is characterized as a progressive disease associated with many complications that are often related directly to the loss of kidney function. Anemia is a common and major medical issue in patients with CKD and can develop early in the course of the disease. Anemia worsens as kidney function declines, and the impact of untreated anemia can be substantial; patients can experience a decreased quality of life and an increased need for red blood cell transfusions.Before the commercial availability of ESAs, dialysis patients were frequently dependent on blood transfusions to treat symptomatic anemia. These transfusions were associated with significant acute and chronic complications. ESAs were introduced in the late 1980s and have become the standard of care for the management of anemia in CKD. Deciding on the appropriate ESA to use requires consideration about route of use, frequency of use, initial dose, appropriate monitoring, and potential adverse effects.Efficacy, safetyApproval of peginesatide was based on data from two randomized, active-controlled, open-label, multicenter clinical trials involving 1,608 patients with CKD who were on dialysis. The trials randomized patients with hemoglobin levels initially stabilized by ESA to receive either peginesatide once monthly or to continue their current ESA (epoetin) treatment. Results showed peginesatide to be as safe and effective as epoetin in maintaining hemoglobin levels within the studies' prespecified range of 10 to 12 g/dL.The most common adverse events, observed in 10% or more of patients receiving dialysis who were treated with peginesatide, were diarrhea, vomiting, hypertension, and arthralgias. As with other ESAs, peginesatide has numerous safety considerations (see sidebar) and was approved with a Risk Evaluation and Mitigation Strategy.Peginesatide (Omontys)Manufacturer: AffymaxDrug class: Erythropoiesis-stimulating agent (ESA)Indication: Treatment of anemia due to chronic kidney disease (CKD) in adults on dialysis■Peginesatide should not be given to patients with CKD not receiving dialysis, for treatment of anemia associated with cancer, or as a substitute for those who require red blood cell transfusions for immediate correction of anemia.Dosage: 0.04 mg/kg administered once monthly as a single I.V. or subcutaneous injection for those who are not currently receiving ESA treatment; therapy should only be initiated when hemoglobin is less than 10 g/dL.■For those previously receiving ESA therapy, the starting monthly dose of peginesatide should be estimated based on the weekly dose of epoetin alfa (Epogen—Amgen; Procrit—Centocor Ortho Biotech) or darbepoetin alfa (Aranesp—Amgen). A table is available in the prescribing information to help estimate doses. The first dose of peginesatide should be given 1 week after the last epoetin alfa dose or in place of the next scheduled dose of darbepoetin alfa.■Dosage adjustments are needed based on hemoglobin rates of rise and decline to target a hemoglobin level between 10 g/dL and 12 g/dL.■Transferrin saturation and serum ferritin should be monitored before and during treatment with peginesatide; supplemental iron should be given when serum ferritin is less than 100 μg/L or when serum transferring saturation is less than 20%.Of note: As with all ESAs, peginesatide has a boxed warning discussing how these agents increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence, especially in patients with higher hemoglobin levels (13–14 g/dL).■Peginesatide is contraindicated for use in patients with uncontrolled hypertension. Appropriate control of hypertension is needed before initiating treatment and during peginesatide therapy.■Dialysis management may need to be adjusted once peginesatide is started; this may■include increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.Patient counselingInstruct patients to read the Medication Guide before starting treatment with peginesatide. Review with patients the serious risks associated with treatment (i.e., increased risk of death, cardiovascular events). Counsel patients to undergo routine blood pressure monitoring and to adhere to prescribed antihypertensive therapies. FDA announced the approval of peginesatide (Omontys—Affymax, Takeda) for the management of anemia in adult patients who have chronic kidney disease (CKD) and are receiving dialysis. This new erythropoiesis-stimulating agent (ESA) is a once-monthly injection, minimizing the need for more frequent injections. This new ESA is unique in that its amino acid sequence is unrelated to that of erythropoietin; therefore, it is unlikely to induce a cross-reactive immune response against either endogenous or recombinant erythropoietin. In addition, it is the only ESA not manufactured by Amgen. The product will be marketed in single-use vials, multiuse vials, and single-use prefllled syringes. Anemia in CKDApproximately 26.3 million people in the United States have CKD, and a 2011 report from the U.S. Renal Data System estimated that 571,414 Americans have end stage renal disease, with approximately 398,861 of these patients on dialysis. CKD is characterized as a progressive disease associated with many complications that are often related directly to the loss of kidney function. Anemia is a common and major medical issue in patients with CKD and can develop early in the course of the disease. Anemia worsens as kidney function declines, and the impact of untreated anemia can be substantial; patients can experience a decreased quality of life and an increased need for red blood cell transfusions.Before the commercial availability of ESAs, dialysis patients were frequently dependent on blood transfusions to treat symptomatic anemia. These transfusions were associated with significant acute and chronic complications. ESAs were introduced in the late 1980s and have become the standard of care for the management of anemia in CKD. Deciding on the appropriate ESA to use requires consideration about route of use, frequency of use, initial dose, appropriate monitoring, and potential adverse effects. Approximately 26.3 million people in the United States have CKD, and a 2011 report from the U.S. Renal Data System estimated that 571,414 Americans have end stage renal disease, with approximately 398,861 of these patients on dialysis. CKD is characterized as a progressive disease associated with many complications that are often related directly to the loss of kidney function. Anemia is a common and major medical issue in patients with CKD and can develop early in the course of the disease. Anemia worsens as kidney function declines, and the impact of untreated anemia can be substantial; patients can experience a decreased quality of life and an increased need for red blood cell transfusions. Before the commercial availability of ESAs, dialysis patients were frequently dependent on blood transfusions to treat symptomatic anemia. These transfusions were associated with significant acute and chronic complications. ESAs were introduced in the late 1980s and have become the standard of care for the management of anemia in CKD. Deciding on the appropriate ESA to use requires consideration about route of use, frequency of use, initial dose, appropriate monitoring, and potential adverse effects. Efficacy, safetyApproval of peginesatide was based on data from two randomized, active-controlled, open-label, multicenter clinical trials involving 1,608 patients with CKD who were on dialysis. The trials randomized patients with hemoglobin levels initially stabilized by ESA to receive either peginesatide once monthly or to continue their current ESA (epoetin) treatment. Results showed peginesatide to be as safe and effective as epoetin in maintaining hemoglobin levels within the studies' prespecified range of 10 to 12 g/dL.The most common adverse events, observed in 10% or more of patients receiving dialysis who were treated with peginesatide, were diarrhea, vomiting, hypertension, and arthralgias. As with other ESAs, peginesatide has numerous safety considerations (see sidebar) and was approved with a Risk Evaluation and Mitigation Strategy.Peginesatide (Omontys)Manufacturer: AffymaxDrug class: Erythropoiesis-stimulating agent (ESA)Indication: Treatment of anemia due to chronic kidney disease (CKD) in adults on dialysis■Peginesatide should not be given to patients with CKD not receiving dialysis, for treatment of anemia associated with cancer, or as a substitute for those who require red blood cell transfusions for immediate correction of anemia.Dosage: 0.04 mg/kg administered once monthly as a single I.V. or subcutaneous injection for those who are not currently receiving ESA treatment; therapy should only be initiated when hemoglobin is less than 10 g/dL.■For those previously receiving ESA therapy, the starting monthly dose of peginesatide should be estimated based on the weekly dose of epoetin alfa (Epogen—Amgen; Procrit—Centocor Ortho Biotech) or darbepoetin alfa (Aranesp—Amgen). A table is available in the prescribing information to help estimate doses. The first dose of peginesatide should be given 1 week after the last epoetin alfa dose or in place of the next scheduled dose of darbepoetin alfa.■Dosage adjustments are needed based on hemoglobin rates of rise and decline to target a hemoglobin level between 10 g/dL and 12 g/dL.■Transferrin saturation and serum ferritin should be monitored before and during treatment with peginesatide; supplemental iron should be given when serum ferritin is less than 100 μg/L or when serum transferring saturation is less than 20%.Of note: As with all ESAs, peginesatide has a boxed warning discussing how these agents increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence, especially in patients with higher hemoglobin levels (13–14 g/dL).■Peginesatide is contraindicated for use in patients with uncontrolled hypertension. Appropriate control of hypertension is needed before initiating treatment and during peginesatide therapy.■Dialysis management may need to be adjusted once peginesatide is started; this may■include increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.Patient counselingInstruct patients to read the Medication Guide before starting treatment with peginesatide. Review with patients the serious risks associated with treatment (i.e., increased risk of death, cardiovascular events). Counsel patients to undergo routine blood pressure monitoring and to adhere to prescribed antihypertensive therapies. Approval of peginesatide was based on data from two randomized, active-controlled, open-label, multicenter clinical trials involving 1,608 patients with CKD who were on dialysis. The trials randomized patients with hemoglobin levels initially stabilized by ESA to receive either peginesatide once monthly or to continue their current ESA (epoetin) treatment. Results showed peginesatide to be as safe and effective as epoetin in maintaining hemoglobin levels within the studies' prespecified range of 10 to 12 g/dL. The most common adverse events, observed in 10% or more of patients receiving dialysis who were treated with peginesatide, were diarrhea, vomiting, hypertension, and arthralgias. As with other ESAs, peginesatide has numerous safety considerations (see sidebar) and was approved with a Risk Evaluation and Mitigation Strategy.Peginesatide (Omontys)Manufacturer: AffymaxDrug class: Erythropoiesis-stimulating agent (ESA)Indication: Treatment of anemia due to chronic kidney disease (CKD) in adults on dialysis■Peginesatide should not be given to patients with CKD not receiving dialysis, for treatment of anemia associated with cancer, or as a substitute for those who require red blood cell transfusions for immediate correction of anemia.Dosage: 0.04 mg/kg administered once monthly as a single I.V. or subcutaneous injection for those who are not currently receiving ESA treatment; therapy should only be initiated when hemoglobin is less than 10 g/dL.■For those previously receiving ESA therapy, the starting monthly dose of peginesatide should be estimated based on the weekly dose of epoetin alfa (Epogen—Amgen; Procrit—Centocor Ortho Biotech) or darbepoetin alfa (Aranesp—Amgen). A table is available in the prescribing information to help estimate doses. The first dose of peginesatide should be given 1 week after the last epoetin alfa dose or in place of the next scheduled dose of darbepoetin alfa.■Dosage adjustments are needed based on hemoglobin rates of rise and decline to target a hemoglobin level between 10 g/dL and 12 g/dL.■Transferrin saturation and serum ferritin should be monitored before and during treatment with peginesatide; supplemental iron should be given when serum ferritin is less than 100 μg/L or when serum transferring saturation is less than 20%.Of note: As with all ESAs, peginesatide has a boxed warning discussing how these agents increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence, especially in patients with higher hemoglobin levels (13–14 g/dL).■Peginesatide is contraindicated for use in patients with uncontrolled hypertension. Appropriate control of hypertension is needed before initiating treatment and during peginesatide therapy.■Dialysis management may need to be adjusted once peginesatide is started; this may■include increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis. Manufacturer: AffymaxDrug class: Erythropoiesis-stimulating agent (ESA)Indication: Treatment of anemia due to chronic kidney disease (CKD) in adults on dialysis■Peginesatide should not be given to patients with CKD not receiving dialysis, for treatment of anemia associated with cancer, or as a substitute for those who require red blood cell transfusions for immediate correction of anemia.Dosage: 0.04 mg/kg administered once monthly as a single I.V. or subcutaneous injection for those who are not currently receiving ESA treatment; therapy should only be initiated when hemoglobin is less than 10 g/dL.■For those previously receiving ESA therapy, the starting monthly dose of peginesatide should be estimated based on the weekly dose of epoetin alfa (Epogen—Amgen; Procrit—Centocor Ortho Biotech) or darbepoetin alfa (Aranesp—Amgen). A table is available in the prescribing information to help estimate doses. The first dose of peginesatide should be given 1 week after the last epoetin alfa dose or in place of the next scheduled dose of darbepoetin alfa.■Dosage adjustments are needed based on hemoglobin rates of rise and decline to target a hemoglobin level between 10 g/dL and 12 g/dL.■Transferrin saturation and serum ferritin should be monitored before and during treatment with peginesatide; supplemental iron should be given when serum ferritin is less than 100 μg/L or when serum transferring saturation is less than 20%.Of note: As with all ESAs, peginesatide has a boxed warning discussing how these agents increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence, especially in patients with higher hemoglobin levels (13–14 g/dL).■Peginesatide is contraindicated for use in patients with uncontrolled hypertension. Appropriate control of hypertension is needed before initiating treatment and during peginesatide therapy.■Dialysis management may need to be adjusted once peginesatide is started; this may■include increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis. Manufacturer: Affymax Drug class: Erythropoiesis-stimulating agent (ESA) Indication: Treatment of anemia due to chronic kidney disease (CKD) in adults on dialysis■Peginesatide should not be given to patients with CKD not receiving dialysis, for treatment of anemia associated with cancer, or as a substitute for those who require red blood cell transfusions for immediate correction of anemia.Dosage: 0.04 mg/kg administered once monthly as a single I.V. or subcutaneous injection for those who are not currently receiving ESA treatment; therapy should only be initiated when hemoglobin is less than 10 g/dL.■For those previously receiving ESA therapy, the starting monthly dose of peginesatide should be estimated based on the weekly dose of epoetin alfa (Epogen—Amgen; Procrit—Centocor Ortho Biotech) or darbepoetin alfa (Aranesp—Amgen). A table is available in the prescribing information to help estimate doses. The first dose of peginesatide should be given 1 week after the last epoetin alfa dose or in place of the next scheduled dose of darbepoetin alfa.■Dosage adjustments are needed based on hemoglobin rates of rise and decline to target a hemoglobin level between 10 g/dL and 12 g/dL.■Transferrin saturation and serum ferritin should be monitored before and during treatment with peginesatide; supplemental iron should be given when serum ferritin is less than 100 μg/L or when serum transferring saturation is less than 20%.Of note: As with all ESAs, peginesatide has a boxed warning discussing how these agents increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence, especially in patients with higher hemoglobin levels (13–14 g/dL).■Peginesatide is contraindicated for use in patients with uncontrolled hypertension. Appropriate control of hypertension is needed before initiating treatment and during peginesatide therapy.■Dialysis management may need to be adjusted once peginesatide is started; this may■include increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis. Patient counselingInstruct patients to read the Medication Guide before starting treatment with peginesatide. Review with patients the serious risks associated with treatment (i.e., increased risk of death, cardiovascular events). Counsel patients to undergo routine blood pressure monitoring and to adhere to prescribed antihypertensive therapies. Instruct patients to read the Medication Guide before starting treatment with peginesatide. Review with patients the serious risks associated with treatment (i.e., increased risk of death, cardiovascular events). Counsel patients to undergo routine blood pressure monitoring and to adhere to prescribed antihypertensive therapies. Instruct patients to read the Medication Guide before starting treatment with peginesatide. Review with patients the serious risks associated with treatment (i.e., increased risk of death, cardiovascular events). Counsel patients to undergo routine blood pressure monitoring and to adhere to prescribed antihypertensive therapies.