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LABELS · 5626304b-344f-4155-9afa-d7cfe733d819

RETACRIT

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-06-22
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE 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, ESA dose, or dosing strategy that does not increase these risks ( 2.2 ). • Use the lowest RETACRIT 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 ( 2.4 ). • Use ESAs only for anemia from myelosuppressive chemotherapy ( 1.3 ). • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.5 ). • Discontinue following the completion of a chemotherapy course ( 2.4 ). Perisurgery: • Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended ( 5.1 ). Chronic Kidney Disease: • In controlled trials, patients with chronic kidney disease (CKD) 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, ESA dose, or dosing strategy that does not increase these risks [see Dosage and Administration (2.2) ] . • Use the lowest RETACRIT 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 (2.4) ] . • Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage (1.3) ] . • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage (1.5) ] . • Discontinue following the completion of a chemotherapy course [see Dosage and Administration (2.4) ] . Perisurgery: • Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended [see Dosage and Administration (2.5) , Warnings and Precautions (5.1) ] .

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: • Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ). • Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery ( 1.4 ). Limitations of Use RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being ( 1.5 ). RETACRIT is not indicated for use: • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy ( 1.5 ). • In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.5 ). • In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion ( 1.5 ). • In patients scheduled for surgery who are willing to donate autologous blood ( 1.5 ). • In patients undergoing cardiac or vascular surgery ( 1.5 ). • As a substitute for RBC transfusions in patients who require immediate correction of anemia ( 1.5 ). 1.1 Anemia Due to Chronic Kidney Disease RETACRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion. 1.2 Anemia Due to Zidovudine in Patients with HIV Infection RETACRIT is indicated for the treatment of anemia due to zidovudine administered at ≤ 4,200 mg/week in patients with HIV infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL. 1.3 Anemia Due to Chemotherapy in Patients with Cancer RETACRIT 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. 1.4 Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery RETACRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. RETACRIT is not indicated for patients who are willing to donate autologous blood pre-operatively. 1.5 Limitations of Use RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being. RETACRIT 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. • In patients scheduled for surgery who are willing to donate autologous blood. • In patients undergoing cardiac or vascular surgery. • As a substitute for RBC transfusions in patients who require immediate correction of anemia.
Full extracted label fields
application numbers
  1. BLA125545
boxed warning exact
  1. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE 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, ESA dose, or dosing strategy that does not increase these risks ( 2.2 ). • Use the lowest RETACRIT 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 ( 2.4 ). • Use ESAs only for anemia from myelosuppressive chemotherapy ( 1.3 ). • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.5 ). • Discontinue following the completion of a chemotherapy course ( 2.4 ). Perisurgery: • Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended ( 5.1 ). Chronic Kidney Disease: • In controlled trials, patients with chronic kidney disease (CKD) 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, ESA dose, or dosing strategy that does not increase these risks [see Dosage and Administration (2.2) ] . • Use the lowest RETACRIT 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 (2.4) ] . • Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage (1.3) ] . • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage (1.5) ] . • Discontinue following the completion of a chemotherapy course [see Dosage and Administration (2.4) ] . Perisurgery: • Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended [see Dosage and Administration (2.5) , Warnings and Precautions (5.1) ] .
brand names
  1. RETACRIT
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e6e4dd0c-25ca-40b2-ba6b-6138a68621fe
generic names
  1. EPOETIN ALFA-EPBX
id
5626304b-344f-4155-9afa-d7cfe733d819
indications and usage exact
  1. 1 INDICATIONS AND USAGE RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: • Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ). • Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery ( 1.4 ). Limitations of Use RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being ( 1.5 ). RETACRIT is not indicated for use: • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy ( 1.5 ). • In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.5 ). • In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion ( 1.5 ). • In patients scheduled for surgery who are willing to donate autologous blood ( 1.5 ). • In patients undergoing cardiac or vascular surgery ( 1.5 ). • As a substitute for RBC transfusions in patients who require immediate correction of anemia ( 1.5 ). 1.1 Anemia Due to Chronic Kidney Disease RETACRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion. 1.2 Anemia Due to Zidovudine in Patients with HIV Infection RETACRIT is indicated for the treatment of anemia due to zidovudine administered at ≤ 4,200 mg/week in patients with HIV infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL. 1.3 Anemia Due to Chemotherapy in Patients with Cancer RETACRIT 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. 1.4 Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery RETACRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. RETACRIT is not indicated for patients who are willing to donate autologous blood pre-operatively. 1.5 Limitations of Use RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being. RETACRIT 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. • In patients scheduled for surgery who are willing to donate autologous blood. • In patients undergoing cardiac or vascular surgery. • As a substitute for RBC transfusions in patients who require immediate correction of anemia.
indications and usage tables exact
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    1. 59353-002-01
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    4. 59353-003-10
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    6. 59353-004-10
    7. 59353-010-01
    8. 59353-010-10
    9. 59353-120-01
    10. 59353-120-10
    11. 59353-220-01
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    5. 59353-120
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    1. HUMAN PRESCRIPTION DRUG
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          Appl No
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      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

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      1 INDICATIONS AND USAGE RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: • Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). o
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          1 INDICATIONS AND USAGE RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for:
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                                                                              1.3 Anemia Due to Chemotherapy in Patients with Cancer RETACRIT 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.
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                                                                              application numbers
                                                                              1. BLA125545
                                                                              brand names
                                                                              1. RETACRIT
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                                                                              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. 1.4 Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery RETACRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. RETACRIT is not indicated for patients who are willing to donate autologous blood pre-operatively. 1.5 Limitations of Use RETACRIT has not been shown to improve quality of life, fatigue, or patient w
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                                                                                  1.4 Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery RETACRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery.
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                                                                                  e need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. RETACRIT is not indicated for patients who are willing to donate autologous blood pre-operatively. 1.5 Limitations of Use RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being. RETACRIT is not indicated for use: • In patients with cancer receiving hormonal agents,
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                                                                                      dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. RETACRIT is not indicated for patients who are willing to donate autologous blood pre-operatively. 1.5 Limitations of Use RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being. RETACRIT is not indicated for use: • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. • In patie
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                                                                                                    • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
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                                                                                                    Passage 20 · unclassified context
                                                                                                    application numbers
                                                                                                    1. BLA125545
                                                                                                    brand names
                                                                                                    1. RETACRIT
                                                                                                    classification reasons
                                                                                                    1. no_unambiguous_positive_indication_predicate
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                                                                                                    pending
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                                                                                                    unclassified_context
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                                                                                                    ell-being. RETACRIT 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. • In patients scheduled for surgery who are willing to donate autologous blood. • I
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                                                                                                    id
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                                                                                                          • In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
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                                                                                                          Source null
                                                                                                          tumor histology
                                                                                                          Source null
                                                                                                          use intent
                                                                                                          unclear
                                                                                                          Passage 21 · unclassified context
                                                                                                          application numbers
                                                                                                          1. BLA125545
                                                                                                          brand names
                                                                                                          1. RETACRIT
                                                                                                          classification reasons
                                                                                                          1. no_unambiguous_positive_indication_predicate
                                                                                                          clinical review status
                                                                                                          pending
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                                                                                                          unclassified_context
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                                                                                                          3366
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                                                                                                          gic 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. • In patients scheduled for surgery who are willing to donate autologous blood. • In patients undergoing cardiac or vascular surgery. • As a substitute for RBC transfusions in patients who require im
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                                                                                                          extraction review status
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                                                                                                                Source null
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                                                                                                                Passage 22 · unclassified context
                                                                                                                application numbers
                                                                                                                1. BLA125545
                                                                                                                brand names
                                                                                                                1. RETACRIT
                                                                                                                classification reasons
                                                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                                                clinical review status
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                                                                                                                context span
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                                                                                                                ancer 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. • In patients scheduled for surgery who are willing to donate autologous blood. • In patients undergoing cardiac or vascular surgery. • As a substitute for RBC transfusions in patients who require immediate correction of anemia.
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                                                                                                                      • In patients scheduled for surgery who are willing to donate autologous blood.
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                                                                                                                      Source null
                                                                                                                      use intent
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                                                                                                                      Passage 23 · unclassified context
                                                                                                                      application numbers
                                                                                                                      1. BLA125545
                                                                                                                      brand names
                                                                                                                      1. RETACRIT
                                                                                                                      classification reasons
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                                                                                                                      exact text
                                                                                                                      re. • In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. • In patients scheduled for surgery who are willing to donate autologous blood. • In patients undergoing cardiac or vascular surgery. • As a substitute for RBC transfusions in patients who require immediate correction of anemia.
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                                                                                                                            • In patients undergoing cardiac or vascular surgery.
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                                                                                                                            tumor histology
                                                                                                                            Source null
                                                                                                                            use intent
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                                                                                                                            Passage 24 · unclassified context
                                                                                                                            application numbers
                                                                                                                            1. BLA125545
                                                                                                                            brand names
                                                                                                                            1. RETACRIT
                                                                                                                            classification reasons
                                                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                                                            clinical review status
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                                                                                                                            content role
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                                                                                                                            ve chemotherapy in whom the anemia can be managed by transfusion. • In patients scheduled for surgery who are willing to donate autologous blood. • In patients undergoing cardiac or vascular surgery. • As a substitute for RBC transfusions in patients who require immediate correction of anemia.
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                                                                                                                            current approval status
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                                                                                                                            duplicate text group
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                                                                                                                            extraction review status
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                                                                                                                            generic names
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                                                                                                                            id
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                                                                                                                            label id
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                                                                                                                            positive predicate support span
                                                                                                                            Source null
                                                                                                                            qualifier mentions
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                                                                                                                                  • As a substitute for RBC transfusions in patients who require immediate correction of anemia.
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                                                                                                                                  spl effective date
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                                                                                                                                  spl set id
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                                                                                                                                  Source null
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                                                                                                                                  biomarker and test
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                                                                                                                                  disease stage
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                                                                                                                                  limitations
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                                                                                                                                  line
                                                                                                                                  Source null
                                                                                                                                  prior therapy
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                                                                                                                                  regimen
                                                                                                                                  Source null
                                                                                                                                  tumor histology
                                                                                                                                  Source null
                                                                                                                                  use intent
                                                                                                                                  unclear

                                                                                                                                  Preserved source evidence · Not medical advice