Cresp 40mcg Injection (Vial)

Darbepoetin Alfa 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. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Limitations of Use Darbepoetin Alfa has not been shown to improve quality of life, fatigue, or patient well-being. Darbepoetin Alfa 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. Anemia Due to Chronic Kidney Disease Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. Anemia Due to Chemotherapy in Patients with Cancer Darbepoetin Alfa 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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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed 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, Darbepoetin Alfa dose, or dosing strategy that does not increase these risks. Use the lowest Darbepoetin Alfa dose sufficient to reduce the need for red blood cell (RBC) transfusions. Cancer: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non- small cell lung, head and neck, lymphoid, and cervical cancers. To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions. Use ESAs only for anemia from myelosuppressive chemotherapy. ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue following the completion of a chemotherapy course. 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. Use the lowest dose to avoid RBC transfusions. Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using Darbepoetin Alfa to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit ( 5.1 and 14.1 ). Use caution in patients with coexistent cardiovascular disease and stroke. Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer. Hypertension: Control hypertension prior to initiating and during treatment with Darbepoetin Alfa. Seizures: Darbepoetin Alfa increases the risk for seizures in patients with CKD. Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms. PRCA: If severe anemia and low reticulocyte count develop during Darbepoetin Alfa treatment, withhold Darbepoetin Alfa and evaluate for PRCA. Serious Allergic Reactions: Discontinue Darbepoetin Alfa and manage reactions. Severe Cutaneous Reactions: Discontinue Darbepoetin Alfa. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer Hypertension Seizures Pure Red Cell Aplasia Serious Allergic Reactions Severe Cutaneous Reactions Patients with CKD: Adverse reactions in ≥ 10% of Darbepoetin Alfa-treated patients in clinical studies were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. Patients with Cancer Receiving Chemotherapy: Adverse reactions in ≥ 1% of Darbepoetin Alfa-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events. 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 Darbepoetin Alfa with a total of 1357 patients (Darbepoetin Alfa 766, epoetin alfa 591). The median duration of exposure for patients receiving Darbepoetin Alfa was 340 days, with 580 patients exposed for greater than 6 months and 360 patients exposed for greater than 1 year. The median (25 th, 75 th percentiles) weight-adjusted dose of Darbepoetin Alfa was 0.50 mcg/kg. The median (range) age for patients administered Darbepoetin Alfa was 62 years (18 to 88). In the Darbepoetin Alfa 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 Darbepoetin Alfa. Table 5. Adverse Reactions Occurring in ≥ 5% of Patients with CKD Adverse Reaction Patients Treated w ith Darbepoetin Alfa (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 Darbepoetin Alfa 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. In one study, Darbepoetin Alfa was administered to 81 pediatric patients with CKD who had stable hemoglobin concentrations while previously receiving epoetin alfa. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.