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ARANESP is a brand name for Darbepoetin Alfa, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of Anemia in Chronic Kidney Disease • ARANESP® (darbepoetin alfa injection) is indicated for the treatment of anemia associated with chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. o Aranesp is not intended for patients who require immediate correction of severe…
Verbatim from this product's HC label. Tap a section to expand.
). • Patients with uncontrolled hypertension should not be treated with Aranesp; blood pressure should be adequately controlled before initiation of therapy with Aranesp. • Aranesp should be used with caution in patients with a history of seizures.
• Antibody-mediated Pure Red Cell Aplasia (PRCA) has been reported after months to years of treatment with ESAs. Chronic Kidney Disease Patients • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target hemoglobin levels of 130 g/L and above.
Individualize dosing to achieve and maintain hemoglobin levels within the range of 100 to 115 g/L, not to exceed 120 g/L. Cancer Patients • ESAs increased the risks for death, serious adverse cardiovascular reactions and thromboembolic events in some controlled clinical trials.
• ESAs shortened overall survival and/or increased the risk of tumour progression or recurrence in some clinical studies in patients with breast, head and neck, lymphoid, cervical and non-small cell lung cancers when dosed to target a hemoglobin level of ≥ 120 g/L.
• To minimize the above risks, use the lowest dose needed to avoid red blood cell (RBC) transfusions. • Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy. Aranesp is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
• If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long-life expectancy and who are receiving myelosuppressive chemotherapy. • Discontinue Aranesp following the completion of a chemotherapy course.
1 Dosing Considerations IMPORTANT: See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX and 7 WARNINGS AND PRECAUTIONS: Increased Mortality, Serious Adverse Cardiovascular Reactions, Thromboembolic Events and Stroke. Aranesp dosing regimens are different for each of the indications described in the 1 INDICATIONS section of this Product Monograph.
Aranesp should be administered under the supervision of a healthcare professional. Due to the longer serum half-life, Aranesp should be administered less frequently than Epoetin alfa (for example, where Epoetin alfa is administered three times a week, Aranesp should be administered weekly).
1 Adverse Reaction Overview All Patients Thrombotic/Vascular Events The following thrombotic/vascular events have been reported in patients receiving ESAs (some with fatal outcomes): venous and arterial thromboses and embolism (such as deep venous thrombosis, arterial thrombosis, pulmonary emboli, aneurysms, retinal thrombosis, clotting of vascular access), cerebrovascular accidents (including cerebral infarction and cerebral hemorrhage) and transient ischemic attacks.
Chronic Kidney Disease Patients In all studies with CKD patients, the most frequently reported serious adverse reactions with Aranesp were vascular access thrombosis, congestive heart failure, sepsis, and cardiac arrhythmia. The most commonly reported adverse reactions were infection, hypertension, hypotension, myalgia, headache, and diarrhea (see 7 WARNINGS AND PRECAUTIONS, Increased Mortality, Serious Adverse Cardiovascular Reactions, Thromboembolic Events and Stroke).
, discontinuation of Aranesp, adjustment in dosage, or the need for concomitant medication to treat an adverse reaction symptom) were hypotension, hypertension, fever, myalgia, nausea, and chest pain. Cancer Patients Receiving Chemotherapy The most frequently reported serious adverse events included death, fever, pneumonia, dehydration, vomiting, and dyspnea.
2 Clinical Trial Adverse Reactions). 2 Clinical Trial Adverse Reactions). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Chronic Kidney Disease Patients The data described below reflect exposure to Aranesp in 1598 CKD patients, including 675 exposed for at least 6 months, of whom 185 were exposed for greater than 1 year.
, Increased Mortality, Serious Adverse Cardiovascular Reactions, Thromboembolic Events and Stroke, and 4 DOSAGE AND ADMINISTRATION). • Patients with uncontrolled hypertension should not be treated with Aranesp; blood pressure should be adequately controlled before initiation of therapy with Aranesp.
• Aranesp should be used with caution in patients with a history of seizures. • Antibody-mediated Pure Red Cell Aplasia (PRCA) has been reported after months to years of treatment with ESAs. Chronic Kidney Disease Patients • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target hemoglobin levels of 130 g/L and above.
Individualize dosing to achieve and maintain hemoglobin levels within the range of 100 to 115 g/L, not to exceed 120 g/L. Cancer Patients • ESAs increased the risks for death, serious adverse cardiovascular reactions and thromboembolic events in some controlled clinical trials.
• ESAs shortened overall survival and/or increased the risk of tumour progression or recurrence in some clinical studies in patients with breast, head and neck, lymphoid, cervical and non-small cell lung cancers when dosed to target a hemoglobin level of ≥ 120 g/L.
• To minimize the above risks, use the lowest dose needed to avoid red blood cell (RBC) transfusions. • Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy. Aranesp is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
• If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long-life expectancy and who are receiving myelosuppressive chemotherapy. • Discontinue Aranesp following the completion of a chemotherapy course.
Aranesp is contraindicated in patients: • with uncontrolled hypertension • who develop Pure Red Cell Aplasia (PRCA) following treatment with any ESAs Aranesp® (darbepoetin alfa injection) Page 5 of 67 • with sensitivity to mammalian cell-derived products • with known hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
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When changing the route of administration, the same dose should be used and the hemoglobin monitored so that the appropriate dose adjustments can be made to keep the hemoglobin at the desired concentration. Chronic Kidney Disease Patients The dose should be started and slowly adjusted, as described in Section Recommended Dose and Dosage Adjustment, based on hemoglobin levels.
If a patient fails to respond or maintain a response, other etiologies should be considered and evaluated (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests; Lack or Loss of Response to Aranesp, Pure Red Cell Aplasia).
It should be recognized that subcutaneous administration of recombinant human proteins may increase the risk of immunogenicity. In patients on hemodialysis, the IV route is recommended. Correction of Anemia in Chronic Kidney Disease Patients The treatment of anemia in chronic renal failure patients should be individualized.
) as well as national guidelines. ESA therapy should only be initiated if hemoglobin is less than 100 g/L. Conversion to Aranesp from Recombinant Human Erythropoietin in CKD Patients The clinical studies demonstrated that the relationship between baseline rHuEPO and maintenance Aranesp is nonlinear across the dosing spectrum.
Consequently, the starting weekly dose of Aranesp should be estimated on the basis of the weekly Epoetin alfa dose at the time of substitution (see Table 1). Due to the longer serum half-life, Aranesp should be administered less frequently than rHuEPO.
Patients receiving rHuEPO 2 or 3 times weekly should change to once weekly Aranesp at a dose equivalent to their total weekly dose of rHuEPO. Patients receiving rHuEPO once per week should change to Aranesp once every 2 weeks at a dose that is equivalent to the sum of 2 weekly doses of rHuEPO.
The same route of administration should be used. For patients prescribed prefilled syringes the calculated dose should be rounded upward to the next available syringe strength. Aranesp® (darbepoetin alfa injection) Page 7 of 67 Table 1.
2 Recommended Dose and Dosage Adjustment, Dose Adjustment for Chronic Kidney Disease Patients). Data from approximately 800 patients receiving Aranesp in clinical studies were analyzed to assess the dose required to maintain hemoglobin; no difference was observed between the average weekly dose administered by the IV or SC routes of administration.
Because of intersubject variability, titration to the optimal therapeutic Aranesp dose is required for individual patients. 2 Recommended Dose and […]
Aranesp was evaluated in active-controlled (n = 823) and uncontrolled studies (n = 775). The rates of adverse events and association with Aranesp are best assessed in the results from studies in which Aranesp was used to stimulate erythropoiesis in patients anemic at study baseline (n = 348), and, in particular, the subset of these patients in randomized controlled trials (n = 276).
Because there were no substantive differences in the rates of adverse reactions between these subpopulations, or between these subpopulations and the entire population of patients treated with Aranesp, data from all 1598 patients were pooled.
Aranesp® (darbepoetin alfa injection) Page 19 of 67 The population encompassed an age range from 18 to 91 years. Fifty-seven percent of the patients were male. The percentages of Caucasian, Black, Asian, and Hispanic patients were 83%, 11%, 3%, and 1%, respectively.
66 mcg/kg). Some of the adverse events reported are typically associated with CKD, or recognized complications of dialysis, and may not necessarily be attributable to Aranesp therapy. No important differences in adverse event rates between treatment groups were observed in controlled studies in which patients received Aranesp or other ESAs.
The data in Table 5 reflect those adverse events occurring in at least 5% of CKD patients treated with Aranesp. Table 5. Adverse Events Occurring in ≥ 5% of CKD Patients Event CKD Patients Treated With Aranesp (n = 1598) Application site Injection Site Pain 7% Body as a whole Peripheral Edema 11% Fatigue 9% Fever 9% Death 7% Chest Pain, Unspecified 6% Fluid Overload 6% Access Infection 6% Influenza-like Symptoms 6% Access Hemorrhage 6% Asthenia 5% Cardiovascular Hypertension 23% Hypotension 22% Cardiac Arrhythmias/Cardiac Arrest 10% Angina Pectoris/Cardiac Chest Pain 8% Thrombosis Vascular Access 8% Congestive Heart Failure 6% CNS/PNS Headache 16% Dizziness 8% Aranesp® (darbepoetin alfa injection) Page 20 of 67 Table 5.
Adverse Events Occurring in ≥ 5% of CKD Patients Event CKD Patients Treated With Aranesp (n = 1598) Gastrointestinal Diarrhea 16% Vomiting 15% Nausea 14% Abdominal Pain 12% Constipation 5% Musculoskeletal Myalgia 21% Arthralgia 11% Limb Pain 10% Back Pain 8% Resistance mechanism Infectiona 27% Respiratory Upper Respiratory Infection 14% Dyspnea 12% Cough 10% Bronchitis 6% Skin and appendages Pruritus 8% a Infection includes sepsis, bacteremia, pneumonia, peritonitis, and abscess.
The incidence rates for other clinically significant events are shown in Table 6. Table 6. 22 events per patient year of Aranesp therapy. , vascular access thrombosis, venous thrombosis, and pulmonary emboli) with Aranesp therapy were similar to those observed with rHuEPO therapy in these trials.
Cancer Patients Receiving Chemotherapy The data described below reflect the exposure to Aranesp in 873 cancer patients. Aranesp was evaluated in seven studies that were active-controlled and/or placebo-controlled studies of up to 6 months duration.
The Aranesp-treated patient demographics were as follows: median age of 63 years (range of 20 to 91 years); 40% male; 88% Caucasian, 5% Hispanic, 4% Black, and 3% Asian. Over 90% of patients had locally […]
1 Dosing Considerations IMPORTANT: See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX and 7 WARNINGS AND PRECAUTIONS: Increased Mortality, Serious Adverse Cardiovascular Reactions, Thromboembolic Events and Stroke. Aranesp dosing regimens are different for each of the indications described in the 1 INDICATIONS section of this Product Monograph.
Aranesp should be administered under the supervision of a healthcare professional. Due to the longer serum half-life, Aranesp should be administered less frequently than Epoetin alfa (for example, where Epoetin alfa is administered three times a week, Aranesp should be administered weekly).
When changing the route of administration, the same dose should be used and the hemoglobin monitored so that the appropriate dose adjustments can be made to keep the hemoglobin at the desired concentration. Chronic Kidney Disease Patients The dose should be started and slowly adjusted, as described in Section Recommended Dose and Dosage Adjustment, based on hemoglobin levels.
If a patient fails to respond or maintain a response, other etiologies should be considered and evaluated (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests; Lack or Loss of Response to Aranesp, Pure Red Cell Aplasia).
It should be recognized that subcutaneous administration of recombinant human proteins may increase the risk of immunogenicity. In patients on hemodialysis, the IV route is recommended. Correction of Anemia in Chronic Kidney Disease Patients The treatment of anemia in chronic renal failure patients should be individualized.
) as well as national guidelines. ESA therapy should only be initiated if hemoglobin is less than 100 g/L. Conversion to Aranesp from Recombinant Human Erythropoietin in CKD Patients The clinical studies demonstrated that the relationship between baseline rHuEPO and maintenance Aranesp is nonlinear across the dosing spectrum.
Consequently, the starting weekly dose of Aranesp should be estimated on the basis of the weekly Epoetin alfa dose at the time of substitution (see Table 1). Due to the longer serum half-life, Aranesp should be administered less frequently than rHuEPO.
Patients receiving rHuEPO 2 or 3 times weekly should change to once weekly Aranesp at a dose equivalent to their total weekly dose of rHuEPO. Patients receiving rHuEPO once per week should change to Aranesp once every 2 weeks at a dose that is equivalent to the sum of 2 weekly doses of rHuEPO.
The same route of administration should be used. For patients prescribed prefilled syringes the calculated dose should be rounded upward to the next available syringe strength. Aranesp® (darbepoetin alfa injection) Page 7 of 67 Table 1.
2 Recommended Dose and Dosage Adjustment, Dose Adjustment for Chronic Kidney Disease Patients). Data from approximately 800 patients receiving Aranesp in clinical studies were analyzed to assess the dose required to maintain hemoglobin; no difference was observed between the average weekly dose administered by the IV or SC routes of administration.
Because of intersubject variability, titration to the optimal therapeutic Aranesp dose is required for individual patients. When a patient’s hemoglobin is stabilized […]