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Drug overview for ARANESP (darbepoetin alfa in polysorbate 80):
Generic name: DARBEPOETIN ALFA IN POLYSORBATE 80 (DAR-be-POE-e-tin AL-fa)
Drug class: Erythropoiesis-Stimulating Agents
Therapeutic class: Hematological Agents
Darbepoetin alfa, a biosynthetic (recombinant DNA origin) form of the glycoprotein hormone erythropoietin, is a hematopoietic agent that principally affects erythropoiesis.
Darbepoetin alfa has not been shown to improve quality of life, fatigue, or patient well-being.
Generic name: DARBEPOETIN ALFA IN POLYSORBATE 80 (DAR-be-POE-e-tin AL-fa)
Drug class: Erythropoiesis-Stimulating Agents
Therapeutic class: Hematological Agents
Darbepoetin alfa, a biosynthetic (recombinant DNA origin) form of the glycoprotein hormone erythropoietin, is a hematopoietic agent that principally affects erythropoiesis.
Darbepoetin alfa has not been shown to improve quality of life, fatigue, or patient well-being.
DRUG IMAGES
ARANESP 25 MCG/ML VIAL
ARANESP 40 MCG/ML VIAL
ARANESP 100 MCG/ML VIAL
ARANESP 60 MCG/ML VIAL
ARANESP 200 MCG/ML VIAL
ARANESP 200 MCG/0.4 ML SYRINGE
ARANESP 500 MCG/1 ML SYRINGE
ARANESP 300 MCG/0.6 ML SYRINGE
ARANESP 60 MCG/0.3 ML SYRINGE
ARANESP 25 MCG/0.42 ML SYRING
ARANESP 40 MCG/0.4 ML SYRINGE
ARANESP 100 MCG/0.5 ML SYRINGE
ARANESP 150 MCG/0.3 ML SYRINGE
ARANESP 10 MCG/0.4 ML SYRINGE
The following indications for ARANESP (darbepoetin alfa in polysorbate 80) have been approved by the FDA:
Indications:
Anemia due to chemotherapy and radiotherapy combination
Anemia in chronic kidney disease
Chemotherapy-induced anemia
Professional Synonyms:
Anemia co-occurrent and due to chronic kidney disease
Anemia due to chronic kidney disease
Anemia due to CKD
Anemia in CKD
Indications:
Anemia due to chemotherapy and radiotherapy combination
Anemia in chronic kidney disease
Chemotherapy-induced anemia
Professional Synonyms:
Anemia co-occurrent and due to chronic kidney disease
Anemia due to chronic kidney disease
Anemia due to CKD
Anemia in CKD
The following dosing information is available for ARANESP (darbepoetin alfa in polysorbate 80):
No enhanced Dosing information available for this drug.
Darbepoetin alfa is administered by IV or subcutaneous injection. The subcutaneous route of administration was most frequently associated with cases of pure red cell aplasia (PRCA) in patients with CKD receiving ESAs. The manufacturer recommends the IV route of administration in patients on hemodialysis.
Because of its longer plasma half-life, darbepoetin alfa should be administered less frequently than epoetin alfa. Patients being switched from epoetin alfa to darbepoetin alfa should receive darbepoetin alfa by the same route of administration (IV or subcutaneous) that they were receiving epoetin alfa. Patients receiving epoetin alfa 2 or 3 times weekly should be switched to darbepoetin alfa once weekly, and those receiving epoetin alfa once weekly should be switched to darbepoetin alfa once every 2 weeks.
The first dose of darbepoetin alfa should be administered in place of epoetin alfa at the time of the next scheduled dose. Darbepoetin alfa should not be diluted or administered in conjunction with other drug solutions. Commercially available prefilled syringes and single-use vials of darbepoetin alfa should be stored in the carton until use between 2-8degreesC, and not be exposed to light, frozen, or shaken prior to use.
If shaken or frozen, the product should not be used. Unused portions of the single-use vials or prefilled syringes of darbepoetin alfa should be discarded and vials should not be reentered. Contents of vials and prefilled syringes of darbepoetin alfa should be inspected visually for discoloration and/or particulate matter prior to administration; if either is present, the solution should be discarded.
The needle cover of the prefilled syringe contains natural latex proteins in the form of dry natural rubber (latex). Individuals sensitive to latex should not handle the needle cover due to the potential for allergic reactions.
Because of its longer plasma half-life, darbepoetin alfa should be administered less frequently than epoetin alfa. Patients being switched from epoetin alfa to darbepoetin alfa should receive darbepoetin alfa by the same route of administration (IV or subcutaneous) that they were receiving epoetin alfa. Patients receiving epoetin alfa 2 or 3 times weekly should be switched to darbepoetin alfa once weekly, and those receiving epoetin alfa once weekly should be switched to darbepoetin alfa once every 2 weeks.
The first dose of darbepoetin alfa should be administered in place of epoetin alfa at the time of the next scheduled dose. Darbepoetin alfa should not be diluted or administered in conjunction with other drug solutions. Commercially available prefilled syringes and single-use vials of darbepoetin alfa should be stored in the carton until use between 2-8degreesC, and not be exposed to light, frozen, or shaken prior to use.
If shaken or frozen, the product should not be used. Unused portions of the single-use vials or prefilled syringes of darbepoetin alfa should be discarded and vials should not be reentered. Contents of vials and prefilled syringes of darbepoetin alfa should be inspected visually for discoloration and/or particulate matter prior to administration; if either is present, the solution should be discarded.
The needle cover of the prefilled syringe contains natural latex proteins in the form of dry natural rubber (latex). Individuals sensitive to latex should not handle the needle cover due to the potential for allergic reactions.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ARANESP 500 MCG/1 ML SYRINGE | Maintenance | Adults inject 1 milliliter (500 mcg) by subcutaneous route every 3 weeks in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site) |
No generic dosing information available.
The following drug interaction information is available for ARANESP (darbepoetin alfa in polysorbate 80):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Erythropoietic agents/Lenalidomide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The mechanism of this interaction is unknown. CLINICAL EFFECTS: Concurrent use of erythropoietic agents, such as darbepoetin or epoetin, with lenalidomide may increase the risk of thrombosis.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of lenalidomide states the risk of venous thromboembolism (VTE) may be increased when patients are taking concomitant therapy with erythropoietin stimulating agents. Use caution with concomitant use after a patient specific risk-benefit assessment has been completed. Observe patients for signs and symptoms of VTE and instruct patients to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling.(1) The National Comprehensive Cancer Network (NCCN) Guidelines include use of erythropoietic stimulating agents as a high risk factor for venous thromboembolism (VTE). Other risk factors include: active cancer, advanced stage cancer, certain cancer types, regional bulky lymphadenopathy, familial and/or acquired hypercoagulability, medical comorbidities, poor performance status, older age, major surgery, central venous catheter, chemotherapy including lenalidomide plus high-dose dexamethasone, hormone replacement therapy, contraceptives, tamoxifen/raloxifene, diethylstilbestrol, smoking, obesity, or activity level/exercise.(3) The NCCN Guidelines utilize a Risk Assessment Model to determine chemoprophylaxis. In patients with 0-1 risk factors, consider VTE chemoprophylaxis with aspirin 81-325 mg once daily. In patients with >/= 2 risk factors, consider VTE chemoprophylaxis with low-molecular weight heparin (LMWH) with a dose equivalent to enoxaparin 40 mg once daily or full-dose warfarin with a dose to maintain a target international normalized ratio (INR) 2-3.(3) DISCUSSION: The National Comprehensive Cancer Network (NCCN) Guidelines include use of erythropoietin as an individual risk factor for venous thromboembolism (VTE). Patients should be assessed for total risk based on NCCN guidelines and recommended for the appropriate VTE chemoprophylaxis agent based on risk category.(3) A pooled analysis of two placebo-controlled trials in multiple myeloma noted an incidence rate for VTE of 23% in patients receiving lenalidomide, dexamethasone and erythropoietic therapy versus 5% in patients without erythropoietic therapy. A multivariate analysis indicated an independent correlation between thrombosis and patients with concomitant erythropoietin therapy.(4) A pooled analysis of 125 patients from 3 trials with multiple myeloma on lenalidomide therapy noted a 17% incidence of VTE in patients on lenalidomide with concurrent erythropoietin therapy.(5) Several studies have evaluated the optimal VTE prophylaxis agent with lenalidomide-treated patients. Patients receiving lenalidomide/dexamethasone and no chemoprophylaxis had a VTE incidence of 11-75%, 26% with the use of aspirin, 17% with the use of aspirin/LMWH/warfarin combination therapy, and 2-15% with the use of LMWH. (6) |
LENALIDOMIDE, REVLIMID |
| Lovotibeglogene Autotemcel/Erythropoietic agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Erythropoietic agents may interfere with hematopoietic stem cell (HSC) mobilization of CD34+ cells.(1) CLINICAL EFFECTS: Use of erythropoietic agents before mobilization may result in unsuccessful stem cell mobilization.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discontinue erythropoietic agents at least 2 months prior to mobilization.(1) DISCUSSION: Erythropoietic agents may interfere with the manufacturing of lovotibeglogene autotemcel therapy. There are no data regarding use of erythropoietin between apheresis and conditioning or after lovotibeglogene autotemcel therapy.(1) |
LYFGENIA |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Vadadustat/Erythropoietin Stimulating Agents SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Vadadustat and erythropoietin stimulating agents (ESAs) both stimulate endogenous erythropoietin production, resulting in increased red blood cell production.(1-2) CLINICAL EFFECTS: Concurrent use of vadadustat and erythropoietin stimulating agents may increase the risk of thrombosis. PREDISPOSING FACTORS: Predisposing factors include a history of thromboembolic disorder, thrombophilia, malignancy, hyperlipidemia, hypertension, heart failure, diabetes mellitus, chronic kidney disease, COPD, obesity, tobacco smoking, major surgery with prolonged post-operative immobilization, and being bed-ridden. PATIENT MANAGEMENT: ESAs should be stopped before initiating vadadustat.(1) For patients receiving temporary ESA rescue treatment, vadadustat should be held until hemoglobin levels are greater than or equal to 10 g/dL. The pause in vadadustat treatment should be extended to: - 2 days after last dose of epoetin - 7 days after last dose of darbepoetin alfa - 14 days after last dose of methoxy polyethylene glycol-epoetin beta Vadadustat should be resumed at the prior dose or one dose higher, with subsequent titration according to the dose titration guidelines in the vadadustat package insert.(1-2) Monitor hemoglobin levels every two weeks until stable, then monitor at least monthly.(1-2) Observe patients for signs and symptoms of venous thromboembolism and instruct patients to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. DISCUSSION: Vadadustat increases endogenous erythropoietin by decreasing degradation of hypoxia-inducible factor (HIF), which increases transcription of the HIF-responsive genes including EPO. Thromboembolic events were reported as very common (13.7%) in two active-controlled clinical trials in chronic kidney disease.(1-2) Controlled clinical trials of patients showed that ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, and other thromboembolic events with a higher target hemoglobin.(3) |
VAFSEO |
The following contraindication information is available for ARANESP (darbepoetin alfa in polysorbate 80):
Drug contraindication overview.
*Uncontrolled hypertension. *Pure red cell aplasia (PRCA) that begins after treatment with darbepoetin alfa or other erythropoietin proteins. *Serious allergic reactions to darbepoetin alfa.
*Uncontrolled hypertension. *Pure red cell aplasia (PRCA) that begins after treatment with darbepoetin alfa or other erythropoietin proteins. *Serious allergic reactions to darbepoetin alfa.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Pure red cell aplasia |
| Severe uncontrolled hypertension |
There are 9 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute decompensated heart failure |
| Acute myocardial infarction |
| Cerebrovascular accident |
| Deep venous thrombosis |
| Pulmonary thromboembolism |
| Thromboembolic disorder |
| Thrombotic disorder |
| Vascular access thrombosis |
| Vitamin b12 deficiency |
There are 6 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Edema |
| Folate deficiency |
| Hypertension |
| Iron deficiency anemia |
| Porphyria |
| Seizure disorder |
The following adverse reaction information is available for ARANESP (darbepoetin alfa in polysorbate 80):
Adverse reaction overview.
Adverse effects occurring in at least 10% of patients with CKD receiving darbepoetin alfa in clinical studies include hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. Adverse effects occurring in at least 1% of adults with cancer receiving chemotherapy and darbepoetin alfa in clinical studies include abdominal pain, edema, and thrombovascular events (myocardial infarction, pulmonary embolism, cerebrovascular accidents, CNS hemorrhage).
Adverse effects occurring in at least 10% of patients with CKD receiving darbepoetin alfa in clinical studies include hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. Adverse effects occurring in at least 1% of adults with cancer receiving chemotherapy and darbepoetin alfa in clinical studies include abdominal pain, edema, and thrombovascular events (myocardial infarction, pulmonary embolism, cerebrovascular accidents, CNS hemorrhage).
There are 25 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Chronic heart failure Dyspnea Hypertension Thrombotic disorder |
Acute myocardial infarction Angina Cerebrovascular accident Hypotension Pulmonary thromboembolism Seizure disorder Thromboembolic disorder Transient cerebral ischemia Vascular access thrombosis |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Bronchospastic pulmonary disease Deep venous thrombosis Erythema multiforme Exfoliative dermatitis Hypertensive crisis Pure red cell aplasia Shortened time to tumor progression Stevens-johnson syndrome Toxic epidermal necrolysis Urticaria |
There are 9 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Cough Edema Injection site sequelae Pain in extremities Peripheral edema |
Acute abdominal pain Erythema Hypervolemia Skin rash |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ARANESP (darbepoetin alfa in polysorbate 80):
Safety and efficacy of darbepoetin alfa in the treatment of pediatric patients ages 1 month to 16 years old with CKD on dialysis and not on dialysis have been established. No data are available in patients less than 1 month old. The use in this patient population is supported by evidence from the use in adults in controlled trials, a study evaluating weekly and every 2 week dosing in 114 pediatric patients ages 1 to 16 years of age, and an observational registry study in 319 pediatric patients ages less than 1 to 16 years of age.
Safety and efficacy were similar between adult and pediatric patients with CKD on dialysis and not on dialysis when darbepoetin alfa was used for the initial treatment of anemia, or when transitioning from epoetin to darbepoetin. Safety and efficacy in pediatric cancer patients not established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Safety and efficacy were similar between adult and pediatric patients with CKD on dialysis and not on dialysis when darbepoetin alfa was used for the initial treatment of anemia, or when transitioning from epoetin to darbepoetin. Safety and efficacy in pediatric cancer patients not established.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There is insufficient evidence to determine if darbepoetin use in pregnant women causes birth defects or miscarriage. In animal studies, darbepoetin increased early post-implantation loss at equivalent clinical recommended starting doses, and when administered IV during organogenesis, there was no evidence of embryofetal toxicity or adverse outcomes in doses up to 20 mcg/kg/day. Consider the benefits and risks of darbepoetin for the mother and possible risks to the fetus when prescribing darbepoetin.
Not known whether darbepoetin alfa is distributed into milk. Caution is advised if the drug is administered in nursing women.
No substantial differences in safety and efficacy of darbepoetin alfa relative to younger adults were observed, but increased sensitivity cannot be ruled out.
The following prioritized warning is available for ARANESP (darbepoetin alfa in polysorbate 80):
WARNING: Discuss the risks and benefits of darbepoetin alfa with your doctor, as this medication may rarely cause very serious (possibly fatal) side effects, including blood clots, heart attack, stroke, or heart failure. It is very important to keep all lab appointments since your doctor will need to carefully check your red blood cell count and hemoglobin level. The lowest effective dose of this medication should be used.
When used to treat anemia related to cancer, darbepoetin alfa may also increase the risk of death and/or cause your tumor to grow faster. This medication should be stopped after completing a treatment course of chemotherapy as directed by your doctor.
WARNING: Discuss the risks and benefits of darbepoetin alfa with your doctor, as this medication may rarely cause very serious (possibly fatal) side effects, including blood clots, heart attack, stroke, or heart failure. It is very important to keep all lab appointments since your doctor will need to carefully check your red blood cell count and hemoglobin level. The lowest effective dose of this medication should be used.
When used to treat anemia related to cancer, darbepoetin alfa may also increase the risk of death and/or cause your tumor to grow faster. This medication should be stopped after completing a treatment course of chemotherapy as directed by your doctor.
The following icd codes are available for ARANESP (darbepoetin alfa in polysorbate 80)'s list of indications:
| Anemia due to chemotherapy and radiotherapy combination | |
| D64.81 | Anemia due to antineoplastic chemotherapy |
| Z51.0 | Encounter for antineoplastic radiation therapy |
| Anemia in chronic kidney disease | |
| D63.1 | Anemia in chronic kidney disease |
| N18.4 | Chronic kidney disease, stage 4 (severe) |
| N18.5 | Chronic kidney disease, stage 5 |
| N18.6 | End stage renal disease |
| Z99.2 | Dependence on renal dialysis |
| Chemotherapy-induced anemia | |
| D64.81 | Anemia due to antineoplastic chemotherapy |
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