Adult Dosing

Anemia in chronic renal failure

• Initial dose: 0.45 mcg/kg IV/SC qwk or 0.75 mcg/kg SC q2 wk in patients not receiving dialysis
• Maintenance dose:
• Increase dose by 25% if Hgb does not increase by 1 g/dL in 4 wks or if Hgb levels are <10 g/dL; may increase q4 wks. Individualize dose to achieve Hgb in the range 10-12 g/dL, if this is not achieved despite dose titration over 12 wks, do not increase further; use lowest effective dose to avoid need for recurrent RBC transfusions
• Decrease dose by 25% if Hgb increases >1 g/dL/2wks or if Hgb approaches 12 g/dL. If Hgb continues to increase, temporarily withhold till Hgb decreases. Then restart at 25% decreased dose

Estimated darbepoetin alfa starting doses (mcg/week)

Previous Weekly Epoetin alfa Dose (Units/week)	Weekly Aranesp® Dose (mcg/week)
< 1500	6.25
1500 - 2499	6.25
2500 - 4999	12.5
5000 - 10999	25
11000 - 17999	40
18000 - 33999	60
34000 - 89999	100
90000	200

Cancer patients receiving chemotherapy

• Initial dose: 2.25 mcg/kg SC qwk or 500 mcg SC q3wk; do not initiate unless Hgb <10 g/dL
• Titration: increase dose up to 4.5 mcg/kg if Hgb response <1 g/dL/6wk
• Maintenance dose: For both qwk and q3wk dosing schedules, the dose should be adjusted for each patient to maintain the lowest Hgb level sufficient to avoid RBC transfusion
• If Hgb increases by >1.0 g/dL/2 wks or when the Hgb reaches a level needed to avoid transfusion, dose should be reduced by 40%
• If the Hgb exceeds the level needed to avoid transfusion, hold until levels decrease. Resume therapy at a dose 40% below the previous dose

Note:

• Only initiate therapy in patients if hemoglobin is <10g/dL and if there is a minimum of 2 additional months of planned chemotherapy

Pediatric Dosing

Anemia in chronic renal failure

• Use of this drug for the initial treatment to correct anemia has not been studied

Conversion from epoetin alfa to darbepoetin alfa

• Maintain same route of administration; estimated dose and frequency based on epoetin alfa dose and frequency; if epoetin alfa given 2-3 times per week, give darbepoetin alfa qwk; if epoetin alfa given q week, give darbepoetin alfa q2 wk

Estimated darbepoetin alfa starting doses (mcg/week)

Previous Weekly Epoetin alfa Dose (Units/week)	Weekly Aranesp® Dose (mcg/week)
< 1500	Insufficient data to determine an conversion dose
1500 - 2499	6.25
2500 - 4999	10
5000 - 10999	20
11000 - 17999	40
18000 - 33999	60
34000 - 89999	100
90000	200

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis
• Treatment of anemia due to concomitant chemotherapy in patients with metastatic, non-myeloid malignancies

• Hypersensitivity to any of the ingredients of the product
• Patients with uncontrolled hypertension

• Hypersensitivity to albumin
• ESA-associated pure red cell aplasia

• Increased mortality and serious cardiovascular events have been observed when administered to target hemoglobin levels >11 g/dL
• Hemoglobin target levels, darbepoetin alfa dose, or dosing strategy that do not increase these risks have not been identified by any trial. Use the lowest dose sufficient to reduce the need for red blood cell (RBC) transfusions
• ESAs (erythropoesis-stimulating agents) shortened overall survival and time-to-tumor progression in patients with breast, head and neck, lymphoid, cervical and non-small cell lung carcinoma
• Prescribers and hospitals should enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense darbepoetin alfa to patients with cancer, due to the associated risks
• To minimize these risks, as well as risk of serious cardiovascular and thrombovascular events, use lowest dose needed to avoid RBC transfusion
• Use ESAs only for anemia from myelosuppressive chemotherapy. Not indicated for patients on myelosuppressive chemotherapy when the anticipated outcome is cure
• Discontinue once chemotherapy course is completed

Renal Dose Adjustment

• Renal impairment: No dose adjustment

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Use lowest dose that will increase hemoglobin gradually to a level sufficient to avoid the need for red blood cell (RBC) transfusion [US Black Box Warning]
• Autoinjectors are designed to deliver the full content, hence, only to be used in patients who require full dose
• Drug increases risk of death and serious cardiovascular events when given to target hemoglobin level above 11 g/dL [US Black Box Warning]
• In chronic renal failure patients, darbepoetin alfa increases the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events when target for higher hemoglobin level (13-14 g/dL)
• Increases the risk of life-threatening thromboembolic reactions in cancer patients
• Do not use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy
• Increased risk of death and an increased risk of tumor progression and recurrence have been reported
• Hypersensitivity to latex (prefilled syringe)
• May cause potentially serious allergic reactions; discontinue the drug immediately and permanently if such reactions occur and institute appropriate therapy
• Patients with CRF not on dialysis may require lower maintenance doses than those receiving dialysis. During the transition period onto dialysis, closely monitor hemoglobin and blood pressure and carefully adjust their maintenance doses
• Darbepoetin therapy causes an increase in RBCs and a decrease in plasma volume that may reduce dialysis efficiency
• Monitor hemoglobin level weekly until stabilized and maintenance dose is established.
• Monitor hemoglobin level weekly for at least 4 weeks until hemoglobin level has stabilized in response to dose change
• Blood pressure is to be monitored regularly. Monitor renal function, check iron stores and supplement if needed
• In case of suboptimal response to therapy other causes of anemia should be excluded or corrected

Cautions: Use cautiously in

• History of hypertension
• Hematologic disorder
• History of CAD
• History of CHF
• Folic acid or vitamin B₁₂ deficiency
• Sickle cell disease
• Hemolytic disease
• Pure red cell aplasia
• Porphyria
• Iron deficiency

Supplemental Patient Information

• Instruct patients to report chest pain or other pain, muscle tremors, weakness, and cough or other respiratory symptoms

Pregnancy Category:C

Breastfeeding: Safety unknown; because many drugs are excreted in human milk manufacturer advises caution.

• CV: Hypertension, hypotension, anemia, cardiac arrhythmias/cardiac arrest, angina pectoris/cardiac chest pain, thrombosis vascular access, MI, CHF, thromboembolism
• CNS: Headache, dizziness, stroke, seizures
• GI: Diarrhea, vomiting, nausea, abdominal pain, constipation
• MUSC: Muscle Spasm, arthralgia, limb pain, back pain, myalgia
• RESP: Upper Respiratory Infection, dyspnea, cough, bronchitis
• HEMA: Pure red cell aplasia, anemia
• DERM: Pruritus
• LOCAL: Injection Site Pain
• MISC: Peripheral edema, fatigue, fever, death, unspecified chest pain, fluid overload, access infection, influenza-like symptoms, access hemorrhage, asthenia, infection, tumor progression, allergic reaction

• Hematopoietic; stimulates erythropoiesis in bone marrow, increasing red blood cell production
• Metabolism: Unknown; CYP450: Unknown
• Renally excreted: minimally
• Half-Life:
• SC route in CRF: 49 hrs
• IV route in CRF: 21 hrs

US Trade Name(s)

• Aranesp

US Availability

Aranesp (polysorbate soln)

• INJ: 25 mcg/ mL vials
• INJ: 40 mcg/ mL vials
• INJ: 60 mcg/ mL vials
• INJ: 100 mcg/ mL vials
• INJ: 150 mcg/0.75 mL vials
• INJ: 200 mcg/ mL vials
• INJ: 300 mcg/ mL vials
• INJ: 500 mcg/ mL vials
• SingleJect (prefilled syringe): 25 mcg/0.42 mL
• SingleJect (prefilled syringe): 40 mcg/0.4 mL
• SingleJect (prefilled syringe): 60 mcg/0.3 mL
• SingleJect (prefilled syringe): 100 mcg/0.5 mL
• SingleJect (prefilled syringe): 150 mcg/0.3 mL
• SingleJect (prefilled syringe): 200 mcg/0.4 mL
• SingleJect (prefilled syringe): 300 mcg/0.6 mL
• SingleJect (prefilled syringe): 500 mcg/mL
• SureClick (autoinjector): 25 mcg/0.42 mL
• SureClick (autoinjector): 40 mcg/0.4 mL
• SureClick (autoinjector): 60 mcg/0.3 mL
• SureClick (autoinjector): 100 mcg/0.5 mL
• SureClick (autoinjector): 150 mcg/0.3 mL
• SureClick (autoinjector): 200 mcg/0.4 mL
• SureClick (autoinjector): 300 mcg/0.6 mL
• SureClick (autoinjector): 500 mcg/mL

Aranesp (albumin soln)

• INJ: 25 mcg/ mL vials
• INJ: 40 mcg/ mL vials
• INJ: 60 mcg/ mL vials
• INJ: 100 mcg/ mL vials
• INJ: 150 mcg/0.75 mL vials
• INJ: 200 mcg/ mL vials
• INJ: 300 mcg/ mL vials
• INJ: 500 mcg/ mL vials
• SingleJect (prefilled syringe): 25 mcg/0.42 mL
• SingleJect (prefilled syringe): 40 mcg/0.4 mL
• SingleJect (prefilled syringe): 60 mcg/0.3 mL
• SingleJect (prefilled syringe): 100 mcg/0.5 mL
• SingleJect (prefilled syringe): 150 mcg/0.3 mL
• SingleJect (prefilled syringe): 200 mcg/0.4 mL
• SingleJect (prefilled syringe): 300 mcg/0.6 mL
• SingleJect (prefilled syringe): 500 mcg/mL
• SureClick (autoinjector): 25 mcg/0.42 mL
• SureClick (autoinjector): 40 mcg/0.4 mL
• SureClick (autoinjector): 60 mcg/0.3 mL
• SureClick (autoinjector): 100 mcg/0.5 mL
• SureClick (autoinjector): 150 mcg/0.3 mL
• SureClick (autoinjector): 200 mcg/0.4 mL
• SureClick (autoinjector): 300 mcg/0.6 mL
• SureClick (autoinjector): 500 mcg/mL

Canadian Trade Name(s)

• Aranesp

Canadian Availability

Aranesp (polysorbate soln)

• INJ: 15 mcg/mL vials
• INJ: 25 mcg/mL vials
• INJ: 40 mcg/mL vials
• INJ: 60 mcg/mL vials
• INJ: 100 mcg/mL vials
• INJ: 200 mcg/mL vials
• INJ: 325 mcg/mL vials
• INJ: 500 mcg/mL vials

UK Trade Name(s)

• Aranesp

UK Availability

Aranesp (polysorbate soln)

• INJ (prefilled syringe): 10 mcg/0.4 mL
• INJ (prefilled syringe): 15 mcg/0.38 mL
• INJ (prefilled syringe): 20 mcg/0.5 mL
• INJ (prefilled syringe): 30 mcg/0.3 mL
• INJ (prefilled syringe): 40 mcg/0.4 mL
• INJ (prefilled syringe): 50 mcg/0.5 mL
• INJ (prefilled syringe): 60 mcg/0.3 mL
• INJ (prefilled syringe): 80 mcg/0.4 mL
• INJ (prefilled syringe): 100 mcg/0.5mL
• INJ (prefilled syringe): 130 mcg/0.65mL
• INJ (prefilled syringe): 150 mcg/0.3 mL
• INJ (prefilled syringe): 300 mcg/0.6 mL
• INJ (prefilled syringe): 500 mcg/mL
• SureClick (autoinjector): 10 mcg/0.4 mL
• SureClick (autoinjector): 15 mcg/0.38 mL
• SureClick (autoinjector): 20 mcg/0.5 mL
• SureClick (autoinjector): 30 mcg/0.3 mL
• SureClick (autoinjector): 40 mcg/0.4 mL
• SureClick (autoinjector): 50 mcg/0.5 mL
• SureClick (autoinjector): 60 mcg/0.3 mL
• SureClick (autoinjector): 80 mcg/0.4 mL
• SureClick (autoinjector): 100 mcg/0.5mL
• SureClick (autoinjector): 130 mcg/0.65mL
• SureClick (autoinjector): 150 mcg/0.3 mL
• SureClick (autoinjector): 300 mcg/0.6 mL
• SureClick (autoinjector): 500 mcg/mL

Australian Trade Name(s)

• Aranesp

Australian Availability

Aranesp

• INJ (prefilled syringe): 10 mcg/0.4 mL
• INJ (prefilled syringe): 20 mcg/0.5 mL
• INJ (prefilled syringe): 30 mcg/0.3 mL
• INJ (prefilled syringe): 40 mcg/0.4 mL
• INJ (prefilled syringe): 50 mcg/0.5 mL
• INJ (prefilled syringe): 60 mcg/0.3 mL
• INJ (prefilled syringe):80 mcg/0.4 mL
• INJ (prefilled syringe):100 mcg/0.5mL
• INJ (prefilled syringe): 150 mcg/0.3 mL
• SureClick: 20 mcg/0.5 mL
• SureClick: 40 mcg/0.4 mL
• SureClick: 60 mcg/0.3 mL
• SureClick: 80 mcg/0.4 mL
• SureClick: 100 mcg/0.5 mL
• SureClick: 150 mcg/0.3 mL

[Outline]

Hematology/Oncology

Erythropoietins (Recombinant Human)

Pricing data from www.DrugStore.com in U.S.A.

• Aranesp (Albumin Free) 100 MCG/0.5ML SOLN [Box] (AMGEN)
  2 0.5ml = $2332.03
  6 0.5ml = $6875.18
• Aranesp (Albumin Free) 60 MCG/ML SOLN [Vial] (AMGEN)
  1 ml = $390.99
  4 ml = $1557.96
• Aranesp (Albumin Free) 300 MCG/ML SOLN [Vial] (AMGEN)
  1 ml = $1782.58
  3 ml = $5153.89
• Aranesp (Albumin Free) 100 MCG/ML SOLN [Box] (AMGEN)
  4 ml = $2423.46
  12 ml = $7040.27

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.