Indication

Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.READ MORE

Limitations of Use
  • Aranesp® has not been shown to improve quality of life, fatigue, or patient well-being.
  • Aranesp® is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.

ARANESP® PROVIDES
CONVENIENT
DOSING OPTIONS

Designed for individualized treatment
  • Convenience of less frequent
    dosing with QW and Q2W intervals
    vs TIW dosing1
  • Multiple dosing options can be
    combined to individualize
    treatment of patients1
dosing options

 

Aranesp® is also available in 150, 200, 300, and 500 mcg dose strengths. Aranesp® is available in single-dose vials and prefilled syringes, except the 10, 150, and 500 mcg dose strengths, which are available only as prefilled syringes.

 

The IV route of administration is recommended for adult patients on hemodialysis.

DOSE COMBINATIONS

Aranesp® single-dose strengths can be combined to
more
precisely titrate doses and individualize anemia
management
for patients with CKD on dialysis.1,*

Precision dosing with the 10 mcg dose
dose strength dose strength

With the 10 mcg dose strength, doses can be precisely
titrated within 5 mcg intervals.1,*

*Except 15 mcg dose.

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Multiple Dosing Options Brochure

DOWNLOAD Prescribing Information

 
 

Take a glance at the following doses to see which
single-dose strengths may be combined to individualize anemia management.

dose-strength-mcg-table dose-strength-mcg-table
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ARANESP® SINGLEJECT® PREFILLED SYRINGES

 
  • Prefilled syringes may reduce potential for dosing errors2
  • UltraSafe® Needle Guard is designed to protect from unintentional needlesticks3
  • Bar-coded label identifies drug and dose
  • No additional wholesale acquisition costs compared to vials4

Dosing information:
Aranesp® (darbepoetin
alfa) for anemia due
to CKD

  • In controlled trials, patients experienced
    greater risks for death, serious adverse
    cardiovascular reactions, and stroke when
    administered ESAs to target a Hb level of
    greater than 11 g/dL.
  • No trial has identified a Hb target level,
    Aranesp® dose, or dosing strategy that does
    not increase these risks.
  • Individualize dosing and use the lowest dose of Aranesp® sufficient to reduce the need for RBC transfusions.
  • Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events.
Considerations
  • Correct or exclude other causes of anemia
    before initiating Aranesp®.
  • Evaluate the iron status in all patients before
    and during treatment.
  • Administer supplemental iron therapy if serum ferritin is < 100 mcg/L or serum transferrin saturation is < 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.
  • Appropriately control hypertension prior to
    initiation of and during treatment with Aranesp®.
    • Reduce or withhold Aranesp® if blood
      pressure becomes difficult to control.
INITIATING ARANESP® FOR ADULT
PATIENTS WITH CKD ON DIALYSIS
  • Initiate Aranesp®  treatment when the Hb level is
    < 10 g/dL.
  • QW recommended starting dose:
    0.45 mcg/kg as an IV or SC injection
    once weekly, as appropriate.
  • Q2W recommended starting dose:
    0.75 mcg/kg as an IV or SC injection
    once every 2 weeks, as appropriate.
    • The IV route of administration is recommended for patients on hemodialysis.
 
 
INITIATING ARANESP® FOR ADULT
PATIENTS WITH CKD NOT ON DIALYSIS
  • Consider initiating Aranesp® treatment only when the Hb level is < 10 g/dL
    and the following
    considerations apply:
    • The rate of Hb decline indicates the likelihood of
      requiring a RBC transfusion, and
    • Reducing the risk of alloimmunization and/or
      other RBC
      transfusion-related risks is a goal
  • Q4W recommended starting dose: 0.45 mcg/kg
    body weight as an IV or SC
    injection once at 4 week intervals as appropriate.
Initiating Aranesp® for pediatric patients (less than 18 years) with CKD
  • Initiate Aranesp® treatment when the Hb
    level is < 10 g/dL.
On dialysis and not on dialysis:
  • QW recommended starting dose: 0.45 mcg/kg as an IV or SC injection once weekly, as appropriate.
Not on dialysis:
  • Q2W recommended starting dose: 0.75 mcg/kg as an IV or SC injection once every 2 weeks, as appropriate.
MONITORING

Following initiation of therapy and after each
dose
adjustment, monitor Hb at least weekly
until the Hb
is stable and sufficient to minimize
the need for
RBC transfusion.

  • Thereafter, Hb should be monitored at least

    monthly, provided that Hb levels remain stable.
 
 
DOSE ADJUSTMENTS

When adjusting therapy, consider Hb rise, rate of decline,
ESA
responsiveness, and Hb variability.

  • A single Hb excursion may not require a
    dosing change.
  • Do not increase the dose more frequently than
    once
    every 4 weeks.
  • Decreases in dose can occur more frequently.
  • Avoid frequent dose adjustments.
REDUCE OR INTERRUPT DOSE
  • If Hb rises rapidly (eg, more than 1 g/dL in any
    2-week period), reduce the dose by 25% or
    more, as needed, to reduce rapid responses.
FOR ADULT PATIENTS WITH CKD
  • On dialysis: reduce or interrupt dose if the Hb
    level approaches or exceeds 11 g/dL.
  • Not on dialysis: if the Hb level exceeds 10
    g/dL, reduce or interrupt the dose of Aranesp®,
    and use the lowest dose of Aranesp®
    sufficient to reduce the need for RBC
    transfusions.
FOR PEDIATRIC PATIENTS (LESS THAN 18
YEARS) WITH CKD
  • If the hemoglobin level approaches or exceeds
    12 g/dL, reduce or interrupt the dose of
    Aranesp®.
INCREASE DOSE
  • If the Hb has not increased by more than 1 g/dL
    after 4 weeks of therapy, increase the dose by
    25% when appropriate.
Patients who do not respond adequately to Aranesp®
  • For patients who do not respond adequately
    over a 12-week escalation period, increasing
    the Aranesp® dose further is unlikely to improve response and may increase risks.
  • Use the lowest dose that will maintain a Hb
    level sufficient to reduce the need for RBC
    transfusions.
  • Evaluate other causes of anemia.
  • If typical causes of lack or loss of Hb response
    are excluded, evaluate for pure red cell aplasia (PRCA).
  • Discontinue Aranesp® if responsiveness does
    not improve.

Patients with CKD and an insufficient Hb
response to ESA therapy or a rate of Hb rise
of > 1 g/dL over 2 weeks may be at an even
greater risk for cardiovascular reactions
and mortality than other patients.

CONVERSION TO ARANESP®

Converting patients on dialysis from epoetin alfa to QW Aranesp®1
previous-epoeti-alfa-unit-table
Pinch to zoom.

The dose conversions depicted above do not accurately estimate the once-monthly dose of Aranesp® in patients with CKD not on dialysis.

For pediatric patients receiving a weekly epoetin alfa dose of < 1,500 units/week. The available data are insufficient to determine an Aranesp® conversion dose.

Remember to convert your patient's previous epoetin alfa per-administration dose to a per-week measurement. Here's an example how1:

epoetin-alpha-dose-per-week-table
Pinch to zoom.
doctorsroomdoc-office-image

Aranesp® is administered less frequently than epoetin alfa1

  • Administer Aranesp® once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly
  • Administer Aranesp® once every 2 weeks in patients who were receiving epoetin alfa once weekly
  • Maintain the route of administration (intravenous or subcutaneous injection)
  • The dose conversion in the chart above does not accurately estimate the once-monthly dose of Aranesp®

USE THE FDA-APPROVED ESA CONVERSION TABLE IN THE ARANESP® PI TO CONVERT PATIENTS ON DIALYSIS FROM EPOETIN ALFA TO ARANESP®1
  • Pediatric patients with CKD: Aranesp® safety and efficacy were similar between adults and pediatric patients with CKD when Aranesp® was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Aranesp®
 
 
THERE IS NO SINGLE DCR WHEN CONVERTING FROM EPOETIN ALFA TO ARANESP®1
  • Depending on the dose of epoetin alfa at the time of substitution, the Aranesp®:epoetin alfa DCR may range from 200:1 to 900:1
pl-based-epoetin-alpha pl-based-epoetin-alpha
Pinch to zoom.
Hb = hemoglobin; QW = once weekly; Q2W = once every 2 weeks; TIW = 3 times weekly; IV = intravenous; CKD = chronic kidney disease; DCR = dose conversion ratio; ESA = erythropoiesis-stimulating agent; RBC = red blood cell count; Q4W = once every 4 weeks; SC = subcutaneous.

Important Safety Information including Boxed WARNINGS

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, Aranesp® dose, or dosing strategy that does not increase these risks.
  • Use the lowest Aranesp® 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.
  • Aranesp® is contraindicated in patients with:
  • Uncontrolled hypertension
  • Pure red cell aplasia (PRCA) that begins after treatment with Aranesp® or other erythropoietin protein drugs
  • Serious allergic reactions to Aranesp®
  • Use caution in patients with coexistent cardiovascular disease and stroke.
  • Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.
  • Control hypertension prior to initiating and during treatment with Aranesp®.
  • Aranesp® increases the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency.
  • For lack or loss of hemoglobin response to Aranesp®, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA.
  • Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp®.
  • This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration.
  • PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp® is not approved).
  • If severe anemia and low reticulocyte count develop during treatment with Aranesp®, withhold Aranesp® and evaluate patients for neutralizing antibodies to erythropoietin.
  • Permanently discontinue Aranesp® in patients who develop PRCA following treatment with Aranesp® or other erythropoietin protein drugs. Do not switch patients to other ESAs.
  • Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp®. Immediately and permanently discontinue Aranesp® if a serious allergic reaction occurs.
  • Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including Aranesp®) in the postmarketing setting. Discontinue Aranesp® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.
  • Adverse reactions (≥ 10%) in Aranesp® clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension.

Indication

Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

Limitations of Use

  • Aranesp® has not been shown to improve quality of life, fatigue, or patient well-being.
  • Aranesp® is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.

References

1. Data on file, Amgen; [OutcomesPlus Tables for Commercial: Monthly Hemoglobin Categories Over Time; October 30, 2014]. 2. Gilbertson DT, Peng Y, Bradbury B, Ebben JP, Collins AJ. Hemoglobin level variability: anemia management among variability groups. Am J Nephrol. 2009;30(6):491-498. 3. Ebben JP, Gilbertson DT, Foley RN, Collins AJ. Hemoglobin level variability: associations with comorbidity, intercurrent events, and hospitalizations. Clin J Am Soc Nephrol. 2006;1(16):1205-1210. 4. Chan KE, Lazarus JM, Wingard RL, Hakim RM. Association between repeat hospitalization and early intervention in dialysis patients following hospital discharge. Kidney Int. 2009;76(3):331-341. 5. Bradbury BD, Critchlow CW, Weir MR, Stewart R, Krishnan M, Hakim RH. Impact of elevated C-reactive protein levels on erythropoiesis-stimulating agent (ESA) dose and responsiveness in hemodialysis patients. Nephrol Dial Transplant. 2009;24(3):919-925. 6. Solid CA, Foley RN, Gilbertson DT, Collins AJ. Perihospitalization hemoglobin-epoetin associations in U.S. hemodialysis patients, 1998 to 2003. Hemodial Int. 2007;11(4):442-447. 7. Aranesp® (darbepoetin alfa) prescribing information, Amgen. 8. Gilbertson DT, Monda KL, Bradbury BD, Collins AJ. RBC transfusions among hemodialysis patients (1999-2010): influence of hemoglobin concentrations below 10g/dL. Am J Kidney Dis. 2013;62(5):919-928. 9. Data on file, Amgen; [ESA OutcomesPlus Monthly Report; May 2017]. 10. Khan I, Krishnan M, Kothawala A, Ashfaq A. Association of dialysis facility-level hemoglobin measurement and erythropoiesis-stimulating agent dose adjustment frequencies with dialysis facility-level hemoglobin variation: a retrospective analysis. BMC Nephrol. 2011;12:22. 11. Elliott S, Lorenzini T, Asher S, et al. Enhancement of therapeutic protein in vivo activities through glycoengineering. Nat Biotechnol. 2003;21(4):414-421. 12. Egrie JC, Browne JK. Development and characterization of novel erythropoiesis stimulating protein (NESP). Br J Cancer. 2001;84(suppl 1):3-10. 13. Guyton AC, Hall JE. Red blood cells, anemia, and polycythemia. In: Textbook of Medical Physiology. 11th ed. Philadelphia, PA: WB Saunders; 2006:419-428. 14. Dessypris EN. Erythropoiesis. In: Lee GR, Foerster J, Lukens J, Wintrobe MM, eds. Wintrobe's Clinical Hematology Vol. 1. 10th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 1998:169-192. 15. Papayannopoulou T, D'Andrea AD, Abkowitz JL, Migliaccio AR. Biology of erythropoiesis, erythroid differentiation, and maturation. In: Hoffman R, Benz EJ Jr, Shattil SJ, et al, eds. Hematology: Basic Principles and Practice. 4th ed. Philadelphia, PA: Elsevier Churchill Livingstone; 2005:267-288. 16. Bunn H. Pathophysiology of the anemias. In: Isselbacher KJ, Wilson JD, Braunwald E, eds. Harrison's Principles and Practice of Internal Medicine. 13th ed. New York, NY: McGraw-Hill; 1994:1717-1721. 17. Hillman RS, Finch CA. General characteristics of the erythron. In: Red Cell Manual. 7th ed. Philadelphia, PA: F.A. Davis Company; 1996:1-15.
 

Important Safety Information including Boxed WARNINGS

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, Aranesp® dose, or dosing strategy that does not increase these risks.
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