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.
Important Safety Information Indication arrow-down Prescribing Information Medication Guide Instructions for Use For Patients Oncology Healthcare Professionals
cliniccentercliniccenter

ARANESP® HAS
EXTENSIVE CLINICAL
EXPERIENCE

Aranesp® is a proven option for patients with anemia due to CKD

tilde 19K tilde 19K

patients received Aranesp®
during clinical trials1,*

1-2-million 1-2-million

patient-years
of experience2,†

*Cumulative estimate based on subjects who received ≥ 1 dose (actual

exposure) for completed and ongoing (per protocol randomization)
clinical
studies from launch through October 31, 2016.


†US exposure estimate methodology based on total monthly dollar
revenue,
assumed monthly revenue per patient, assumed patient loss
rate, and
assumed route of administration share from 2002 through
November 30,
2017. It assumes an increase on the patient level, not
accounting for dose
increases, and does not reflect price increases
since 2008.

ARANESP® SUSTAINED EFFICACY
AT
EXTENDED DOSING INTERVALS
ellipse ellipse
95% 95%
 

More than 95% of patients
on
dialysis had their Hb
successfully
maintained
with Aranesp®3,‡

‡Vanrenterghem et al, Kidney Int. 2002. Data from
a multicenter, randomized, open-label study
comparing epoetin, given 1, 2, or 3 times weekly
IV or SC, with Aranesp®, at a reduced dose
frequency, in dialysis patients (N = 522). Dose
adjustments were made as necessary and per
study protocol to maintain individual patients’ Hb
within a target range of –1.0 to +1.5 g/dL of their
baseline Hb and between 9 g/dL and 13 g/dL for up
to 52 weeks. The primary endpoint was the
change in Hb between baseline and the
evaluation period at weeks 25 to 32 of treatment.
The mean change in Hb from baseline to the
evaluation period was similar in the Aranesp® and
epoetin groups, and the difference between the
two treatment groups was 0.03 g/dL. This was
not a statistically significant or clinically relevant
difference. 97% (178/183) of patients’ Hb levels
were successfully maintained on Aranesp® QW or
less after conversion from epoetin during the
evaluation period.

clinicexterior clinicexterior

AMGEN IS COMMITTED
TO
COMPREHENSIVE
SUPPORT

Amgen sales support team

Your sales rep team and key account managers are
your source of
support for any questions about
ordering or details about Aranesp®.

phone icon

1-877-255-1114

Facility management tools

Obtain tools from your Amgen Sales Support Team to
help
your facility.

Coverage and reimbursement support

An Amgen Reimbursement Specialist can assist you
with insurance
verification, co-pays, and reimbursement resources.

delivery delivery

CONSISTENT SUPPLY4,§

Reliability in supply is essential to Amgen

Since 2001, Amgen has consistently supplied
Aranesp®
to support patients.4,§

In the last 10 years, even in the wake of natural
disasters
and other disruptive events, customers**
have not
experienced a supply shortage of Aranesp®.4,5

§Based on 99.9% of product shipped to Amgen Authorized Distributors of Record only.
**US wholesalers only (data through April 17, 2017).

Learn more about Amgen manufacturing at
amgenbiotech.com

EDUCATIONAL
RESOURCES

anemia-hub anemia-hub

ANEMIAHUB.COM

Designed specifically for nephrology healthcare
professionals,
anemiahub.com is your comprehensive source for anemia
management education.

  • Order and download HCP and patient materials to utilize in your practice
  • Watch Amgen Anemia Management Institute (AMI)® educational videos
    to stimulate constructive thinking

Not an Anemia HubTM member? Register here

 
 

Downloads

Assessment and Management Brochure

Multiple Dosing Options Brochure

Prescribing Information

30-years-logo 30-year-logo

For nearly 30 years,
Amgen has
demonstrated
a commitment to the

nephrology community.

Hb Instability and Intervention

Dosing Options

CKD = chronic kidney disease; IV = intravenous; SC = subcutaneous; Hb = hemoglobin; QW = once weekly; HCP = healthcare professional.

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.
Please click to see accompanying Aranesp® full prescribing information, including Boxed WARNINGS and Medication Guide.

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; [Aranesp® (darbepoetin alfa) Periodic Benefit-Risk Evaluation Report; December 21, 2016]. 2.Data on file, Amgen; [Patient Years; December 2017]. 3. Vanrenterghem Y, Bárány P, Mann JFE, et al. Randomized trial of darbepoetin alfa for treatment of renal anemia at a reduced dose frequency compared with rHuEPO in dialysis patients. Kidney Int. 2002;62(6):2167-2175. 4. Data on file, Amgen; [Historic Aranesp® Shipment Summary; April 27, 2017]. 5. Data on file, Amgen; 2018.
 

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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