ARANESP® (DARBEPOETIN ALFA) INDICATION
Aranesp® is indicated for the treatment of anemia in
patients with non-myeloid malignancies where anemia is due to the effect
of concomitant myelosuppressive chemotherapy, and upon initiation,
there is a minimum of two additional months of planned chemotherapy.
LIMITATIONS OF USE
Aranesp® has not been shown to improve quality of life,
fatigue, or patient well-being.
Aranesp® is not indicated for use:
- In patients with cancer receiving hormonal agents, biologic products,
or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
- In patients with cancer receiving myelosuppressive chemotherapy
when the anticipated outcome is cure.
- As a substitute for red blood cell (RBC) transfusions in
patients who require immediate correction of anemia.
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.
- 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.
- Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE
Oncology Program to prescribe and/or dispense Aranesp® to patients with cancer. To enroll in the
ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further
- 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®
- In controlled clinical trials of patients with cancer, Aranesp®
and other ESAs increased the risks for death and serious adverse cardiovascular
reactions. These adverse reactions included myocardial infarction and stroke.
- 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®.
- 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
- 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.
- Adverse reactions (≥ 1%) in clinical studies in cancer patients receiving chemotherapy
were abdominal pain, edema, and thrombovascular events.
Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.