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.
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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.

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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

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.

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

Important Safety Information

Aranesp® may cause serious side effects that can lead to death, including:

For people with cancer:

  • In patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers: Your tumor may grow faster and you may die sooner if you choose to take Aranesp®.
  • Your healthcare provider will talk with you about these risks.

For all people who take Aranesp®, including people with cancer or chronic kidney disease:

  • Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with Aranesp® to increase red blood cells (RBCs) to near the same level found in healthy people.
  • Blood clots. Blood clots may happen at any time while taking Aranesp®. If you are receiving Aranesp® for any reason and are going to have surgery, talk with your healthcare provider about whether you need to take a blood thinner to lessen the chance of blood clots during or following surgery.
  • Call your healthcare provider or get medical help right away if you have any of these symptoms:

    • Chest pain
    • Trouble breathing or shortness of breath
    • Pain or swelling in your legs
    • A cool or pale arm or leg
    • Sudden confusion, trouble speaking, or trouble understanding others' speech
    • Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
    • Sudden trouble seeing
    • Sudden trouble walking, dizziness, loss of balance or coordination
    • Loss of consciousness (fainting)
    • Hemodialysis vascular access stops working

If you decide to take Aranesp®, your healthcare provider should prescribe the smallest dose that is necessary to reduce your chance of needing RBC transfusions.

If your hemoglobin level stays too high or goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take Aranesp®, even if you do not have an increase in your hemoglobin level.

Do not take Aranesp® if you:

  • Have cancer and have not been counseled by your healthcare provider about treatment with Aranesp®.
  • Have high blood pressure that is not controlled (uncontrolled hypertension).
  • Have been told by your healthcare provider that you have, or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with Aranesp® or other erythropoietin medicines.
  • Have had a serious allergic reaction to Aranesp®.

Before taking Aranesp®, tell your doctor if you: have heart disease; have high blood pressure; have had a seizure or stroke; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed.

If you know you are allergic to latex, talk to your healthcare provider before using Aranesp® because the needle cover on the prefilled syringe contains latex.

Aranesp® may cause other serious side effects, including:

  • High blood pressure. High blood pressure is a common side effect of Aranesp® in people with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medication while taking Aranesp®. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often.
  • Seizures. If you have seizures while taking Aranesp®, get medical help right away and tell your healthcare provider.
  • Antibodies to Aranesp®. Your body may make antibodies to Aranesp® that can block or lessen your body’s ability to make RBCs and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking Aranesp®.
  • Serious allergic reactions. Serious allergic reactions can cause a skin rash, itching, shortness of breath, wheezing, dizziness and fainting due to a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using Aranesp® and call your healthcare provider or get medical help right away.
  • Severe skin reactions. Signs and symptoms of severe skin reactions with Aranesp® may include: skin rash with itching, blisters, skin sores, peeling or areas of skin coming off. If you have any signs or symptoms of a severe skin reaction, stop using Aranesp® and call your healthcare provider or get medical help right away.

Common side effects of Aranesp® include:

  • Shortness of breath
  • Cough
  • Low blood pressure during dialysis
  • Abdominal pain
  • Edema (swelling) of the arms or legs

These are not all the possible side effects of Aranesp®. Tell your healthcare provider about any side effects that bother you or do not go away.

You are encouraged to report negative side effects of prescription drugs to the US Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indications

Aranesp® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease in patients on dialysis and not on dialysis.

Aranesp® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chemotherapy that will be used for at least two months after starting Aranesp®.

Limitations of Use

Aranesp® has not been proven to improve quality of life, fatigue, or well-being.

Aranesp® should not be used for the treatment of anemia:

  • If you have cancer and you will not be receiving chemotherapy that may cause anemia for at least 2 more months
  • If you have a cancer that has a high chance of being cured
  • If your anemia caused by chemotherapy treatment can be managed by RBC transfusion.
  • In place of emergency treatment for anemia (red blood cell transfusions)

Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

Important Safety Information

Aranesp® may cause serious side effects that can lead to death, including:
For people with cancer
  • In patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers: Your tumor may grow faster and you may die sooner if you choose to take Aranesp®.
  • Your healthcare provider will talk with you about these risks.
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