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®.

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)
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Why is it important to speak up about the possibility of anemia before starting chemotherapy?

It takes approximately between 2 and 6 weeks from the beginning of Aranesp® therapy for your anemia to get better.1 This means that the sooner you are aware of your anemia management options, the better prepared you’ll be to start treatment if you need it.

Could you be at risk for anemia?

When undergoing chemotherapy in the past, did you experience anemia? In many people with cancer who are receiving chemotherapy, once hemoglobin levels begin to fall, they can continue to decrease. In a clinical study, it was shown that 35% of patients had a decrease in their hemoglobin levels (from below 10 g/dL to below 9 g/dL) within 3 weeks of chemotherapy.2

How do I know if I have anemia?

If you think you may have anemia, it’s important to speak to your healthcare team right away. The symptoms of anemia may start off as mild and can be similar to other conditions or to the side effects of chemotherapy. Talk to your healthcare provider about anemia when receiving chemotherapy, especially if you are experiencing3,4:

  • Dizziness or fainting
  • Pale skin, including decreased pinkness of the lips, gums, lining of the eyelids, nail beds, and palms
  • Fast heartbeat
  • Feeling cold

Could my chemotherapy be causing my anemia?

Yes—chemotherapy is known to be a cause of anemia. The job of chemotherapy is to destroy fast-growing cells, such as tumor cells. Due to its effectiveness at doing just this, it can sometimes kill friendly cells, such as the cells that produce your red blood cells. When you have a lower than normal number of red blood cells, this is called anemia.3

Why are red blood cells so important?

Red blood cells contain hemoglobin (hee-moh-glow-bin), a protein that carries oxygen to your organs and tissues. Without the right amount of hemoglobin, your muscles and organs may not be getting enough oxygen to function properly.5

How is anemia diagnosed?

Only your healthcare provider can diagnose anemia by running standard lab tests that measure your blood’s hemoglobin levels.4

Normal levels of hemoglobin are 12-16 g/dL for women and 13.5-17.5 g/dL for men. In mild anemia, hemoglobin levels are 10 g/dL for women and 10-13.5 g/dL for men. In moderate anemia, hemoglobin levels are 8- < 10 g/dL. In severe anemia, hemoglobin levels are < 8 g/dL. Normal levels of hemoglobin are 12-16 g/dL for women and 13.5-17.5 g/dL for men. In mild anemia, hemoglobin levels are 10 g/dL for women and 10-13.5 g/dL for men. In moderate anemia, hemoglobin levels are 8- < 10 g/dL. In severe anemia, hemoglobin levels are < 8 g/dL.

*Normal hemoglobin values may vary slightly based on your local laboratory.6

What could Aranesp® do for me?

If you have anemia as a result of chemotherapy, Aranesp® may reduce the need for a transfusion to replace your red blood cells.1,7

References

Important Safety Information

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®
  • 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 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 (≥ 1%) in Aranesp® clinical studies in cancer patients receiving chemotherapy were abdominal pain, edema, and thrombovascular events.

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.
  • In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion.
  • As a substitute for RBC transfusions in patients who require immediate correction of anemia.

Please see Aranesp® full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

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Important Safety Information 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.

Important Safety Information

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®
  • 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 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 (≥ 1%) in Aranesp® clinical studies in cancer patients receiving chemotherapy were abdominal pain, edema, and thrombovascular events.

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.
  • In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion.
  • As a substitute for RBC transfusions in patients who require immediate correction of anemia.

Please see Aranesp® full Prescribing Information, including Boxed WARNINGS, and Medication Guide.