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®. READ MORE

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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Patient with anemia due to CKD interacting with a loved one

What is anemia?

Anemia is linked to a shortage of red blood cells.

Every part of the body needs oxygen to work and survive. Red blood cells have the important job of carrying oxygen around the body. When the body has fewer healthy red blood cells than normal, anemia develops.

Illustration indicating fewer red blood cells

Anemic levels of red blood cells

Illustration indicating normal number of red blood cells

Normal levels of red blood cells

When you have anemia, your body does not get enough oxygen, so it has to work harder to do all of its jobs—like making the heart beat.

  • If you have anemia, you may have fatigue or tiredness, shortness of breath, unusually pale skin, or weakness
  • Anemia has other symptoms too. Talk with your dialysis care team about how you’re feeling
Patient with anemia due to CKD walking with a loved one

What causes anemia?

How does CKD cause anemia?

Anemia has many causes. If your doctor has diagnosed you with anemia due to CKD, it means your kidneys are not making enough of the hormone erythropoietin (ee-rith-row-PO-eh-tin).

Erythropoietin is the hormone made by the kidneys that tells your body to create red blood cells.

Healthy kidneys

Illustration indicating how healthy kidneys make enough erythropoietin to produce a normal number of red blood cellsIllustration indicating how healthy kidneys make enough erythropoietin to produce a normal number of red blood cells

Damaged kidneys

Illustration indicating how damaged kidneys do not make enough erythropoietin, resulting in fewer red blood cells Illustration indicating how damaged kidneys do not make enough erythropoietin, resulting in fewer red blood cells

During treatment for CKD, your doctor monitors your hemoglobin (Hb) to see if your red blood cell count is low. Hb is the protein found in red blood cells that is responsible for carrying the oxygen your body needs.

Patient with anemia due to CKD

Your doctor will help you choose the best treatment for your anemia.

Treatment options

Treatment for anemia with CKD isn’t one-size-fits-all.

It’s important to weigh the pros and cons of each option with your care team, and your doctor will choose an appropriate treatment based on your individual needs.

What are the treatment options for people who have anemia due to CKD?

Iron supplements

Many patients with CKD do not have enough iron, which is needed to make red blood cells and carry oxygen. Iron supplementation is widely used to treat this deficiency. Your doctor will monitor your dosage.

Erythropoiesis-stimulating agents (ESAs)

ESAs act like erythropoietin, which tells your body to make more red blood cells. An ESA, like ARANESP®, is available only through your doctor, who will review the risks and benefits of this specific treatment.

Remember that having enough iron is important before and during ESA therapy.

Red blood cell transfusions

Transfusions can quickly increase the number of red blood cells within 1 to 4 hours; they may require hospitalization. Your doctor can cover the benefits and risks of transfusion, including the possible reactions and infections that could result.

Your doctor will help you choose the best treatment for your anemia.

Patient with anemia due to CKD

What you can do

Take steps with your care team to help proactively manage your anemia.

Your doctor will talk to you about treating your anemia. But there are many things you can do to help manage your anemia, such as:

  • Learn more about chronic kidney disease and anemia
  • Talk with your healthcare team (primary care doctor, nephrologist, dietitian, nurse) about proactive treatment options
  • Keep all of your dialysis appointments and stay for your full treatment
  • Keep up to date on your hemoglobin lab results
  • Work with a dietitian to improve your eating habits
  • Take all your medicines as they are prescribed

Consider asking your care team the following questions 

  • What is causing my anemia?
  • If I have CKD, should I be concerned about anemia?
  • How will I know if I have anemia?
  • Why is it important to manage anemia?
  • How do we plan to treat my anemia?
  • What are the risks and benefits of each treatment type?

By keeping your physicians informed, you can help them provide the best possible care for you. Here are some tips to help you:

  • Before an appointment, think about anything you may want to ask and write it down
  • Talk about any new problems or symptoms, especially if you have changes in how you are feeling
  • Bring a list of changes in any of your medications
  • Be sure to listen carefully and take notes to help you remember instructions for your care
  • Ask questions if you do not understand and make sure all your questions are answered

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.

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®.