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)
Important Safety Information Indications Prescribing Information Medication Guide For Healthcare Professionals Contact Us

A common complication of chronic kidney disease (CKD),

anemia may impact you whether
you're on dialysis or not, and may
not improve without treatment.

Learn about ARANESP® and how your doctor may be able to help you manage your anemia.

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Patient with anemia due to CKD interacting with loved ones

Your doctor will determine the right Hb level for you and treat you with the smallest dose of ARANESP® needed to help avoid blood transfusion.

What is ARANESP®?

ARANESP® is a well-studied treatment given to more than 1.3 million people* with anemia due to CKD.

ARANESP® is a prescription medicine used to treat anemia caused by CKD in patients on dialysis and not on dialysis. It acts like a hormone called erythropoietin (ee-rith-row-PO-eh-tin). This hormone plays an important role in making red blood cells.

ARANESP® is used to treat anemia by helping the body create more red blood cells. When the amount of blood cells are lower than normal, you also have decreased levels of hemoglobin (also called Hb). Hb is the iron-rich protein that allows the red blood cells to carry oxygen from your lungs to the rest of your body. Less Hb means less oxygen to your tissues and organs—like your heart and your brain—so they might not get enough oxygen to function properly.

It's important for your doctor to monitor your Hb levels regularly to ensure they don’t go up too high or too quickly.

ARANESP® decreases the need for red blood cell transfusions.

Blood transfusions can be given for anemia, however, blood transfusions may also have risks, such as different types of reactions and infections.

ARANESP® increases Hb levels and decreases the need for blood transfusions. ARANESP® should not be used in place of red blood cell transfusion for the emergency treatment of anemia.

*The number of people using ARANESP® is an estimate based on sales revenue data from the launch of ARANESP® in September 2001 through May 31, 2024. Data on incident and prevalent number of patients on dialysis and market share are used to estimate number of patients exposed.

Your doctor will determine the right Hb level for you and treat you with the smallest dose of ARANESP® needed to help avoid blood transfusion.

Patient with anemia due to CKD participating in a leisure activity

How ARANESP® is given

With ARANESP®, your doctor can use precise dosing to help manage anemia.

If you are not on dialysis:

  • You are usually treated once every 4 weeks
  • Your doctor will help decide how ARANESP® will be administered

If you are on dialysis:

  • Your doctor will decide if you should take ARANESP® when you receive dialysis or if you or your caregiver will be trained to inject ARANESP® at home
  • You can be treated once a week or once every two weeks
  • If you are on hemodialysis, you should receive ARANESP® during dialysis treatment

How is your ARANESP® treatment monitored?

It takes time for your body to make new red blood cells and raise your hemoglobin (Hb) level. With ARANESP® treatment, increased Hb levels aren't observed until 2 to 6 weeks.

Your doctor will test your blood regularly—at least weekly at the beginning of your treatment—to measure your Hb levels and make sure ARANESP® is working.

  • Your doctor will determine the right Hb level for you and prescribe the smallest dose of ARANESP® required to reduce your need for blood transfusions
  • ARANESP® may be prescribed when your Hb level is less than 10 g/dL
  • Throughout your ARANESP® treatment, your doctor will also check your iron levels because iron helps your red blood cells carry oxygen. The majority of patients taking ARANESP® for their anemia require iron therapy
Patient with anemia due to CKD participating in a leisure activity

Ask your doctor about any questions you may have about ARANESP® or refer to the Medication Guide for more information.

Side effects

What are possible side effects of ARANESP®?

You may get serious heart problems, such as a heart attack or heart failure, and stroke. You may die sooner if you are treated with ARANESP® to reach a normal or near normal Hb level. If your Hb level stays too high or goes up too quickly, this may also lead to these serious problems. These problems may happen even if you take ARANESP® and do not have an increase in your Hb level.

Common side effects of ARANESP® include:

  • Shortness of breath
  • Cough
  • Low blood pressure during dialysis
  • Abdominal pain
  • Swelling of the arms or legs

These are not all the possible side effects of ARANESP®. Ask your doctor for a complete list and talk to your doctor about any side effects that bother you or that do not go away.

Before you take ARANESP®, tell your nurse and doctor about any conditions you have, including if you:

  • Have heart disease
  • Have high blood pressure
  • Have had a seizure (convulsion) or stroke
  • Receive dialysis treatment
  • Are pregnant or plan to become pregnant. It is not known if ARANESP® may harm your unborn baby. Talk to your healthcare provider about possible pregnancy and birth control choices that are right for you
  • Are breast-feeding or planning to breast-feed. It is not known if ARANESP® passes into the breast milk
  • Have any allergies, including to latex (the needle cover on the prefilled syringe contains latex)

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Ask your doctor about any questions you may have about ARANESP® or refer to the Medication Guide for more information.

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®.