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Precautions and Warnings With Darbepoetin Alfa

Specific Warnings and Precautions for Darbepoetin Alfa

Warnings and precautions to be aware of prior to taking darbepoetin alfa include the following:
  • In studies that involved people with chronic kidney disease, an increase in risk of death, stroke, and serious cardiovascular problems (such as heart attacks) was reported when darbepoetin was used to target a hemoglobin level (a measure of red blood cells) greater than 11 g/dL. None of the studies that have been completed have identified a hemoglobin target level, darbepoetin dose, or dosing strategy that does not increase these risks.


  • Your healthcare provider should measure your hemoglobin frequently and adjust your darbepoetin alfa dosage so that your hemoglobin does not increase too quickly or too much. However, this will not prevent all cardiovascular problems, and you and your healthcare provider must weight the potential benefits of darbepoetin alfa with these risks.
  • Darbepoetin alfa is not approved to be used before surgery for preventing the need for blood transfusions. Studies have suggested that this use may be dangerous.
  • Darbepoetin alfa may accelerate the worsening of cancer and may shorten survival, particularly when it increases hemoglobin levels too much. This risk must be weighed against the potential benefits of darbepoetin alfa.
  • Darbepoetin alfa may cause high blood pressure (hypertension). This can be a problem, especially if you already have high blood pressure. Your healthcare provider should monitor your blood pressure closely while you are taking darbepoetin alfa.
  • In studies, some people who took darbepoetin alfa experienced seizures. If you have a seizure while taking darbepoetin alfa, tell your healthcare provider immediately.
  • Rarely, people can form antibodies to darbepoetin alfa, causing severe anemia. If your anemia worsens while you are taking darbepoetin alfa, your healthcare provider should check to see if you are forming these antibodies. In this situation, you may need to stop taking darbepoetin alfa permanently.
  • Some forms of darbepoetin alfa contain albumin, a human blood protein. As with all albumin products, theoretically, there is an extremely small risk of contracting an infection (including very serious infections) from the albumin. However, there are no cases of this ever happening with an albumin product.
  • Darbepoetin alfa has not been studied in people with sickle cell anemia, porphyria, hemolytic anemia, or thalassemia.
  • Darbepoetin alfa is unlikely to interact with other medications (see Drug Interactions With Darbepoetin Alfa).
  • Darbepoetin alfa is considered a pregnancy Category C medication. This means that it may not be safe for use during pregnancy. Talk to your healthcare provider about the risks and benefits of using the drug during pregnancy (see Aranesp and Pregnancy).
  • It is not known whether darbepoetin alfa passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Aranesp and Breastfeeding).
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Drug Information -- Darbepoetin Alfa

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