Aranesp Side Effects

Aranesp (darbepoetin alfa) is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Aranesp is used to treat anemia (a lack of red blood cells in the body).

You should not use Aranesp if you are allergic to darbepoetin alfa or epoetin alfa (Epogen or Procrit), or if you have:

  • untreated or uncontrolled high blood pressure; or
  • if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using darbepoetin alfa or epoetin alfa.

To make sure you can safely take Aranesp, tell your doctor if you have any of these other conditions:

  • heart disease, congestive heart failure, high blood pressure;
  • kidney disease (or if you are on dialysis);
  • a history of stroke, heart attack, or blood clots;
  • a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;
  • cancer;
  • a seizure disorder; or
  • if you are allergic to latex.

FDA pregnancy category C. It is not known whether Aranesp will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether darbepoetin alfa passes into breast milk or if it could harm a nursing baby. Do not use Aranesp without telling your doctor if you are breast-feeding a baby. Some women using Aranesp have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need to use birth control while you are using Aranesp.

Get emergency medical help if you have any of these signs of an allergic reaction to Aranesp: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Contact your doctor if you feel light-headed or unusually weak or tired. These may be signs that your body has stopped responding to Aranesp.

Aranesp can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Aranesp.

Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance; or
  • pain, swelling, warmth, or redness in one or both legs.

Stop using Aranesp and call your doctor at once if you have other serious side effects such as:

  • fever, chills, body aches, flu symptoms;
  • feeling like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • seizure (black-out or convulsions); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious Aranesp side effects may include:

  • stomach pain;
  • mild cough;
  • mild skin rash or redness; or
  • pain, bruising, swelling, warmth, redness, oozing, or bleeding where the IV needle is placed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.