What is Anemia?
Anemia is a condition in which a person's blood contains a lower than normal amount of red blood cells (RBCs). Red blood cells are responsible for delivering oxygen throughout the body, a process necessary for life. Anemia is a sign of disease, and not a disease itself. It is very common in CKD.

What is Iron Deficiency Anemia?
Iron deficiency is the most common cause of anemia. Iron deficiency anemia occurs when there is too little iron in your body to make healthy red blood cells. Your body may also not have enough iron in storage to continue making healthy red blood cells.

Anemia often has no symptoms. However, symptoms that may indicate anemia include:

  • Feeling tired
  • Shortness of breath
  • Loss of appetite
  • Headaches
  • Fast heartbeat
  • Colder hands and feet than usual
  • Paleness

Anemia, over a long period of time, can cause you to have problems with your heart. If you already have heart problems, it can make those problems worse.

The Kidneys, Iron, and Anemia
The healthy kidney produces a hormone called erythropoietin (commonly known as EPO). It acts as a messenger telling the bone marrow to create new red blood cells. The bone marrow is also supplied with a small amount of iron, which helps to build healthy new RBCs. Then the RBCs carry oxygen to all parts of the body. Every living human cell needs oxygen to live. Muscles are made up of millions of cells and an important muscle is the heart. This is why heart conditions can develop or worsen if there are not enough RBCs to deliver oxygen to the cells of the heart. Oxygen is the fuel for cell survival.

Too little iron may be caused by the following:

  • Diet restrictions
  • The body is not able to absorb enough iron
  • Blood loss: if you lose blood, you lose RBCs and iron, too
  • Erythropoiesis stimulating agents (ESAs) such as EPO speed up the creation of RBCs and quickly use a lot of the iron in your body to make RBCs
American Regent. Enriching the lives of anemia patients. ™

Important Safety Information
Venofer® (iron sucrose injection, USP) should not be taken if you have symptoms of too much iron in your blood, a known allergy to Venofer® or any of its inactive components, and if you have anemia not caused by iron deficiency. Serious hypersensitivity reactions (serious allergic reactions) have been reported in patients taking Venofer®, including serious and life threatening reactions (shock, loss of consciousness, collapse, convulsion, severe difficulty in breathing). Hypotension (low blood pressure) has been reported in patients who receive IV iron whether or not they are on dialysis. Hypotension (low blood pressure) following administration of Venofer® may be related to how fast and how much of the drug is given.

In studies in non-dialysis dependent-CKD patients, the most common side effects of Venofer were taste disturbance (7.7%), swelling of the arms and legs (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of non-dialysis dependent-CKD patients treated with erythropoietin, the most common side effects of Venofer were diarrhea (16.5%), swelling of the arms and legs (16.5%), nausea (13.2%), vomiting (12.1%), joint pain (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).

In studies in hemodialysis dependent-CKD patients, the most common side effects of Venofer were low blood pressure (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In additional studies in hemodialysis dependent-CKD patients, the most common side effects were congestive heart failure, severe infections, and taste disturbance. In the study of peritoneal dialysis-dependent CKD patients most common side effects were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), sore throat (6.7%), swelling of the arms and legs (5.3%), and nausea (5.3%).


These are not all the possible side effects of Venofer®. For more information ask your healthcare professional or contact American Regent at 1-800-645-1706.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Full Prescribing Information.