Anemia (uh-NEE-mee-uh): any condition in which the number of red blood cells, the amount of hemoglobin, and the volume of packed red blood cells in the blood are lower than normal levels

Chronic Kidney Disease [CKD]: a disease in which kidney function is slowly reduced

Dialysis (dy-AL-ih-sis): kidney replacement therapy in which blood is filtered through a membrane to remove waste products and excess fluid

ESA: erythropoiesis stimulating agent

Erythropoiesis stimulating agent [ESA] (eh-RITH-roh-poy-EE-sis): drug which acts like erythropoietin to stimulate formation of red blood cells

Erythropoietin [EPO] (eh-rith-roh-POY-eh-tin): a protein produced by the kidney that increases the formation of red blood cells

FDA: Food and Drug Administration

Ferritin (FER-uh-tin): an iron-protein complex found in the intestinal mucosa, spleen, bone marrow, reticulocytes, and liver. It regulates iron storage and transport

Hematocrit [Hct] (heh-MAH-toe-krit): percentage of the volume of a blood sample occupied by cells

Hemodialysis (hee-moh-dy-AL-ih-sis): see dialysis

Hemoglobin [Hb] (hee-moh-GLOH-bin): the oxygen-carrying compound in red blood cells

Iron deficiency: depletion of iron stores to the degree that red blood cell production is impaired

Iron deficiency anemia: anemia accompanied by indicators of low iron status

RBC: red blood cell

TSAT: transferrin saturation (see Transferrin saturation)

Transferrin (trans-FER-in): iron-transporting protein that circulates in the blood

Transferrin saturation [TSAT] (trans-FER-in satch-uh-RAY-shun): the amount of protein-bound iron in circulation

Transfusion (tranz-FYOO-zhun): transfer of blood or blood components from one individual to another
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.