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Venofer® (iron sucrose injection, USP) is used intravenously to replenish body iron stores in patients with iron deficiency anemia. Venofer® is indicated in the treatment of iron deficiency anemia in:

  • Adult non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin
  • Adult non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin
  • Adult hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
  • Adult peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin

Venofer® should not be taken if you have symptoms of too much iron in your blood, a known allergy to Venofer® or any of its components, or have anemia not caused by iron deficiency.


What is Venofer® (iron sucrose injection, USP)?

Venofer® is an intravenous iron used to replenish iron stores and correct iron deficiency anemia in CKD patients with iron deficiency anemia.

How does Venofer® work?
Venofer® helps your body make healthy red blood cells by supplying iron, a necessity for red blood cell production.

What is Venofer® treatment?
Your healthcare professional will administer an injection of Venofer® in his or her office or clinic. Depending on your individual condition, your healthcare professional will determine how many injections you will need.

What are the side effects of taking Venofer® (iron sucrose injection, USP)?
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.  See Important Safety Information below and Full Prescribing Information for more information.

The most common side effects of Venofer® observed in clinical trials are:  low blood pressure (hypotension), taste disturbance, swelling in arms and lets, diarrhea, constipation, nausea, dizziness, and high blood pressure.  Tell your doctor if you experience any of these symptoms.  Please see Full Prescribing Information for more information.

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.

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.


References