For patients and family


 

Q: Why is my doctor prescribing Venofer(iron sucrose injection, USP)?
A: Your body needs iron to create red blood cells (RBCs), which carry oxygen to every organ. If you do not have enough iron of your own, your doctor may prescribe a course of Venofer® injected into your vein (called intravenous, or IV) to help manage your anemia. Taking iron by mouth (oral iron) may be enough if you are not losing blood or receiving an erythropoietin (a therapy to increase red blood cell production). However, most patients with CKD taking an erythropoietin will need to receive iron through the vein. Oral iron will not be enough once the erythropoietin begins to make new RBCs. The amount of iron your body stores will not be enough to make all the new RBCs you need. Without enough iron, erythropoietin cannot completely correct anemia. If you are on an erythropoietin and you are not getting enough iron, your doctor may treat you with Venofer®.
   
Q: How safe is Venofer®?
A: Venofer® has been used worldwide for over 50 years. Extensive research and clinical trials have consistently demonstrated its safety. Since 1992, over 9 million patients have been successfully treated with Venofer®. Venofer® (iron sucrose injection, USP) requires no test dose, even in patients who have had reactions to other IV irons. However, a person can experience a serious or life-threatening reaction to Venofer®. If you have had a reaction to intravenous iron in the past, you need to discuss with your doctor whether a different type of intravenous iron may be better for you. Other side effects may include hypotension, taste disturbance, swelling, diarrhea, constipation, nausea, dizziness, and hypertension. It is important for you to immediately notify your doctor, nurse, or other member of the healthcare staff if you experience any unusual symptoms during or just after the drug is given. See Important Safety Information below and Full Prescribing Information for more information.
   
Q: How many treatments will I need?
A: Your doctor will determine how many doses of Venofer® you will need to get your iron and hemoglobin levels back to normal based on the results of your blood tests.
   
Q: What should I expect when I get my first dose?
A: A little soreness and/or redness at the injection site is common.  See Important Safety Information below as well for possible side effects.
   
Q: Why does my doctor test my blood so often?
A: The blood tests that you take monthly or quarterly will give your doctor a picture of how healthy your RBCs are, and whether you are receiving enough iron. (These tests may be taken less often if your RBC count remains good.)
   
Your RBC tests are:

  • Hemoglobin: This is the part of the RBC containing the iron that carries oxygen.
  • Hematocrit: This is the measure that tells how many RBCs are in a specific amount of blood.
   
The two iron blood tests you should know about are:

  • Ferritin: This is a protein that keeps iron in "storage" until it is needed. When you have a serious infection, it is possible that your body will hold onto the iron in storage, but you won’t have enough iron in your blood cells. You should receive treatment for your infection before continuing to receive your supplemental iron therapy.
  • Transferrin Saturation: Transferrin is a protein that takes the iron from the storage protein (ferritin), or the iron that you're being treated with, and brings it to the bone marrow where it may be used to build healthy RBCs.
   
Q: Are there differences between Venofer® and other IV irons?
A: Yes. Some of the major differences between Venofer® and other IV irons are the size of the dose, how fast it is given to you, and the ability to take it safely even without a test dose. While all IV irons help to treat iron deficiency anemia, other products may not be given as easily in your doctor's office or outpatient setting as Venofer® can be.


 
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.