Venofer injection contains iron sucrose, a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

Venofer is used to treat iron deficiency anemia in people with kidney disease.

Venofer is not for treating other forms of anemia not caused by iron deficiency.

Venofer is for use in adults and children at least 2 years old.

You should not receive Venofer if you have ever had an allergic reaction to an iron injection, or if you have iron overload (the buildup of excess iron) or hemochromatosis.

Iron sucrose can make it harder for your body to absorb iron medications you take by mouth. Tell your doctor if you are taking iron supplements or other iron-based oral medications.

Before you receive Venofer, tell your doctor if you have low blood pressure, hepatitis, or if you have received many blood transfusions in the past.

Before taking this medicine

You should not be treated with this medicine if you have ever had an allergic reaction to an iron injection.

To make sure Venofer injection is safe for you, tell your doctor if you have:

• hemochromatosis or iron overload (the buildup of excess iron).

Tell your doctor if you are pregnant or plan to become pregnant. Iron sucrose can harm an unborn baby if you have a severe reaction to this medicine during your second or third trimester. However, not treating iron deficiency anemia during pregnancy may cause complications such as premature birth or low birth weight. The benefit of treating your condition during pregnancy may outweigh any risks.

If you are breastfeeding, tell your doctor if you notice diarrhea or constipation in the nursing baby.

Venofer is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine is sometimes given slowly, and the infusion can take up to 2.5 hours to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Venofer is injected.

You will be watched closely for at least 30 minutes to make sure you do not have an allergic reaction.

You will need frequent medical tests to help your doctor determine how long to treat you with Venofer.

You should not be treated with this medicine if you have ever had an allergic reaction to an iron injection.

To make sure Venofer injection is safe for you, tell your doctor if you have:

• hemochromatosis or iron overload (the buildup of excess iron).

Tell your doctor if you are pregnant or plan to become pregnant. Iron sucrose can harm an unborn baby if you have a severe reaction to this medicine during your second or third trimester. However, not treating iron deficiency anemia during pregnancy may cause complications such as premature birth or low birth weight. The benefit of treating your condition during pregnancy may outweigh any risks.

If you are breastfeeding, tell your doctor if you notice diarrhea or constipation in the nursing baby.

Call your doctor for instructions if you miss an appointment for your Venofer injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction to Venofer: hives, rash, itching; feeling light-headed; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

• problems with your dialysis vein access point;

• chest pain;

• high blood pressure - severe headache, blurred vision, pounding in your neck or ears;

• low blood pressure - a light-headed feeling, like you might pass out; or

• signs of inflammation in the lining of your stomach - pain or swelling, bloating, nausea, vomiting, loss of appetite, diarrhea, fever.

Common Venofer side effects may include:

• fever, cold or flu symptoms (sore throat, cough, stuffy nose, sneezing);

• high or low blood pressure;

• headache, dizziness;

• nausea, vomiting, diarrhea;

• muscle or joint pain, back pain;

• pain or swelling in an arm or leg;

• itching; or

• bruising or irritation where the medicine was injected.

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.

Treatment with Venofer injections can make it harder for your body to absorb iron medications you take by mouth. Tell your doctor if you are taking iron supplements or other iron-based oral medications, such as:

• ferrous fumarate;

• ferrous gluconate; or

• ferrous sulfate, and others.

This list is not complete. Other drugs may interact with iron sucrose, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.