Venofer

Generic name: iron sucrose (injection)
Drug class: Iron products

Medically reviewed by  A Ras MD.

What is Venofer used for?

Venofer is a prescription medicine that is used to treat anemia.

Description

Venofer (iron sucrose injection, USP), an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:

[Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11)

where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide.

Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Venofer is available in 5 mL single-dose vials (100 mg elemental iron per 5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL).  Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.

Mechanism of Action

Venofer is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose. Following intravenous administration, Venofer is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.

Before taking Venofer, tell your doctor:

• If you are allergic to Venofer; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Too much iron in your body or anemia from a cause other than low iron.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Venofer with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Venofer?

• Tell all of your health care providers that you take Venofer. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Venofer best taken?

Use Venofer as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given into a vein for a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Venofer that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Swelling in the arms or legs.
• Irritation where Venofer is given.
• You will be watched closely by your doctor for 30 minutes after each dose. Call your doctor right away if you have chest pain, cough or the need to cough, dizziness, passing out, shortness of breath, sweating, or throat tightness.

What are some other side effects of Venofer?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea.
• Headache.
• Muscle cramps.
• Upset stomach or throwing up.
• Change in taste.
• Joint pain.
• Back pain.
• Nose or throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Venofer?

• If you need to store Venofer at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – CARTON LABELING