Ferrlecit

What is Ferrlecit used for?

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

Description

Ferrlecit® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000–440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt.

The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22011)5]n≈200•

Ferrlecit is supplied as a clear, dark brown liquid in colorless glass vials. Each sterile, single-dose vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7–9.7.

Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.

Before taking Ferrlecit, tell your doctor:

• If you are allergic to Ferrlecit; 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 Ferrlecit 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 Ferrlecit?

• Tell all of your health care providers that you take Ferrlecit. This includes your doctors, nurses, pharmacists, and dentists.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Ferrlecit.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• You will be watched closely while you receive Ferrlecit and for some time after your dose. Talk with your doctor.
• This medicine has benzyl alcohol in it. Benzyl alcohol may cause very bad and sometimes deadly side effects in newborns or infants. If you have questions, talk with the 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 Ferrlecit best taken?

Use Ferrlecit 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 Ferrlecit 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 potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Chest pain or pressure or a fast heartbeat.
• A burning, numbness, or tingling feeling that is not normal.
• Swelling.
• Cough.
• Fever or chills.
• Flushing.
• Shortness of breath.
• Feeling very tired or weak.
• Very bad back pain.
• Very bad groin or thigh pain.

What are some other side effects of Ferrlecit?

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:

• Cramps.
• Stomach pain or diarrhea.
• Upset stomach or throwing up.
• Not hungry.
• Feeling dizzy, tired, or weak.
• Headache.
• Irritation where Ferrlecit is given.
• Signs of a common cold.

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 Ferrlecit?

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

Label

PRINCIPAL DISPLAY PANEL – 5 ML VIAL CARTON

• NDC 0024-2792-10
  Rx only
• Ferrlecit®
  sodium ferric gluconate
  complex in sucrose injection
• 62.5 mg elemental iron/
  5 mL Sterile Single-dose Vial
• For Intravenous Use Only
• Ten 5 mL single-dose vials
• SANOFI