What is Ferrlecit?

Sodium ferric gluconate complex injection is used to treat iron deficiency anemia (not enough iron in the blood). It is used in patients with kidney disease who are receiving dialysis and a medicine called epoetin to prevent anemia. Sodium ferric gluconate complex is an iron replacement product.

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, the number of red blood cells is lower than normal. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

This medicine is to be given only by or under the direct supervision of a doctor.

A nurse or other trained health professional will give you this medicine in a hospital or dialysis clinic. This medicine is given through a needle placed in one of your veins.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sodium ferric gluconate complex injection in children. However, safety and efficacy have not been established in children younger than 6 years of age.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sodium ferric gluconate complex injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving sodium ferric gluconate complex injection.

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bictegravir
• Dimercaprol
• Eltrombopag

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Delafloxacin
• Minocycline
• Mycophenolic Acid
• Zinc

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Phytic Acid Containing Food

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.

• Iron overload—Use is not recommended in patients with this condition.

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; lightheadedness, dizziness, or fainting; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you or your child begin using this medicine, or when the dose is increased.

This medicine contains benzyl alcohol which may cause serious reactions (e.g., gasping syndrome) for a newborn or premature infant. Discuss this with your doctor if you are concerned.