Ferric Gluconate

• If you have an allergy to ferric gluconate or any other part of ferric gluconate.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Anemia from a cause other than low iron stores or too much iron in your body.

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 ferric gluconate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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

• It is given as an infusion into a vein over a period of time.
• It may be given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

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:

• Loose stools (diarrhea).
• Cramps.
• Upset stomach or throwing up.
• Not hungry.
• Stomach pain.
• Dizziness.
• Headache.
• Feeling tired or weak.
• Irritation where the shot is given.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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.

• Iron Salt

Iron-deficiency anemia, hemodialysis patients: IV: 125 mg elemental iron per dialysis session. Most patients will require a cumulative dose of 1 g elemental iron over approximately 8 sequential dialysis treatments to achieve a favorable response.

Note: A test dose of 2 mL diluted in NS 50 mL administered over 60 minutes was previously recommended (not in current manufacturer labeling). Doses >125 mg are associated with increased adverse events.

Chemotherapy-associated anemia (off-label use): IV infusion: 125 mg once every week for 6 doses (Pedrazzoli, 2008) or for 8 doses (Henry, 2007)

Refer to adult dosing.

Adverse events were not observed in animal reproduction studies. It is recommended that pregnant women meet the dietary requirements of iron with diet and/or supplements in order to prevent adverse events associated with iron deficiency anemia in pregnancy. Treatment of iron deficiency anemia in pregnant women is the same as in nonpregnant women and in most cases, oral iron preparations may be used. Except in severe cases of maternal anemia, the fetus achieves normal iron stores regardless of maternal concentrations.

6 years and older: 0.12 mL/kg (1.5 mg/kg elemental iron) diluted in 25 mL 0.9% sodium chloride IV over 1 hour per dialysis session

Maximum dose: 125 mg elemental iron per dose

Comments:
-Administer during the dialysis session itself.
-Doses over 125 mg elemental iron may have higher incidence or severity of adverse events.

Use: Treatment of iron deficiency anemia in patients with chronic kidney disease receiving hemodialysis who are receiving epoetin therapy.

Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.