Ferric Gluconate

Ferric gluconate is a prescription medication used for the treatment of iron deficiency anemia.

• Ferric gluconate is available under the following different brand names: Ferrlecit, Nulecit

Adult and pediatric dosage

Injectable solution

• 12.5mg elemental Fe/mL; 10 mL ampules

Iron Deficiency Anemia

Adult dosage

• 125 mg IV infusion over 1 hour; not to exceed 250 mg/infusion for 8 hemodialysis sessions
• May dilute in 100 mL 0.9% NaCl and administer over 1 hour
• May administer undiluted; not to exceed administration rate of 12.5 mg/mins.
• Pediatric dosage
• Children below 6 years: Safety and efficacy not established
• Children below 6 years: 1.5 mg/kg elemental iron IV infusion over 1 hour for 8 hemodialysis sessions
• Not to exceed 125 mg/dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Ferric gluconate include:

• nausea,
• vomiting,
• diarrhea,
• injection site reactions (pain, redness, swelling, or irritation),
• headache,
• cramps,
• high or low blood pressure,
• dizziness,
• general ill feeling (malaise),
• shortness of breath,
• chest pain,
• leg cramps and
• pain.

Serious side effects of Ferric gluconate include:

• a light-headed feeling,
• chest pain,
• trouble breathing,
• flushing (warmth, redness, or tingly feeling),
• fast or uneven heart rate, or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, uneven heartbeats, or seizures).

Rare side effects of Ferric gluconate include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Ferric gluconate has no noted severe interactions with any other drugs.
• Ferric gluconate has no noted serious interactions with any other drugs.
• Ferric gluconate has no noted moderate interactions with any other drugs.
• Ferric gluconate has no noted minor interactions with the following drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to drug or excipient

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ferric gluconate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ferric gluconate?”

Cautions

• DO NOT mix Ferrlecit with other meds or add to TPN; compatibility has not been established
• Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis; patients receiving therapy require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin, and transferrin saturation)

Adverse effects due to benzyl alcohol

• Not approved for use in neonates or infants; serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs
• The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations; the minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known

Hypersensitivity

• Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, were reported in patients receiving the drug in post-marketing experience
• Patients may present with shock, clinically significant hypotension, loss of consciousness, or collapse
• Monitor patients for signs and symptoms of hypersensitivity during and after administration for at least 30 minutes and until clinically stable following completion of the infusion
• Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions

Hypotension

• Therapy may cause clinically significant hypotension
• Hypotension associated with lightheadedness, malaise, fatigue, weakness, or severe pain in the chest, back, flanks, or groin reported
• Hypotensive reactions may or may not be associated with signs and symptoms of hypersensitivity reactions and usually resolve within one to two hours
• Transient hypotension may occur during dialysis; administration may augment hypotension caused by dialysis; monitor patients for signs and symptoms of hypotension during and following administration

Drug interactions overview

• Drug-drug interactions not studied; drug may reduce the absorption of concomitantly administered oral iron preparations

Pregnancy and Lactation

• Parenteral iron administration may be associated with hypersensitivity reactions, which may have serious consequences, such as fetal bradycardia
• Advise pregnant women of the potential risk to the fetus; available data from post marketing reports with Ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage
• Ferrlecit contains benzyl alcohol as a preservative; because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs
• Consider alternative iron replacement therapies without benzyl alcohol
• There are risks to mother and fetus associated with untreated iron deficiency anemia in pregnancy
• In absence of maternal toxicity, Ferrlecit was not teratogenic to offspring of pregnant mice or rats at clinically relevant exposures
• Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as postpartum anemia; adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight
• Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with intravenous iron administration which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimester

Lactation

• The drug contains benzyl alcohol; because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in a breastfed infant is unlikely; however, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs; consider alternative iron replacement therapies without benzyl alcohol for use during lactation
• There are no available data on the presence of Ferrlecit in human or animal milk, effects on milk production, or breastfed child