Sodium Ferric Gluconate Complex

Ferrlecit is used to replete the body content of iron. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport.

• Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Ferrlecit is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.ICD-10: D64.9, E61.1, N18.9

• Ferrlecit is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] .contraindicated

Adult Patients - The recommended adult dosage is 10 mL (125 mg of elemental iron) diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour per dialysis session or undiluted as a slow intravenous injection (at a rate of up to 12.5 mg/min) per dialysis session. ( 2.2 ) Pediatric Patients - The recommended pediatric dosage is 0.12 mL/kg (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour per dialysis session. ( 2.3 ) Do not mix Ferrlecit with other medications or add to parenteral nutrition solutions for intravenous infusion. Administer in 0.9% saline. ( 2 ) 2.1 Important Administration Instructions The dosage of Ferrlecit is expressed in terms of mg of elemental iron. Each 5 mL sterile, single-dose vial contains 62.5 mg of elemental iron (12.5 mg/mL). Do not mix Ferrlecit with other medications or add to parenteral nutrition solutions for intravenous infusion. The compatibility of Ferrlecit with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit. If diluted, use immediately. Ferrlecit treatment may be repeated if iron deficiency reoccurs. 2.2 Adult Dosage and Administration The recommended dosage of Ferrlecit for the repletion treatment of iron deficiency in hemodialysis patients is 10 mL of Ferrlecit (125 mg of elemental iron).

Hypersensitivity Reactions: Monitor patients for signs and symptoms of hypersensitivity during and after Ferrlecit administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferrlecit when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. ( 5.1 ) Hypotension: Ferrlecit may cause hypotension. Monitor patients for signs and symptoms of hypotension during and following each Ferrlecit dose. ( 5.2 ) Iron Overload: Regularly monitor hematologic responses during Ferrlecit therapy. Do not administer Ferrlecit to patients with iron overload. ( 5.3 ) Benzyl Alcohol Toxicity: Premature and low-birth-weight infants may be more likely to develop toxicity. ( 5.4 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferrlecit in postmarketing 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 Ferrlecit administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferrlecit when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see Adverse Reactions (6) ] .

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity [see Contraindications (4) and Warnings and Precautions (5.1) ] Hypotension [see Warnings and Precautions (5.2) ] The most commonly reported adverse reactions (≥10%) in adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, dyspnea, chest pain, leg cramps, and pain. In patients 6 to 15 years of age the most common adverse reactions (≥10%) were hypotension, headache, hypertension, tachycardia and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most commonly reported adverse reactions (≥10%) in adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, abnormal erythrocytes (e.g., changes in morphology, color, or number of red blood cells), dyspnea, chest pain, leg cramps and pain. In patients 6 to 15 years of age the most common adverse reactions (≥10%) were hypotension, headache, hypertension, tachycardia and vomiting.

Pregnancy: Risk of hypersensitivity reaction which may have serious consequences for the fetus. Use only if clearly needed (contains benzyl alcohol). ( 8.1 ) Lactation: Not recommended when breastfeeding. ( 8.2 ) Pediatric Use: Safety and effectiveness have not been established in pediatric patients <6 years of age. ( 8.4 ) 8.1 Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1) ] , which may have serious consequences, such as fetal bradycardia (see Clinical Considerations ) . Advise pregnant women of the potential risk to the fetus. Available data from postmarketing 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 [see Warnings and Precautions (5.4) and Use in Specific Populations (8.4) ] . Consider alternative iron replacement therapies without benzyl alcohol. There are risks to the mother and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations ) .

Metabolism

Multiple sequential single-dose intravenous pharmacokinetic studies were performed on 14 healthy iron-deficient volunteers. Entry criteria included hemoglobin ≥10.5 gm/dL and transferrin saturation ≤15% (TSAT) or serum ferritin value ≤20 ng/mL.

The Ferrlecit iron complex is not dialyzable. No data is available regarding overdose of Ferrlecit in humans. Excessive dosages of Ferrlecit may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer Ferrlecit to patients with iron overload [see Warnings and Precautions (5.3) ] . Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events [see Adverse Reactions (6.2) ] . Ferrlecit at elemental iron doses of 125 mg/kg, 78.8 mg/kg, 62.5 mg/kg and 250 mg/kg caused deaths in mice, rats, rabbits, and dogs respectively. The major symptoms of acute toxicity were decreased activity, staggering, ataxia, increases in the respiratory rate, tremor, and convulsions.

• Feb 18, 1999NDANDA020955Sanofi Aventis Us
• Mar 31, 2011ANDAANDA078215Hikma

1. 1Nausea49023%
2. 2Vomiting43421%
3. 3Abdominal Pain38618%
4. 4Dyspnoea36717%
5. 5Sepsis27313%
6. 6General Physical Health Deterioration26413%
7. 7Off Label Use25012%
8. 8Abdominal Distension24912%
9. 9Ascites24011%
10. 10Hyponatraemia23711%
11. 11Multiple Organ Dysfunction Syndrome23711%
12. 12Appendicitis23611%
13. 13Stress23311%
14. 14Appendicolith23211%
15. 15Constipation23211%

The 10 most recently updated of 13 ClinicalTrials.gov registrations naming Sodium Ferric Gluconate Complex as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• IV Iron in Acute Decompensated Heart Failure
  Completed · Phase 4 · Interventional · 34 enrolled · Rambam Health Care Campus
  NCT04063033updated 2023-04-11
• IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI
  Unknown · Phase 4 · Interventional · 200 enrolled · Rambam Health Care Campus
  NCT04797832updated 2022-10-27
• Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
  Completed · Phase 2 · Interventional · 60 enrolled · Kyntra Bio
  NCT01414075updated 2021-10-01
• Comparing the Efficacy of Different Iron Formulations: Sucrosomal Ferric Pyrophosphate, SunActive®Fe and Intravenous Ferric Gluconate
  Completed · Interventional · 148 enrolled · University of Palermo
  NCT03771092updated 2018-12-10
• Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
  Completed · Phase 3 · Interventional · 735 enrolled · American Regent, Inc.
  NCT00704353updated 2018-02-20
• 2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.
  Completed · Phase 2 · Phase 3 · Interventional · 146 enrolled · Watson Pharmaceuticals
  NCT00223977updated 2013-07-08
• Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients
  Completed · Phase 4 · Interventional · 59 enrolled · Watson Pharmaceuticals
  NCT00223964updated 2012-08-14
• Effect of Two Iron Preparations on Protein in the Urine
  Completed · Phase 4 · Interventional · 12 enrolled · Watson Pharmaceuticals
  NCT00354692updated 2012-08-14
• Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients
  Completed · Phase 4 · Interventional · 89 enrolled · Watson Pharmaceuticals
  NCT00224055updated 2012-03-29
• Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
  Completed · Phase 4 · Interventional · 52 enrolled · Watson Pharmaceuticals
  NCT00224042updated 2012-03-29

Frequently asked questions

How does Sodium Ferric Gluconate Complex work?

Ferrlecit is used to replete the body content of iron. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport.

What is Sodium Ferric Gluconate Complex used for?

According to FDA labeling, Sodium Ferric Gluconate Complex carries indications including: Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Ferrlecit is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sodium Ferric Gluconate Complex?

Sodium Ferric Gluconate Complex is classified as Parenteral Iron Replacement, Electrolyte Activity, Increased Erythroid Cell Production.

What are the brand names for Sodium Ferric Gluconate Complex?

Sodium Ferric Gluconate Complex is marketed under brand names including Ferrlecit.

What are the contraindications for Sodium Ferric Gluconate Complex?

Sodium Ferric Gluconate Complex labeling lists contraindications including: Ferrlecit is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] .. Always consult the full prescribing information and a clinician.