Sodium Ferric Gluconate

Pronunciation: SOE-dee-um FER-ik GLOO-koe-nate
Class: Parenteral iron

Trade Names

Ferrlecit
- Injection, solution 12.5 mg/mL of elemental iron

Pharmacology

Provides iron to replenish Hgb and depleted iron stores.

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Pharmacokinetics

Absorption

C max is 19 mg/L after a 125 mg dose.

Elimination

Half-life is 0.85 to 1.45 h. Total Cl is 3.02 to 5.35 L/h.

Indications and Usage

Treatment of iron deficiency anemia in patients with chronic kidney disease receiving hemodialysis who are receiving supplemental erythropoietin.

Contraindications

Hypersensitivity to any component of the product.

Dosage and Administration

Dosage is expressed as mg of elemental iron.

Adults and children older than 15 y

IV 125 mg/dose. Most patients require a minimum cumulative dose of 1 g over 8 dialysis sessions.

Children and adolescents 6 to 15 y of age

IV 1.5 mg/kg/dose (max, 125 mg/dose).

General Advice

  • May be administered at sequential dialysis sessions by infusion or slow IV injection during the dialysis session. For adults, administer undiluted as a slow IV injection (up to 12.5 mg/min) or diluted in 100 mL of sodium chloride 0.9% and infused over 1 h. For children, dilute in 25 mL of sodium chloride 0.9% and administer over 1 h.
  • Do not administer with other medications or add to parenteral nutrition solutions for IV infusion.
  • Compatibility with IV infusion vehicles other than sodium chloride 0.9% has not been evaluated.
  • Treatment may be repeated if iron deficiency recurs.

Storage/Stability

Store vials at 59° to 86°F. Protect from freezing. Use immediately after dilution.

Drug Interactions

Oral iron preparations

May have reduced absorption.

Adverse Reactions

Cardiovascular

Hypotension (35%); hypertension (23%); tachycardia (17%); syncope, thrombosis (6%); phlebitis, shock (postmarketing).

CNS

Headache (24%); dizziness (13%); asthenia (7%); fatigue, paresthesia (6%); convulsion, loss of consciousness, nervousness (postmarketing).

Dermatologic

Pruritus (6%); pallor, skin discoloration (postmarketing).

EENT

Pharyngitis (9%); rhinitis (6%); abnormal vision, dysgeusia, hypoesthesia (postmarketing).

GI

Diarrhea, nausea, vomiting (35%); abdominal pain (9%); anorexia (6%); dry mouth (postmarketing).

Hematologic

Abnormal erythrocytes (11%); hemorrhage (postmarketing).

Local

Injection-site reactions (33%).

Metabolic-Nutritional

Hyperkalemia (6%); generalized edema (5%).

Musculoskeletal

Leg cramps (10%); back pain (postmarketing).

Respiratory

Dyspnea (11%); coughing, upper respiratory tract infections (6%).

Miscellaneous

Cramps (25%); chest pain, pain (10%); infection (8%); fever (5%); allergic reaction, anaphylactic-type reactions, hypertonia (postmarketing).

Precautions

Monitor

Periodic monitoring of hematologic and iron parameters is required. Monitor patients for signs and symptoms of hypersensitivity during and after administration for at least 30 min and until clinically stable following completion of the infusion. Monitor patients for signs and symptoms of hypotension during and following infusion.


Pregnancy

Category B .

Lactation

Benzyl alcohol present in maternal serum is likely to cross into human milk, and may be orally absorbed by a breast-feeding infant. Exercise caution when administered to a breast-feeding woman.

Children

Safety and efficacy are not established for children younger than 6 y.

Elderly

Use with caution, usually starting at the low end of the dosing range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.

Hypersensitivity

Rare cases of serious hypersensitivity reactions have been reported.

Benzyl alcohol

This product contains benzyl alcohol and should not be used in premature infants and neonates.

Flushing and hypotension reactions

Associated with too rapid administration. Do not exceed 125 mg/h (2.1 mg/min).

Hemosiderosis

Unwarranted therapy with parenteral iron will cause excess storage of iron and possibly cause iatrogenic hemosiderosis.

Hypotension

Hypotension associated with light-headedness, malaise, fatigue, weakness, or severe chest, back, flank, or groin pain has been reported. This reaction may or may not be associated with hypersensitivity and usually resolves within 1 to 2 h.

Overdosage

Symptoms

Accumulation of iron in iron storage sites, hemosiderosis.

Patient Information

  • Explain name, dose, action, and potential adverse reactions of drug.
  • Advise patients that medication will be prepared and administered by a health care provider during dialysis sessions and that medication will not be administered at home.
  • Instruct patients to immediately inform health care provider if any of the following occur during or shortly after the administration of drug: light-headedness; weakness; anxiety; sweating; rapid heartbeat; shortness of breath or difficulty breathing; swelling of the throat; rash; itching; chest, back, flank, or groin pain.
  • Caution patients not to take oral iron supplements while receiving IV iron.

Copyright © 2009 Wolters Kluwer Health.

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