sodium ferric gluconate complex

REMS

Treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are concurrently receiving erythropoietin.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Anemia not due to iron deficiency;
Hemochromatosis, hemosiderosis, or other evidence of iron overload;
Hypersensitivity to sodium ferric gluconate complex in sucrose injection; contains benzyl alcohol.

Use Cautiously in:

Any evidence of tissue iron overload;
Geri: Elderly;
OB: Use only if clearly needed;
Lactation: Benzyl alcohol may cause serious adverse effects in infant;
Pedi: Children <6 yr (safety not established); benzyl alcohol may cause serious adverse effects (including gasping syndrome) or death in neonates and infants;
OB: Lactation or children <6 years.

Adv. Reactions/Side Effects ⬆ ⬇

CNS: dizziness, headache, syncope

CV: hypotension, hypertension, chest pain

GI: nausea, vomiting, diarrhea

Derm: flushing, urticaria

Local: pain or erythema at injection

MS: arthralgia, myalgia

Misc: ANAPHYLAXISALLERGIC REACTIONS INCLUDING , fever, lymphadenopathy

Interactions ⬆ ⬇

Drug-drug:

Chloramphenicol and vitamin E may ↓ hematologic response to iron therapy.

Availability ⬆ ⬇

(Generic available)

Injection: 62.5 mg/5 mL

Route/Dosage ⬆ ⬇

IV (Adults ): 10 mL (125 mg elemental iron) repeated during 8 sequential dialysis treatments to a total cumulative dose of 1 g.
IV (Children 6–15 yr): 0.12 mL/kg (1.5 mg/kg elemental iron) (should not exceed 125 mg/dose).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

An essential mineral found in hemoglobin, myoglobin, and many enzymes.
Enters the bloodstream and is transported to the organs of the reticuloendothelial system (liver, spleen, bone marrow) where it becomes part of iron stores.

Therapeutic effects:

Resolution or prevention of iron deficiency anemia.

Classifications ⬆ ⬇

Therapeutic Classification: antianemics

Pharmacologic Classification: iron supplements

Pharmacokinetics ⬆ ⬇

Absorption: Approximately 5–10% of dietary iron is absorbed (up to 30% in deficiency states). Absorption with IV administration is complete. Well absorbed following IM administration.

Distribution: Remains in the body for many mo. Crosses the placenta; enters breast milk.

Protein Binding: ≥90%.

Metabolism/Excretion: Mostly recycled; small daily losses occurring via desquamation, sweat, urine, and bile.

Half-Life: .

Time/Action Profile ⬆ ⬇

(effects on erythropoiesis)

ROUTE	ONSET	PEAK	DURATION
IV	4 days	1–2 wk	wks–mos

Patient/Family Teaching ⬆ ⬇

Explain purpose of iron therapy to patient.
Instruct patient to report symptoms of hypersensitivity reaction to health care professional immediately.

Pronunciation ⬆ ⬇

SOE-dee-um FERR-ic GLOO-ko-nate

Code ⬆

NDC Code

0024- sanofi-aventis U.S. LLC
- 0024-2792- Ferrlecit
  - 0024-2792-10- 10 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) > 5 mL in 1 VIAL, SINGLE-USE

0024- sanofi-aventis U.S. LLC
- 0024-2794- Ferrlecit
  - 0024-2794-10- 10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) > 5 mL in 1 VIAL, SINGLE-USE

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Indications ⬇