sodium ferric gluconate complex

(redirected from Ferrlecit)

sodium ferric gluconate complex

(soe-dee-um ferr-ic gloo-ko-nate) ,

Ferrlecit

(trade name)

Classification

Therapeutic: antianemics
Pharmacologic: iron supplements
Pregnancy Category: B

Indications

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

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.

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 months. Crosses the placenta; enters breast milk.
Protein Binding: ≥90%.
Metabolism and Excretion: Mostly recycled; small daily losses occurring via desquamation, sweat, urine, and bile.
Half-life: .

Time/action profile (effects on erythropoiesis)

ROUTEONSETPEAKDURATION
IV4 days1–2 wkwks–mos

Contraindications/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; Geriatric: Elderly; Obstetric: Use only if clearly needed; Lactation: Benzyl alcohol may cause serious adverse effects in infant; Pediatric: Children <6 yr (safety not established); benzyl alcohol may cause serious adverse effects (including gasping syndrome) or death in neonates and infants; Obstetric / Pediatric: Lactation or children <6 years.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache
  • syncope

Cardiovascular

  • hypotension (most frequent)
  • hypertension
  • chest pain

Gastrointestinal

  • nausea
  • vomiting
  • diarrhea

Dermatologic

  • flushing (most frequent)
  • urticaria

Local

  • pain or erythema at injection

Musculoskeletal

  • arthralgia
  • myalgia

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)
  • fever
  • lymphadenopathy

Interactions

Drug-Drug interaction

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

Route/Dosage

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

Availability (generic available)

Injection: 62.5 mg/5 mL

Nursing implications

Nursing assessment

  • Assess nutritional status and dietary history to determine possible cause of anemia and need for patient teaching.
  • Assess bowel function for constipation or diarrhea. Notify physician or other health care professional and use appropriate nursing measures should these occur.
  • Monitor BP and heart rate frequently following IV administration until stable. Rapid infusion rate may cause hypotension and flushing.
  • Monitor for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing) for at least 30 min following administration. Notify health care professional immediately if these occur. Keep epinephrine and resuscitation equipment close by in the event of an anaphylactic reaction.
  • Lab Test Considerations: Monitor hemoglobin, hematocrit, and reticulocyte values prior to and every 3 wk during the first 2 mo of therapy and periodically thereafter. Serum ferritin and iron levels may also be monitored to assess effectiveness of therapy.
  • Early symptoms of overdose include stomach pain, fever, nausea, vomiting (may contain blood), and diarrhea. Late symptoms include bluish lips, fingernails, and palms; drowsiness; weakness; tachycardia; seizures; metabolic acidosis; hepatic injury; and cardiovascular collapse. Patient may appear to recover prior to the onset of late symptoms. Therefore, hospitalization continues for 24 hr after patient becomes asymptomatic to monitor for delayed onset of shock or GI bleeding. Late complications of overdose include intestinal obstruction, pyloric stenosis, and gastric scarring.
    • If patient is comatose or seizing, gastric lavage with sodium bicarbonate is performed. Deferoxamine is the antidote. Additional supportive treatments to maintain fluid and electrolyte balance and correction of metabolic acidosis are also indicated.

Potential Nursing Diagnoses

Activity intolerance (Indications)

Implementation

  • Discontinue oral iron preparations prior to parenteral administration.
    • Ferrlecit is for IV use only.
  • Before initiating therapeutic doses, a test dose of 2 mL (25 mg of elemental iron) should be administered. Dilute test dose in 50 mL of 0.9% NaCl and administer IV over 60 min.
    • To administer therapeutic dose of 10 mL (125 mg of elemental iron) dilute in 100 mL of 0.9% NaCl. Dialysis patients frequently require a cumulative dose of 1 g of elemental iron, administered over 8 sessions of sequential dialysis.
  • Rate: Administer over 1 hr.

Patient/Family Teaching

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

Evaluation/Desired Outcomes

  • Improvement in anemia of chronic renal failure.
References in periodicals archive ?
There are four intravenous (IV) iron products available in Canada: Iron Dextran (Infufer [Sandoz Canada Inc.], DexIron [Lutipold Pharmaceuticals Inc.]), Iron Sucrose (Venofer [Genpharm Inc.]), Sodium Ferric Gluconate (Ferrlecit [Sanofi-Aventis Canada Inc.]) and Ferumoxytol (Feraheme [Takeda Canada Inc.]).
Four main iron preparations are used in the USA: two iron dextrans (LMWID, INFeD; HMWID, Dexferrum), sodium ferric gluconate (Ferrlecit), iron sucrose (Venofer), and ferumoxytol (Feraheme) [23-27].
Nulecit is said to be the first bioequivalent and therapeutically equivalent alternative to sanofiaventis' Ferrlecit.
Nulecit is reportedly the first bioequivalent and therapeutically equivalent alternative to Sanofi-Aventis' Ferrlecit.
Nulecit is the first bioequivalent and therapeutically equivalent alternative to sanofi-aventis' (EPA: SAN) Ferrlecit.
The other drugs reviewed that also had no new safety concerns were anti-neoplastic agent Camptosar (irinotecan), antineoplastic agent Paraplatin (carboplatin), platelet-reducing agent Agrylin (anagrelide), and hematinic agent Ferrlecit (sodium ferric gluconate complex).
Ferris gluconate, marketed as Ferrlecit, is associated with an extremely low rate of allergic reactions and no deaths when given intravenously (125 mg over an hour) after a test dose is administered.
We used the form of iron gluconate currently used in Europe and approved for use in the US, sodium ferric gluconate complex in sucrose (Ferrlecit), from R & D Laboratories, and iron dextran (InFed) from Schein Pharmaceuticals.
Iron gluconate is a sodium ferric gluconate complex in sucrose and is indicated for the treatment of iron deficiency in dialysis-associated anemia in patients receiving erythropoietin therapy (e-CPS, 2012, Ferrlecit).
For the full year 2009, Watson's Global Brand segment product sales decreased 1% or USD3.3m to USD393.7m, compared to USD397.0m for 2008, due to lower sales of Ferrlecit and INFeD, which was partially offset by sales of newly launched products Rapaflo and Gelnique.
Key products include Ferrlecit, an intravenous iron for use in the dialysis setting; Trelstar, an LHRH agonist for treating advanced prostate cancer; Androderm, a transdermal patch for testosterone replacement therapy in men; and Oxytrol, a transdermal patch for treating overactive bladders.