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 ?
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.
Surveyed nephrologists project share will continue to remain stable over the next six months, except in CKD-ND patients where nephrologists project significant declines for both Venofer and Ferrlecit.
Other significant events in the IV iron market include the recent availability Sanofi's Ferrlecit as a branded generic, Nulecit, marketed by Watson.
Patient share: Shifts in 2014 include ongoing gains for Ferrlecit (Sanofi) in the IV iron market and the impact of new medications such as Velphoro (Vifor Fresenius Medical Care Renal Pharma) in the phosphate binder space.
Fitch recognizes Watson's efforts to bolster the brand name drug business through licensing agreements following the loss of revenues from Ferrlecit due to the lapse of a distribution agreement at the end of 2009.
Table 11: US Non-Dialysis IV Iron Therapy Market by Products (2012): Percentage Breakdown by Volume of IV Administered for Venofer, INFeD, Feraheme, Ferrlecit, Dexferrum and Generic Sodium Ferric Gluconate (includes corresponding Graph/Chart) III-5
Market share for Fresenius's Venofer has increased substantially compared to the prior year among nephrologists primarily affiliated with Fresenius units, share of Sanofi-Aventis' Ferrlecit has increased substantially among nephrologists primarily affiliated with independent units, and share of AMAG's Feraheme has decreased substantially among nephrologists primarily affiliated with small/medium dialysis organizations and independent units, where use of the product had been the greatest.
The report entitled TreatmentTrends: Renal Anemia (EU5) 2013 also finds that Vifor Fresenius Medical Care (FMC) Renal Pharma's Venofer leads in reported patient share in the hemodialysis setting across the major European markets, followed by Sanofi's Ferrlecit / Ferlixit.
Fitch recognizes the immediate challenge of replacing brand name drug revenues from Ferrlecit after the lapse of a distribution agreement at the end of 2009.
In the IV iron market, Fresenius' Venofer continues to lead in hemodialysis patient share, followed by Sanofi's Ferrlecit in a distant second.
However, Fitch believes that some of this growth will be offset by the potential loss after 2009 of Ferrlecit, which represented 12% of Watson's gross profit in 2008.
April 15, 2013 /PRNewswire/ -- BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, finds that in hemodialysis (HD), Sanofi's Ferrlecit patient share has experienced a significant 9 percent increase between Q4 2012 and Q1 2013.