ferric citrate


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ferric citrate

(fe-rik si-trate)

Classification

Therapeutic: electrolyte modifiers
Pharmacologic: phosphate binders
Pregnancy Category: B

Indications

Control of serum phosphorous in chronic renal failure patients on dialysis.

Action

Binds phosphorous and precipitates it as ferric phosphate.

Therapeutic effects

Maintenance of normal phosphorous levels.

Pharmacokinetics

Absorption: Some absorption follows oral administration and may lead to iron overload.
Distribution: Unknown.
Metabolism and Excretion: Following binding, precipitated ferric phosphate is excreted in stool.
Half-life: Unknown.

Time/action profile (lowering of serum phosphorous)

ROUTEONSETPEAKDURATION
POwithin 1 wkunknownunknown

Contraindications/Precautions

Contraindicated in: Iron overload syndromes including hemochromatosis).
Use Cautiously in: GI bleeding/inflammation; Obstetric: Use cautiously during pregnancy (consider effects on vitamins/nutrient and potential iron overload); Lactation: Consider possible iron transport into milk; Pediatric: Safe and effective use in children has not been established.

Adverse Reactions/Side Effects

Gastrointestinal

  • diarrhea (most frequent)
  • discolored feces (most frequent)
  • nausea (most frequent)
  • constipation
  • vomiting

Miscellaneous

  • iron overload

Interactions

Drug-Drug interaction

Will bind and ↓ absorption of doxycycline (should be given one hr prior to ferric citrate).

Route/Dosage

Oral (Adults) 2 tablets (2 g ferric citrate) three times daily. Adjust by 1–2 tablets/day at weekly (or longer) intervals to attain target phosphorous levels.

Availability

Tablets: 1 g (contains 210 mg ferric iron)

Nursing implications

Nursing assessment

  • Monitor clinical responses or blood levels of concurrent medications; may decrease bioavailability of medications administered concurrently.
  • Lab Test Considerations: Monitor serum phosphorous prior to starting and periodically during therapy to keep serum phosphorous at target levels.
    • Assess iron parameters (serum ferritin and transferritin saturation TSAT) prior to starting and periodically during therapy. May cause ↑ serum ferritin and TSAT requiring reduced dose or discontinuation of IV iron therapy.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Oral: Administer 3 times daily with meals.

Patient/Family Teaching

  • Instruct patient to take ferric citrate as directed and to continue with prescribed diet.
  • Advise patient that ferric citrate may cause dark stools; this is normal for medications containing iron.
  • Inform patient that ferric citrate may cause diarrhea, nausea, constipation, and vomiting. Notify health care professional if GI symptoms become severe or persistent.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications. Medications may need to be taken separately from ferric citrate.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Normal serum phosphorous levels.
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References in periodicals archive ?
100, 200, and 300[micro]L aliquots of standard 50 mM ferric citrate (Merck, Germany) solution were added to each sample and differential pulse polarography experiment was done for them exactly with the conditions mentioned above.
Ferric citrate coordination complex (FCCC), an investigational oral product also known as Zerenex, effectively lowered patients elevated serum phosphate into normal range while repleting iron stores, boosting hemoglobin, and reducing levels of the cardiotoxic protein fibroblast growth factor 23 (FGF23), Dr.
Again, addition of ferric citrate to the IDA serum before immunoprecipitation restored the size of the complex to ~330 kDa.
Ltd; the risk that the EMA may not concur with our interpretation of our Phase 3 study results, supportive data, conduct of the studies, or any other part of our MAA submission and could ultimately deny approval of the MAA; the risk that we may not be successful in the development of ferric citrate for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "This first regulatory approval of ferric citrate is a monumental achievement for the Zerenex program, and we congratulate our partner, JT/Torii, on achieving this important and exciting milestone.
has filed its New Drug Application for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease.
Nephrologists' insights on ferric citrate: Over 40 percent of nephrologists strongly believe that ferric citrate, an iron-based phosphate binder, will enable them to reduce use of IV iron and ESAs in dialysis patients.
Julia Lewis, Professor of Medicine, Department of Nephrology, Vanderbilt University School of Medicine, and member of the Executive Committee of the Collaborative Study Group, and Study Chair of the Zerenex Phase 3 registration program, presented the updated dataset from the study entitled "A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis," in a symposium held earlier today in Hong Kong, during the 2013 World Congress of Nephrology (WCN) and a poster presented yesterday, Sunday, June 2, 2013.
Keryx saw its shares sliding despite receiving FDA approval for ferric citrate, its oral, ferric iron-based compound.
Food and Drug Administration (FDA) approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
JT), has filed its New Drug Application (NDA) with the Japanese Ministry of Health, Labour and Welfare for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD).
According to the Company, the patents, which will expire in 2024, claim pharmaceutical compositions comprising a form of ferric citrate having an intrinsic dissolution rate of 1.