ferumoxytol

ferumoxytol

(fer-u-mox-y-tole) ,

Feraheme

(trade name)

Classification

Therapeutic: antianemics
Pharmacologic: iron supplements
Pregnancy Category: C

Indications

Treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).

Action

Consists of a superparamagnetic iron oxide coated with a carbohydrate shell; when the iron-carbohydrate complex enters the reticuloendothelial system (RES), iron is released from the iron-carbohydrate complex within macrophages. This iron can either enter the intracellular storage iron pool or be transferred to erythroid precursor cells for incorporation into hemoglobin.

Therapeutic effects

Improvement in anemia in patients with chronic kidney disease.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability of iron-carboydrate complex, however iron is not liberated until incorporation into RES.
Distribution: Taken up by RES.
Metabolism and Excretion: Iron can either become part of intracellular ferritin or be transferred to erythroid precursor cells.
Half-life: 15 hr.

Time/action profile (effect on anemia)

ROUTEONSETPEAKDURATION
IVunknownunknownup to 1 mo

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Evidence of iron overload;Anemia not due to iron deficiency; Lactation: Avoid use.
Use Cautiously in: MRI; Geriatric: Consider age-related ↓ in hepatic, renal, or cardiac function, and concurrent diseases or other drug therapy; dose cautiously; Obstetric: Use only if potential benefit justifies potential risk to the fetus; Pediatric: Safety and effectiveness not established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness (most frequent)

Cardiovascular

  • hypotension (life-threatening)
  • hypertension
  • peripheral edema

Gastrointestinal

  • constipation (most frequent)
  • diarrhea (most frequent)
  • nausea (most frequent)

Hematologic

  • iron overload

Miscellaneous

  • hypersensitivity reactions including anaphylaxis and anaphylactoid reactions (life-threatening)

Interactions

Drug-Drug interaction

May ↓ absorption of concurrently administered oral iron preparations.

Route/Dosage

Intravenous (Adults ≥ 18yr) 510 mg initially, followed by a second 510-mg IV injection 3 to 8 days later. Course may be repeated after 1 mo.

Availability

Aqueous colloid for intravenous injection: 510-mg elemental iron/17 mL (30 mg/mL) vials

Nursing implications

Nursing assessment

  • Assess nutritional status and dietary history to determine need for patient teaching.
  • Assess bowel function for constipation or diarrhea. Notify health care professional and use appropriate measures should these occur.
  • Monitor BP frequently following administration until stable. May cause hypotension. For patients receiving hemodialysis, administer ferumoxytol once the BP is stable and at least 1 hr of hemodialysis has been completed.
  • Observe patient for signs and symptoms of anaphylaxis (cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, rash, pruritus, urticaria, laryngeal edema, wheezing) for at least 30 min following injection. May occur with first or subsequent doses. Notify health care professional immediately if these occur. Keep epinephrine and resuscitation equipment close by in the event of an anaphylactic reaction.
  • Conduct MRI studies prior to administration. Alteration of MRI studies may persist for up to 3 mo following a dose; if imaging is required within 3 mo after administration, use T1- or proton density-weighted MR pulse sequences to decrease effects; MRI using T2-weighted pulse sequences should not be performed earlier than 4 weeks after administration; maximum alteration of vascular MRI is evident for 1–2 days after dose. Ferumoxytol does not interfere with x-ray, computed tomography (CT), or positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound, or nuclear imaging.
  • Lab Test Considerations: Monitor hemoglobin, ferritin, iron and transferrin saturation prior to and at least 1 mo following second dose and regularly thereafter. Iron and transferrin bound iron may be overestimated within first 24 hr by measuring iron in the Fereheme complex.

Potential Nursing Diagnoses

Activity intolerance

Implementation

  • Intermittent Infusion: Administer undiluted. Do not administer solutions that are discolored or contain particulate matter. Solution may be stored at room temperature.
  • Rate: Administer at a rate of 1 mL/sec (30 mg/sec).

Patient/Family Teaching

  • Explain purpose of iron therapy to patient.
  • Advise patients to avoid MRI studies during and for 3 mo following ferumoxytol therapy.
  • May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Advise patient to report signs and symptoms of hypersensitivity reactions (rash, itching, dizziness, swelling, and breathing problems) to health care professional immediately.

Evaluation/Desired Outcomes

  • Improvement in iron deficiency anemia.
References in periodicals archive ?
3m of collaboration revenue in 2015 related to the termination of the company's ex-US ferumoxytol marketing agreement.
The use of ferumoxytol (1-3 mg/kg administered as a slow intravenous infusion outside of the scanner) in renal failure patients is a good option that avoids the issue of possible nephrogenic systemic fibrosis in this group.
Ferumoxytol is the only SPIO nanoparticle that has been approved by the FDA, but researchers have not been able to label MSCs with Ferumoxytol in cell culture (ex vivo) without the help of a transfection agent.
According to the company, Ferumoxytol is protected in the US by six issued patents covering the composition and dosage form of the product.
Canadian labelling recommendations for the newer IV iron, ferumoxytol, also included a 30 minute observational period following injection.
In this most recent study, they wanted to build upon their work by testing how adding heparin to the ferumoxytol and protamine sulfate mix (a combination called HPF) might affect the NSC labeling.
The submission requests EMA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to include all adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used.
PHILADELPHIA--Treatment with the investigational intravenous iron replacement agent ferumoxytol significantly raised hemoglobin levels in patients with chronic kidney disease who had a suboptimal response to oral iron therapy in a post hoc analysis of data from three open-label phase III trials.
The company said the FDA has accepted additional data filed on its anemia drug candidate ferumoxytol, and should make a ruling on the drug's approval by Dec.
In the study, more than 300 patients with kidney disease and anemia were randomly assigned to receive treatment with either ferumoxytol or oral iron therapy.
Cytogen also has exclusive United States marketing rights to COMBIDEX(R) (ferumoxtran-10) for all applications, and the exclusive right to market and sell ferumoxytol (previously Code 7228) for oncology applications in the United States.
The patent will now expire on 30 June 2023, and is aimed at reducing polysaccharide iron oxide complexes, including ferumoxytol.