ferumoxytol

(redirected from Feraheme)

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 ?
Today we also announced strong earnings in a year when we made significant investments in our new products, as well as in next generation opportunities for Makena and Feraheme -- which resulted in two sNDA approvals by the FDA this month.
M2 EQUITYBITES-October 14, 2016-AMAG Pharmaceuticals achieves two key milestones in Makena and Feraheme development programs
M2 PHARMA-October 14, 2016-AMAG Pharmaceuticals achieves two key milestones in Makena and Feraheme development programs
FDA drug safety communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme ferumoxytol).
AMAG Pharmaceuticals is a specialty pharmaceutical company that markets Feraheme (ferumoxytol), which is used to treat iron deficiency anemia in adult patients with chronic kidney disease, MuGard, a mucoadhesive oral wound rinse used for the management of oral mucositis and other types of oral wounds and Makena (hydroxyprogesterone caproate injection), a hormone medicine used to lower the risk of preterm birth for certain pregnant women.
She will also oversee the company's compliance with FDA and regulatory requirements for Feraheme (ferumoxytol) Injection and MuGard Mucoadhesive Oral Wound Rinse.
This deal will facilitate future product acquisitions in an attractive new therapeutic field and is a good fit with Amag's market expansion plans for its Feraheme product, president and CEO William Heiden noted.
Feraheme is contraindicated in patients with any allergy to other parenteral iron products or in patients with multiple (two or more) drug allergies.
is a specialty pharmaceutical company that manufactures and markets Feraheme in the United States.
The company was just eight months into sales of its current flagship product, Feraheme, an intravenous iron compound that helps treat iron deficiency anemia.
Lexington MA) breathed a sigh of relief after the FDA did not ask the drugmaker to carry a black-box warning on its key drug Feraheme, sending the company's shares up 16% for the week.
The increase in operating costs and expenses was primarily due to increased selling, general and administrative expenses to prepare for the planned commercialization of Feraheme (ferumoxytol injection).