Ferumoxytol

Pronunciation: FER-ue-MOX-i-tol
Class: Iron

Trade Names

Feraheme
- Injection, solution 30 mg of elemental iron per mL

Pharmacology

Replenishes Hgb and depleted iron stores.

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Pharmacokinetics

Absorption

C max and T max were 206 mcg/mL and 0.32 h, respectively. C max values increase with dose.

Distribution

Vd was approximately 3.16 L.

Elimination

Half-life is approximately 15 h. Cl was approximately 69.1 mL/h. Cl decreases with increasing dose and half-life increases with dose.

Special Populations

Renal Function Impairment

Ferumoxytol is not removed by hemodialysis.

Gender

No gender differences were observed.

Indications and Usage

Treatment of iron deficiency anemia in adults with chronic kidney disease.

Contraindications

Hypersensitivity to any components.

Dosage and Administration

Hemodialysis
Adults

IV Administer once BP is stable and the patient has completed at least 1 h of hemodialysis.

Iron Deficiency Anemia
Adults

IV 510 mg initially, followed by a second 510 mg injection 3 to 8 days later. Readminister the recommended dose to patients with persistent or recurrent iron deficiency anemia.

General Advice

  • Administer as an undiluted IV injection delivered at a rate of up to 1 mL/sec (30 mg/sec).

Storage/Stability

Store at 59° to 86°F.

Drug Interactions

Oral iron

May reduce the absorption of coadministered oral iron preparations.

Laboratory Test Interactions

Iron overload

24 h following administration, laboratory assays may overestimate serum iron and transferrin-bound iron by also measuring iron in the ferumoxytol complex.

Adverse Reactions

Cardiovascular

Hypotension (3%); edema, peripheral edema (2%); chest pain, hypertension (1%); cardiac/cardiorespiratory arrest, CHF, clinically significant hypotension, cyanosis, ischemic myocardial events, pulse absent, tachycardia/rhythm abnormalities (postmarketing).

CNS

Dizziness (3%); headache (2%).

Dermatologic

Pruritus, rash (1%).

GI

Diarrhea (4%); nausea (3%); constipation, vomiting (2%); abdominal pain (1%).

Musculoskeletal

Back pain, muscle spasms (1%).

Respiratory

Cough, dyspnea (1%).

Miscellaneous

Hypersensitivity (4%); pyrexia (1%); angioedema, life-threatening anaphylactic reactions, loss of consciousness, syncope, unresponsiveness (postmarketing).

Precautions

Monitor

Observe patients for at least 30 min following injection for signs and symptoms of hypersensitivity. Monitor for signs and symptoms of hypotension following each injection. Regularly monitor the hematologic response (eg, Hgb, ferritin, iron, transferrin saturation) at least 1 mo following the second injection and regularly during therapy.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and effectiveness not established.

Elderly

Exercise caution in dose administration, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Hypersensitivity

Serious hypersensitivity reactions, including anaphylaxis and/or anaphylactoid reactions, may occur.

Hypotension

May occur. May be severe in some patients.

Iron overload

Do not administer to patients with iron overload.

MRI

May affect the diagnostic ability of MRI. Conduct MRI studies prior to administration. Alteration of MRI may persist for up to 3 mo following the last dose of ferumoxytol. If MRI is required within 3 mo after ferumoxytol administration, use T1- or proton density–weighted magnetic resonance pulse sequences; do not perform MRI using T2-weighted pulse sequences earlier than 4 wk after administration of ferumoxytol. Maximum alteration of vascular MRI is anticipated to be evident for 1 to 2 days following ferumoxytol administration.

Overdosage

Symptoms

Accumulation of iron in storage sites, potentially leading to hemosiderosis.

Patient Information

  • Ask patients about history of reactions to parenteral iron products.
  • Advise patients that medication will be prepared and administered by a health care provider and that the medication will not be administered at home.
  • Advise patients to report any signs and symptoms of hypersensitivity that may develop following administration, such as breathing problems, dizziness, itching, light-headedness, rash, and swelling.
  • Caution patients not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by a health care provider.

Copyright © 2009 Wolters Kluwer Health.

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