- Injection, solution 30 mg of elemental iron per mL
Replenishes Hgb and depleted iron stores.
C max and T max were 206 mcg/mL and 0.32 h, respectively. C max values increase with dose.
Vd was approximately 3.16 L.
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 PopulationsRenal 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.
Hypersensitivity to any components.
Dosage and AdministrationHemodialysis
IV Administer once BP is stable and the patient has completed at least 1 h of hemodialysis.Iron Deficiency Anemia
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.
- Administer as an undiluted IV injection delivered at a rate of up to 1 mL/sec (30 mg/sec).
Store at 59° to 86°F.
Drug InteractionsOral iron
May reduce the absorption of coadministered oral iron preparations.
Laboratory Test InteractionsIron overload
24 h following administration, laboratory assays may overestimate serum iron and transferrin-bound iron by also measuring iron in the ferumoxytol complex.
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).
Dizziness (3%); headache (2%).
Pruritus, rash (1%).
Diarrhea (4%); nausea (3%); constipation, vomiting (2%); abdominal pain (1%).
Back pain, muscle spasms (1%).
Cough, dyspnea (1%).
Hypersensitivity (4%); pyrexia (1%); angioedema, life-threatening anaphylactic reactions, loss of consciousness, syncope, unresponsiveness (postmarketing).
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.
Category C .
Safety and effectiveness not established.
Exercise caution in dose administration, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Serious hypersensitivity reactions, including anaphylaxis and/or anaphylactoid reactions, may occur.
May occur. May be severe in some patients.
Do not administer to patients with iron overload.
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.
Accumulation of iron in storage sites, potentially leading to hemosiderosis.
- 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.