Trade Names:Feraheme- Injection 30 mg of elemental iron per mL
Replenishes hemoglobin and depleted iron stores.
The C max and T max were 206 mcg/mL and 0.32 h, respectively. The C max values increased with dose.
The estimated value of volume of distribution (Vd) following 2 doses of ferumoxytol 510 mg administered IV within 24 h was 3.16 L.
Half-life of ferumoxytol is approximately 15 h. The estimated value of Cl following 2 doses of ferumoxytol 510 mg administered IV within 24 h was 69.1 mL/h. The Cl was decreased by increasing the dose of ferumoxytol, and the terminal half-life values increased with dose.
Ferumoxytol is not removed by hemodialysis.
Treatment of iron deficiency anemia in adults with chronic kidney disease.
Evidence of iron overload, anemia not caused by iron deficiency, hypersensitivity to ferumoxytol or any of its components.
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.
HemodialysisAdultsIV Administer once the blood pressure is stable and the patient has completed at least 1 h of hemodialysis.
Store at 59° to 86°F.
May reduce the absorption of coadministered oral iron preparations.
24 h following administration, laboratory assays may overestimate serum iron and transferrin-bound iron by also measuring iron in the ferumoxytal complex.
Hypotension (3%); hypertension (1%).
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%); edema, peripheral edema (2%); chest pain, pyrexia (1%).
MonitorObserve patients for at least 30 minutes following injection. Monitor for signs and symptoms of hypotension following each injection. Regularly monitor the hematologic response during therapy. |
Category C .
Undetermined.
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.
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.
Accumulation of iron in storage sites, potentially leading to hemosiderosis.
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