Ferumoxytol

Trade Names:Feraheme- Injection 30 mg of elemental iron per mL

Pharmacology

Replenishes hemoglobin and depleted iron stores.

Pharmacokinetics

Absorption

The C _max and T _max were 206 mcg/mL and 0.32 h, respectively. The C _max values increased with dose.

Distribution

The estimated value of volume of distribution (Vd) following 2 doses of ferumoxytol 510 mg administered IV within 24 h was 3.16 L.

Elimination

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.

Special Populations

Ferumoxytol is not removed by hemodialysis.

Indications and Usage

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

Contraindications

Evidence of iron overload, anemia not caused by iron deficiency, hypersensitivity to ferumoxytol or any of its components.

Dosage and Administration

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.

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

General Advice

• Administer as an undiluted IV injection delivered at a rate of up to 1 mL/sec (30 mg/sec).
• Inspect parenteral product visually for the absence of particulate matter and discoloration prior to administration.

Storage/Stability

Store at 59° to 86°F.

Drug Interactions

May reduce the absorption of coadministered oral iron preparations.

Laboratory Test Interactions

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

Adverse Reactions

Cardiovascular

Hypotension (3%); hypertension (1%).

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%); edema, peripheral edema (2%); chest pain, pyrexia (1%).

Precautions

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.

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.

Overdosage

Symptoms

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

Patient Information

• Advise patient that medication will be prepared and administered by a health care provider and that the medication will not be administered at home.
• Advise patient 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 patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.

Copyright © 2009 Wolters Kluwer Health.