FERABRIGHT

Ferumoxytol maximum concentration (C max ) increases proportionally and area under the concentration-time curve (AUC) increases more than proportionally over a dose range from 1 mg/kg (70 mg in a patient with body weight of 70 kg- not an approved dosing regimen for FERABRIGHT) to 510 mg elemental iron. Rate of infusion ranging from 2 mL/min to 60 mL/min has no significant influence on pharmacokinetics (PK) of ferumoxytol.

DistributionThe volume of distribution is 3.4 L.

EliminationFerumoxytol ...

The effectiveness of FERABRIGHT for intra-axial malignant brain lesion visualization was evaluated in a blinded read study of MRIs acquired from one open-label, intra-patient controlled clinical trial. The trial enrolled adult patients with known or suspected primary and secondary intra-axial neoplasms in the brain. Each patient received MRI before and after intravenous administration of an approved gadolinium-based contrast agent. Within seven days, MRI was performed before and after administration of a single dose of FERABRIGHT. Images from a total of 153 patients with known or suspected pri...

The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and Other Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypotension [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (≥0.65%) are nausea, pruritus, constipation, headache, diarrhea, increased blood pressure, bleeding, hyperpigmentation, vein injury, taste alteration, burning/tingling sensation with injection, red sclera, allergic rhinitis...

FERABRIGHT is contraindicated in patients with known hypersensitivity to ferumoxytol, any of FERABRIGHT’s components, or any other intravenous iron products. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to ferumoxytol, any of FERABRIGHT’s components, or any other intravenous iron products ( 4 )

Hypotension: Monitor for signs and symptoms of hypotension following administration. ( 5.2 ) Iron Overload: Avoid use of FERABRIGHT in patients with iron overload. ( 5.3 ) Magnetic Resonance Imaging Test Interference: Conduct anticipated MRI studies (other than the intended FERABRIGHT brain imaging) prior to the administration of FERABRIGHT or use T1- or proton density-weighted pulse sequences if MRI is required within 3 months after administration. ( 5.4 ) Differences in Magnetic Resonance Imag...