Feridex I.V.

INDICATIONS

Feridex I.V. (ferumoxides injectable solution) is indicated for I.V. administration as an adjunct to MRI (in adult patients) to enhance the T2 weighted images used in the detection and evaluation of lesions of the liver that are associated with an alteration in the RES.

DOSAGE AND ADMINISTRATION

Dose

The recommended dosage of Feridex I.V. (ferumoxides injectable solution) is 0.56 milligrams of iron (0.05 mL Feridex I.V. (ferumoxides injectable solution) ) per kilogram of body weight, that is diluted in 100 mL of 5% dextrose solution and given over 30 minutes. (See Drug Preparation Section). The diluted drug is administered through a 5 micron filter at a rate of 2 to 4 milliliters per minute.

Feridex I.V. (ferumoxides injectable solution) should not be administered undiluted.

Drug Preparation
  1. The vial should be used at room temperature. Mix by inverting the vial 10 to 20 times.
  2. Draw up the appropriate dose of Feridex I.V. (ferumoxides injectable solution) into a sterile syringe.
  3. Dilute Feridex I.V. (ferumoxides injectable solution) by injecting it into 100 mL of 5% dextrose solution (D5W).
  4. The bag should be inverted two or three times to assure dilution.
  5. The drug product should be administered within 8 hours following dilution.
Imaging

Post-contrast imaging may begin immediately after the dose is infused and may be performed up to 3.5 hours after the end of the infusion. T2-weighted pulse sequences provide the maximum contrast effect.

HOW SUPPLIED

Feridex I.V. (ferumoxides injectable solution) is black to reddish brown liquid containing 11.2 mg Fe/mL (56 mg of iron/vial) in a vial with a tear off seal. Feridex I.V. (ferumoxides injectable solution) is supplied in 5 mL single dose vials in boxes of 1 (NDC 59338-7035-1) and 5 (NDC 59338-7035-5). An administration filter is supplied for each vial.

Feridex I.V. (ferumoxides injectable solution) is stable for 24 hours after dilution.

Storage

Storage at 2–30 °C (35–86 °F). DO NOT FREEZE.

If there are indications that the package has been exposed to freezing, DO NOT USE.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470. Manufactured by: Advanced Magnetics, Inc, Cambridge, MA 02138. REV 08.

Last reviewed on RxList: 12/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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