Product Details

FERUMOXYTOL 30MG/ML 17ML SDV SAN 1/EA

Manufacturer: Sandoz

MFG#: 781315401

NDC: 781315401

PID: 649362

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Additional Information

Product NameFerumoxytol 30 mg/mL 17 mL SDV SAN 1/Ea
Generic NameFerumoxytol
Drug ClassIntravenous Iron Replacement Therapy
Mechanism of ActionProvides bioavailable iron for hemoglobin synthesis via controlled release
Strength30 mg/mL (510 mg per 17 mL vial)
Dosage FormInjectable Solution
Common Side EffectsHypotension, nausea, dizziness, headache
Serious Adverse EffectsAnaphylaxis, hypersensitivity reactions, iron overload
PrecautionsMonitor for infusion-related reactions, blood iron levels, and signs of iron overload
Administration InstructionsAdminister as a slow IV bolus or dilute for infusion over at least 15 minutes
PackagingSingle-dose glass vial
Storage Conditions20°C to 25°C (Controlled Room Temperature); protect from light
UsesIron deficiency anemia (IDA) in adults with chronic kidney disease (CKD)

Description

Ferumoxytol is an intravenous iron replacement therapy used for the treatment of iron deficiency anemia (IDA) in adults with chronic kidney disease (CKD). It consists of superparamagnetic iron oxide nanoparticles coated with a carbohydrate shell, allowing controlled release of bioavailable iron. The mechanism involves rapid uptake by the reticuloendothelial system, enabling iron incorporation into hemoglobin and restoring iron levels.

Each single-dose vial contains 510 mg of elemental iron in 17 mL (30 mg/mL) as a sterile, aqueous colloidal solution. The formulation includes mannitol and polysorbate to maintain stability and solubility. The solution should be stored at controlled room temperature, between 20°C and 25°C, and protected from light.

Common adverse effects include hypotension, nausea, dizziness, and headache. Serious risks involve hypersensitivity reactions, including anaphylaxis, and iron overload. Patients require monitoring for infusion-related reactions and blood iron parameters. Caution is necessary in individuals with a history of multiple drug allergies or those at risk for iron accumulation disorders.

Frequently Asked Questions (FAQs)

The cost of FERUMOXYTOL 30MG/ML 17ML SDV SAN 1/EA is $available for registerd members only

FERUMOXYTOL 30MG/ML 17ML SDV SAN 1/EA is manufactured by Sandoz.

You can purchase FERUMOXYTOL 30MG/ML 17ML SDV SAN 1/EA on our website at https://preview_supplies.pipelinemedical.com/Products/Detail/ferumoxytol-sd-30mg-ml-17ml-649362

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