Ferumoxytol Injection Iron Replacement 510 mg Single-Dose Vial 17 mL (RX)

Ferumoxytol Injection by Sandoz is a high-potency intravenous iron replacement medication, supplied as a 30 mg/mL solution in a convenient 17 mL single-dose vial. Designed for healthcare professionals, Ferumoxytol provides rapid and effective treatment of iron deficiency anemia (IDA), particularly in adult patients with chronic kidney disease (CKD) or when oral iron therapy is ineffective or not tolerated.

What is Ferumoxytol Used For?

Ferumoxytol Injection is indicated for:

• Treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD), including those on dialysis and non-dialysis-dependent.
• Patients who cannot tolerate oral iron supplements or for whom they have proven ineffective.

CDC Guidelines and Recommendations

• The Centers for Disease Control and Prevention (CDC) recommend intravenous iron supplementation for CKD patients with iron deficiency anemia, particularly when oral iron is insufficient.
• Intravenous iron therapy, such as ferumoxytol, is endorsed to quickly restore iron stores, improve hemoglobin levels, and reduce symptoms related to anemia (CDC Chronic Kidney Disease Surveillance System).

Dosage & Administration

Standard Adult Dosage:

• Each vial contains 510 mg of elemental iron (30 mg/mL x 17 mL).
• Recommended dose: two separate IV injections of 510 mg each, administered over at least 15 minutes, 3 to 8 days apart (total cumulative dosage: 1,020 mg).
• Dosage and frequency should be determined by the prescribing healthcare provider based on individual patient needs.

Details and Features

• Content: 30 mg/mL elemental iron, 17 mL per single-use vial.
• NDC: 00781-3154-01
• Brand: Sandoz, a trusted pharmaceutical supplier.
• Formulation: Stable, ready-to-use injectable solution.
• Administration: Intravenously, under professional medical supervision.

Mechanism of Action

Ferumoxytol consists of a superparamagnetic iron oxide core surrounded by a carbohydrate shell, allowing for controlled release of iron into the body. The released iron is rapidly incorporated into hemoglobin and other essential iron-dependent proteins, quickly correcting iron deficiency and enabling efficient erythropoiesis (red blood cell production).

Directions for Use

1. Inspect vial for particulate matter or discoloration prior to use.
2. Do not dilute or mix with other medications.
3. Administer via IV injection or infusion, as directed by a healthcare professional.
4. Each dose should be given slowly, over at least 15 minutes, to reduce the risk of adverse reactions.
5. Monitor patient closely during and after administration for any signs of hypersensitivity.

Important Warnings

• Hypersensitivity Reactions: Serious, potentially fatal hypersensitivity reactions, including anaphylaxis, have occurred. Patients should be monitored during and for at least 30 minutes after administration.
• Hypotension: Monitor blood pressure, as a drop in blood pressure can occur following administration.
• Iron Overload: Evaluate iron parameters before each dose; avoid in patients with evidence of iron overload.
• Use in Pregnancy: Limited data available; consult physician prior to use if pregnant or breastfeeding.

Potential Side Effects

The most common adverse reactions include:

• Nausea
• Dizziness
• Hypotension (low blood pressure)
• Diarrhea
• Headache
• Flushing
• Edema

Serious Side Effects:

• Hypersensitivity reactions such as rash, urticaria, chest pain, or swelling of the face/lips/throat require immediate medical attention.
• Severe hypotension, which may require cardiovascular support.

Storage

• Store at controlled room temperature (20° to 25°C or 68° to 77°F).
• Do not freeze or expose to extreme heat.

Ferumoxytol Injection by Sandoz offers a safe, efficient, and reliable solution for rapid iron repletion in adults with chronic kidney disease or those who cannot tolerate oral iron, helping to restore energy, reduce anemia symptoms, and improve quality of life under proper medical supervision.

For complete prescribing information, always refer to the official product monograph or consult your healthcare provider.