Drug Guide
Ferumoxytol
Classification
Therapeutic: Iron replacement therapy
Pharmacological: Superparamagnetic iron oxide nanoparticle
FDA Approved Indications
- Treatment of iron deficiency anemia in adult patients with chronic kidney disease
Mechanism of Action
Ferumoxytol is an iron oxide core coated with a carbohydrate shell. It delivers elemental iron to the body, which is utilized for hemoglobin synthesis and erythropoiesis. The nanoparticle is taken up by macrophages and releases iron intracellularly, replenishing iron stores.
Dosage and Administration
Adult: Fractionated IV doses (e.g., 510 mg infusions over 15 minutes), repeated as needed based on clinical response.
Pediatric: Not approved/approved for adult patients only; consult specific pediatric guidelines.
Geriatric: Adjustments not specifically required but monitor for adverse reactions.
Renal Impairment: Use with caution; dosage adjustments generally not necessary but monitor iron status.
Hepatic Impairment: Use with caution; no specific dosing guidelines established.
Pharmacokinetics
Absorption: Administered intravenously; absorption occurs directly into the bloodstream.
Distribution: Distributed mainly to macrophages of the reticuloendothelial system.
Metabolism: Metabolized by macrophages; releases iron for incorporation into hemoglobin.
Excretion: Iron utilized in erythropoiesis or stored; excess iron excreted via sweat, urine, and other pathways.
Half Life: Approximately 15 hours.
Contraindications
- Known hypersensitivity to ferumoxytol or any excipients.
- Serious hypersensitivity reactions to IV iron products.
Precautions
- Monitor for allergic and hypersensitivity reactions during and after infusion.
- Use with caution in patients with a history of allergies or multiple drug allergies.
- Not for intramuscular or subcutaneous use.
Adverse Reactions - Common
- Nausea (Uncommon)
- Headache (Uncommon)
- Arthralgia (Uncommon)
- Dizziness (Uncommon)
Adverse Reactions - Serious
- Anaphylaxis and hypersensitivity reactions (Rare)
- Hypotension (Rare)
- Latex allergy (if latex-containing components used in container) (Rare)
Drug-Drug Interactions
- Other intravenous iron products (risk of overdose and hypersensitivity)
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Assess iron status (ferritin, transferrin saturation), monitor for signs of hypersensitivity during administration.
Diagnoses:
- Risk for hypersensitivity reaction
- Impaired tissue perfusion related to hypersensitivity or adverse reactions
Implementation: Administer IV as per prescribed dose over 15 minutes. Observe patients during and for 30 minutes post-infusion for hypersensitivity reactions.
Evaluation: Evaluate hemoglobin response and iron stores post-treatment.
Patient/Family Teaching
- Report any symptoms of allergic or hypersensitivity reactions (rash, difficulty breathing, dizziness).
- Inform about the purpose of the treatment and possible side effects.
- Advise to inform healthcare provider about any prior allergic reactions to IV iron.
Special Considerations
Black Box Warnings:
- Serious hypersensitivity reactions, including anaphylaxis, can occur; appropriate settings and emergency equipment should be available.
Genetic Factors: None specific.
Lab Test Interference: Potential interference with MRI imaging due to magnetic properties of the nanoparticle.
Overdose Management
Signs/Symptoms: Allergic reactions, hypotension, symptoms of hypersensitivity, iron overload.
Treatment: Discontinue infusion immediately, provide supportive therapy (epinephrine, antihistamines, corticosteroids) as needed, and manage symptoms accordingly.
Storage and Handling
Storage: Store at controlled room temperature (20°C to 25°C). Keep container tightly closed.
Stability: Stable until expiration date when stored properly.