MonoFer Ferumoxytol Injection

1. Indications and Usage
Iron Deficiency Anemia (IDA) in Chronic Kidney Disease (CKD):
Indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.
Note: This indication is specifically approved for patients with CKD. Use in non-CKD patients (e.g., IBD, menorrhagia) is currently off-label in the US.
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Injection ONLY.
Recommended Dosage:
Dose: 510 mg administered as a rapid IV injection.
Frequency: Two doses of 510 mg, administered approximately 3 to 8 days apart (Label specifies 3-8 days; clinical practice often accepts up to 1 week).
Administration Instructions:
Injection Rate: Administer undiluted as a rapid IV injection over not less than 17 seconds(approx. 1 mL/sec).
Observation: Patients should be observed for signs of hypersensitivity for at least 30 to 60 minutes after each administration.
3. Mechanism of Action
Iron Replacement:
Ferumoxytol consists of a superparamagnetic iron oxide core coated with semi-synthetic carbohydrate (hydroxyethyl starch).
Reticuloendothelial System Uptake:
The iron core is released slowly from the carbohydrate shell and is taken up by cells of the reticuloendothelial system (liver, spleen, bone marrow). It is then incorporated into iron stores (ferritin) or utilized for erythropoiesis.
4. Safety and Warnings
Hypersensitivity Reactions:
Serious hypersensitivity reactions, including fatal anaphylaxis, have been reported.
Black Box Warning (Historical): Previously carried a Black Box Warning for anaphylaxis, which was removed by the FDA in 2021, but the risk remains a critical safety consideration.
Patients must be monitored for at least 30 minutes post-administration.
Hypotension:
Clinically significant hypotension has been reported, sometimes independent of hypersensitivity.
5. Adverse Reactions
Most Common (≥ 1%):
Diarrhea, constipation, nausea, vomiting, dizziness, headache, hypertension, and peripheral edema.
Infusion-Related Reactions:
Flushing, cough, chest tightness, and dyspnea (usually transient).
6. Drug Interactions
Oral Iron Preparations:
Do not administer oral iron preparations for at least 5 days after the last dose of ferumoxytol, as high serum iron levels may interfere with the absorption of oral iron.
MRI Interference (Unique Interaction):
Ferumoxytol is a superparamagnetic contrast agent. It can interfere with Magnetic Resonance Imaging (MRI) interpretation for up to 3 months after administration. Radiologists must be notified if an MRI is planned within this window.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Ferumoxytol (Iron oxide, coated with hydroxyethyl starch).
Appearance: Dark brown to black solution.
Storage:
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).