Ferinject Ferric Carboxymaltose Injection

1. Indications and Usage
Iron Deficiency Anemia (IDA):
Indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have unsatisfactory response to oral iron.
Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD):
Indicated for the treatment of iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease.
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Injection ONLY.
Can be administered as an undiluted slow IV injection or diluted IV infusion.
Recommended Dosage (Adults):
Weight ≥ 50 kg: 750 mg administered as two separate injections (dose volume 15 mL), at least 7 days apart.
Weight < 50 kg: 15 mg/kg administered as two separate injections, at least 7 days apart.
Maximum Dose: The cumulative dose per course of treatment should not exceed 1500 mg.
Administration Instructions:
IV Injection: Administer at a rate of approximately 100 mg (2 mL) per minute.
IV Infusion: Dilute up to 1000 mg in no more than 250 mL of 0.9% Sodium Chloride Injection (concentration ≥ 2 mg/mL) and infuse over at least 15 minutes.
Avoid extravasation, as it may cause brownish discoloration of the injection site.
3. Mechanism of Action
Iron Complex:
Ferric carboxymaltose is a colloidal iron(III)-hydroxide carbomacrolyte complex.
Iron Delivery:
The complex is designed to release iron in a controlled manner for uptake by iron-transport and iron-storage proteins (transferrin and ferritin), thereby replenishing iron stores for erythropoiesis.
4. Safety and Warnings
Hypersensitivity Reactions:
Serious and sometimes fatal hypersensitivity reactions (including shock, hypotension, and loss of consciousness) have been reported.
Patients should be observed for signs of hypersensitivity for at least 30 minutes after administration.
Hypophosphatemia:
Clinically significant hypophosphatemia may occur, which can lead to osteomalacia with repeated exposures. Monitor serum phosphate levels.
Oxidative Stress:
As with other IV iron products, there is a potential risk of oxidative stress.
5. Adverse Reactions
Most Common (≥ 2%):
Nausea, hypertension, hypophosphatemia, dizziness, headache, vomiting, flushing, and injection site discoloration.
Other Reported Reactions:
Hypotension, arthralgia, fatigue, rash, and pruritus.
6. Drug Interactions
Oral Iron Preparations:
Do not administer oral iron preparations for at least 5 days after the last dose of ferric carboxymaltose, as the high serum iron levels may interfere with the absorption of oral iron.
Other Interactions:
No formal drug-drug interaction studies have been conducted.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Ferric Carboxymaltose.
Appearance: Clear, dark red solution.
Storage:
Store at 20°C to 25°C (68°F to 77°F). Do not freeze.