Injectafer Ferric Carboxymaltose 100 mg IV Iron Infusion Injection 2 mL (RX)

Injectafer (Ferric Carboxymaltose) 100 mg – Intravenous Iron Infusion Injection Injectafer (generic ferric carboxymaltose) is a parenteral iron preparation used to treat iron-deficiency anemia (IDA) when oral iron is not tolerated or effective. It is a stable colloidal complex of trivalent iron (Fe³⁺) bound to a carboxymaltose carbohydrate shell. Each mL of Injectafer contains 50 mg of elemental iron (so a 2 mL vial contains 100 mg iron). After IV administration, the complex is taken up by reticuloendothelial cells and slowly releases iron to transferrin for hemoglobin synthesis, with minimal free (labile) iron in the plasma. Injectafer is supplied as a sterile dark-brown solution (50 mg/mL) in single-dose vials. Packaging includes 2 mL vials (100 mg iron) as well as larger 15 mL (750 mg) and 20 mL (1000 mg) vials. Indications and Use Injectafer is indicated for treating iron deficiency anemia in patients who cannot take adequate oral iron. Specifically, it is approved for: IDA in adults and children (≥1 year) with intolerance or inadequate response to oral iron. IDA in adult patients with chronic kidney disease (CKD) who are not on dialysis. Iron deficiency in heart failure (NYHA class II/III): Injectafer is FDA-approved to improve exercise capacity in iron-deficient adults with symptomatic chronic heart failure. (European and American guidelines recommend IV ferric carboxymaltose in such HF patients to improve symptoms and quality of life.) Beyond these label indications, intravenous ferric carboxymaltose is often used in other settings of significant iron deficiency (e.g. heavy menstrual bleeding, postpartum anemia, inflammatory bowel disease, or preoperative anemia) when rapid repletion is needed or oral therapy fails. Dosage and Administration Dosage depends on body weight and iron deficit. For adults ≥50 kg, the recommended total dose per treatment course is 1,500 mg, given as two 750 mg IV doses at least 7 days apart. An alternative regimen is a single dose of 15 mg/kg (up to 1,000 mg). For patients <50 kg, give 15 mg/kg IV in two doses separated by ≥7 days. (Heart-failure patients follow a specific weight-based schedule per product labeling.) If anemia or iron deficiency persists, courses may be repeated after re-evaluation. Injectafer must be administered intravenously. The label advises either a slow IV push or a diluted infusion. For infusion, up to 1,000 mg iron may be diluted in ≤250 mL of 0.9% saline (maintaining ≥2 mg/mL) and infused over at least 15 minutes. For a direct IV push, the injection should be given very slowly – roughly 100 mg (2 mL) per minute (e.g. a 750 mg dose over ~7–8 minutes). In practice, 750 mg is often administered as an infusion over ≥15 minutes. During and after administration, vital signs should be monitored. Patients must be observed for at least 30 minutes post-dose for signs of adverse reaction. Avoid extravasation: if the drug leaks out of the vein, it can cause long-lasting brown skin discoloration; stop the injection if this occurs. Side Effects and Precautions Common side effects (≥2% incidence) include nausea, flushing, dizziness, injection-site reactions, rash/erythema, and hypertension. Headache, vomiting and other GI symptoms have also been reported. Because Injectafer contains iron, stools may darken temporarily. Patients should be warned about these expected effects. Allergic reactions: Serious hypersensitivity (including anaphylaxis) can occur. In clinical trials, life-threatening reactions were very rare (~0.1%), but because of the potential severity, administer Injectafer only where resuscitation measures are available. Monitor patients for signs of allergic reaction (rash, difficulty breathing, hypotension, etc.) during and for 30 minutes after the infusion. If a severe reaction occurs, stop the infusion immediately. Patients with a history of sensitivity to any IV iron (especially dextran or carboxymaltose) should not receive Injectafer. Hypophosphatemia: A distinctive adverse effect of ferric carboxymaltose is low blood phosphate. Injectafer can provoke transient hypophosphatemia – occasionally severe (leading to osteomalacia or fractures) – especially after repeated dosing. Most cases resolve within ~3 months. Risk factors include malnutrition, vitamin D deficiency, certain GI disorders, or medications affecting phosphate handling. The label advises correcting any pre-existing low phosphate and monitoring phosphate in at-risk patients during repeat courses. Patients should be educated to report muscle weakness or bone pain, which could indicate significant hypophosphatemia. Other: Transient blood pressure changes (mostly hypertension) and flushing are common during or shortly after the infusion. Monitor blood pressure and treat as needed. IV iron can also cause changes in liver enzymes or iron indices; routine lab monitoring (CBC, iron studies) should be done before and periodically during therapy. Injectafer is contraindicated in patients with known allergy to ferric carboxymaltose or any of its components. Like all IV iron, it should be used cautiously in active infections. Injectafer is for IV use only. It is pregnancy category C (safety in pregnancy is not fully established); severe maternal reactions could potentially affect the fetus. Decisions in pregnancy must weigh maternal benefit versus fetal risk. Nursing mothers may transfer some iron to breast milk, but this is generally not a contraindication. How It Works Ferric carboxymaltose is a polynuclear iron(III)-hydroxide complex (~150 kDa) stabilized by a carbohydrate shell. After IV infusion, macrophages take up the complex and gradually break it down. The released iron binds to transferrin and is carried to the bone marrow for hemoglobin production. Because the complex is stable, there is little free (labile) iron released in plasma, reducing the risk of oxidative stress. This allows large doses of iron to be given more safely than older IV formulations. In essence, Injectafer serves as an iron reservoir that corrects the body’s iron deficit. Storage and Handling Injectafer vials are single-use. They should be stored at room temperature. Do not mix Injectafer with other medications or diluents besides 0.9% saline. Discard any unused solution (the label states “Discard Unused Portion”). Inspect the vial before use; the solution is dark brown and should not be used if it is visibly discolored or cloudy. In summary, Injectafer 100 mg/2 mL (ferric carboxymaltose) is a high-dose IV iron indicated for IDA when oral iron is inadequate. It delivers 50 mg Fe³⁺ per mL in a stable complex. Proper dosing, slow IV administration, and monitoring are essential. Common side effects are mild, but clinicians must watch for rare serious reactions (allergy and hypophosphatemia). As with any medication, treatment should follow official guidelines and individual patient needs.