Ferric carboxymaltose is an intravenous iron replacement medicine used to treat iron deficiency anaemia, particularly when oral iron isn't tolerated or hasn't worked well enough. It belongs to a class of medicines called parenteral (injectable) iron preparations, notable for allowing a large iron dose to be given in a short infusion. It is a prescription-only, healthcare-provider-administered medicine.

• Therapeutic Class: Iron replacement therapy (parenteral iron).

• Pharmacological Class: Iron carbohydrate complex.

• Drug Family: Colloidal iron (III) hydroxide-carbohydrate complexes.

• ATC Classification: B03AC (Iron, parenteral preparations) — specifically ferric carboxymaltose.

• Approved: Iron deficiency anaemia (IDA) in adult and pediatric patients 1 year and older who have intolerance to oral iron or an unsatisfactory response to oral iron; and iron deficiency anaemia in adult patients with non-dialysis-dependent chronic kidney disease.

• Commonly used for: Patients with confirmed iron deficiency anaemia unable to correct it adequately with oral iron tablets, including patients with heavy menstrual bleeding, gastrointestinal conditions affecting iron absorption, heart failure with iron deficiency, or before certain surgeries.

• Off-label use (only under medical guidance): Sometimes used in other iron-deficiency settings (e.g., certain pregnancy-related anaemia situations) under specialist guidance.

● Injection (intravenous, single-use vial): commonly 750 mg iron/15 mL (50 mg elemental iron per mL); other vial sizes are available in some markets.

Ferric carboxymaltose is an iron-carbohydrate complex designed to release iron in a controlled way once inside the body. This allows a relatively large dose of iron to be given directly into the bloodstream over a short infusion time, replenishing the body's iron stores more quickly than oral iron typically can, and bypassing the gut absorption issues that limit oral iron in some patients.

• Standard dose (adults, weighing 50 kg or more): A total course of 1,500 mg of iron, given as two doses of 750 mg each, separated by at least 7 days.

• Condition-wise dose (single-dose option): In some protocols, a single dose of 750 mg (or 15 mg/kg, whichever is smaller) can be given as an IV push injection.

• Route: Intravenous, given as a slow IV push (e.g., 100 mg per minute) or as an infusion diluted in saline, administered by a healthcare professional.

• Missed dose: Rescheduled by the treating clinical team based on the planned dosing course.

• Overdose: Can cause iron overload and worsen known side effects such as low phosphate levels; requires medical attention.

• Common: Nausea, headache, flushing, high blood pressure, injection-site reactions, and low blood phosphate levels (hypophosphatemia).

• Serious: Severe hypersensitivity/anaphylactic reactions (though uncommon), and symptomatic hypophosphatemia requiring clinical intervention, reported particularly in patients at risk of low phosphate.

• Emergency symptoms: Difficulty breathing or swallowing, swelling of the face/lips/tongue/throat, dizziness or feeling faint, a drop in blood pressure, or severe skin itching with a red rash or raised bumps.

• Recovery advice: Most common side effects are mild and temporary; phosphate levels are sometimes checked in patients with risk factors for hypophosphatemia, particularly with repeated dosing.

• Pregnancy: Used only if clearly needed, as fetal bradycardia (slow heart rate) has been reported in post-marketing use; discussed with the treating doctor.

• Breastfeeding: Used with medical guidance; specific safety data are limited.

• Liver disease: Used with routine monitoring; no specific formal dose adjustment established.

• Kidney disease: One of its approved uses is specifically for non-dialysis chronic kidney disease-related anaemia; used with routine monitoring.

• Elderly: Used with routine monitoring; no specific age-based dose adjustment required.

• Children: Approved for iron deficiency anaemia in children 1 year and older who are intolerant to or have had unsatisfactory response to oral iron.

● Oral iron supplements: not typically combined at the same time as IV iron dosing; oral iron is usually paused during the IV iron treatment course.

● Other parenteral iron products: not combined with other IV iron preparations.

● Medicines affecting phosphate levels: caution advised given ferric carboxymaltose's own association with hypophosphatemia.

● Hemoglobin and iron studies (ferritin, transferrin saturation) to assess response and guide further dosing.

● Blood pressure monitoring during and shortly after infusion.

● Serum phosphate levels, particularly in patients with risk factors for hypophosphatemia or those receiving repeated doses.

● Observation for signs of hypersensitivity reaction during and after each infusion.

Iron sucrose, Ferric derisomaltose, Sodium ferric gluconate (other intravenous iron preparations, differing in dosing schedule and hypophosphatemia risk); oral iron supplements, for patients able to tolerate and absorb them adequately.

Generally used as a standalone iron replacement course; not typically combined with oral iron during the treatment course, though oral iron may be resumed afterward if ongoing supplementation is needed.

● Iron Deficiency Anaemia Treatments

● Parenteral (Intravenous) Iron Therapies

● Chronic Kidney Disease Supportive Care

1. 7 Unexpected Warning Signs of Iron Deficiency

2. Low Haemoglobin: Sign, Symptoms, Causes & Treatment

1. https://daiichisankyo.us/press-releases/-/article/injectafer-ferric-carboxymaltose-injection-receives-fda-approval-for-the-treatment-of-pediatric-patients-with-iron-deficiency-anemia

2. https://pubmed.ncbi.nlm.nih.gov/25428711/

The information on this page is for educational purposes only and is not a substitute for medical advice. Please consult your doctor to know if this treatment is appropriate for your condition.