Ferric Carboxymaltose

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

• Injectafer is indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease.ICD-10: D64.9, E61.1, N18.9

• Injectafer is contraindicated in patients with a history of hypersensitivity to Injectafer or any of its components [see Warnings and Precautions ( 5.1 ) ]. Hypersensitivity to Injectafer or any of its inactive components.contraindicated

For patients weighing 50 kg or more, the recommended dosage is Injectafer 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. For adult patients weighing 50 kg or more, an alternative dose of Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. ( 2.1 ) For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. ( 2.1 ) See Section 2.1, Table 1 for dosage in patients with iron deficiency and heart failure. ( 2.1 ) Injectafer treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. ( 2.3 ) 2.1 Recommended Dosage Recommended Dosage for Treatment of Iron Deficiency Anemia For patients weighing 50 kg or more, the recommended dosage is: Injectafer 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. In adult patients, Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. Recommended Dosage in Patients with Iron Deficiency with Heart Failure See Table 1 for recommended dosage for treatment of iron deficiency in patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of each administration. ( 5.1 ) Symptomatic Hypophosphatemia: Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment. ( 5.2 ) Hypertension: Monitor patients closely for signs and symptoms of hypertension following each Injectafer administration. ( 5.3 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Injectafer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions [see Adverse Reactions ( 6.1 , 6 .2 )]. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1,775) of subjects receiving Injectafer. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1,775) of these subjects.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypophosphatemia [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Laboratory Test Alterations [see Warnings and Precautions ( 5.4 )] The most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness. ( 6.1 ) The most common adverse reactions in pediatric patients (≥4%) are hypophosphatemia, injection site reactions, rash, headache, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. Adults In two randomized clinical studies [Studies 1 and 2, see Clinical Studies ( 14 ) ], a total of 1,775 patients were exposed to Injectafer 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days up to a cumulative dose of 1,500 mg of iron. Adverse reactions reported by ≥1% of treated patients are shown in the following table. Table 2.

Pregnancy: Risk of hypersensitivity reactions which may have serious consequences for the fetus. ( 8.1 ) 8.1 Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [ see Warnings and Precautions ( 5.1 )], which may have serious consequences, such as fetal bradycardia ( see Clinical Considerations ). Advise pregnant women of the potential risk to a fetus. Published studies and available data from postmarketing reports with intravenous Injectafer are insufficient to assess the risk of major birth defects and miscarriage. There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see Clinical Considerations). In animal reproduction studies, administration of ferric carboxymaltose to rabbits during the period of organogenesis caused adverse developmental outcomes including fetal malformations and increased implantation loss at maternally toxic doses of approximately 12% to 23% of the human weekly dose of 750 mg (based on body surface area). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

After administration of a single dose of Injectafer of 100 to 1,000 mg of iron in iron deficient adult patients, maximum iron concentration of 37 µg/mL to 333 µg/mL were obtained respectively after 15 minutes to 1.21 hours post dose. The volume of distribution was estimated to be 3 L.

Excessive dosages of Injectafer may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. A patient who received Injectafer 18,000 mg over 6 months developed hemosiderosis with multiple joint disorder, walking disability, and asthenia. In the postmarketing setting, hypophosphatemic osteomalacia has been reported in patients who have received repeated high-cumulative courses of Injectafer.

• Jul 25, 2013NDANDA203565Am Regent

1. 1Hypophosphataemia82318%
2. 2Nausea54812%
3. 3Pain4249.3%
4. 4Dyspnoea3898.5%
5. 5Headache3648.0%
6. 6Product Quality Issue3237.1%
7. 7Dizziness3066.7%
8. 8Anxiety2906.3%
9. 9Urticaria2876.3%
10. 10Arthralgia2736.0%
11. 11Emotional Distress2585.6%
12. 12Anhedonia2545.6%
13. 13Pruritus2495.4%
14. 14Blood Phosphorus Decreased2154.7%
15. 15Asthenia2064.5%

The 10 most recently updated of 206 ClinicalTrials.gov registrations naming Ferric Carboxymaltose as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression
  Recruiting · Phase 4 · Interventional · 2,860 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT06833788updated 2026-06-02
• Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
  Recruiting · Phase 1 · Interventional · 70 enrolled · Sichuan Huiyu Pharmaceutical Co., Ltd
  NCT07606105updated 2026-05-26
• Hypoferritinemia Without Anemia Among Reproductive Age Females
  Completed · Interventional · 1,331 enrolled · Akram Medical Complex
  NCT06437080updated 2026-05-19
• Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients
  Completed · Interventional · 128 enrolled · Sindh Institute of Urology and Transplantation
  NCT06994065updated 2026-04-22
• Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC)
  Recruiting · Phase 3 · Interventional · 330 enrolled · Asan Medical Center
  NCT05226169updated 2026-04-03
• Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome
  Recruiting · Phase 4 · Interventional · 538 enrolled · Fundación para la Investigación del Hospital Clínico de Valencia
  NCT07476859updated 2026-03-24
• The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department
  Not yet recruiting · Phase 4 · Interventional · 150 enrolled · Children's Hospital of Orange County
  NCT07414199updated 2026-02-17
• EFFICACY OF IV VERSUS ORAL IRON IN THE TREATMENT OF IRON DEFICIENCY ANEMIA DURING PREGNANCY
  Completed · Phase 1 · Interventional · 112 enrolled · Dr Salaha Azam
  NCT07384663updated 2026-02-03
• The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension
  Recruiting · Phase 4 · Interventional · 306 enrolled · Ziekenhuis Oost-Limburg
  NCT07359599updated 2026-01-30
• Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation
  Recruiting · Phase 4 · Interventional · 402 enrolled · Erasmus Medical Center
  NCT07370688updated 2026-01-27

Frequently asked questions

How does Ferric Carboxymaltose work?

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

What is Ferric Carboxymaltose used for?

According to FDA labeling, Ferric Carboxymaltose carries indications including: Injectafer is indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the brand names for Ferric Carboxymaltose?

Ferric Carboxymaltose is marketed under brand names including Injectafer.

What are the contraindications for Ferric Carboxymaltose?

Ferric Carboxymaltose labeling lists contraindications including: Injectafer is contraindicated in patients with a history of hypersensitivity to Injectafer or any of its components [see Warnings and Precautions ( 5.1 ) ]. Hypersensitivity to Injectafer or any of its inactive components.. Always consult the full prescribing information and a clinician.