Ferric Carboxymaltose
Injection, Solution · Intravenous
• FERRIC CARBOXYMALTOSE INJECTION can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention [see Warnings and Precautions ( 5 . 1 )].
• Hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors for hypophosphatemia [see Warnings and Precautions ( 5.1 )].
• Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a repeat course of therapy within three months [see Dosage and Administration ( 2.1 , 2.3) ] . Correct pre-existing hypophosphatemia prior to administering FERRIC CARBOXYMALTOSE INJECTION [see Warnings and Precautions ( 5.1 )] .
• Advise patients receiving FERRIC CARBOXYMALTOSE INJECTION about the…
Uses
Ferric carboxymaltose injection 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.
• Iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. Ferric carboxymaltose injection is an iron replacement product 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. ( 1 ) adult patients who have non-dialysis dependent chronic kidney disease. ( 1 )
• iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. ( 1 )
Dosage and administration
For patients weighing 50 kg or more, the recommended dosage is ferric carboxymaltose injection 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 ferric carboxymaltose injection 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. ( 2. 2) For patients weighing less than 50 kg, the recommended dosage is ferric carboxymaltose injection 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. ( 2.2 ) See Section 2.2, Table 1 for dosage in patients with iron deficiency and heart failure. ( 2. 2) Ferric carboxymaltose injection treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. ( 2.3 ) 2.1 Laboratory Testing Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a repeat course of therapy within three months [see Boxed Warning and Dosage and Administration ( 2.3 ) ]. Correct pre-existing hypophosphatemia prior to administering ferric carboxymaltose injection [see Warnings and Precautions ( 5.1 )]. 2.2 Recommended Dosage Recommended Dosage for Treatment of Iron Deficiency Anemia For patients weighing 50 kg or more, the recommended dosage is: Ferric carboxymaltose injection 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, ferric carboxymaltose injection 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 ferric carboxymaltose injection 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. Table 1: Recommended Dosage in Patients with Iron Deficiency with Heart Failure Weight less than 70 kg Weight 70 kg or more Hb (g/dL) Hb (g/dL) < 10 10 to 14 > 14 to < 15 < 10 10 to 14 > 14 to < 15 Day 1 1,000 mg 1,000 mg 500 mg 1,000 mg 1,000 mg 500 mg Week 6 500 mg No dose No dose 1,000 mg 500 mg No dose Administer a maintenance dose of 500 mg at 12, 24 and 36 weeks if serum ferritin <100 ng/mL or serum ferritin 100-300 ng/mL with transferrin saturation <20%. There are no data available to guide dosing beyond 36 weeks or with Hb ≥15 g/dL. 2.3 Repeat Dosage Courses Ferric carboxymaltose injection treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. 2.4 Preparation and Administration Administer ferric carboxymaltose injection intravenously, either as an undiluted slow intravenous push or by infusion. When administered via infusion, dilute up to 1,000 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes. When added to an infusion bag containing 0.9% sodium chloride injection, USP, at concentrations ranging from 2 to 4 mg of iron per mL, ferric carboxymaltose injection solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL. Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of ferric carboxymaltose injection is intended for a single dose. When administering ferric carboxymaltose injection 500 or 750 mg as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. For ferric carboxymaltose injection 1,000 mg, administer as a slow intravenous push over 15 minutes. Avoid extravasation of ferric carboxymaltose injection since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the ferric carboxymaltose injection administration at that site. Discard unused portion.
Dosage forms and strengths
Injection: 50 mg/mL, dark brown, non-transparent, sterile, aqueous solution. 750 mg iron/15 mL single-dose vial Injection: 50 mg/mL 750 mg iron/15 mL single-dose vial
Contraindications
Ferric carboxymaltose injection is contraindicated in patients with a history of hypersensitivity to ferric carboxymaltose injection or any of its components [see Warnings and Precautions ( 5.2) ]. Hypersensitivity to ferric carboxymaltose injection or any of its inactive components.
Warnings and precautions
Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after ferric carboxymaltose injection administration for at least 30 minutes and until clinically stable following completion of each administration. ( 5. 2) Hypertension: Monitor patients closely for signs and symptoms of hypertension following each ferric carboxymaltose injection administration. ( 5.3 ) 5.1 Symptomatic Hypophosphatemia Symptomatic hypophosphatemia, including severe cases, with serious outcomes such as osteomalacia and fractures requiring clinical intervention have occurred in patients treated with ferric carboxymaltose injection in the post-marketing setting. These cases have occurred after single and multiple doses of ferric carboxymaltose injection. Risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). However, individuals without apparent risk factors have experienced symptomatic hypophosphatemia. In most cases, hypophosphatemia resolved within three months. Check serum phosphate levels prior to a repeat course of treatment if the patient is at risk for low serum phosphate or if the patient will receive a repeat course of therapy within three months of the prior course [see Dosage and Administration ( 2.1 , 2.3 )] . Correct pre-existing hypophosphatemia prior to administering ferric carboxymaltose injection. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Treat hypophosphatemia as medically indicated. Consider permanent discontinuation of ferric carboxymaltose injection for severe symptomatic hypophosphatemia or persistent hypophosphatemia. 5.2 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving ferric carboxymaltose injection . 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 ferric carboxymaltose injection administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer ferric carboxymaltose injection 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 ferric carboxymaltose injection . 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. 5.3 Hypertension In clinical studies, hypertension was reported in 4% (67/1,775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1,775) of subjects in these two clinical trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each ferric carboxymaltose injection administration [see Dosage and Administration ( 2 )]. 5.4 Laboratory Test Alterations In the 24 hours following administration of ferric carboxymaltose injection, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in ferric carboxymaltose injection.
Side effects
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Symptomatic Hypophosphatemia [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [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 ferric carboxymaltose injection 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. Adverse reactions reported in ≥1% of Study Patients in Clinical Trials 1 and 2 Ferric Carboxymaltose Injection (N=1,775) % Pooled Comparators a (N=1,783) % Oral iron (N=253) % Nausea 7.2 2 1.2 Hypertension* 4 2 0.4 Flushing* 4 0.2 0 Injection site reactions* 3 3.2 0 Erythema* 3 0.6 0 Hypophosphatemia 2.1 0.1 0 Dizziness* 2.1 1.3 0.4 Vomiting 2 1 0.4 Injection Site Discoloration** 1.4 0.3 0 Headache* 1.3 1.2 0.4 Hepatic enzyme increased* 1.2 0.2 0 Dysgeusia* 1.2 2.1 0 Hypotension 1 2 0 Rash* 1 0.3 0 Constipation 0.5 0.9 3.2 a Includes oral iron and all formulations of IV iron other than ferric carboxymaltose injection *Grouped Terms: Hypertension includes hypertension, blood pressure increased, and hypertensive crisis. Flushing includes flushing and hot flush. Injection site reactions include injection site extravasation, injection site discoloration, injection site pain, injection site irritation, injection site bruising, injection site reaction, injection site discomfort, injection site erythema, injection site hematoma, injection site hemorrhage, injection site pruritus, injection site rash, and injection site swelling. Erythema includes erythema and injection site erythema. Dizziness includes dizziness, balance disorder, and vertigo. **Injection site discoloration was also included in the injection site local administration reactions grouped term. Headache includes headache and migraine. Hepatic enzyme increased includes alanine aminotransferase increased and aspartate aminotransferase increased. Dysgeusia includes dysgeusia and ageusia. Rash includes rash, urticaria, skin exfoliation, blister, erythema multiforme, injection site rash, rash maculo-papular, and rash pruritic. Other adverse reactions reported by ≥0.5% of treated patients include abdominal pain, diarrhea, gamma glutamyl transferase increased, paresthesia, and sneezing. Transient decreases in laboratory blood phosphorus levels (<2 mg/dL) have been observed in 27% (440/1,638) of patients in clinical trials. Pooled data from two Phase 3 studies 1VIT09030 (NCT00981045) and 1VIT09031 (NCT00982007) with a dosing regimen of ferric carboxymaltose injection 15 mg/kg up to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mg of iron were analyzed to compare rates of adverse reactions in two Phase 3 parallel group studies 1VIT07017 (NCT00548860) and 1VIT07018 (NCT00548691) with a dosing regimen of ferric carboxymaltose injection 15 mg/kg up to a maximum of 1,000 mg single dose (Table 3). Table 3. Adverse Reactions (≥1% in any Treatment Group) In Patients Receiving Two Doses of 15 mg/kg to a Maximum of 750 mg to a Cumulative Dose of 1,500 mg or a Single Dose of ferric carboxymaltose injection 15 mg/kg to a Maximum of 1,000 mg Ferric Carboxymaltose Injection 15 mg/kg to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mg Ferric Carboxymaltose Injection 15 mg/kg to a maximum of 1,000 mg single dose IVIT09030 and IVIT09031 b (N=1,775) % IVIT07017 and IVIT07018 a (N=1,200) % Any Adverse Reaction 24 12 Injection site reactions* 3 4 Injection site extravasation** 0.2 2 Hepatic enzyme increased* 1.2 1.2 Rash* 1 1.2 Headache* 1.3 1 Dizziness* 2.1 1 Dysgeusia* 1.2 1 Nausea 7.2 1 Hypertension* 4 1 Hypophosphatemia 2.1 1 Erythema* 3 0.3 Flushing* 4 0.3 Vomiting 2 0.2 Injection site discoloration** 1.4 <0.1 Hypotension 1 <0.1 ab Included studies 1VIT07017, 1VIT07018, 1VIT09030 and 1VIT09031 *Grouped Terms **Injection site extravasation and injection site discoloration were also included in the injection site reactions grouped term. Pediatric Patients The safety of ferric carboxymaltose injection in pediatric patients was evaluated in study 1VIT17044 (NCT03523117; Study 3). Study 1VIT17044 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received ferric carboxymaltose injection 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1,500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received ferric carboxymaltose injection was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting. Table 4 summarizes the adverse reactions in Study 3. Table 4.
Use in specific populations
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 ( 5.2 )], 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 ferric carboxymaltose injection 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as ferric carboxymaltose injection ) which may cause fetal bradycardia, especially during the second and third trimester. Data Human Data Published data from randomized controlled studies, prospective observational studies and retrospective studies on the use of ferric carboxymaltose in pregnant women have not reported an association with intravenous ferric carboxymaltose and major birth defects and miscarriage. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy. Animal Data Administration of ferric carboxymaltose to rats as a one-hour intravenous infusion up to 30 mg/kg/day iron on gestation days 6 to 17 did not result in adverse embryonic or fetal findings. This daily dose in rats is approximately 40% of the human weekly dose of 750 mg based on body surface area. In rabbits, ferric carboxymaltose was administered as a one-hour infusion on gestation days 6 to 19 at iron doses of 4.5, 9, 13.5, and 18 mg/kg/day. Malformations were seen starting at the daily dose of 9 mg/kg (23% of the human weekly dose of 750 mg). Spontaneous abortions occurred starting at the daily iron dose of 4.5 mg/kg (12% of the human weekly dose of 750 mg based on body surface area). Pre-implantation loss was at the highest dose. Adverse embryonic or fetal effects were observed in the presence of maternal toxicity. A pre- and post-natal development study was conducted in rats at intravenous doses up to 18 mg/kg/day of iron (approximately 23% of the weekly human dose of 750 mg based on body surface area). There were no adverse effects on survival of offspring, their behavior, sexual maturation or reproductive parameters. 8.2 Lactation Risk Summary The available published data on the use of ferric carboxymaltose in lactating women demonstrate that iron is present in breast milk. Among the breastfed infants, adverse reactions included constipation and diarrhea but none of the adverse reactions reported were considered related to ferric carboxymaltose exposure through breastmilk. There is no information on the effects of ferric carboxymaltose on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ferric carboxymaltose injection in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of ferric carboxymaltose injection for IDA in pediatric patients aged 1 year and older who have normal kidney function and have either intolerance to oral iron or have had unsatisfactory response to oral iron have been established. Use of ferric carboxymaltose injection for this indication in this age group is supported by evidence from adequate and well-controlled studies of ferric carboxymaltose injection in adults with additional pharmacodynamic and safety data in pediatric patients aged 1 year and older [see Adverse Reactions ( 6.1 ) and Clinical Pharmacology ( 12.3 )]. Safety and effectiveness of ferric carboxymaltose injection have not been established in pediatric patients less than 1 year of age with IDA. Safety and effectiveness of ferric carboxymaltose injection have not been established to improve exercise capacity in pediatric patients with ID and symptomatic heart failure. 8.5 Geriatric Use Of the 1,775 subjects in clinical studies of ferric carboxymaltose injection , 50% were 65 years and over, while 25% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Pregnancy
8.1 Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [ see Warnings and Precautions ( 5.2 )], 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 ferric carboxymaltose injection 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as ferric carboxymaltose injection ) which may cause fetal bradycardia, especially during the second and third trimester. Data Human Data Published data from randomized controlled studies, prospective observational studies and retrospective studies on the use of ferric carboxymaltose in pregnant women have not reported an association with intravenous ferric carboxymaltose and major birth defects and miscarriage. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy. Animal Data Administration of ferric carboxymaltose to rats as a one-hour intravenous infusion up to 30 mg/kg/day iron on gestation days 6 to 17 did not result in adverse embryonic or fetal findings. This daily dose in rats is approximately 40% of the human weekly dose of 750 mg based on body surface area. In rabbits, ferric carboxymaltose was administered as a one-hour infusion on gestation days 6 to 19 at iron doses of 4.5, 9, 13.5, and 18 mg/kg/day. Malformations were seen starting at the daily dose of 9 mg/kg (23% of the human weekly dose of 750 mg). Spontaneous abortions occurred starting at the daily iron dose of 4.5 mg/kg (12% of the human weekly dose of 750 mg based on body surface area). Pre-implantation loss was at the highest dose. Adverse embryonic or fetal effects were observed in the presence of maternal toxicity. A pre- and post-natal development study was conducted in rats at intravenous doses up to 18 mg/kg/day of iron (approximately 23% of the weekly human dose of 750 mg based on body surface area). There were no adverse effects on survival of offspring, their behavior, sexual maturation or reproductive parameters.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of ferric carboxymaltose injection for IDA in pediatric patients aged 1 year and older who have normal kidney function and have either intolerance to oral iron or have had unsatisfactory response to oral iron have been established. Use of ferric carboxymaltose injection for this indication in this age group is supported by evidence from adequate and well-controlled studies of ferric carboxymaltose injection in adults with additional pharmacodynamic and safety data in pediatric patients aged 1 year and older [see Adverse Reactions ( 6.1 ) and Clinical Pharmacology ( 12.3 )]. Safety and effectiveness of ferric carboxymaltose injection have not been established in pediatric patients less than 1 year of age with IDA. Safety and effectiveness of ferric carboxymaltose injection have not been established to improve exercise capacity in pediatric patients with ID and symptomatic heart failure.
Geriatric use
8.5 Geriatric Use Of the 1,775 subjects in clinical studies of ferric carboxymaltose injection , 50% were 65 years and over, while 25% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Overdosage
Excessive dosages of ferric carboxymaltose injection may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. A patient who received ferric carboxymaltose injection 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 ferric carboxymaltose injection. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
Description
Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)- O -α-D-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate. It has a relative molecular weight of approximately 150,000 Da corresponding to the following empirical formula: [FeO x (OH) y (H 2 O) z ] n [{(C 6 H 10 O 5 ) m (C 6 H 12 O 7 )} l ] k , where n ≈ 10 3 , m ≈ 8, l ≈ 11, and k ≈ 4 ( l represents the mean branching degree of the ligand). The chemical structure is presented below: Ferric carboxymaltose injection is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Each mL contains 50 mg iron as ferric carboxymaltose in water for injection. Ferric carboxymaltose injection is available in, 15 mL single-dose vials. Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-7.0. Vial closure is not made with natural rubber latex. structure
Mechanism of action
12.1 Mechanism of Action Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.
How supplied
Ferric carboxymaltose injection is a dark brown, non-transparent, sterile, aqueous solution. NDC 0781-3542-94 750 mg iron/15 mL Single-Dose Vial Individually Boxed 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). [See the USP controlled room temperature.] Do not freeze.
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information) and discuss with the patient the etiology of the iron deficiency anemia and the patient’s iron deficiency anemia treatment options. Symptomatic Hypophosphatemia Advise patients to report any signs or symptoms of hypophosphatemia such as fatigue, muscle weakness or pain, bone and joint pain, or bone fractures [see Warnings and Precautions ( 5.1 ) ]. Prior History of Reactions to Parenteral Iron Products Question patients regarding any prior history of reactions to parenteral iron products [see Warnings and Precautions ( 5.2 )] . Serious Hypersensitivity Reactions Advise patients to report any signs and symptoms of hypersensitivity that may develop during and following ferric carboxymaltose injection administration, such as rash, itching, dizziness, lightheadedness, swelling, and breathing problems [ see Warnings and Precautions ( 5.2 )]. Pregnancy Advise pregnant women about the risk of hypersensitivity reactions which may have serious consequences for the fetus. Advise patients who may become pregnant to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations ( 8.1 )]. Manufactured by American Regent, Inc. New Albany, OH 43054 USA for Sandoz Inc., Princeton, NJ 08540 USA RQ1149-B
Label text from the FDA structured product label by Sandoz, Inc. (revised Sep 2, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ferric Carboxymaltose in 4 products
Ferric Carboxymaltose NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 67457-797 | Ferric Carboxymaltose 50 mg/mL Injection, Solution | Mylan Institutional LLC | ANDA |
| 72078-048 | Ferric Carboxymaltose 50 mg/mL Injection, Solution | Mylan Institutional LLC | ANDA |
| 72078-060 | Ferric Carboxymaltose 50 mg/mL Injection, Solution | Mylan Institutional LLC | ANDA |
| 0781-3542 | Ferric Carboxymaltose 50 mg/mL Injection, Solution | Sandoz, Inc. | NDA AUTHORIZED GENERIC |
Frequently asked questions
What is Ferric Carboxymaltose used for?
Ferric carboxymaltose injection 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. • Iron deficiency in adult patients with heart failure and New York Heart Association class II/III to…
What are the side effects of Ferric Carboxymaltose?
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Symptomatic Hypophosphatemia [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [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… See the full label for the complete list.
Who makes Ferric Carboxymaltose?
Ferric Carboxymaltose is listed by 2 labelers in the FDA NDC directory, including Mylan Institutional LLC, Sandoz, Inc..