{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-18", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Ferric Carboxymaltose Ferric Carboxymaltose FERRIC CARBOXYMALTOSE FERRIC CATION HYDROCHLORIC ACID SODIUM HYDROXIDE WATER" ], "recent_major_changes": [ "Boxed Warning, Symptomatic Hypophosphatemia 08/2026 Warnings and Precautions, Symptomatic Hypophosphatemia ( 5.1 ) 08/2026" ], "boxed_warning": [ "WARNING: SYMPTOMATIC HYPOPHOSPHATEMIA • 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 risk of hypophosphatemia and to report any signs and symptoms of hypophosphatemia (e.g., fatigue, muscle weakness or pain, bone and joint pain, bone fractures) [see Warnings and Precautions (5.1) ] . WARNING: SYMPTOMATIC HYPOPHOSPHATEMIA See full prescribing information for complete boxed warning. • Ferric carboxymaltose injection can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention ( 5.1 ). • Hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors for hypophosphatemia ( 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. Correct pre-existing hypophosphatemia prior to administering ferric carboxymaltose injection ( 2.1 , 2.3 , 5.1 ). • Advise patients receiving ferric carboxymaltose injection about the risk of hypophosphatemia and to report any signs and symptoms of hypophosphatemia (e.g., fatigue, muscle weakness or pain, bone and joint pain, bone fractures) ( 5.1 )." ], "indications_and_usage": [ "1 INDICATIONS AND USAGE Ferric carboxymaltose injection is indicated for the treatment of: • iron deficiency anemia (IDA) in: o adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. o 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: o adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. ( 1 ) o 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": [ "2 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 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_and_administration_table": [ "
Table 1: Recommended Dosage in Patients with Iron Deficiency with Heart Failure
Weight less than 70 kgWeight 70 kg or more
Hb (g/dL)Hb (g/dL)
< 1010 to 14> 14 to < 15< 1010 to 14> 14 to < 15
Day 11,000 mg1,000 mg500 mg1,000 mg1,000 mg500 mg
Week 6500 mgNo doseNo dose1,000 mg500 mgNo dose
" ], "dosage_forms_and_strengths": [ "3 DOSAGE FORMS AND STRENGTHS Injection: 50 mg/mL, dark brown, non-transparent, sterile, aqueous, isotonic colloidal solution for intravenous injection. • 100 mg iron/2 mL single-dose vial Injection: 50 mg/mL ( 3 ) • 100 mg iron/2 mL single-dose vial" ], "contraindications": [ "4 CONTRAINDICATIONS Ferric carboxymaltose injection is contraindicated in patients with a history of hypersensitivity to ferric carboxymaltose or any of its components [see Warnings and Precautions (5.2) ] . Hypersensitivity to ferric carboxymaltose injection or any of its inactive components. ( 4 )" ], "warnings_and_cautions": [ "5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after ferric carboxymaltose 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 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 in the post-marketing setting. These cases have occurred after single and multiple doses of ferric carboxymaltose. 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. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Treat hypophosphatemia as medically indicated. Consider permanent discontinuation of ferric carboxymaltose 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. 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 administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer ferric carboxymaltose 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. 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 administration [see Dosage and Administration (2) ] . 5.4 Laboratory Test Alterations In the 24 hours following administration of ferric carboxymaltose, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in ferric carboxymaltose." ], "adverse_reactions": [ "6 ADVERSE REACTIONS 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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 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 (N = 1,775) % Pooled Comparators Includes oral iron and all formulations of IV iron other than ferric carboxymaltose. (N = 1,783) % Oral iron (N = 253) % Nausea 7.2 2 1.2 Hypertension 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. 4 2 0.4 Flushing 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. 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 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 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 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 15 mg/kg to a Maximum of 1,000 mg Ferric Carboxymaltose 15 mg/kg to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mg Ferric Carboxymaltose 15 mg/kg to a maximum of 1,000 mg single dose IVIT09030 and IVIT09031 Included studies 1VIT07017, 1VIT07018, 1VIT09030 and 1VIT09031 (N = 1,775) % IVIT07017 and IVIT07018 (N = 1,200) % Any Adverse Reaction 24 12 Injection site reactions Grouped Terms 3 4 Injection site extravasation Injection site extravasation and injection site discoloration were also included in the injection site reactions grouped term. 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 Pediatric Patients The safety of ferric carboxymaltose 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 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 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. Adverse Reactions of any Grade in Pediatric Patients Receiving Ferric Carboxymaltose in Study 3 Ferric Carboxymaltose (N = 40) % Oral Ferrous Sulfate (N = 38) % Any Adverse Reactions 35 26 Hypophosphatemia Grouped Terms Injection site reactions include infusion site hematoma, infusion site hypoesthesia and injection site pain. Hypophosphatemia includes hypophosphatemia and blood phosphorus decreased. Rash includes rash, exanthema and urticaria. 13 0 Injection site reactions 8 0 Rash 8 0 Headache 5 3 Vomiting 5 3 Nasopharyngitis 3 5 Flushing 3 0 Gastrointestinal infections 3 0 Liver function test increased 3 0 Platelet count decreased 3 0 White blood cell count decreased 3 0 Patients with Iron Deficiency and Heart Failure The safety of ferric carboxymaltose was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780), CONFIRM-HF (NCT01453608) and AFFIRM-AHF (NCT02937454) in which 1,016 patients received ferric carboxymaltose versus 857 received placebo. The overall safety profile of ferric carboxymaltose was consistent across the studied indications. 6.2 Post-marketing Experience The following adverse reactions have been identified during post approval use of ferric carboxymaltose. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been reported from the post-marketing spontaneous reports with ferric carboxymaltose: • Cardiac disorders: Tachycardia • General disorders and administration site conditions: Chest discomfort, chills, pyrexia • Metabolism and nutrition disorders: Hypophosphatemia • Musculoskeletal and connective tissue disorders: Arthralgia, back pain, hypophosphatemic osteomalacia • Nervous system disorders: Syncope • Respiratory, thoracic and mediastinal disorders: Dyspnea • Skin and subcutaneous tissue disorders: Angioedema, erythema, pruritus, urticaria • Pregnancy: Fetal bradycardia" ], "adverse_reactions_table": [ "
Table 2. Adverse reactions reported in ≥ 1% of Study Patients in Clinical Trials 1 and 2
Ferric Carboxymaltose (N = 1,775) %Pooled ComparatorsIncludes oral iron and all formulations of IV iron other than ferric carboxymaltose. (N = 1,783) %Oral iron (N = 253) %
Nausea 7.221.2
HypertensionInjection 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.420.4
FlushingGrouped 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. 40.20
Injection site reactions33.20
Erythema30.60
Hypophosphatemia 2.10.10
Dizziness2.11.30.4
Vomiting 210.4
Injection Site Discoloration1.40.30
Headache1.31.20.4
Hepatic enzyme increased1.20.20
Dysgeusia1.22.10
Hypotension 120
Rash10.30
Constipation 0.50.93.2
", "
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 15 mg/kg to a Maximum of 1,000 mg
Ferric Carboxymaltose 15 mg/kg to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mgFerric Carboxymaltose 15 mg/kg to a maximum of 1,000 mg single dose
IVIT09030 and IVIT09031Included studies 1VIT07017, 1VIT07018, 1VIT09030 and 1VIT09031 (N = 1,775) %IVIT07017 and IVIT07018 (N = 1,200) %
Any Adverse Reaction 2412
Injection site reactionsGrouped Terms 34
Injection site extravasationInjection site extravasation and injection site discoloration were also included in the injection site reactions grouped term.0.22
Hepatic enzyme increased1.21.2
Rash11.2
Headache1.31
Dizziness2.11
Dysgeusia1.21
Nausea 7.21
Hypertension41
Hypophosphatemia 2.11
Erythema30.3
Flushing4 0.3
Vomiting 2 0.2
Injection site discoloration1.4< 0.1
Hypotension 1< 0.1
", "
Table 4. Adverse Reactions of any Grade in Pediatric Patients Receiving Ferric Carboxymaltose in Study 3
Ferric Carboxymaltose (N = 40) %Oral Ferrous Sulfate (N = 38) %
Any Adverse Reactions 3526
HypophosphatemiaGrouped Terms Injection site reactions include infusion site hematoma, infusion site hypoesthesia and injection site pain. Hypophosphatemia includes hypophosphatemia and blood phosphorus decreased. Rash includes rash, exanthema and urticaria.130
Injection site reactions80
Rash80
Headache 53
Vomiting 53
Nasopharyngitis 35
Flushing 30
Gastrointestinal infections 30
Liver function test increased 30
Platelet count decreased 30
White blood cell count decreased 30
" ], "use_in_specific_populations": [ "8 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 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) 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 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 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 for this indication in this age group is supported by evidence from adequate and well-controlled studies of ferric carboxymaltose 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 have not been established in pediatric patients less than 1 year of age with IDA. Safety and effectiveness of ferric carboxymaltose 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, 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 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) 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." ], "risks": [ "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 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.", "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 in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition." ], "pediatric_use": [ "8.4 Pediatric Use The safety and effectiveness of ferric carboxymaltose 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 for this indication in this age group is supported by evidence from adequate and well-controlled studies of ferric carboxymaltose 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 have not been established in pediatric patients less than 1 year of age with IDA. Safety and effectiveness of ferric carboxymaltose 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, 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": [ "10 OVERDOSAGE Excessive dosages of ferric carboxymaltose may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. A patient who received ferric carboxymaltose 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. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations." ], "description": [ "11 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 (H2O) 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 2 mL single-dose vials. Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-7.0. Each mL of ferric carboxymaltose injection contains 4 mg of sodium. Vial closure is not made with natural rubber latex. Ferric Carboxymaltose Chemical Structure" ], "clinical_pharmacology": [ "12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. 12.2 Pharmacodynamics Using positron emission tomography (PET) it was demonstrated that red cell uptake of 59 Fe and 52 Fe from ferric carboxymaltose ranged from 61% to 99%. In patients with iron deficiency, red cell uptake of radio-labeled iron ranged from 91% to 99% at 24 days after ferric carboxymaltose dose. In patients with renal anemia, red cell uptake of radiolabeled iron ranged from 61% to 84% at 24 days after ferric carboxymaltose dose. 12.3 Pharmacokinetics After administration of a single dose of ferric carboxymaltose 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. The iron injected or infused was rapidly cleared from the plasma, the terminal half-life ranged from 7 to 12 hours. Renal elimination of iron was negligible. After administration of a single dose of ferric carboxymaltose 15 mg/kg in pediatric patients 1-17 years of age, the maximum concentrations ranged between 124 and 418.1 µg/mL and the median time to maximum concentration was 7 minutes. The elimination half-life of ferric carboxymaltose in pediatric patients was approximately 9.7 hours. The total median 72-hour exposure (AUC 0-72h ) after a single dose of ferric carboxymaltose 15 mg/kg in pediatric patients was 4,529.7 µg∙h/mL while the median exposure after a single dose of 1,000 mg in adults was 5,875.3 µg∙h/mL." ], "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." ], "pharmacodynamics": [ "12.2 Pharmacodynamics Using positron emission tomography (PET) it was demonstrated that red cell uptake of 59 Fe and 52 Fe from ferric carboxymaltose ranged from 61% to 99%. In patients with iron deficiency, red cell uptake of radio-labeled iron ranged from 91% to 99% at 24 days after ferric carboxymaltose dose. In patients with renal anemia, red cell uptake of radiolabeled iron ranged from 61% to 84% at 24 days after ferric carboxymaltose dose." ], "pharmacokinetics": [ "12.3 Pharmacokinetics After administration of a single dose of ferric carboxymaltose 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. The iron injected or infused was rapidly cleared from the plasma, the terminal half-life ranged from 7 to 12 hours. Renal elimination of iron was negligible. After administration of a single dose of ferric carboxymaltose 15 mg/kg in pediatric patients 1-17 years of age, the maximum concentrations ranged between 124 and 418.1 µg/mL and the median time to maximum concentration was 7 minutes. The elimination half-life of ferric carboxymaltose in pediatric patients was approximately 9.7 hours. The total median 72-hour exposure (AUC 0-72h ) after a single dose of ferric carboxymaltose 15 mg/kg in pediatric patients was 4,529.7 µg∙h/mL while the median exposure after a single dose of 1,000 mg in adults was 5,875.3 µg∙h/mL." ], "nonclinical_toxicology": [ "13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenicity studies have not been performed with ferric carboxymaltose. Ferric carboxymaltose was not genotoxic in the following genetic toxicology studies: in vitro microbial mutagenesis (Ames) assay, in vitro chromosome aberration test in human lymphocytes, in vitro mammalian cell mutation assay in mouse lymphoma L5178Y/TK+/- cells, in vivo mouse micronucleus test at single intravenous doses up to 500 mg/kg. In a combined male and female fertility study, ferric carboxymaltose was administered intravenously over one hour to male and female rats at iron doses of up to 30 mg/kg. Animals were dosed 3 times per week (on Days 0, 3, and 7). There was no effect on mating function, fertility or early embryonic development. Based on body surface area, the dose of 30 mg/kg in animals is approximately 40% of the human dose of 750 mg." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenicity studies have not been performed with ferric carboxymaltose. Ferric carboxymaltose was not genotoxic in the following genetic toxicology studies: in vitro microbial mutagenesis (Ames) assay, in vitro chromosome aberration test in human lymphocytes, in vitro mammalian cell mutation assay in mouse lymphoma L5178Y/TK+/- cells, in vivo mouse micronucleus test at single intravenous doses up to 500 mg/kg. In a combined male and female fertility study, ferric carboxymaltose was administered intravenously over one hour to male and female rats at iron doses of up to 30 mg/kg. Animals were dosed 3 times per week (on Days 0, 3, and 7). There was no effect on mating function, fertility or early embryonic development. Based on body surface area, the dose of 30 mg/kg in animals is approximately 40% of the human dose of 750 mg." ], "clinical_studies": [ "14 CLINICAL STUDIES 14.1 Iron Deficiency Anemia The safety and efficacy of ferric carboxymaltose for treatment of IDA were evaluated in two randomized, open-label, controlled clinical trials (Trial 1 and Trial 2). In these two trials, ferric carboxymaltose was administered at a dose of 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. Trial 1: Iron Deficiency Anemia in Patients Who Are Intolerant to Oral Iron or Have Had Unsatisfactory Response to Oral Iron Trial 1: A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients with Iron Deficiency Anemia (IDA), (NCT00982007) was a randomized, open-label, controlled clinical study in patients with IDA who had an unsatisfactory response to oral iron (Cohort 1) or who were intolerant to oral iron (Cohort 2) during the 14-day oral iron run-in period. Inclusion criteria prior to randomization included hemoglobin (Hb) < 12 g/dL, ferritin ≤ 100 ng/mL or ferritin ≤ 300 ng/mL when transferrin saturation (TSAT) ≤ 30%. Cohort 1 subjects were randomized to ferric carboxymaltose or oral iron for 14 more days. Cohort 2 subjects were randomized to ferric carboxymaltose or another IV iron per standard of care [90% of subjects received iron sucrose]. The mean age of study patients was 43 years (range, 18 to 94); 94% were female; 42% were Caucasian, 32% were African American, 24% were Hispanic, and 2% were other races. The primary etiologies of IDA were heavy uterine bleeding (47%) and gastrointestinal disorders (17%). Table 5 shows the baseline and the change in hemoglobin from baseline to highest value between baseline and Day 35 or time of intervention. Table 5. Mean Change in Hemoglobin From Baseline to the Highest Value Between Day 35 or Time of Intervention (Modified Intent-to-Treat Population) SD=standard deviation Hemoglobin (g/dL) Mean (SD) Cohort 1 Cohort 2 Ferric Carboxymaltose (N = 244) Oral Iron (N = 251) Ferric Carboxymaltose (N = 245) IV SC Intravenous iron per standard of care (N = 237) Baseline 10.6 (1.0) 10.6 (1.0) 9.1 (1.6) 9.0 (1.5) Highest Value 12.2 (1.1) 11.4 (1.2) 12.0 (1.2) 11.2 (1.3) Change (from baseline to highest value) 1.6 (1.2) 0.8 (0.8) 2.9 (1.6) 2.2 (1.3) p-value 0.001 0.001 Increases from baseline in mean ferritin (264.2 ± 224.2 ng/mL in Cohort 1 and 218.2 ± 211.4 ng/mL in Cohort 2), and transferrin saturation (13 ± 16% in Cohort 1 and 20 ± 15% in Cohort 2) were observed at Day 35 in ferric carboxymaltose-treated patients. Trial 2: Iron Deficiency Anemia in Patients with Non-Dialysis Dependent Chronic Kidney Disease Trial 2: REPAIR-IDA, Randomized Evaluation of efficacy and safety of Ferric Carboxymaltose in Patients with Iron Deficiency Anemia and Impaired Renal function, (NCT00981045) was a randomized, open-label, controlled clinical study in patients with non-dialysis dependent chronic kidney disease. Inclusion criteria included hemoglobin (Hb) ≤ 11.5 g/dL, ferritin ≤ 100 ng/mL or ferritin ≤ 300 ng/mL when transferrin saturation (TSAT) ≤ 30%. Study patients were randomized to either ferric carboxymaltose or Venofer. The mean age of study patients was 67 years (range, 19 to 101); 64% were female; 54% were Caucasian, 26% were African American, 18% Hispanics, and 2% were other races. Table 6 shows the baseline and the change in hemoglobin from baseline to highest value between baseline and Day 56 or time of intervention. Table 6. Mean Change in Hemoglobin From Baseline to the Highest Value Between Baseline and Day 56 or Time of Intervention (Modified Intent-to-Treat Population) Hemoglobin (g/dL) Mean (SD) Ferric Carboxymaltose (N = 1,249) Venofer (N = 1,244) Baseline 10.3 (0.8) 10.3 (0.8) Highest Value 11.4 (1.2) 11.3 (1.1) Change (from baseline to highest value) 1.1 (1.0) 0.9 (0.92) Treatment Difference (95% CI) 0.21 (0.13, 0.28) Increases from baseline in mean ferritin (734.7 ± 337.8 ng/mL) and transferrin saturation (30 ± 17%) were observed prior to Day 56 in ferric carboxymaltose-treated patients. 14.2 Iron Deficiency in Heart Failure Trial 3: FER-CARS-05 (CONFIRM-HF) was a randomized, double-blind, placebo-controlled, study in patients with iron deficiency and chronic heart failure with left ventricular ejection fraction of < 45% and New York Heart Association (NYHA) class II/III to determine whether intravenous ferric carboxymaltose improves exercise capacity measured as change from baseline to 24 weeks in 6-minute walk distance (6MWD). Iron deficiency was defined as serum ferritin < 100 ng/mL or 100 to 300 ng/mL with TSAT < 20%. Patients with Hb of ≥ 15 g/dl were excluded. Of the 304 patients, 150 were randomized to ferric carboxymaltose and 151 to placebo. The median age of study patients was 71 years (range, 35 to 88); 46% were female; 99% were Caucasian. At baseline, mean (SD) Hb was 12 g/dl (1.4), ferritin 57 ng/mL (45), TSAT 19 % (13.7), LVEF 37% (7), brain natriuretic peptide 770 pg/mL (973); and 57 and 43% were classified as NYHA class II and III, respectively. At baseline, 95% of patients were treated with angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), 91% with beta-blocker, 59% with aldosterone antagonists, and 90% with diuretic. The mean change in 6MWD from Baseline to Week 24 in ferric carboxymaltose-treated patients was 18 meters (95% CI 4, 32), and placebo-treated patients was -7 meters (95% CI -21, 7), with between group difference of 25 meters (7, 43), p-value 0.007, favoring ferric carboxymaltose. Results were generally similar within age and sex subgroups. In ferric carboxymaltose-treated patients, change from Baseline to Week 24 in serum ferritin was 269 ng/mL (229, 309), in TSAT was 9% (7, 11), and in Hb was 0.6 g/dL (0.3, 0.8)." ], "clinical_studies_table": [ "
Table 5. Mean Change in Hemoglobin From Baseline to the Highest Value Between Day 35 or Time of Intervention (Modified Intent-to-Treat Population)
SD=standard deviation
Hemoglobin (g/dL) Mean (SD)Cohort 1Cohort 2
Ferric Carboxymaltose(N = 244) Oral Iron (N = 251)FerricCarboxymaltose(N = 245)IV SCIntravenous iron per standard of care (N = 237)
Baseline 10.6 (1.0)10.6 (1.0)9.1 (1.6)9.0 (1.5)
Highest Value12.2 (1.1)11.4 (1.2)12.0 (1.2)11.2 (1.3)
Change (from baseline to highest value)1.6 (1.2)0.8 (0.8)2.9 (1.6)2.2 (1.3)
p-value0.0010.001
", "
Table 6. Mean Change in Hemoglobin From Baseline to the Highest Value Between Baseline and Day 56 or Time of Intervention (Modified Intent-to-Treat Population)
Hemoglobin (g/dL) Mean (SD)Ferric Carboxymaltose (N = 1,249)Venofer (N = 1,244)
Baseline 10.3 (0.8)10.3 (0.8)
Highest Value11.4 (1.2)11.3 (1.1)
Change (from baseline to highest value)1.1 (1.0)0.9 (0.92)
Treatment Difference (95% CI)0.21 (0.13, 0.28)
" ], "how_supplied": [ "16 HOW SUPPLIED/STORAGE AND HANDLING Ferric carboxymaltose injection is a dark brown, non-transparent, sterile, aqueous, isotonic colloidal solution for intravenous injection and supplied as follows: NDC 72078-060-99 100 mg iron/2 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." ], "how_supplied_table": [ "
NDC 72078-060-99100 mg iron/2 mL Single-Dose Vial Individually Boxed
" ], "information_for_patients": [ "17 PATIENT COUNSELING 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 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) ] . The brands listed are trademarks of their respective owners. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Bangalore, India Revised: 8/2026" ], "spl_patient_package_insert": [ "Patient Information Ferric Carboxymaltose Injection (fer' ik kar box'' ee mawl' tose) What is the most important information I should know about ferric carboxymaltose injection? Ferric carboxymaltose injection can cause serious side effects, including: Low blood phosphate levels (hypophosphatemia). Hypophosphatemia has happened after one or more doses of ferric carboxymaltose injection and can be severe or serious, and lead to hospitalization, softening of your bones (osteomalacia), and broken bones (fractures). Hypophosphatemia can happen even if your blood phosphate levels were normal before treatment and you do not have any risk factors for hypophosphatemia. Your healthcare provider will check your blood phosphate levels before a repeat treatment with ferric carboxymaltose injection if you are at risk for hypophosphatemia. If a repeat treatment is needed within 3 months of your last treatment, your healthcare provider will check your blood phosphate levels. Tell your healthcare provider if you develop any of the following signs or symptoms of hypophosphatemia during treatment with ferric carboxymaltose injection: • tiredness • muscle weakness or pain • bone or joint pain • broken bones Your healthcare provider may permanently stop treatment with ferric carboxymaltose injection if you develop severe hypophosphatemia with symptoms or if your blood phosphate levels remain low during treatment with ferric carboxymaltose injection. See “What are the possible side effects of ferric carboxymaltose injection?” for more information about side effects. What is ferric carboxymaltose injection? Ferric carboxymaltose injection is a prescription iron replacement medicine used for the treatment of: • iron deficiency anemia (IDA) in: o adults and children 1 year of age and older who cannot tolerate iron taken by mouth (oral) or who have not responded well to oral iron. o adults who have chronic kidney disease who are not on dialysis (non-dialysis dependent chronic kidney disease). • iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise (improve exercise capacity). It is not known if ferric carboxymaltose injection is safe and effective in children with IDA who are under 1 year of age. It is not known if ferric carboxymaltose injection is safe and effective in children with iron deficiency and mild to moderate heart failure to improve exercise capacity. Who should not receive ferric carboxymaltose injection? Do not receive ferric carboxymaltose injection if you are allergic to ferric carboxymaltose or any of the ingredients in ferric carboxymaltose injection. See the end of this Patient Information leaflet for a complete list of ingredients in ferric carboxymaltose injection. Before receiving ferric carboxymaltose injection, tell your healthcare provider about all of your medical conditions, including if you: • have a history of trouble absorbing certain vitamins or phosphate in your body • have inflammatory bowel disease • have hyperparathyroidism • have low vitamin D levels • have hereditary hemorrhagic telangiectasia (HHT) or Osler-Weber-Rendu syndrome • have had an allergic reaction to iron given into your vein • have previously received ferric carboxymaltose injection • have high blood pressure (hypertension) • are pregnant or plan to become pregnant. Ferric carboxymaltose injection may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ferric carboxymaltose injection. • are breastfeeding or plan to breastfeed. Ferric carboxymaltose passes into your breast milk. It is not known if ferric carboxymaltose injection will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ferric carboxymaltose injection. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive ferric carboxymaltose injection? • Ferric carboxymaltose injection is given into your vein by intravenous (IV) infusion by your healthcare provider. • Ferric carboxymaltose injection is usually given in 2 doses at least 7 days apart for IDA, or 6 weeks apart for iron deficiency with mild to moderate heart failure to improve exercise capacity. • If your healthcare provider decides it is right for you, ferric carboxymaltose injection may be given intravenously by your healthcare provider as a single-dose treatment. • Ferric carboxymaltose injection treatment may be repeated if your healthcare provider decides it is needed. • Ferric carboxymaltose injection can cause discoloration or staining of your skin if leaking happens at your infusion site. Tell your healthcare provider if you notice any leaking from the infusion site during your infusion. What are the possible side effects of ferric carboxymaltose injection? Ferric carboxymaltose injection may cause serious side effects, including: • See “What is the most important information I should know about ferric carboxymaltose injection?” • Allergic reactions. Serious life-threatening allergic reactions that can lead to death have happened in people who receive ferric carboxymaltose injection. Your healthcare provider will watch you during and for at least 30 minutes after you receive ferric carboxymaltose injection. Tell your healthcare provider right away if you develop any of the following signs or symptoms of allergic reactions during or after treatment with ferric carboxymaltose injection: o low blood pressure o feeling dizzy or lightheaded o loss of consciousness o trouble breathing o swelling o fast heartbeat o cold or clammy skin o feet or hands turn blue o itching o rash o hives o wheezing • High blood pressure. High blood pressure, sometimes with redness and warmth of the face (facial flushing), dizziness, or nausea, has happened during treatment with ferric carboxymaltose injection. Your healthcare provider will check your blood pressure and check for any signs and symptoms of high blood pressure after you receive ferric carboxymaltose injection. The most common side effects of ferric carboxymaltose injection in adults include: • nausea • high blood pressure • flushing • injection site reactions • skin redness • low blood phosphate levels • dizziness The most common side effects of ferric carboxymaltose injection in children include: • low blood phosphate levels • injection site reactions • rash • headache • vomiting These are not all the possible side effects of ferric carboxymaltose injection. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of ferric carboxymaltose injection. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about ferric carboxymaltose injection that is written for health professionals. What are the ingredients in ferric carboxymaltose injection? Active ingredient: ferric carboxymaltose. Inactive ingredients: water for injection. Sodium hydroxide or hydrochloric acid may be added to adjust pH to 5.0-7.0. For more information contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX). This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Bangalore, India Revised: 8/2026 MI:FECAIJ100:RX1" ], "spl_patient_package_insert_table": [ "tirednessmuscle weakness or painbone or joint painbroken bonesiron deficiency anemia (IDA) in:adults and children 1 year of age and older who cannot tolerate iron taken by mouth (oral) or who have not responded well to oral iron.adults who have chronic kidney disease who are not on dialysis (non-dialysis dependent chronic kidney disease).iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise (improve exercise capacity).It is not known if ferric carboxymaltose injection is safe and effective in children with IDA who are under 1 year of age.It is not known if ferric carboxymaltose injection is safe and effective in children with iron deficiency and mild to moderate heart failure to improve exercise capacity.have a history of trouble absorbing certain vitamins or phosphate in your bodyhave inflammatory bowel diseasehave hyperparathyroidismhave low vitamin D levelshave hereditary hemorrhagic telangiectasia (HHT) or Osler-Weber-Rendu syndromehave had an allergic reaction to iron given into your veinhave previously received ferric carboxymaltose injectionhave high blood pressure (hypertension)are pregnant or plan to become pregnant. Ferric carboxymaltose injection may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ferric carboxymaltose injection.are breastfeeding or plan to breastfeed. Ferric carboxymaltose passes into your breast milk. It is not known if ferric carboxymaltose injection will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ferric carboxymaltose injection.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Ferric carboxymaltose injection is given into your vein by intravenous (IV) infusion by your healthcare provider.Ferric carboxymaltose injection is usually given in 2 doses at least 7 days apart for IDA, or 6 weeks apart for iron deficiency with mild to moderate heart failure to improve exercise capacity.If your healthcare provider decides it is right for you, ferric carboxymaltose injection may be given intravenously by your healthcare provider as a single-dose treatment.Ferric carboxymaltose injection treatment may be repeated if your healthcare provider decides it is needed.Ferric carboxymaltose injection can cause discoloration or staining of your skin if leaking happens at your infusion site. Tell your healthcare provider if you notice any leaking from the infusion site during your infusion.See “What is the most important information I should know about ferric carboxymaltose injection?”Allergic reactions. Serious life-threatening allergic reactions that can lead to death have happened in people who receive ferric carboxymaltose injection. Your healthcare provider will watch you during and for at least 30 minutes after you receive ferric carboxymaltose injection. Tell your healthcare provider right away if you develop any of the following signs or symptoms of allergic reactions during or after treatment with ferric carboxymaltose injection:low blood pressurefeeling dizzy or lightheadedloss of consciousnesstrouble breathingswellingfast heartbeatcold or clammy skinfeet or hands turn blueitchingrashhiveswheezingHigh blood pressure. High blood pressure, sometimes with redness and warmth of the face (facial flushing), dizziness, or nausea, has happened during treatment with ferric carboxymaltose injection. Your healthcare provider will check your blood pressure and check for any signs and symptoms of high blood pressure after you receive ferric carboxymaltose injection.The most common side effects of ferric carboxymaltose injection in adults include:nauseahigh blood pressure flushing injection site reactionsskin redness low blood phosphate levelsdizzinesslow blood phosphate levelsinjection site reactions rashheadachevomiting
Ferric Carboxymaltose Injection(fer' ik kar box'' ee mawl' tose)
What is the most important information I should know about ferric carboxymaltose injection?Ferric carboxymaltose injection can cause serious side effects, including:Low blood phosphate levels (hypophosphatemia). Hypophosphatemia has happened after one or more doses of ferric carboxymaltose injection and can be severe or serious, and lead to hospitalization, softening of your bones (osteomalacia), and broken bones (fractures). Hypophosphatemia can happen even if your blood phosphate levels were normal before treatment and you do not have any risk factors for hypophosphatemia. Your healthcare provider will check your blood phosphate levels before a repeat treatment with ferric carboxymaltose injection if you are at risk for hypophosphatemia. If a repeat treatment is needed within 3 months of your last treatment, your healthcare provider will check your blood phosphate levels. Tell your healthcare provider if you develop any of the following signs or symptoms of hypophosphatemia during treatment with ferric carboxymaltose injection:
••
••
Your healthcare provider may permanently stop treatment with ferric carboxymaltose injection if you develop severe hypophosphatemia with symptoms or if your blood phosphate levels remain low during treatment with ferric carboxymaltose injection. See “What are the possible side effects of ferric carboxymaltose injection?” for more information about side effects.
What is ferric carboxymaltose injection?Ferric carboxymaltose injection is a prescription iron replacement medicine used for the treatment of:
•oo•
Who should not receive ferric carboxymaltose injection?Do not receive ferric carboxymaltose injection if you are allergic to ferric carboxymaltose or any of the ingredients in ferric carboxymaltose injection. See the end of this Patient Information leaflet for a complete list of ingredients in ferric carboxymaltose injection.
Before receiving ferric carboxymaltose injection, tell your healthcare provider about all of your medical conditions, including if you:
••••••••••
How will I receive ferric carboxymaltose injection?
•••••
What are the possible side effects of ferric carboxymaltose injection?Ferric carboxymaltose injection may cause serious side effects, including:
••
oooooo
oooooo
•
••••
•••
The most common side effects of ferric carboxymaltose injection in children include:
•••
••
These are not all the possible side effects of ferric carboxymaltose injection.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ferric carboxymaltose injection.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about ferric carboxymaltose injection that is written for health professionals.
What are the ingredients in ferric carboxymaltose injection? Active ingredient: ferric carboxymaltose.Inactive ingredients: water for injection. Sodium hydroxide or hydrochloric acid may be added to adjust pH to 5.0-7.0. For more information contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX).
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL – 50 mg/mL NDC 72078-060-99 Ferric Carboxymaltose Injection 100 mg/2 mL (50 mg/mL) For Intravenous Use Only Discard Unused Portion Rx only 2 mL Single-Dose Vial Each mL contains 50 mg iron (as ferric carboxymaltose) in water for injection. Also contains hydrochloric acid and/or sodium hydroxide to adjust pH, if necessary. 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 USP Controlled Room Temperature]. Sterile, nonpyrogenic. Recommended Dosage: See Prescribing Information. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Made in India Code No.: TN/DRUGS/TN00003234 Mylan.com Ferric Carboxymaltose Injection 100 mg/2 mL Carton Label" ], "set_id": "8e8e95f4-8d3a-4658-9f6c-09edf2210341", "id": "37214620-8bd3-4a01-a07c-bedf5cd6ae0a", "effective_time": "20260815", "version": "3", "openfda": { "application_number": [ "ANDA217769" ], "brand_name": [ "Ferric Carboxymaltose" ], "generic_name": [ "FERRIC CARBOXYMALTOSE" ], "manufacturer_name": [ "Mylan Institutional LLC" ], "product_ndc": [ "72078-060" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "FERRIC CARBOXYMALTOSE" ], "rxcui": [ "2602296" ], "spl_id": [ "37214620-8bd3-4a01-a07c-bedf5cd6ae0a" ], "spl_set_id": [ "8e8e95f4-8d3a-4658-9f6c-09edf2210341" ], "package_ndc": [ "72078-060-00", "72078-060-99" ], "is_original_packager": [ true ], "unii": [ "6897GXD6OE" ] } } ] }