Ferric carboxymaltose is a parenteral iron replacement product indicated for the treatment of iron-deficiency anemia in adults and pediatric patients 1 year and older who have had intolerance to oral iron or unsatisfactory response to oral iron and adults who have non-dialysis dependent chronic kidney disease. It is also indicated for iron deficiency in adult patients with New York Heart Association (NYHA) class II and III heart failure to improve exercise capacity. Due to reports of anaphylactic-type reactions, some life-threatening and fatal, monitor patients for signs and symptoms of hypersensitivity during and for at least 30 minutes after administration and until clinically stable after completion of the infusion.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
-Administer as an undiluted slow IV push or by intermittent IV infusion.
-Each vial is for single use only. Discard any unused portion; contains no preservatives.
-Avoid extravasation since brown discoloration of the extravasation site may be long-lasting. If extravasation occurs, discontinue administration at that site.
Intravenous Administration
Slow IV Push
-No dilution necessary.
-Doses up to 750 mg: Administer at a rate of approximately 100 mg/minute (2 mL/minute).
-1,000 mg doses: Administer over 15 minutes.
Intermittent IV Infusion
-Dilute in 0.9% NaCl Injection to a concentration of 2 to 4 mg/mL and infuse over at least 15 minutes. Do not dilute to concentrations less than 2 mg/mL in order to maintain stability.
-Storage: The solution is physically and chemically stable at room temperature for 72 hours when added to an infusion bag containing 0.9% NaCl Injection at concentrations ranging from 2 to 4 mg/mL.
Anaphylactoid reactions, some of which have been life-threatening and fatal, have been reported in patients receiving ferric carboxymaltose. In adult clinical trials, serious anaphylactic/anaphylactoid reactions were reported at an incidence of 0.1% (2/1775). Fetal adverse reactions, including fetal bradycardia, have been associated with maternal hypersensitivity reactions, especially during the second and third trimester of pregnancy. Monitor patients for signs and symptoms of hypersensitivity during and after administration. Continue monitoring for at least 30 minutes and until clinically stable after completion of the infusion. Patients may present with anaphylactic shock, clinically significant hypotension, loss of consciousness, and/or collapse. Ferric carboxymaltose should only be administered when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other potential hypersensitivity reactions, including pruritus, rash (1%), urticaria, wheezing, or hypotension (1%), were reported in 1.5% (26/1,775) of these subjects. Erythema, which included erythema and injection site erythema, was reported in 3% of patients (n = 1,775) who received ferric carboxymaltose as a 2-dose regimen (15 mg/kg/dose [Max: 750 mg/dose]) compared to 0.3% of patients (n = 1,200) who received a single-dose regimen of 15 mg/kg (Max: 1,000 mg/dose) in adult clinical trials. In patients receiving the single-dose regimen, rash and hypotension were reported in 1.2% and less than 0.1% of patients, respectively. In pediatric clinical trials (n = 40), rash, which included rash, exanthema, and urticaria, was reported in 8% of patients who received ferric carboxymaltose.
Gastrointestinal-related adverse reactions reported during adult clinical trials (n = 1,775) in patients who received ferric carboxymaltose as a 2-dose regimen (15 mg/kg/dose [Max: 750 mg/dose]) compared to a pooled comparison of oral iron and other IV formulations of iron include: nausea (7.2% vs. 2%), vomiting (2% vs. 1%), dysgeusia (1.2% vs. 2.1%), and constipation (0.5% vs. 0.9%). In patients receiving the single-dose regimen of ferric carboxymaltose (15 mg/kg/dose [Max: 1,000 mg/dose]) in clinical trials (n = 1,200), nausea and dysgeusia were reported in 1% of patients and vomiting was reported in 0.2% of patients. Abdominal pain and diarrhea were reported in 0.5% or more of patients receiving ferric carboxymaltose in adult clinical trials. In pediatric clinical trials (n = 40), vomiting (5%) and gastrointestinal infections (3%) were reported in patients who received ferric carboxymaltose.
Headache (1.3% vs. 1.2%), dizziness (2.1% vs. 1.3%), and flushing (4% vs. 0.2%) were reported more frequently in patients receiving ferric carboxymaltose (2-dose regimen of 15 mg/kg/dose [Max: 750 mg/dose]) compared with pooled comparators including oral iron and other formulations of IV iron in adult clinical trials (n = 1,775). In patients receiving the ferric carboxymaltose single-dose regimen (15 mg/kg [Max: 1,000 mg/dose] in adult clinical trials (n = 1,200), headache and dizziness were reported in 1% of patients and flushing was reported in 0.3% of patients. Paresthesias were reported in 0.5% or more of patients receiving ferric carboxymaltose in adult clinical trials. In pediatric clinical trials (n = 40), headache (5%) and flushing (3%) were reported in patients who received ferric carboxymaltose.
Monitor patients for signs and symptoms of hypertension after each injection of ferric carboxymaltose. In adult clinical trials, hypertension was reported in 4% of patients (n = 1,775) who received ferric carboxymaltose as a 2-dose regimen (15 mg/kg/dose [Max: 750 mg/dose]) compared to 1% of patients (n = 1,200) who received a single-dose regimen of 15 mg/kg (Max: 1,000 mg/dose). Transient elevations in systolic blood pressure, sometimes accompanied by facial flushing, dizziness, or nausea were observed in 6% (106/1,775) of subjects in clinical trials. In general, these elevations occurred immediately after dosing and resolved within 30 minutes. Sinus tachycardia and chest pain (unspecified) have been reported with postmarketing use of ferric carboxymaltose.
Hypophosphatemia was reported at an incidence of 1% to 2.1% in ferric carboxymaltose-treated patients in adult clinical trials. Transient decreases in laboratory blood phosphorus concentrations (less than 2 mg/dL) were observed in 27% (440/1,638) of patients in adult clinical trials. In pediatric clinical trials (n = 40), hypophosphatemia was reported in 13% of patients who received ferric carboxymaltose. In postmarketing surveillance, symptomatic hypophosphatemia with serious outcomes, including osteomalacia and bone fractures requiring clinical intervention, has been reported in patients treated with ferric carboxymaltose. These cases have occurred mostly after repeated exposure to ferric carboxymaltose in patients with no reported history of renal impairment; however, symptomatic hypophosphatemia has been reported after 1 dose. Possible 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, and malnutrition. In most cases, hypophosphatemia resolved within 3 months. Correct pre-existing hypophosphatemia prior to initiating therapy with ferric carboxymaltose. Monitor serum phosphate concentrations in patients at risk for chronic low serum phosphate. Check serum phosphate concentrations prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a second course of therapy within 3 months. Treat hypophosphatemia as medically indicated.
Injection site reaction, including pain, irritation, swelling, erythema, and rash, was reported in 3% of patients (n = 1,775) who received ferric carboxymaltose as a 2-dose regimen (15 mg/kg/dose [Max: 750 mg/dose]) compared to 4% of patients (n = 1,200) who received a single-dose regimen of 15 mg/kg (Max: 1,000 mg/dose) in adult clinical trials. In pediatric clinical trials (n = 40), injection site reactions, including infusion site hematoma, infusion site hypoesthesia, and injection site pain were reported in 8% of patients who received ferric carboxymaltose. Skin discoloration reported as brown staining near the injection site may occur with extravasation of ferric carboxymaltose. In adult clinical trials, injection site skin discoloration and extravasation were reported in 1.4% and 0.2% of patients, respectively, who received the 2-dose regimen of ferric carboxymaltose compared with 1% and 2% of patients, respectively, who received the single-dose regimen. Avoid extravasation as brown staining may be long-lasting. If extravasation occurs, discontinue administration at that site.
Elevated hepatic enzymes, including increased ALT and AST, were reported in 1.2% of ferric carboxymaltose-treated patients in adult clinical trials. Increased GGT was reported in 0.5% or more of patients. In pediatric clinical trials (n = 40), elevated liver function tests were reported in 3% of patients who received ferric carboxymaltose. Other laboratory abnormalities reported in pediatric clinical trials include decreased platelet count (3%) and decreased white blood cell count (3%).
Dyspnea, fever, chills, back pain, arthralgia, and syncope have been reported with postmarketing use of ferric carboxymaltose.
Sneezing was reported in 0.5% or more of ferric carboxymaltose-treated patients in adult clinical trials. In pediatric clinical trials (n = 40), naso-pharyngitis was reported in 3% of patients who received ferric carboxymaltose.
Do not administer ferric carboxymaltose to patients with evidence of iron overload (e.g., patients with hemochromatosis). Unnecessary or prolonged administration of iron may lead to iron overload and consequently the possibility of exogenous hemosiderosis. Patients with hemoglobinopathy and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias are at particular risk for such iron overload. The type of anemia and the underlying cause or causes should be determined before starting therapy with parenteral ferric carboxymaltose. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause(s) should be corrected, if possible. Patients receiving exogenous iron therapy require periodic monitoring of hematologic and hematinic parameters (i.e., hemoglobin, hematocrit, serum ferritin, and transferrin saturation) to avoid iron overload.
Fetal adverse reactions, including fetal bradycardia, have been associated with maternal hypersensitivity reactions, especially during the second and third trimester of pregnancy. Advise pregnant women of the potential risk to a fetus. Studies of ferric carboxymaltose use in pregnant women have not reported an association with ferric carboxymaltose and major birth defects and miscarriage; however, these studies cannot establish or exclude the absence or any drug-related risk during pregnancy. In animal studies, administration of ferric carboxymaltose during organogenesis caused adverse developmental outcomes, including 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 available published data on the use of ferric carboxymaltose in lactating women demonstrate that iron is present in breast milk. While iron is excreted into breast milk, the iron content of breast milk is not readily affected by the iron content of the maternal diet or the maternal serum iron concentration. 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 breast milk. There are no data available on the effects of ferric carboxymaltose on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for ferric carboxymaltose and any potential adverse effects on the breast-fed infant from ferric carboxymaltose or the underlying maternal condition.
Symptomatic hypophosphatemia with serious outcomes, including osteomalacia and bone fractures requiring clinical intervention, has been reported in patients treated with ferric carboxymaltose. Correct pre-existing hypophosphatemia prior to initiating therapy with ferric carboxymaltose. Monitor serum phosphate concentrations in patients at risk for chronic low serum phosphate. Check serum phosphate concentrations prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a second course of therapy within 3 months. Treat hypophosphatemia as medically indicated. These cases have occurred mostly after repeated exposure to ferric carboxymaltose in patients with no reported history of renal impairment; however, symptomatic hypophosphatemia has been reported after 1 dose. Possible 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, and malnutrition. In most cases, hypophosphatemia resolved within 3 months.
For the treatment of iron-deficiency anemia:
NOTE: The dose of ferric carboxymaltose is expressed in mg of elemental iron. Each mL contains 50 mg of elemental iron.
-for the treatment of iron-deficiency anemia in patients who have an intolerance or unsatisfactory response to oral iron:
Intravenous dosage:
Adults weighing 50 kg or more: 750 mg IV every 7 days or more for 2 doses for a cumulative dose of 1,500 mg or 15 mg/kg/dose (Max: 1,000 mg/dose) IV as a single dose. Treatment may be repeated if iron deficiency recurs.
Adults weighing less than 50 kg: 15 mg/kg/dose IV every 7 days or more for 2 doses. Treatment may be repeated if iron deficiency recurs.
Children and Adolescents: 15 mg/kg/dose (Max: 750 mg/dose) IV every 7 days or more for 2 doses. Treatment may be repeated if iron deficiency recurs.
-for the treatment of iron-deficiency anemia in patients who have non-hemodialysis-dependent chronic kidney disease:
Intravenous dosage:
Adults weighing 50 kg or more: 750 mg IV every 7 days or more for 2 doses for a cumulative dose of 1,500 mg or 15 mg/kg/dose (Max: 1,000 mg/dose) IV as a single dose. Treatment may be repeated if iron deficiency recurs.
Adults weighing less than 50 kg: 15 mg/kg/dose IV every 7 days or more for 2 doses. Treatment may be repeated if iron deficiency recurs.
-for the treatment of iron deficiency in patients with New York Heart Association class II and III heart failure to improve exercise capacity:
NOTE: Guidelines suggest intravenous iron replacement is reasonable in patients with reduced ejection fraction heart failure (HFrEF) and iron deficiency with or without anemia to improve functional status and quality of life.
NOTE: There are no data available to guide dosing beyond 36 weeks or with hemoglobin (Hb) 15 g/dL or more.
Intravenous dosage:
Adults weighing less than 70 kg with Hb less than 10 g/dL: 1,000 mg IV on day 1, followed by 500 mg IV at week 6. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.
Adults weighing less than 70 kg with Hb 10 to 14 g/dL: 1,000 mg IV on day 1. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.
Adults weighing less than 70 kg with Hb more than 14 g/dL to less than 15 g/dL: 500 mg IV on day 1. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.
Adults weighing 70 kg or more with Hb less than 10 g/dL: 1,000 mg IV on day 1, followed by 1,000 mg IV at week 6. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.
Adults weighing 70 kg or more with Hb 10 to 14 g/dL: 1,000 mg IV on day 1, followed by 500 mg IV at week 6. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.
Adults weighing 70 kg or more with Hb more than 14 g/dL to less than 15 g/dL: 500 mg IV on day 1. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.
Therapeutic Drug Monitoring:
Laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in ferric carboxymaltose if measured in the 24 hours after administration of ferric carboxymaltose.
Maximum Dosage Limits:
-Adults
weighing 50 kg or more: 15 mg/kg/dose IV (Max: 1,000 mg/dose) when given as a single-dose or 750 mg IV when given as a 2-dose course (Max: 1,500 mg total cumulative dose) for iron-deficiency anemia; 1,000 mg IV for iron deficiency in heart failure.
weighing less than 50 kg: 15 mg/kg/dose IV for 2 doses (Max: 30 mg/kg total cumulative dose) for iron-deficiency anemia; 1,000 mg IV for iron deficiency in heart failure.
-Geriatric
weighing 50 kg or more: 15 mg/kg/dose IV (Max: 1,000 mg/dose) when given as a single-dose or 750 mg IV when given as a 2-dose course (Max: 1,500 mg total cumulative dose) for iron-deficiency anemia; 1,000 mg IV for iron deficiency in heart failure.
weighing less than 50 kg: 15 mg/kg/dose IV for 2 doses (Max: 30 mg/kg total cumulative dose) for iron-deficiency anemia; 1,000 mg IV for iron deficiency in heart failure.
-Adolescents
15 mg/kg/dose IV (Max: 750 mg/dose) for 2 doses (Max: 30 mg/kg total cumulative dose).
-Children
15 mg/kg/dose IV (Max: 750 mg/dose) for 2 doses (Max: 30 mg/kg total cumulative dose).
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Dimercaprol: (Major) Avoid concomitant use of dimercaprol and products containing iron. Dimercaprol forms toxic-chelates with iron which increases the risk for nephrotoxicity and other adverse effects.
Ferric Maltol: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Iron Salts: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Iron Salts: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Iron: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Sodium Ferric Gluconate Complex; ferric pyrophosphate citrate: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. Normal erythropoiesis is dependent on the concentration of iron and erythropoietin available in the plasma. Administration of iron does not stimulate the production of red blood cells, nor does it correct abnormalities not caused by iron deficiency. A therapeutic response to treatment with iron products is dependent on the patient's ability to absorb and use the iron, and it is influenced by the cause of the deficiency as well as other illnesses that can affect normal erythropoiesis.
Iron-containing proteins and enzymes are important in oxidation-reduction reactions, especially those of the mitochondria. Iron is a component of myoglobin and several heme-enzymes, including the cytochromes, catalase, and peroxidase. Iron is an essential component of the metalloflavoprotein enzymes and the mitochondrial enzyme alpha-glycerophosphate oxidase. Iron-containing proteins and enzymes are important in oxidation-reduction reactions, especially those of the mitochondria. Furthermore, iron is a cofactor for enzymes such as aconitase and tryptophan pyrrolase. Iron deficiency not only causes anemia and decreased oxygen delivery, it also reduces the metabolism of muscle and decreases mitochondrial activity. Iron deficiency can also lead to defects in learning or thermoregulation. Thus iron is important to several metabolic functions which are independent of its importance to erythropoiesis.
Ferric carboxymaltose is administered intravenously. After administration of a single dose of ferric carboxymaltose 100 to 1,000 mg IV in iron deficient adult patients, the iron was rapidly cleared from the plasma with a terminal half-life of 7 to 12 hours. Renal elimination of iron was negligible.
-Route-Specific Pharmacokinetics
Intravenous Route
After administration of a single dose of ferric carboxymaltose 100 to 1,000 mg IV in iron deficient adult patients, the maximum iron concentrations of 37 to 333 mcg/mL were obtained after 15 minutes to 1.21 hours, respectively, post dose. The estimated volume of distribution was 3 L.
-Special Populations
Pediatrics
After administration of a single dose of ferric carboxymaltose 15 mg/kg IV in pediatric patients 1 to 17 years of age, the maximum concentrations ranged between 124 and 418.1 mcg/mL and the median time to maximum concentration was 7 minutes. The elimination half-life was approximately 9.7 hours. The total median 72-hour exposure (AUC0 to 72h) after a single 15 mg/kg IV dose was 4,529.7 mcg x hour/mL compared with a median exposure of 5,875.3 mcg x hour/mL after a single dose of 1,000 mg IV in adults.