Serious side effects, including anaphylactic reactions, may be seen with use of iron dextran. Ferric carboxymaltose is the drug of choice in IV iron therapy, but other IV iron agents can be used. Ferric carboxymaltose is a macromolecular ferric hydroxide carbohydrate complex, which allows for controlled delivery of iron within the cells of the reticuloendothelial system and subsequent delivery to the iron-binding proteins ferritin and transferrin, with minimal risk of release of large amounts of ionic iron in the serum. There are risks to mother and fetus associated with untreated IDA in pregnancy; The ferric carboxymaltose pharmaceutical composition contains 10-30 parts by weight of ferric carboxymaltose, 1-15 parts by weight of meglumine, one or more of pharmaceutically acceptable pH regulators, and water for injection. Iron is vital for the formation of new red blood cells and hemoglobin, a substance that gives these cells the ability to transport oxygen. Ferric Carboxymaltose is an anti-anemic medication. Intravenous ferric carboxymaltose is indicated for iron deficiency when oral preparations are ineffective or not tolerated. Ferric carboxymaltose is an iron (III)-hydroxide carbohydrate complex designed to mimic physiologic ferritin. Administration of ferric carboxymaltose to rabbits during organogenesis caused adverse developmental outcomes including malformations and increased implantation loss at maternally toxic doses of ~12-23% of the human weekly dose of 750 mg (based on body surface area) Clinical considerations. prescriptions for treatment with ferric carboxymaltose injections. Injectafer ® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease. Soluble iron salts have a significant risk of adverse … Brands: Injectafer. Each 20 mL vial contains 1,000 mg of iron as ferric carboxymaltose. Ferric carboxymaltose is an iron replacement product. The present invention relates to novel processes for the preparation of iron (III) carboxymaltose complex. It is freely soluble in water but insoluble in most organic solvents. Injectafer is a prescription iron replacement medicine administered only by or under the supervision of your healthcare provider. The novel design of ferric carboxymaltose offers better advantages compared to other intravenous iron therapies. Exclusion criteria should include at least: 1) pregnant or Ferric carboxymaltose (FCM) is a new intravenous iron form which is approved for patients of iron deficiency having inadequate response to oral iron therapy, intolerance to oral iron, or non-dialysis dependent chronic kidney disease. Breastfed neonates of these mothers appear to have no serious adverse reactions. Injectafer is available in 15 mL single-use vials. There is some evidence that shows polysaccharide iron complexes can be well tolerated in patients with HF and are effective in … Oral iron supplements are usually intolerable because of gastrointestinal side effects. Summary. Evidence from the trials suggests that ferric carboxymaltose is an effective alternative for treating iron deficiency when oral iron is not an option. However, it is not clear if it will have advantages over other parenteral iron formulations such as iron sucrose. Chemical Name: Iron Dextri-Maltose. Each 10 mL vial contains 500 mg of iron as ferric carboxymaltose. Most patients with chronic kidney disease will require supplemental iron (e.g., iron dextran; iron salts; iron sucrose, sucroferric oxyhydroxide; polysaccharide-iron complex; sodium ferric gluconate complex) during epoetin alfa receipt. Evaluate transferrin saturation and serum ferritin before and during epoetin alfa treatment. Find here listing of ferric carboxymaltose manufacturers, ferric carboxymaltose suppliers, dealers & exporters offering ferric carboxymaltose at best price. Each 10 mL vial contains 500 mg of iron as ferric carboxymaltose. Administration of iron does not stimulate the production of red blood cells, nor does it correct abnormalities not caused by iron deficiency. Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron necessary to the function of hemoglobin, myoglobin, and specific enzyme systems; allows transport of oxygen via hemoglobin. Ferric carboxymaltose is a form of injectable iron that is used if you cannot take iron by mouth because of side effects or an unsuccessful response to treatment. FCM injection should be administered under the supervision of trained staff who can evaluate and manage the anaphylactic reaction. Medically reviewed by Drugs.com on April 5, 2021. Ferric carboxymaltose benefit. Thus, for example, a mixture of one or more maltodextrins, ferric hydroxide and water is heated, the resulting iron maltodextrin complex is oxidized using an aqueous sodium hypochlorite solution, followed by maintaining at 25° C. to 125° C. to produce iron (III) carboxymaltose complex. Each 2 mL vial contains 100 mg of iron as ferric carboxymaltose. Overall, this review found that ferric carboxymaltose significantly increased hemoglobin level, serum ferritin concentrations, and transferrin saturation in patients with perioperative anemia who were undergoing elective surgery. Each 20 mL vial contains 1000 mg of iron as ferric carboxymaltose. Inclusion criteria should include at least: 1) body weight of 50 kg or above; 2) Hgb<12g/dL; 2) ferritin ≤ 100ng/mL or ≤300ng/mL when TSAT is ≤30%. Get wide range of ferric carboxymaltose offered by listed companies in India. In patients with iron deficiency, a left ventricular ejection fraction of less than 50%, and who were stabilised after an episode of acute heart failure, treatment with ferric carboxymaltose was safe and reduced the risk of heart failure hospitalisations, with no apparent effect on the risk of cardiovascular death. The molecule consists of an iron-hydroxide core chelated in a carbohydrate shell. Ferric carboxymaltose (Ferinject ) is indicated for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used and there is a clinical need to deliver iron rapidly. In many cases, use of intravenous iron such as ferric carboxymaltose has lower risks of adverse events than a blood transfusion and as long as the person is stable is a better alternative. It contains 24 -32% m/m of iron, 25-50% m/m of ‘dextrin’, some sodium chloride (<6% m/m), and not more than 10% m/m water. A total of 610 iron sucrose infusions were evaluated for safety, with 10 adverse events reported. A European review of worldwide data concluded that ferric carboxymaltose is associated with hypophosphataemia, resulting in hypophosphataemic osteomalacia and fractures, particularly in patients with existing risk factors and following prolonged exposure to high doses—some cases required clinical intervention, including surgery. Ferric carboxymaltose is a iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or those who have non-dialysis dependent chronic kidney disease. Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. Ask your doctor or healthcare provider if Injectafer is right for you. Ferric carboxymaltose is a novel iron complex that consists of a ferric hydroxide core stabilized by a carbohydrate shell. The sponsor describes ferric carboxymaltose as “a complex of polynuclear iron(III) -hydroxide Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. The study was designed to assess the safety and efficacy of iron deficiency anaemia (IDA) correction with intravenous ferric carboxymaltose in pregnant women with mild, moderate and severe anaemia in the second and third trimester. Prospective observational study; 65 anaemic pregnant women received … It is pH neutral (5 to 7) and has physiologic osmolarity. It helps your body make enough red blood cells to carry out oxygen throughout your body. It is usually given as a total of 2 doses, spaced at least 7 days apart. In order to prepare the iron (III) carboxymaltose complex of the invention, the mixture of maltodextrins and ferric hydroxide in an aqueous solution is oxidized with a sodium hypochlorite solution. Preferably, a freshly prepared ferric hydroxide is used. Aims Iron deficiency is common in patients with heart failure (HF). Ferric Carboxymaltose is used for the treatment of patients who have an iron deficiency in their blood. The diagnosis must be based on laboratory tests. Molecular Formula: Fe IIIw ( [C 6 H 10 O 5] a C 6 H 11 O 7) x (OH) y O z • n H 2 O. CAS Number: 9007-72-1. Iron helps your body produce red blood cells that carry oxygen through your blood to tissues and organs. More convenient and optimized dosing. Injectafer® (ferric carboxymaltose injection) is available by prescription only. The study investigators concluded that it was becoming more common to use IV ferric carboxymaltose at their center and that this treatment was both efficacious and tolerable in treating iron-deficiency anemia. FERINJECT (ferric carboxymaltose) 50 mg/mL solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 mL vial contains 100 mg of iron as ferric carboxymaltose. Ferric carboxymaltose is a new treatment option that may be better tolerated. A therapeutic response to … Normal erythropoiesis is dependent on the concentration of iron and erythropoietin available in the plasma. Ferric carboxymaltose is … Compared to iron sucrose (Venofer) that can be infused at a maximum rate of 100 mg per 15 minutes, Ferric carboxymaltose (Injectafer) allows a dose of up to 1000 mg per15 – 20 minutes. Qualitative and quantitative composition. Ferric carboxymaltose (Ferinject) is PBS listed for the treatment of iron-deficiency anaemia, where oral iron preparations are not tolerated, ineffective or otherwise inappropriate. Ferric carboxymaltose does not contain dextran or modified dextran and does not react with dextran antibodies. Hypophosphatemia after FCM treatment is caused by transiently rising plasma levels of the phosphaturic hormone intact FGF23 (iFGF23), which … One mL of solution contains 50 mg of iron as ferric carboxymaltose. Excipient (s) with known effect. Accelerate your drug discovery r… Among 164 evaluable infusions of ferric carboxymaltose, 7 adverse events were reported. 1. Ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) are widely used, but FCM treatment has been reported to be associated with hypophosphatemia 2 to 5 weeks after administration, usually resolving spontaneously after 6 to 12 weeks . Ferric Carboxymaltose. Dosage and administration. 1, 2. Ferric carboxymaltose (Injectafer) is a novel iron formulation that allows higher doses of the drug to be infused at relatively less time. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. Ferric carboxymaltose is a non-dextran, intravenous iron replacement product initially developed by Vifor (International), a subsidiary of the Galenica Group. Injectafer ® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease. Ferric carboxymaltose appears to be acceptable to use in nursing mothers with no special precautions required. Ferric carboxymaltose is used in adults to treat iron deficiency anemia (a lack of red blood cells caused by having too little iron in the body). Ferric carboxymaltose (FCM) is recommended by heart failure guidelines to alleviate heart failure symptoms, to improve exercise capacity and quality of life. 12 Recently, the AFFIRM-AHF (Study to Compare Ferric Carboxymaltose With Placebo in Patients with Acute Heart Failure and Iron Deficiency) has also demonstrated the beneficial impact of FCM on the recurrence of heart failure admissions in … Each 2 mL vial contains 100 mg of iron as ferric carboxymaltose. It replenishes the iron stores in your body. The preparation method for the composition includes the following steps: a, adding ferric carboxymaltose and meglumine into water for injection, and dissolving; b, … Introduction. Intravenous iron carboxymaltose increases breastmilk iron in mothers with iron deficiency anemia. It is also used to treat people who are anemic due to kidney disease. What is Injectafer? 2. Perioperative anemia is a common comorbid condition associated with increased risk of morbidity and mortality in patients undergoing elective surgical … Each mL contains 50 mg iron as ferric carboxymaltose in water for injection. May be prescribed by nurse practitioners within collaborative arrangements Rapid and selective delivery of iron to the reticuloendothelial system of the liver and bone marrow. Ferric carboxymaltose injection comes as a solution (liquid) to inject intravenously (into a vein) by a doctor or nurse in a medical office or hospital outpatient clinic. Class: Iron Preparations. ferric carboxymaltose (fer-ik car-box-ee-mal-tose) , Injectafer (trade name) Classification Therapeutic: antianemics Pharmacologic: iron supplements Pregnancy Category: C Indications Treatment of iron deficiency anemia in adults who cannot tolerate/have an unsatisfactory response to oral iron or who have chronic kidney disease (non-dialysis dependent) Action A colloidal iron complex that releases iron into … Ferric carboxymaltose is a brown, amorphous powder. Ferric carboxymaltose is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via haemoglobin. [17,18] The design of the macromolecular ferric hydroxide carbohydrate complex allows for controlled delivery of iron within the cells of the reticuloendothelial system and subsequent delivery to the iron-binding proteins ferritin and transferrin, with minimal risk … More iron with less administration. What is ferric carboxymaltose? You normally get iron from the foods you eat. Ultimately this always remains a clinical decision based on local guidelines, although National Guidelines are increasingly stipulating IV iron in certain groups of patients. Each 10 mL vial contains 500 mg of iron as ferric carboxymaltose. Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection.
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