Possible side effects nausea feeling dizzy low phosphorus skin flushing. The complex is designed to provide, in a controlled way, utilisable iron for the iron transport and storage proteins in the body transferrin and ferritin, respectively. Injectafer ferric carboxymaltose injection intravenous document number. The active ingredient in injectafer is ferric carboxymaltose, the inactive ingredients are. Study treatment was started in 1110 patients, and 1108 558 in the carboxymaltose group and 550 in the placebo group had at least one postrandomisation value. This complex releases iron which utilizes for iron transport and storage proteins in the body ferritin and transferrin. Ferric carboxymaltose fcm is a parenteral, dextran free iron formulation designed to overcome the limitations of existing intravenous iv iron preparations. You can use an alternative approach if it satisfies the. Intravenous iron is recommended to correct iron deficiency in heart failure hf patients, although not all patients had the same response. Intravenous iron substitution with ferric carboxymaltose was safe and yielded a better. Oral iron iron deficiency anemia in pregnant women after first is the preferred route of administration for mild trimester and postpartum patients.
Each 2 ml vial contains 100 mg of iron as ferric carboxymaltose. Efficacy and safety of intravenous ferric carboxymaltose. Costeffectiveness of ferric carboxymaltose in patients with. Ferric carboxymaltose is usually given when iron taken orally by mouth is not effective. Pdf nutritional iron deficiency anemia is the most common.
The safety and efficacy of high dose ferric carboxymaltose. Ferric carboxymaltose is an iron replacement product. Efficacy of intravenous ferric carboxymaltose in patients with acute. Ferric carboxymaltose is a stable, nondextran iron complex consisting of ferric hydroxide core stabilized by a carbohydrate shell. Each 10 ml vial contains 500 mg of iron as ferric carboxymaltose. In the second study in 304 patients with hf, the confirmhf ferric carboxymaltose evaluation on performance in patients with iron deficiency in combination with chronic heart failure, 10 treatment with fcm for 1 year resulted in a beneficial effect on symptoms, functional capacity by 6minute walking test distance, and qualityoflife parameters.
Among the products, the ferric carboxymaltose segment held the largest market share in 2018 and is projected to dominate the global iv iron drugs market during the forecast period due to its increasing application in drug. Ferric carboxymaltose is an iron complex consisting of a ferric hydroxide core that is stabilized by a carbohydrate shell and allows for controlled delivery of iron to target tissues 51. But, there is limited literature on the use of fcm in pregnancy. Ferric carboxymaltose for iron deficiency at discharge.
Predictors of clinical improvement in heart failure. Study of intravenous ferric carboxy maltose in iron deficiency. Ferasap ferric carboxymaltose assessment of safety and efficacy in pregnancy was the first randomized. Ferric carboxymaltose ferinject, a novel iron complex that consists of a ferric hydroxide core stabilized by a carbohydrate shell, allows for controlled delivery of iron to target tissues. Injectafer is indicated for the treatment of iron deficiency anemia in adult patients. The present invention relates to novel processes for the preparation of iron iii carboxymaltose complex. The criteria also encompass iron maintenance and replenishment. It is freely soluble in water but insoluble in most organic solvents. This study assessed the efficacy of intraoperative highdose intravenous iron therapy in facilitating recovery from postoperative anemia and reducing the transfusion rate in patients with total knee and total hip arthroplasty.
Intravenous iron replacement therapy feraheme, injectafer. Administered intravenously, it is effective in the treatment of irondeficiency anaemia, delivering a replenishment dose of up to mg of iron during a minimum administration time of. Ferric carboxymaltose is a new treatment option that may be better tolerated. Improved process for preparation of ferric carboxymaltose. This prospective randomized controlled study involved 58 subjects. 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. It can cause severeconsequences for both the mother and. 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. Australian public assessment report for ferric carboxymaltose.
Iron sucrose and ferric carboxymaltose are dextran free intravenous iron alternatives. Health, general anemia care and treatment comparative analysis complications and side effects chronic kidney failure ferric carboxymaltose physiological aspects ferritin hemoglobin hemoglobins iron deficiency anemia medical. It can be given in a single high dose in a short time which rapidly refills the iron stores than orally administered comparators. Ferric carboxymaltose is used to treat anemia low red blood cells caused by low iron levels. The role of ferric carboxymaltose in the treatment of iron deficiency. Intravenous ferric carboxymaltose compared with oral iron in. Ferric carboxymaltose as treatment in women with irondeficiency anemia. Each month, subscribers to the formulary monograph service receive 5 to 6 welldocumented monographs on drugs that are newly released or are in late phase 3. Ferric carboxymaltose is a brown, amorphous powder. Costeffectiveness of ferric carboxymaltose in patients. Ferric carboxymaltose is commercially available in market under the brand name ferinject and is administered intravenously in single doses to treat iron deficiency anaemia. Use only those containing sedimentfree, homogeneous solution. Ferric carboxymaltose fcm injection contains iron in ferric state and it forms a complex with carbohydrate polymer.
Us20120214986a1 process for the preparation of iron iii. Request pdf the effect of ferric carboxymaltose versus iron sucrose on hemoglobin levels in pregnant women with anemia. A study on safety and efficacy of ferric carboxymaltose in. Ferric carboxymaltose is an iron complex consisting of a ferric hydroxide core. The iv administration of ferric carboxymaltose results in transient elevations in serum iron, serum ferritin, and transferrin saturation, and, eventually, in. Ferric carboxymaltose 2 qualitative and quantitative composition. Jul 01, 2020 injectafer ferric carboxymaltose injection intravenous document number. Ferric carboxymaltose n 60 iron isomaltoside n 62 ferric carboxymaltose n 57 iron isomaltoside n 125 ferric carboxymaltose n 117 patientdemographics. May 12, 2015 ferric carboxymaltose is a colloidal iron hydroxide carboxymaltose complex. Dec 06, 2018 the incidence of hypophosphatemia was significantly higher in the ferric carboxymaltose versus the ferumoxytol group ferric carboxymaltose treated patients versus none of the ferumoxytol. Injectafer ferric carboxymaltose injection is an iron replacement product 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 in adult patients with nondialysis dependent chronic kidney disease.
Ferinject solution for injectioninfusion is a colloidal solution of the iron complex ferric carboxymaltose. In animal reproduction studies, administration of ferric carboxymaltose to rabbits during the period of organogenesis causedadverse 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. When compared to oral iron in pregnancy iron sucrose. Full text an economic analysis of ferric derisomaltose. Health, general hemoglobin health aspects hemoglobins hemorrhage care and treatment iron deficiency anemia causes of risk factors pregnancy. Intravenous ferric carboxymaltose is a stable complex with the. Intravenous ferric carboxymaltose for anaemia in pregnancy core. We evaluated the impact of ferric carboxymaltose fcm in analytical and clinical improvement and analyzed the response according to different parameters. Ferric carboxymaltose fcm is a stable, nondextrancontaining iron formulation developed for rapid iv administration in high doses with controlled delivery of iron into target tissues. Iron deficiency anemia associated with chronic kidney disease must meet all. Draft guidance on ferric carboxymaltose recommended apr 2016 this draft guidance, when finalized, will represent the current thinking of the food and drug administration fda, or the agency on this topic. Compared with the no ferric carboxymaltose group, patients in the ferric carboxymaltose group experienced. Ferric carboxymaltose is a colloidal iron iii hydroxide in complex with carboxymaltose, a carbohydrate polymer that release iron. Pharmacokinetics of ferric bepectatea new intravenous iron.
Injectafer iron carboxymaltose injection nda 22054. Ferinject ferric carboxymaltose patient information. Pdf the objective of the present study is to compare the safety and efficacy of ferric. Auspar ferinject ferric carboxymaltose vifor pharma pty ltd pm20170084614 ceu6 final 1 october 2019 page 9 of 58 description date and request for advisory committee advice sponsors preadvisory committee response. Treatmentrelated adverse events were significantly fewer with ferric carboxymaltose than with oral iron 2. Nov 04, 2009 ferric carboxymaltose complex, also known as iron iii carboxymaltose, is indicated for the treatment of iron deficiency anaemia, and which is marketed by vifor under the brand name ferinject. Experience with intravenous ferric carboxymaltose in patients with. This formulation isolates the iron from the plasma until the complex is phagocytized by reticuloendothelial system macrophages in the liver, spleen and bone marrow. Find information on ferric carboxymaltose injectafer in daviss drug guide including dosage, side effects, interactions, nursing implications, mechanism of action, half life, administration, and more. Original article by renal society of australasia journal. Effect of ferric carboxymaltose on exercise capacity in.
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 nondialysis dependent chronic kidney disease. A comparative study of injection ferric carboxymaltose and iron. To evaluate safety and efficacy of intravenous ferric carboxymaltose fcm versus standard medical care smc for irondeficiency anemia ida in. Anemia during pregnancy is most commonlycaused by iron deficiency anemia. There are no data on the effect of ferric carboxymaltose on human fertility. It was a prospective observational study from june 2011 to. Ferric carboxymaltose an overview sciencedirect topics. Pediatric pharmacotherapy university of virginia school. Ferric carboxymaltose in patients with heart failure and iron.
Pdf intravenous ferric carboxymaltose for the treatment of iron. Ferric carboxymaltose is a colloidal iron hydroxide carboxymaltose complex. Jci insight randomized trial of intravenous ironinduced. The iron is then released into an intracellular storage iron pool or. Ferric carboxymaltose as treatment in women with iron. Fda approved indications injectafer is indicated for treatment of iron deficiency anemia ida in adult patients who have. Oct 30, 2020 ferinject ferric carboxymaltose patient information leaflet pil by vifor pharma uk limited.
Flow of patients through the study of ferric carboxymaltose for postcolectomy anemia. Group f received mg intravenous ferric carboxymaltose and group c received normal saline. Our results validate several randomized, of single dose intravenous ferric carboxymaltose in the management of renal anemia a single center indian journal of obstetrics and gynecology research, apriljune 2015. Diagnostic hemoglobin for anemia in men changed from. Ferinject ferric carboxymaltose 50 mgml solution for injection. Two are currently approved for use in europe ferric carboxymaltose and. There were no effects of ferric carboxymaltose on the fertility or reproductive performance of rats given thrice weekly iv doses of up to 30 mgkg roughly equal to the maximum weekly clinical dose, based on body surface area bsa.
The ferric carboxymaltose pharmaceutical composition contains 1030 parts by weight of ferric carboxymaltose, 115 parts by weight of meglumine, one or more of pharmaceutically acceptable ph regulators, and water for injection. Based on products, the market is segmented into iron dextran, iron sucrose, ferric carboxymaltose, and other products. Rbc uptake of iron released from ferric carboxymaltose ranges between 6199%. Between march 21, 2017, and july 30, 2019, 1525 patients were screened, of whom 12 patients were randomly assigned to study groups. Jul 01, 2019 injectafer ferric carboxymaltose injection document number. It is the policy of health plans affiliated with centene corporation that injectafer is. The preparation method for the composition includes the. This larger study, prefer, evaluated the efficacy and tolerability of a single infusion of ferric carboxymaltose fcm in improving fatigue symptoms, qualityoflife qol, and cognitive function in irondeficient, premenopausal women without active or chronic medical conditions to exclude the mainly inflammationrelated chronic fatigue syndrome. Erythropoiesis may be limited by absolute or functional iron deficiency or when chronic inflammatory conditions lead to iron sequestration. Evaluation of a single dose of ferric carboxymaltose in. P ferric carboxymaltose can be rapidly administered, is more effective and is better tolerated than oral iron for treatment of iron deficiency in ndckd patients. Each of the side effects above was reported in 2% or greater of patients.
Ferric carboxymaltose us patents expiry expiration. Product under development ferric carboxymaltose interquim. Each 20 ml vial contains mg of iron as ferric carboxymaltose. Qunibi wy, martinez c, smith m, benjamin j, mangione a, et al. Ferric carboxymaltose anemia heart failure free 30. 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. Comparison of ferric carboxymaltose and iron polymaltose efficacy in renal anaemia. Ferric carboxymaltose for iron deficiency at discharge after. Intravenous iron drugs market size iv iron drugs industry. Efficacy and safety of intravenous ferric carboxymaltose compared. C indications treatment of iron deficiency anemia in adults who cannot toleratehave an unsatisfactory response to oral iron or who have chronic kidney disease nondialysis dependent. Product information ferric carboxymaltose therapeutic. The safety and efficacy of high dose ferric carboxymaltose in. Length of authorization coverage will be provided for 35 days.
Intravenous ferric carboxymaltose was administered at a dose determined by the. Ferric carboxymaltose injectafer daviss drug guide. Ferric carboxymaltose as treatment in women with irondeficiency. Beneficial effects of longterm intravenous iron therapy. Injectafer definition of injectafer by medical dictionary. Ferric carboxymaltose and ferumoxytol are 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 who have chronic kidney disease ckd. Intravenous iron replacement therapy feraheme injectafer. Fcm can be administered in a single, rapid session 15 min infusion at large doses 15 mgkg. Use only those containing sediment free, homogeneous solution. Pdf evaluation of a single dose of ferric carboxymaltose. A lot of studies have been published on the use of fcm for treatment of anemia in the postpartum period and other diseases with associated anemia.
Ferinject ferric carboxymaltose summary of product. Iron deficiency anemia ida is the most common form of nutritional anemia. Ferric carboxymaltose anemia heart failure free 30day. Apr 02, 2021 intravenous iv ferric carboxymaltose fcm is an innovative iv iron formulation and stable iron complex that consists of a ferric hydroxide core stabilized by a nondextran carbohydrate shell. Ferric carboxymaltose for interquim sa product under development pdf document on. You should not receive injectafer if you are allergic to ferric carboxymaltose or any of the other ingredients in injectafer. It contains 24 32% mm of iron, 2550% mm of dextrin, some sodium chloride ferric carboxymaltose as a complex of polynuclear ironiii hydroxide. Injectafer ferric carboxymaltose dosing, indications. Jcm free fulltext the effect of intraoperative ferric. The effect of ferric carboxymaltose versus iron sucrose on. Pharmacokinetics of ferric bepectatea new intravenous. Ferrlecit sodium ferric gluconate complex infed iron dextran venofer iron sucrose feraheme ferumoxytol, injectafer ferric carboxymaltose, and monoferric ferric.
Ferric carboxymaltose fcm is a novel dextran free intravenous iron which. Efficacy and safety of intravenous ferric carboxymaltose in. Iron helps your body produce red blood cells that carry oxygen through your blood to tissues and organs. Patents listed in the fda orange book drug database of ferric carboxymaltose with information and expiryexpiration dates. We investigated the safety and efficacy of high dose administration of fcm in our anemic chronic kidney disease ckd patients.
Intolerance to oral iron or have had unsatisfactory response to oral iron. Costeffectiveness of ferric carboxymaltose in patients with iron deficiency and chronic heart failure in austria. Ferric carboxymaltose injectafer injection is an iron replacement product. Ultimately this always remains a clinical decision based on local guidelines, although national guidelines are increasingly stipulating iv iron in certain. Ferric carboxymaltose free download as powerpoint presentation.
75 1228 559 1250 1608 1275 129 716 1218 660 288 1335 871 986 948 89 27 450 855 1728 343 371 632 696