Following intravenous iv administration of ferric carboxymaltose at. Evidence suggest that fcm is highly effective in correcting. Ferric carboxymaltose in patients with heart failure and. In rabbits, ferric carboxymaltose was administered as a. 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. 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. Click add files and select the files you want to include in your pdf. Clinical experience also supports the use of ferric carboxymaltose in this patient population. Deaths occurred less frequently with ferric carboxymaltose 5304, 1. Not more than mg of iron 20 ml was administered in one week.
Us20120214986a1 process for the preparation of iron iii. Ferric carboxymaltose can improve hb levels and iron stores for irondeficiency anaemia associated with a variety of conditions prospective trials have demonstrated efficacy in patients with inflammatory bowel disease, chronic kidney disease, menorrhagia and postpartum anaemia. The concentration of iron present in the product is 50 mg per millilitre. For prevention they are only recommended in those with poor absorption, heavy menstrual periods, pregnancy, hemodialysis, or a diet low in iron. Aim to replenish iron stores in a woman where oral replacement is not adequate or tolerated. Ferinject may be administered by intravenous injection using undiluted solution up to a maximum single dose of 1,000 mg iron up to a. Individual woman circumstances may mean that practice diverges from this lop. Ferric carboxymaltose injectafer injection is an iron replacement product. Diagnostic hemoglobin for anemia in men changed from. You should not receive injectafer if you are allergic to ferric carboxymaltose or any of the other ingredients in injectafer. Possible side effects nausea feeling dizzy low phosphorus skin flushing. Ferric carboxymaltose ferinject infusion ferinject infusion checklist and patient consent. Highlights of prescribing information these highlights do not include all the information needed to use injectafer safely and effectively.
Australian public assessment report for ferric carboxymaltose. Click, drag, and drop to reorder files or press delete to remove any content you dont want. Food, drug, and cosmetic act fdca for injectafer ferric carboxymaltose injection, 750 mg iron15 ml. Iron dextran in iron deficiency secondary to heavy uterine bleeding the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. How to merge pdfs and combine pdf files adobe acrobat dc. The patient is an adult with iron deficiency anemia and documentation of any of the following. Iron dose ferric carboxymaltose maximum volume of sterile sodium chloride 0. Pharmacodynamics profile of intravenous ferric carboxymaltose in pediatric subjects 1.
Ferric carboxymaltose is approved for intravenous bolus use and intravenous infusion, but not intramuscular injection. Patients with ida of any etiology in whom oral iron was unsatisfactory or intolerable received ferumoxytol n5997 or fcm. Injectafer ferric carboxymaltose products affected injectafer pa criteria criteria details covered uses feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease ckd. Pharmacodynamics and safety of ferric carboxymaltose. Pharmacokinetics of ferric bepectatea new intravenous. Check with your doctor or nurse immediately if any of the following side effects occur while taking ferric carboxymaltose. Safe to use breastfeeding safe to use monitoring blood pressure, heart rate, respiratory rate, oxygen saturation, temperature. Ferinject 50 mg ironml solution for injectioninfusion. The iron is then released into an intracellular storage iron pool or. It contains 24 32% mm of iron, 2550% mm of dextrin, some sodium chloride ferric carboxymaltose as a complex of polynuclear ironiii hydroxide. Administering ferric carboxymaltose ferric carboxymaltose can be given either as a slow intravenous undiluted injection or as an infusion diluted in sterile 0. Ferinject ferric carboxymaltose patient information. The role of ferric carboxymaltose in the treatment of iron. Download the womens health brochure injectafer hcp.
For injectafer, must be used for the treatment of iron deficiency anemia in adult patients with nondialysisdependent chronic kidney disease ckd and have a medical reason why a preferred product cannot be used, such as iron dextran infed, dexferrum, iron sucrose venofer, or. Soda pdf merge tool allows you to combine two or more documents into a single pdf file for free. Capitals indicate lifethreatening, underlines indicate most frequent. Injectafer ferric carboxymaltose injection is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Ferric carboxymaltose adult page 2 of 2 adult medication monograph the royal womens hospital.
A ferric carboxymaltose complex containing 5% 50 mgml of iron. Ferric carboxymaltose fcm is a novel dextranfree intravenous iron which consists of a ferric hydroxide core stabilized by a carbohydrate shell lysengwilliamson and keating, 2009. Is an additional dose of intravenous ferric carboxymaltose useful. In section 1 indications and usage, a minor editorial change to add the word or 2. What is injectafer ferric carboxymaltose injection. To change the order of your pdfs, drag and drop the files as you want. Within 24 hours after the first dose of ferric carboxymaltose on day 0, mean biologically active intact fibroblast growth factor 23 increased from 46.
Each 10 ml vial contains 500 mg of iron as ferric carboxymaltose. Iron helps your body produce red blood cells that carry oxygen through your blood to tissues and. Mar 02, 2011 hypophosphatemia with ferric carboxymaltose vs. Ferric carboxymaltose fcm, a dextran free iron formulation can be administered in large doses without the risk of severe anaphylactic reactions in postpartum anemia ppa. In both cases, an intravenous cannula should be fitted and initially flushed with 10 ml of saline in order to check placement and possible leakage. Ferric carboxymaltose injection is an iron replacement product that is used to treat iron deficiency anemia not enough iron in the blood in patients with nondialysis dependent chronic kidney disease ckd, and in patients who are taking iron supplements that did not work well. Each ml contains 50 mg iron as ferric carboxymaltose in water for injection. Injectafer ferric carboxymaltose injection, for intravenous use initial u. Ferric carboxymaltose is used to treat anemia low red blood cells caused by low iron levels. Merge pdf files combine pdfs in the order you want with the easiest pdf merger available. In the randomised comparison of iv ferric carboxymaltose with iv placebo in patients with heart failure, all cause withdrawal occurred in 9% of patients on ferric carboxymaltose and % with placebo. A single dose of ferric carboxymaltose injection should not exceed mg of iron 20 ml per day or 15 mg of iron 0. Ferric iron carboxymaltose by infusion ferinject this lop is developed to guide clinical practice at the royal hospital for women.
Nb iv ferric carboxymaltose infusion contraindicated in first trimester antenatal postnatal neither 3. One ml of solution contains 50 mg of iron as ferric carboxymaltose. The objective of the present study is to compare the safety and efficacy of ferric carboxymaltose fcm, intravenous iv iron sucrose and oral iron in the treatment of post partum anemia ppa. Efficacy and safety of intravenous ferric carboxymaltose. Evaluation of iron stores in hemodialysis patients on. Gallen, switzerland is a nextgeneration, parenteral, dextranfree, strong, and robust iron complex suitable for i. Ferric carboxymaltose is a colloidal iron iii hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.
Ferric carboxymaltose is administered intravenously. Effects of iron isomaltoside vs ferric carboxymaltose on. Making the choice oral iron therapy is suitable and effective as first line therapy in most patients, including most obstetric patients,4,5 with iron deficiency or iron deficiency anaemia. Ferric carboxymaltose intravenous route description and. The criteria also encompass iron maintenance and replenishment. Pdf merge combinejoin pdf files online for free soda pdf. 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. Patients who do not meet the sa criteria for community funded ferric carboxymaltose poac will fund the administration of iv ferric carboxymaltose if recommended by a specialist even where the special authority criteria for community funding of ferric carboxymaltose are not met. This allows controlled delivery of iron to the cells of the reticuloendothelial system and subsequent delivery of ironbinding proteins. It contains 24 32% mm of iron, 2550% mm of dextrin, some sodium chloride ferric carboxymaltose fcm is a nondextran iron preparation recently approved in the united states for intravenous treatment of iron deficiency anemia ida in adult patients with intolerance or unsatisfactory response to oral iron or with nondialysisdependent chronic kidney disease. Administration of ferric carboxymaltose to rats as a onehour intravenous infusion up to 30 mgkgday iron on gestation days 6 to 17 did not result in adverse embryonic or fetal findings. Along with its needed effects, ferric carboxymaltose may cause some unwanted effects. Ferric carboxymaltose in heart failure and iron deficiency 10.
The active ingredient in injectafer is ferric carboxymaltose, the inactive ingredients are. You can merge pdfs or a mix of pdf documents and other files. In section 1 indications and usage, a minor editorial change to. The active substance is iron as ferric carboxymaltose, an iron carbohydrate compound. Comparative safety of intravenous ferumoxytol versus. Ferric carboxymaltose injectafer arizona complete health. Ferric carboxymaltose side effects, dosage, interactions. Ferasap fer ric carboxymaltose a ssessment of sa fety and efficacy in p regnancy was the first randomized, controlled trial to assess fcm in pregnant. Effect of ferric carboxymaltose on exercise capacity in patients with iron deficiency and chronic heart failure effecthf dirk j.
Ask your doctor or healthcare provider if injectafer is right for you. Does the patient meet the criteria for iv iron infusion in the poac clinical guideline. In rabbits, ferric carboxymaltose was administered. Ferric carboxymaltose is a colloidal iron hydroxide carboxymaltose complex. Ban similar structures search, synonyms, formulas, resource links, and other chemical information. This application seeks approval of injectafer ferric carboxymaltose for the broad. Although not all of these side effects may occur, if they do occur they may need medical attention. Feb 27, 2020 injectafer ferric carboxymaltose injection is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. 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.
These criteria are provided in the procedure manual. Pdf ferric carboxymaltose injection in postpartum iron. Criteria for bluecross blueshield of arizona injectafer. Ferric carboxymaltose injection is used to treat irondeficiency anemia a lower than normal number of red blood cells due to too little iron in adults who cannot tolerate or who could not successfully be treated with iron supplements taken by mouth. Pdf pharmacodynamics and safety of ferric carboxymaltose. Pregnancy and breastfeeding medicines guide internet. This prior approval supplemental new drug application provides for revisions to the following sections of the approved labeling. Intravenous iron formulations such as ferric carboxymaltose, iron dextran, ferric gluconate, and iron sucrose may potentially solve these issues and may be more convenient both to healthcare providers and patients, if oral iron therapy does not provide the required correction of iron deficiency or is not welltolerated by patients 4, 6, 9. Ferric carboxymaltose fcm is a relatively new formulation with a complex carbohydrate shell that tightly binds elemental iron, allowing a large dose to be administered in a relatively short period of time. Injectafer ferric carboxymaltose dose, indications, adverse. After administration of a single dose of ferric carboxymaltose of 100 mg of iron in iron deficient patients, the iron was rapidly cleared from the plasma with a terminal halflife of 712 hours. Dailymed injectafer ferric carboxymaltose injection.
In dialysis patients, fcm is labelled for the administration of up to 200mg per dialysis. Anaphylaxis may occur with iv iron and resuscitation facilities should be available. Each 2 ml vial contains 100 mg of iron as ferric carboxymaltose. Ferric carboxymaltose is likely to be the preferred option for most patients requiring parenteral iron supplementation as it can provide a higher dose of iron administered in a shorter timeframe. Each 20 ml vial contains mg of iron as ferric carboxymaltose. Dec 11, 2018 ferinject ferric carboxymaltose patient information leaflet pil by vifor pharma uk limited. Nov 09, 2018 ferric carboxymaltose is an iron replacement product. Ferric carboxymaltose fcm, ferinject, vifor international inc. Injectafer ferric carboxymaltose will be considered for coverage under the pharmacy benefit program when the following criteria are met. Intravenous ferric carboxymaltose for the treatment of iron deficiency. Pdf the objective of the present study is to compare the safety and efficacy of ferric carboxymaltose fcm, intravenous iv iron sucrose and. This retrospective study was performed using the data derived from the medical files of 516 iron deficiency anemia patients treated in the.
Newer intravenous iron drugs such as iron sucrose and ferric carboxymaltose fcm appear to have better safety profiles 10, 11. Ferric carboxymaltose 2 qualitative and quantitative composition. Consider alternative limited safety information 2nd trimester. Rearrange individual pages or entire files in the desired order. Feraheme and injectafer are indicated for the treatment of iron. This daily dose in rats is approximately 40% of the human weekly dose of 750 mg based on body surface area. The other ingredients are sodium hydroxide for ph adjustment, hydrochloric acid for ph adjustment, and water for injection. Ferric carboxymaltose is a brown, amorphous powder. 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 nondialysis dependent chronic kidney disease. This formulation isolates the iron from the plasma until the complex is phagocytized by reticuloendothelial system macrophages in the liver, spleen and bone marrow.
Ferric carboxymaltose drug bnfc content published by nice. The patient may elect to pay for the ferric carboxymaltose. Each of the side effects above was reported in 2% or greater of patients. Ferric carboxymaltose api manufacturers suppliers drug. Fcm has been studied in numerous therapeutic areas including ibd 11 and has almost 1. Ferric carboxymaltose11 in 20, ferric carboxymaltose, the newest of the iv irons became available in the us. Ferric carboxymaltose is indicated for the treatment of irondeficiency anemia ida in adults. Each 20 ml vial contains 1,000 mg of iron as ferric carboxymaltose. 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. New zealand data sheet 1 ferinject 50 mgml solution for injection ferinject ferric carboxymaltose 50 mgml solution for injection 2 qualitative and quantitative composition each 2 ml vial contains 100 mg of iron as ferric carboxymaltose.
Injectafer ferric carboxymaltose injection is available by prescription only. Medicinal forms there can be variation in the licensing of different medicines containing the same drug. Bmi ferric carboxymaltose therapy pregnancy 1st trimester. What ferinject looks like and contents of the pack. It has been used in europe and other countries since 2009. Administration of ferric carboxymaltose to rats as a onehour intravenous infusion up to 30 mgkgday iron on gestation days 6 to 17 did not result in adverse embryofetal findings. Effect of ferric carboxymaltose on exercise capacity in. Ferric carboxymaltose definition of ferric carboxymaltose. Mar 10, 2020 data from a multicenter, randomized, controlled, openlabel trial supports the use of ferric carboxymaltose in patients with inflammatory bowel disease ibd and iron deficiency anemia evstatiev 2011. The nda submission is an electronic submission in ectd format. Ferric carboxymaltose ferinject for irondeficiency anaemia. Iron supplements, also known as iron salts and iron pills, are a number of iron formulations used to treat and prevent iron deficiency including iron deficiency anemia.
775 1529 1462 365 448 1092 714 495 877 892 1199 163 1131 1557 433 226 98 1024 225 1067 1283 334 1190 256 426 394 115 367 1386 1196 1193 1194 1243 1366 608