The ferric ion has limited absorption through the gi tract. Use ferric carboxymaltose as ordered by your doctor. In rabbits, ferric carboxymaltose was administered. 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. It is usually given as a total of 2 doses, spaced at least 7 days apart. Ferric carboxymaltose intravenous route description and. Each of the side effects above was reported in 2% or greater of patients treated with ferric. Ferric carboxymaltose anemia heart failure free 30day. Intravenous ferric carboxymaltose for anaemia in pregnancy. Dailymed injectafer ferric carboxymaltose injection.
Clinical protocol for iron carboxymaltose infusion silver chain. Medicinal forms there can be variation in the licensing of different medicines containing the same drug. 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. The treatment of iron deficiency anemia in children with inflammatory bowel disease is a particular challenge and often insufficient.
Each ml contains 50 mg iron as ferric carboxymaltose in water for injection. Patents listed in the fda orange book drug database of ferric carboxymaltose with information and expiryexpiration dates. It is strongly recommended you download this document to your own computer and open from there. Feraheme and injectafer are indicated for the treatment of iron.
Product auspar ferinject ferric carboxymaltose vifor pharma pty ltd pm20170084614 ceu6 final 1 october 2019this is the product information that was approved. Pdf ferric carboxymaltose as treatment in women with. 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. Iron helps your body produce red blood cells that carry oxygen through your blood to tissues and organs. Ferric carboxymaltose is usually given when iron taken orally by mouth is not effective. Budget impact of intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency in france article pdf available in esc heart failure 63 april 2019 with 52 reads. What is injectafer ferric carboxymaltose injection. Ferric carboxymaltose ferrik carboxeemoltoes is an iron complex.
During a 28day treatment period, ferric citrate at fixed doses of 1, 6, and 8 gday produced a difference in serum phosphorus from end of therapy to baseline of. Safety and efficacy of ferric carboxymaltose in anemic. Effectiveness and safety of ferric carboxymaltose treatment in. Possible side effects nausea feeling dizzy low phosphorus skin flushing. Injectafer ferric carboxymaltose dose, indications, adverse. 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, and in adult patients with nondialysis dependent chronic kidney disease. Australian public assessment report for ferric carboxymaltose. Injectafer is indicated for the treatment of iron deficiency anemia in adult patients. Injectafer is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients. Ferric carboxymaltose as treatment in women with irondeficiency anemia article pdf available in anemia 20174 april 2017 with 34 reads how we measure reads.
Ferric carboxymaltose fcm is a new parenteral iron product and the first of the new agents approved for rapid and highdose replenishment of depleted iron. The effectiveness of ferric carboxymaltose on the improvement of. Ferinject ferric carboxymaltose 50 mgml solution for injection. List of drug master files dmf of ferric carboxymaltose active pharmaceutical ingredient api submitted to the u. Vifor pharma uk limited provided pdf versions of ctrs of phase 23 studies of iv ferric carboxymaltose ferinject, irrespective of clinical condition or design. This medicine is used to treat anemia in people with chronic kidney disease or people who cannot take iron by mouth. Thus, for example, heating a mixture of one or more maltodextrins, ferric hydroxide and water, oxidizing the iron maltodextrin complex obtained using an aqueous sodium hypochlorite solution and maintaining at 25c to 125c to obtain iron iii carboxymaltose complex. Iron helps your body produce red blood cells that carry oxygen through your blood to tissues and. Injectafer is a prescription iron replacement medicine administered only by or under the supervision of your healthcare provider. Ferric carboxymaltose free download as powerpoint presentation. Malformations were seen starting at the daily dose of 9 mgkg 23% of the human weekly dose of 750 mg. This daily dose in rats is approximately 40% of the human weekly dose of 750 mg based on body surface area. You can use this ferric carboxymaltose import data for multiple kinds of analysis.
In rabbits, ferric carboxymaltose was administered as a onehour infusion on gestation days 6 to 19 at iron doses of 4. Jul 11, 2016 randomized, placebocontrolled trial of ferric carboxymaltose in rls patients with irondeficiency anemia the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Iron deficiency anemia, colon cancer, iron injections, oral iron, ferric carboxymaltose. Mar 02, 2011 to assess the safety of an investigational intravenous iron ferric carboxymaltose fcm or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of fcm or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding hub. Its properties permit the administration of large doses 15 mgkg.
Ferric carboxymaltose definition of ferric carboxymaltose. Ferric carboxymaltose is used to treat anemia low red blood cells caused by low iron levels. 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. Iron is used to make healthy red blood cells, which carry oxygen and nutrients throughout the body. Intravenous ferric carboxymaltose for the treatment of iron deficiency. Ferric carboxymaltose patents expiry expiration dates. Ferric carboxymaltose significantly increased hemoglobin in women with mild, moderate, and severe iron deficiency anemia and women with iron deficiency alone at 3 and 6 week postinfusion.
Injectafer is injected into your vein to treat iron deficiency anemia in adults. Injectafer ferric carboxymaltose injection company. 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. The role of ferric carboxymaltose in the treatment of iron. Intravenous ferric carboxymaltose is a stable complex with the advantage of being nondextrancontaining and a very low immunogenic potential and therefore not predisposed to anaphylactic reactions. Ferinject is used for the treatment of patients with iron deficiency, when oral iron preparations are ineffective or cannot be used. 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. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. 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. This allows controlled delivery of iron to the cells of the reticuloendothelial system and subsequent delivery of ironbinding proteins. 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.
Ferric carboxymaltose as treatment in women with iron. Ferric carboxymaltose solutions containing 24 mgml of iron in 0. Ferric carboxymaltose side effects, dosage, interactions. 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. Each 20 ml vial contains mg of iron as ferric carboxymaltose. Side effects of injectafer ferric carboxymaltose injection.
Us20120214986a1 process for the preparation of iron iii. Pdf the objective of the present study is to compare the safety and efficacy of ferric carboxymaltose fcm, intravenous iv iron sucrose and. Ferric carboxymaltose drug bnf content published by nice. The cumulative dose for repletion of iron using ferinject is determined based on the patients body weight and hb level and must not be. Sep 24, 2011 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. In rabbits, ferric carboxymaltose was administered as a. 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. Ferric carboxymaltose is administered intravenously. Oct 11, 2019 how is this medicine ferric carboxymaltose best taken. Injectafer should be used only if you have not responded well to treatment with oral iron, or if you are intolerant to oral iron treatment.
Because it is free of dextran and its derivatives, fcm does not crossreact with dextran antibodies 15, 16 and never needed the administration of a test dose. Feb 01, 2020 ferric carboxymaltose is a colloidal iron iii hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. Pdf treatment of iron deficiency and iron deficiency anemia. 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. Intravenous ferric carboxymaltose for the treatment of iron. Summary of ferric carboxymaltose fcm use and iron dosing. Randomized, placebocontrolled trial of ferric carboxymaltose. Pdf budget impact of intravenous ferric carboxymaltose in.
Ferric carboxymaltose drug bnfc content published by nice. Ep2496595a2 process for the preparation of iron iii. Ferric carboxymaltose api dmfs us drug master file. The first dose of ferric carboxymaltose ferinject is given at 20mgkg to a maximum of mg. Ferric carboxymaltose fcm is a parenteral iron preparation with characteristics that allow larger single doses to be administered over a shorter infusion period compared with existing iv iron preparations. 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. 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 is an iron replacement product. Feb 27, 2020 injectafer ferric carboxymaltose injection is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Feb 27, 2020 injectafer ferric carboxymaltose injection is an iron carbohydrate complex used to treat iron deficiency anemia 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. Maximum dose of ferric carboxymaltose ferinject per infusion is 20mgkg to maximum of mg. Ferric carboxymaltose ferinject for irondeficiency anaemia. This draft guidance, when finalized, will represent the current thinking of the food and drug. Nov 09, 2018 ferric carboxymaltose is an iron replacement product.
The incidence of hypophosphatemia was significantly higher in the ferric carboxymaltose versus the ferumoxytol group pdf or word document large file warning. Metaanalysis of efficacy and safety of intravenous ferric. How to access a pdf or word document large file warning. A ferric carboxymaltose complex containing 5% 50 mgml of iron. Fcm can correct irondeficiency anaemia ida across a range of clinical conditions, with efficacy and tolerability similar to those of iv. Deaths occurred less frequently with ferric carboxymaltose 5304, 1.
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