A list of drugs that interact with ferric carboxymaltose. Draft guidance on ferric carboxymaltose food and drug. Thus, it is necessary to combine clinical judgment with a routine evaluation of laboratory parameters. Patents listed in the fda orange book drug database of ferric carboxymaltose with information and expiryexpiration dates.
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. This daily dose in rats is approximately 40% of the human weekly dose of 750 mg based on body surface area. To discuss an alternative approach, contact the office of generic drugs. Intravenous ferric carboxymaltose for the treatment of. Ferric carboxymaltose fcm is an intravenous iron formulation to correct iron. 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. Jan 08, 2014 ferric carboxymaltose is effective for iron replacement in patients with iron deficiency anemia. In key trials, ferric carboxymaltose increased hb levels and replenished iron stores as effectively as iv iron sucrose but requiring fewer doses. Ferric carboxymaltose has also been assessed in other conditions. This medicine is used to treat anemia in people with chronic kidney disease or people who. Pdf efficacy and safety of ferric carboxymaltose and other.
Ferric carboxymaltose ferinject for irondeficiency anaemia. High blood pressure has happened with ferric carboxymaltose. For intravenous infusion ferinject, give intermittently in sodium chloride 0. Sep 17, 2012 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. Ferric carboxymaltose an overview sciencedirect topics. Tecoland supplies ferric carboxymaltose bulk active pharmaceutical ingredient api to the pharmaceutical industry. Oral iron supplementation is usually the first choice for the treatment of iron deficiency anemia, but in many conditions, oral iron is less than ideal mainly because of gastrointestinal adverse events and the long course needed to treat the disease and replenish body. The role of ferric carboxymaltose in the treatment of iron.
Chloramphenicol decreases the efficacy of intravenous ferric carboxymaltose. Advise patient to notify health care professional if signs and symptoms of hypersensitivity reaction occurs. Efficacy and tolerability of intravenous ferric carboxymaltose in. A maximum dose of mg iron can be delivered intravenously over 15 minutes, which may make it a suitable treatment for irondeficiency anaemia outside of the hospital setting. Maximum dose of ferric carboxymaltose ferinject per infusion is 20mgkg to maximum of mg. Although not all of these side effects may occur, if they do occur they may need medical attention. This includes your doctors, nurses, pharmacists, and dentists.
Sodium hydroxide andor hydrochloric acid may have been added to adjust the ph to 5. Pricing, sizing, legal catgories and other medicinal forms information for ferric carboxymaltose. Ferric carboxymaltose drug bnf content published by nice. Among the patients assigned to ferric carboxymaltose, 47% had an nyha functional class i or ii at week 24, as compared with 30% of pa tients assigned to placebo odds ratio for improvement by. Pdf the pharmacology and safety profile of ferric carboxymaltose. Ferric carboxymaltose definition of ferric carboxymaltose. Explain purpose of ferric carboxymaltose to patient. Ferric carboxymaltose is a nondextran, intravenous iron replacement product initially developed by vifor international, a subsidiary of the galenica group. Ferric carboxymaltose solutions containing 24 mgml of iron in 0. Ferric carboxymaltose is a new stable iron preparation that can be. 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. Nov 09, 2018 ferric carboxymaltose is an iron replacement product.
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. Ferric carboxymaltose is a new stable iron preparation that can be administered in single. Ask patient if they have a history of reactions to parenteral iron products. Ferric carboxymaltose is an iron replacement product. Each ml contains 50 mg iron as ferric carboxymaltose in water for injection. Iron is used to make healthy red blood cells, which carry oxygen and nutrients throughout the body. Ferric carboxymaltose is a new stable iron preparation that can be administered.
Injectafer is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients. Consequently, fewer doses of ferric carboxymaltose may be needed to replenish. 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. Injectafer ferric carboxymaltose injection is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Ferric carboxymaltose interactions bnfc content published.
Treatment with ferric carboxymaltose for 24 weeks in patients who had chronic heart failure and iron deficiency with or without anemia improved symptoms, functional capacity, and the quality of life. In rabbits, ferric carboxymaltose was administered as a. Contains nonbinding recommendations draft guidance on ferric carboxymaltose recommended apr 2016 this draft guidance, when finalized, will represent the current thinking of the food and drug. 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 iron is a mineral that the body needs to produce red blood cells. Pharmacodynamics profile of intravenous ferric carboxymaltose in pediatric subjects 1. Have your blood pressure checked as you have been told by your doctor. 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 feb 27, 2020 what is injectafer. Injectafer is a prescription iron replacement medicine administered only by or under the supervision of your healthcare provider. Common and rare side effects for ferric carboxymaltose. Injectafer ferric carboxymaltose injection, for intravenous use. Intravenous ferric carboxymaltose for the treatment of iron. Ferric carboxymaltose patents expiry expiration dates. Ferric carboxymaltose side effects, dosage, interactions. Welcome to contact us for further details including current dmf status for the product and up to date regulatory status of the manufacturing facility. Highlights of prescribing information these highlights do not include all the information needed to use injectafer safely and effectively. 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 in patients with heart failure and. Efficacy and safety of ferric carboxymaltose and other. It is freely soluble in water but insoluble in most organic solvents. Ferric carboxymaltose has efficacy comparable with or greater than iv iron sucrose and oral iron in patients with iron deficiency anemia associated with ckd, gynecologic bleeding, inflammatory bowel disease, and other medical conditions.
What are some things i need to know or do while i take ferric carboxymaltose. Ferric carboxymaltose is an intravenous iron preparation that can be delivered by slow push injection or as an infusion diluted in saline doses of up to mg of elemental iron can be administered in one session, taking up to 15 minutes, followed by 30 minutes of observation. Australian public assessment report for ferric carboxymaltose. Each 10 ml vial contains 500 mg of iron as ferric carboxymaltose. Along with its needed effects, ferric carboxymaltose may cause some unwanted effects. Ferric carboxymaltose ferrik carboxeemoltoes is an iron complex. Its properties permit the administration of large doses 15mgkg. Iron helps your body produce red blood cells that carry oxygen through your blood to tissues and. Tell all of your health care providers that you take ferric carboxymaltose. Ferric carboxymaltose is used to treat anemia low red blood cells caused by low iron levels. Prevention may also be used in low birth weight babies. 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. Ferric carboxymaltose is a new formulation of iron that can be safely administered at higher.
Nutritional iron deficiency anemia is the most common deficiency disorder, affecting more than two billion people worldwide. Dailymed injectafer ferric carboxymaltose injection. It contains 24 32% mm of iron, 2550% mm of dextrin, some sodium chloride sep 25, 2019 what are some things i need to know or do while i take ferric carboxymaltose. Symptomatic severe hypophosphatemia after intravenous. The present invention relates to novel processes for the preparation of iron iii carboxymaltose complex. This medicine is used to treat anemia in people with chronic kidney disease or people who cannot take iron by mouth. 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. Ferric carboxymaltose is a brown, amorphous powder. 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. Injectafer is injected into your vein to treat iron deficiency anemia in adults.
Nov 27, 2014 ferric carboxymaltose ferinject, injectafer is an intravenous iron preparation approved in numerous countries for the treatment of iron deficiency. Possible side effects nausea feeling dizzy low phosphorus skin flushing. A single high dose of ferric carboxymaltose up to 750 mg of iron in the us and 1,000 mg of iron in the eu can be infused in a short time frame 15 min. For prevention they are only recommended in those with poor absorption, heavy menstrual periods, pregnancy, hemodialysis, or a diet low in iron. Find information about common, infrequent and rare side effects of ferric carboxymaltose intravenous. Geisser and others published the pharmacology and safety profile of ferric carboxymaltose ferinject.
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 of the side effects above was reported in 2% or greater of patients treated with ferric. Us20120214986a1 process for the preparation of iron iii. 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.
Injectafer ferric carboxymaltose dosing, indications. Treatment with ferric carboxymaltose was not associated with an unacceptable sideeffect or adverseevent profile. 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. 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. Feb 01, 2020 injectafer ferric carboxymaltose injection is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. In a trial of 200 patients with crohns disease or ulcerative colitis, treatment with up to three intravenous infusions of ferric carboxymaltose one week apart up to mg iron a week was found to be noninferior to oral ferrous sulfate 100 mg iron twice a day. 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. Ferric carboxymaltose received us food and drug administration fda approval for the treatment of iron deficiency anemia in adult patients who are intolerant of oral iron or have had an unsatisfactory response to oral iron and in adult patients with nondialysisdependent chronic kidney disease ckd. Our ferric carboxymaltose is manufactured by cgmp compliant facility. What is injectafer ferric carboxymaltose injection. The first dose of ferric carboxymaltose ferinject is given at 20mgkg to a maximum of mg. Feb 27, 2020 injectafer ferric carboxymaltose injection is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. 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.
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