Carboximaltose Férrica

Abstract

Technology: Ferric Carboxymaltose (CMF) is a complex of colloidal iron hydroxide with stronger binding of elemental iron to carbohydrate polymer than some other preparations of iron IV. CMF can be administered in a single dose of up to 1,000 mg of elemental iron (20 ml of a solution of 50 mg of elemental iron/ml). European product labeling specifies a Maximum single dose of 20 mg/kg body weight. Product labeling in the United States specifies a maximum single dose of 15 mg/kg body weight. Indication: CMF labeled indications are for the treatment of iron deficiency anemia. iron in adults (ADF) and pediatric patients ≥1 year of age with intolerance to oral iron or unsatisfactory response to oral iron and for the treatment of ADF in adults with chronic kidney disease not dependent on dialysis. Otherwise, Off-Label use in adults applies for surgery abdominal pain (management of perioperative anemia), anemia associated with chemotherapy, anemia due to iron deficiency in inflammatory bowel disease; iron deficiency in heart failure with reduced ejection fraction and restless legs syndrome. Questions: (i) Is IV Iron Carboxymaltose effective and safe to reduce the need for transfusion of red blood cells in the treatment of iron deficiency anemia in patients in the pre and postoperative period of surgery cardiac? (ii) If the previous question is yes, what is the local budget impact of its incorporation within a 12-month horizon? Methods: Searches were carried out in electronic databases: Pubmed, VHL Regional Portal, Scopus and Web of Science, totaling 116 studies. After excluding duplicates, the screening was performed by two reviewers independently based on their titles and abstracts. the publications remainders were read in full, excluding those that did not meet the criteria for previously established eligibility. Results: In the end, five studies were included for analysis of this NTRR, three studies observational and two randomized clinical trials. Of the five studies, four pointed favorable results for the use of CMF to reduce the need for red blood cell transfusion in the treatment of iron deficiency anemia in patients with indication for cardiac surgery and in the postoperative period. The expected budget impact for one year is BRL 221,400.00, considering the annual consumption of 360 ampoules at a unit cost of R$ 615.00 per ampoule. Conclusion: According to the findings gathered in this NTRR, it is recommended for the specific use of this technical note the incorporation of iron CMF for the treatment of adult patients with anemia due to iron deficiency with indication for cardiac surgery.