In May 2021, US FDA has approved Injectafer for the treatment of adult patients with iron deficiency anemia. Injectafer is a ferric carboxymaltose injection. The drug has demonstrated benefits in treating patients who are intolerant or show an inadequate response to oral iron or have non-dialysis-dependent chronic kidney disease. The dosage approved by FDA was a single 1000 mg dose. FDA had previously approved a two-dose, once weekly, 750 mg regimen in the year 2013. 

Another dosage of Injectafer has already been used in 1.7 million patients in the United States itself. Healthcare providers look forward to the additional dosing alternative for patients with iron deficiency anemia. 

The safety and efficacy of Injectafer for treating iron-deficiency anemia have already been proven in two randomized, open-label, controlled clinical trials. IN these trials, Injectafer was administered at a dose of 15 mg/Kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least one week up to a cumulative dose of 1500 mg iron. 

Trial 1: Iron deficiency anemia in patients who are intolerant to oral iron or have had unsatisfactory responses to oral iron

Trial 2: Iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease. 

Later, trials 3 and 4 were conducted to evaluate and confirmthe safety and tolerability of Injectafer in patients weighing 50 Kg or more. The dosage administered was15 mg/Kg to a maximum of 1000 mg in a single dose per course. To date, Injectafer has been approved in 75 countries and is one of the most extensively studies intravenous iron (more than 40 clinicaltrials and 880 patients across the globe). 

Reference:

1. Internet Source. Press Release. FDA approves single-dose Injectafer treatment for patients with iron deficiency anemia. FDA. June 2021. Accessed on July 29 from https://www.healio.com/news/nephrology/20210614/fda-approves-singledose-injectafer-treatment-for-patients-with-iron-deficiency-anemia
2. Injectafer Label. FDA. Accessed on July 29 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203565s005lbl.pdf 
3. Internet Source. Sankyo D. Injectafer receives FDA approval for single dose option for the treatment of adult patients with iron deficiency anemia. May 6, 2021. Accessed on July 29 from https://www.prnewswire.com/news-releases/injectafer-ferric-carboxymaltose-injection-receives-fda-approval-for-single-dose-option-for-the-treatment-of-adult-patients-with-iron-deficiency-anemia-301285079.html