FDA OKs Injectafer for iron deficiency anemia in heart failure
The US Food and Drug Administration has expanded the indication for ferric carboxymaltose injection to include treatment of iron deficiency in adults with New York Heart Association class II/III heart failure .
"This new indication for Injectafer marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure," Ravi Tayi, MD, MPH, chief medical officer at American Regent, said in a news release. Ferric carboxymaltose injection is also indicated for the treatment of iron deficiency anemia in adults and children as young as 1 year of age who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have nondialysis dependent chronic kidney disease.that evaluated the efficacy and safety of ferric carboxymaltose injection in adults with chronic HF and iron deficiency.
No new safety signals emerged. The most common treatment emergent adverse events were headache, nausea, hypertension, injection site reactions, hypophosphatemia, and dizziness. According to the company, ferric carboxymaltose injection has been studied in more than 40 clinical trials that included over 8800 patients worldwide and has been approved in 86 countries.Send news tips to
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