The FDA has expanded the indication for ferric carboxymaltose injection (Injectafer) to include treating iron deficiency in adults with NYHA class II/III heart failure. This approval is the first for intravenous iron replacement therapy in heart failure patients. Injectafer is also indicated for iron deficiency anemia in adults and children intolerant to oral iron and in adult patients with chronic kidney disease. The approval for heart failure was based on data from the CONFIRM-HF trial, showing improved exercise capacity with Injectafer. Safety profile remains favorable with common adverse events like headache and nausea. Ferric carboxymaltose has been extensively studied in over 40 trials worldwide.
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