FDA добавила предупреждение к препарату Injectafer из-за риска опасного снижения уровня фосфатов

The Food and Drug Administration (FDA) has added a boxed warning to the prescribing information for Injectafer® (ferric carboxymaltose injection), highlighting the risk for symptomatic hypophosphatemia and the need for phosphate monitoring. Injectafer is an iron replacement product indicated for the treatment of iron deficiency anemia in adult and pediatric patients aged 1 year and older who have either intolerance or an unsatisfactory response to oral iron; in adults who have non-dialysis dependent chronic kidney disease; and for iron deficiency in adults with heart failure and New York Heart Association class II/III to improve exercise capacity. According to the FDA, the boxed warning was necessary due to continued reports of symptomatic hypophosphatemia linked to Injectafer, despite prior label changes warning of this risk. A review of cases from the FDA’s Adverse Events Reporting System (FAERS) database showed symptomatic hypophosphatemia, including severe cases with serious outcomes such as osteomalacia and fractures, has occurred in patients after both single and multiple infusions with Injectafer. Notably, patients without risk factors for hypophosphatemia have also experienced this adverse event. To mitigate this risk, phosphate monitoring is recommended prior to a repeat course of Injectafer treatment if the patient is at risk for low serum phosphate or if a repeat infusion is expected within 3 months of the prior course. Prior to administering Injectafer, pre-existing hypophosphatemia should be corrected. Serum phosphate levels should be monitored in patients at risk for chronic low serum phosphate. Hypophosphatemia should be treated as medically indicated. If severe or persistent hypophosphatemia occurs, permanent discontinuation should be considered. Health care providers are urged to report adverse events to the FDA’s MedWatch program. References: - US Food and Drug Administration. FDA adds boxed warning to labeling for ferric carboxymaltose injection (Injectafer) to describe risk of low phosphate levels. September 1, 2026. https://www.fda.gov/drugs/drug-safety-communications/fda-adds-boxed-warning-labeling-ferric-carboxymaltose-injection-injectafer-describe-risk-low. - Injectafer. Package insert. American Regent; 2026. Accessed September 1, 2026. https://injectaferhcp.com/assets/prescribing-information-portlet/Injectafer.pdf.