Injectafer and hypophosphatemia study
WebbMost studies did not report phosphate monitoring methodology or an explicit definition of hypophosphatemia. Hypophosphatemia rates ranged from 0.0% to 92.1% for ferric carboxymaltose (FCM), 0.0% to 40.0% for iron sucrose, 0.4% for ferumoxytol, and 0.0% for low-molecular-weight (LMW) iron dextran. Randomized controlled studies described ... WebbThis evaluation also seeked to determine if the rate of patients who may have had hypophosphatemia related to Injectafer use. This MUE was …
Injectafer and hypophosphatemia study
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Webb29 juni 2024 · In December 2016, a study published in the medical journal PLoS One found that 45.5% of individuals who received Injectafer as an iron replacement therapy … Webb6 dec. 2024 · Rates of hypophosphatemia at each study visit are shown in Figure 2. Compared with none of the ferumoxytol-treated patients, 29.1% of ferric carboxymaltose–treated patients remained hypophosphatemic at the end of the 5-week …
Webb6 feb. 2024 · Injectafer-induced hypophosphatemia (HPP) is an Injectafer side effect causing muscle weakness, fatigue, and severe nausea. In turn, these hypophosphatemia symptoms can lead to Injectafer-related medical complications including osteomalacia, arrhythmias, cardiac arrest, respiratory failure, and rhabdomyolysis. WebbSymptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of
WebbA number of independent studies and case reports have found that the Injectafer iron infusion may cause phosphorous levels in the body to drop to dangerous levels In 2016, … WebbThe median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions …
WebbStudy 3 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an …
Webb24 juli 2024 · A Norwegian study, published in July 2024, reported on the hypophosphatemia incidence among inflammatory bowel disease (IBD) patients who … netherlands regulationsWebb3 aug. 2024 · A Randomized, Open-label, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside/Ferric … netherlands regulated companies searchWebbSeveral studies have found that Injectafer (ferric carboxymaltose or FCM), when used to treat patients with iron deficiency anemia (IDA), can increase the risk of … itzy shoot mp3 downloadWebbDespite studies linking Injectafer to hypophosphatemia, the FDA had not issued a recall for the drug. In fact, the agency approved a new single dose formula of Injectafer in May 2024. The current formula is a two-dose course of treatment for a total of 1,500 mg. The new single dose is one injection of 1,000 mg. netherlands registryWebbInjectafer safely and effectively. See full prescribing information for Injectafer. INJECTAFER ® (ferric carboxymaltoseinjection), for intravenous u se Initial U.S. Approval: 2013 -----RECENT MAJOR CHANGES----- Warnings and Precautions, Symptomatic Hypophosphatemia. (5.2) 02/2024 Dosage and Administration, Recommended Dosage. netherlands regulator registerWebbSevere hypophosphatemia occurred in 11.3% of patients in the study who were treated with Injectafer and 0% of patients treated with Monoferric. What to Do if You Have Developed Hypophosphatemia Medical evidence dating back several years has found that some iron therapies are associated with hypophosphatemia due to a decrease in … netherlands regulatory frameworkWebbInjectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components. WARNINGS AND PRECAUTIONS. Symptomatic … netherlands regulatory authority