the United States Food and Drug Administration (FDA) approved ferumoxytol (Feraheme 2 injection, AMAG Pharmaceuticals), an iron-containing product for intravenous (IV) administration, for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). The safety and efficacy of ferumoxytol were assessed in three randomized, open-label, controlled clinical trials. Two trials evaluated patients with nondialysis dependent CKD and a third trial assessed patients undergoing hemodialysis. Randomization was either to ferumoxytol or oral iron. Ferumoxytol was administered as two 510 mg IV injections, separated by 3-8 days. Oral iron, Ferro-Sequels 1 , was administered at a dose of 100 mg twice daily for 21 days. In all three clinical trials, ferumoxytol administration increased the mean blood hemoglobin (Hgb) concentrations by 1.0 g/dL over the 35 day period, a mean increase that was greater than what was observed in patients receiving oral iron. Patients receiving ferumoxytol also had increases in blood transferrin saturation (TSAT) and ferritin values. For the proposed ferumoxytol dosing regimen, 4.9% of patients had serum ferritin 800 ng/mL and TSAT 50% post-treatment. The most important ferumoxytol safety concerns were hypersensitivity reactions and/or hypotension. Anaphylaxis or anaphylactoid reactions were reported in 0.2% of subjects, and other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria, or wheezing) were reported in 3.7%. Hypotension was observed in 1.9%, including three patients with serious hypotensive reactions. Ferumoxytol administration may transiently affect the diagnostic ability of magnetic resonance imaging and the drug label provides further information regarding this effect. Am. J. Hematol. 85:315-319,
Navigation with fluorescence guidance is emerging as a promising strategy to improve the efficacy of oncologic surgery in the last decade. The onus is on the surgical community to objectively assess the added value of this technique for routine use daily clinical practice, which will directly impact both the Food and Drug Administration (FDA) approval process and insurance reimbursement. In addition, it is critical to characterize the potential benefits over existing practices and to elucidate both the costs and safety risks. This report is the result a consensus meeting of the American Society of Image Guided Surgery (ASIGS) on February 6th, 2015 at Miami, Florida and reflects a consensus of the participant’s opinions. Our objective is to critically evaluate the platform technology and its optical imaging agents and make recommendations for successful clinical trial development for clinical implementation of this highly promising approach in oncologic surgery.
Brain health, or cognitive health, refers to skills such as remembering, learning new things, planning, concentrating, or making decisions. When cognitive health is impaired (referred to as cognitive impairment), a person has trouble with these skills that affect the things he or she can do in everyday life. People of all ages can experience cognitive impairment, which can range from mild to severe. A person with mild cognitive impairment may be aware of increased difficulty remembering, but it may not be obvious to others. Most likely, these individuals can still do their everyday activities. Individuals with more severe cognitive impairment usually have difficulty expressing themselves and understanding others. They may be unable to complete tasks such as preparing meals or managing finances. They may require help to manage their medicines and medical conditions. Ultimately, individuals may become unable to care for themselves, lose their independence, and require institutional care.
After completing this course, the reader will be able to:1. Describe the mechanism of action of eculizumab in PNH.2. Discuss the efficacy findings upon which the approval of eculizumab was based.3. Manage the safety concerns surrounding the use of eculizumab for the treatment of patients with PNH.This article is available for continuing medical education credit at CME.TheOncologist.com. CME CME ABSTRACT
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