Iron sucrose: assessing the similarity between the originator drug and its intended copies

2017 ◽  
Vol 1407 (1) ◽  
pp. 63-74 ◽  
Author(s):  
Tiziana Di Francesco ◽  
Erik Philipp ◽  
Gerrit Borchard
Keyword(s):  
Iron Sucrose ◽  
Intended Copies

scholarly journals Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial

2020 ◽  
Vol 36 (1) ◽  
pp. 111-120 ◽  
Author(s):  
Sunil Bhandari ◽  
Philip A Kalra ◽  
Mario Berkowitz ◽  
Diogo Belo ◽  
Lars L Thomsen ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Single Dose ◽  
Kidney Disease ◽  
Iron Deficiency ◽  
Iron Sucrose ◽  
Hypersensitivity Reactions ◽  
Open Label ◽  
Pronounced Increase ◽  
Safety And Efficacy ◽  
Significant Difference

Abstract Background The optimal intravenous (IV) iron would allow safe correction of iron deficiency at a single infusion over a short time. The FERWON-NEPHRO trial evaluated the safety and efficacy of iron isomaltoside 1000/ferric derisomaltose (IIM) in patients with non-dialysis-dependent chronic kidney disease and iron deficiency anaemia. Methods In this randomized, open-label and multi-centre trial conducted in the USA, patients were randomized 2:1 to a single dose of 1000 mg IIM or iron sucrose (IS) administered as 200 mg IV injections up to five times within a 2-week period. The co-primary endpoints were serious or severe hypersensitivity reactions and change in haemoglobin (Hb) from baseline to Week 8. Secondary endpoints included incidence of composite cardiovascular adverse events (AEs). Results A total of 1538 patients were enrolled (mean estimated glomerular filtration rate 35.5 mL/min/1.73 m2). The co-primary safety objective was met based on no significant difference in the incidence of serious or severe hypersensitivity reactions in the IIM and IS groups [0.3% versus 0%; risk difference: 0.29% (95% confidence interval: –0.19; 0.77; P > 0.05)]. Incidence of composite cardiovascular AEs was significantly lower in the IIM versus IS group (4.1% versus 6.9%; P = 0.025). Compared with IS, IIM led to a more pronounced increase in Hb during the first 4 weeks (P ≤ 0.021), and change in Hb to Week 8 showed non-inferiority, confirming that the co-primary efficacy objective was met. Conclusions Compared with multiple doses of IS, a single dose of IIM induced a non-inferior 8-week haematological response, comparably low rates of hypersensitivity reactions, and a significantly lower incidence of composite cardiovascular AEs.

In vitro study on the effects of iron sucrose, ferric gluconate and iron dextran on redox-active iron and oxidative stress

2011 ◽  
Vol 60 (07) ◽  
pp. 459-465
Author(s):  
Brigitte Sturm ◽  
Hannes Steinkellner ◽  
Nina Ternes ◽  
Hans Goldenberg ◽  
Barbara Scheiber-Mojdehkar
Keyword(s):  
Oxidative Stress ◽  
In Vitro Study ◽  
Iron Sucrose ◽  
Vitro Study ◽  
Iron Dextran ◽  
Active Iron ◽  
Redox Active ◽  
And Oxidative Stress

Efficacy and Safety of Iron Sucrose for Iron Deficiency in Patients With Dialysis-Associated Anemia: North American Clinical Trial

2001 ◽  
Vol 37 (2) ◽  
pp. 300-307 ◽  
Author(s):  
Chaim Charytan ◽  
Nathan Levin ◽  
Mourhege Al-Saloum ◽  
T. Hafeez ◽  
Suzanne Gagnon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Iron Deficiency ◽  
North American ◽  
Iron Sucrose ◽  
Efficacy And Safety

Intravenous iron sucrose complex in the treatment of iron deficiency anemia during pregnancy

1996 ◽  
Vol 69 (2) ◽  
pp. 121-124 ◽  
Author(s):  
Abdul-Kareem Al-Momen ◽  
Abdulaziz Al-Meshari ◽  
Lulu Al-Nuaim ◽  
Abdulaziz Saddique ◽  
Zainab Abotalib ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Intravenous Iron ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Anemia During Pregnancy

Parenteral Iron Therapy: A Single Institution's Experience Over a 5-Year Period

2005 ◽  
Vol 3 (6) ◽  
pp. 791-795 ◽  
Author(s):  
Christopher A. Laman ◽  
Scott B. Silverstein ◽  
George M. Rodgers
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Iron Dextran ◽  
Serious Adverse Events ◽  
Exact Test ◽  
Parenteral Iron ◽  
Parenteral Iron Therapy ◽  
Event Rates

Many patients require parenteral iron therapy for optimal correction of anemia, including cancer patients who require erythropoietic drugs. Available parenteral iron therapy options include iron dextran, iron gluconate, and iron sucrose. The purpose of this study is to summarize our institution's experience with parenteral iron therapy over a 5-year period, with a focus on comparative safety profiles. All patients receiving parenteral iron therapy over this period were included in the analysis. Chi-squared test and Fisher's exact test were used to compare the adverse event rates of each product. A total of 121 patients received 444 infusions of parenteral iron over this period. Iron dextran was the most commonly used product (85 patients) and iron sucrose was the least used (2 patients). Iron gluconate was used by 34 patients. Overall adverse event rates per patient with iron dextran and iron gluconate were 16.5% and 5.8%, respectively (P = .024). Premedication with diphenhydramine and acetaminophen before infusions of iron dextran reduced adverse event rates per infusion from 12.3% to 4.4% (P = .054). Test doses of iron dextran were used 88% of the time for initial infusions of iron dextran. All adverse events for all parenteral iron products were mild or moderate. There were no serious adverse events and no anaphylaxis was observed. Our results suggest that, if test doses and premedications are used, iron dextran is an acceptable product to treat iron deficiency.

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