Women's Health
Ferinject® benefits
Ferinject® has been helping patients for over 15 years4
Ferinject® (ferric carboxymaltose) is indicated for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used, or there is a clinical need to deliver iron rapidly. The diagnosis of iron deficiency must be based on laboratory tests.4
Benefits in women’s health
Ferinject® demonstrates efficacy in treating iron deficiency (ID)/iron deficiency anaemia (IDA) in women, including those with abnormal uterine bleeding and during pregnancy and postpartum.2–8
IV iron products should not be used during pregnancy unless clearly necessary. IV iron treatment should be confined to the 2nd and 3rd trimester if the benefit is judged to outweigh the potential risk to mother and the foetus.4
Ferinject®:
Offers rapid iron delivery and repletion of iron stores4
Can be administered in 15 minutes:4
- ≤1000 mg to adults and adolescents (≥14 years)
- ≤750 mg (max. 15 mg/kg body weight) to children and adolescents (1–13 years)
Helps address ID/IDA and is shown to enhance quality of life for women2–8
Explore the efficacy of Ferinject® in women’s health
Iron-deficient women: PREFER randomised study2
Study
A randomised, placebo-controlled, single-blinded, comparative superiority study assessing the efficacy and tolerability of Ferinject® vs placebo in 294 iron-deficient, premenopausal women with symptomatic, unexplained fatigue. The primary endpoint was the proportion of patients achieving a ≥1 point decrease in total Piper Fatigue Scale score from baseline to Day 56.2
Outcomes
A single infusion of Ferinject® improved fatigue, mental quality of life and cognitive function vs placebo.2
Heavy menstrual bleeding and IDA: RCT3
Study
A phase 3, open-label RCT evaluating efficacy and safety of Ferinject® vs ferrous sulphate in 477 women with anaemia, iron deficiency and heavy uterine bleeding. The primary efficacy endpoint was the proportion of subjects with a Hb increase of ≥2 g/dL after treatment.3
Outcomes
Ferinject® was more effective vs ferrous sulphate in correcting anaemia, replenishing iron stores and improving quality of life.3
Heavy menstrual bleeding and IDA: Open-label randomised trial5
Study
A multicentre, open-label, randomised study assessing the safety and efficacy of Ferinject® vs standard medical care (93% oral iron, typically ferrous sulphate) for iron deficiency anaemia in 2045 women, either postpartum or with heavy menstrual bleeding. The primary endpoint was the incidence of serious adverse events, including death, hospitalisation, disability, congenital anomaly/birth defect and life-threatening events.5
Outcomes
Incidence of serious AEs was significantly higher in the standard medical care (93% ferrous sulphate) group vs those treated with Ferinject® (2.2% vs 0.6%; P=0.004). Ferinject® was associated with a significantly greater increase in Hb level vs standard medical care (mean Hb change from baseline: 2.33 vs 1.47; P<0.001). A single infusion of Ferinject® (up to 1000 mg) is an effective treatment for IDA in women with heavy menstrual bleeding, improving Hb and replenishing iron stores more effectively than ferrous sulphate.5
IDA in pregnancy: FER-ASAP RCT6
Study
A phase 3b, open-label RCT comparing the efficacy and safety of Ferinject® vs first-line ferrous sulphate in 252 pregnant women (16–33 weeks' gestation) with iron deficiency anaemia. The primary efficacy endpoint was change in Hb from baseline to Week 3.6
Outcomes
Ferinject® led to faster and more effective anaemia correction and improvements in vitality and social functioning vs ferrous sulphate.6
IV iron products should not be used during pregnancy unless clearly necessary. IV iron treatment should be confined to the 2nd and 3rd trimester if the benefit is judged to outweigh the potential risk to mother and the foetus.4
Postpartum IDA: Open-label RCT7
Study
A phase 3, multicentre, open-label RCT comparing the safety and efficacy of Ferinject® vs ferrous sulphate in 349 postpartum women with iron deficiency anaemia. The primary endpoint was change in Hb levels from baseline to Week 12.7
Outcomes
Ferinject® treatment rapidly normalised iron and resulted in better patient compliance vs ferrous sulphate.7
Postpartum IDA: Open-label randomised trial5
Study
A multicentre, open-label, randomised study assessing the safety and efficacy of Ferinject® vs standard medical care (93% oral iron, typically ferrous sulphate) for iron deficiency anaemia in 2045 women, either postpartum or with heavy menstrual bleeding. The primary endpoint was the incidence of serious adverse events, including death, hospitalisation, disability, congenital anomaly/birth defect and life-threatening events.5
Outcomes
Incidence of serious AEs was significantly higher in the standard medical care (93% ferrous sulphate) group vs those treated with Ferinject® (2.2% vs 0.6%; P=0.004). Ferinject® was associated with a significantly greater increase in Hb level vs standard medical care (mean Hb change from baseline 2.35 vs 1.86; P<0.001). A single infusion of Ferinject® (up to 1000 mg) is an effective treatment for IDA in postpartum women, improving Hb and replenishing iron stores more effectively than ferrous sulphate.5
Wealth of evidence
Ferinject® has a well-established benefit–risk profile based on over 15 years of experience.4
Ferinject® is supported by over 30 published company-sponsored RCTs2–33*†‡
More than 9000 patients have received Ferinject® in these trials2–33*
Over 30 million patient-years of exposure to Ferinject® since launch34
Re-write her journey with Ferinject® – offer rapid iron delivery and repletion and more4
References & footnotes
Abbreviations
AE, adverse event; FAS, full analysis set; Hb, haemoglobin; ID, iron deficiency; IDA, iron deficiency anaemia; ITT, intention to treat; IV, intravenous; RCT, randomised controlled trial.
References
- Dugan C et al. The misogyny of iron deficiency. Anaesthesia 2021;76(Suppl 4):56–62.
- Favrat B et al. Evaluation of a single dose of ferric carboxymaltose in fatigued, iron-deficient women – PREFER a randomized, placebo-controlled study. PLoS One 2014;9(4):e94217.
- Van Wyck DB et al. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion 2009;49(12):2719–28.
- Ferinject® Summary of Product Characteristics.
- Seid MH et al. Ferric carboxymaltose as treatment in women with iron-deficiency anemia. Anemia 2017:2017:9642027.
- Breymann C et al. Ferric carboxymaltose vs. oral iron in the treatment of pregnant women with iron deficiency anemia: an international, open-label, randomized controlled trial (FER-ASAP). J Perinat Med 2017;45(4):443–53.
- Breymann C et al. Comparative efficacy and safety of intravenous ferric carboxymaltose in the treatment of postpartum iron deficiency anemia. Int J Gynaecol Obstet 2008;101(1):67–73.
- Seid MH et al. Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol 2008;199(4):435.e1–7.
- Ponikowski P et al. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency. Eur Heart J 2015;36(11):657–68.
- Anker SD et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med 2009;361(25):2436–48.
- Van Veldhuisen DJ et al. Effect of ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency. Circulation 2017;136(15):1374–83.
- Ponikowski P et al. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet 2020;396(10266):1895–904.
- Bailie GR et al. Safety and tolerability of intravenous ferric carboxymaltose in patients with iron deficiency anaemia. Hemodialysis Int 2010;14(1):47–54.
- Barish CF et al. Safety and efficacy of intravenous ferric carboxymaltose (750 mg) in the treatment of iron deficiency anaemia: two randomised, controlled trials. Anemia 2012;2012:172104.
- Boomershine CS et al. A blinded, randomised, placebo-controlled study to investigate the efficacy and safety of ferric carboxymaltose in iron-deficient patients with fibromyalgia. Rheumatol Ther 2018;5(1):271–81.
- Charytan C et al. Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anaemia in patients with chronic kidney disease: a randomised, active-controlled, multi-centre study. Nephrol Dial Transplant 2013;28(4):953–64.
- Evstatiev R et al. Ferric carboxymaltose prevents recurrence of anaemia in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2013;11(3):269–77.
- Evstatiev R et al. FERGIcor, a randomised controlled trial on ferric carboxymaltose for iron deficiency anaemia in inflammatory bowel disease. Gastroenterology 2011;141(3):846–53.
- Geisser P, Bank-Bochita J. Pharmacokinetics, safety and tolerability of intravenous ferric carboxymaltose: a dose-escalation study in volunteers with mild iron-deficiency anaemia. Arzneimittelforsch 2010;60(6a):362–72.
- Hedenus M et al. Intravenous iron alone resolves anaemia in patients with functional iron deficiency and lymphoid malignancies undergoing chemotherapy. Med Oncol 2014;31(12):302.
- Hussain I et al. Direct comparison of the safety and efficacy of ferric carboxymaltose versus iron dextran in patients with iron deficiency anaemia. Anemia 2013;2013:169107.
- Kulnigg S et al. A novel intravenous iron formulation for treatment of anaemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomised controlled trial. Am J Gastroenterol 2008;103(5):1182–92.
- Kulnigg-Dabsch S et al. Iron deficiency generates secondary thrombocytosis and platelet activation in IBD: the randomised, controlled thromboVIT trial. Inflamm Bowel Dis 2013;19(8):1609–16.
- Macdougall IC et al. FIND-CKD: a randomised trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant 2014;29(11):2075–84.
- Onken JE et al. Ferric carboxymaltose in patients with iron-deficiency anaemia and impaired renal function: the REPAIR-IDA trial. Nephrol Dial Transplant 2014;29(4):833–42.
- Onken JE et al. A multicentre, randomised, active-controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anaemia. Transfusion 2014;54(2):306–15.
- Qunibi WY et al. A randomised controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patients. Nephrol Dial Transplant 2011;26(5):1599–607.
- Trenkwalder C et al. Ferric carboxymaltose in patients with restless legs syndrome and nonanaemic iron deficiency: a randomised trial. Mov Disord 2017;32(10):1478–82.
- Van Wyck DB et al. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anaemia: a randomised controlled trial. Obstet Gynecol 2007;110(2 Pt 1):267–78.
- Allen RP et al. Clinical efficacy and safety of IV ferric carboxymaltose (FCM) treatment of RLS: a multi-centred, placebo-controlled preliminary clinical trial. Sleep Med 2011;12(9):906–13.
- Ikuta K et al. Comparison of efficacy and safety between intravenous ferric carboxymaltose and saccharated ferric oxide in Japanese patients with iron-deficiency anaemia due to hypermenorrhoea: a multi-center, randomised, open-label noninferiority study. Int J Hematol 2019;109(1):41–9.
- Mentz RJ et al. Ferric carboxymaltose in heart failure with iron deficiency. N Engl J Med 2023;389(11):975–86.
- Ponikowski P et al. Efficacy of ferric carboxymaltose in heart failure with iron deficiency: an individual patient data meta-analysis. Eur Heart J 2023;44(48):5077–91.
- CSL. Ferinject®. Available at: https://pro.cslvifor.ch/en/products/ferinject/Ferinject.php (Accessed August 2025).